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What Is Oxycodone
Oxycodoneused to treat moderate to severe pain. It comes in five forms:
immediate-release tablet extended-release tablet immediate-release capsule extended-release capsule solution All forms of this drug are oral, which means they’re taken by mouth. (Immediate-release drugs are released into the bloodstream right away. Extended-release drugs are released into the bloodstream slowly over time.) Oxycodone immediate-release tablets are available as the brand-name drugs Oxaydo and Roxicodone. Oxycodone extended-release tablets are available as the brand-name drug OxyContin. Oxycodone immediate-release tablets are available as generic drugs. There is no generic version of the extended-release tablets. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in every strength or form as the brand-name drug. Oxycodone may be used as part of a combination therapy. This means you may need to take it with other medications. Oxycodone is a controlled substance. That means it can only be used under a doctor’s close supervision. Why it’s used Oxycodone is used to treat moderate to severe pain. It can be used short term or long term, depending on your condition. How it works Oxycodone belongs to a class of drugs called opioid agonists. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions. Oxycodone is similar to a group of natural substances in the brain called endorphins. These substances work to decrease the pain messages that your body sends to your brain. By mimicking these substances, oxycodone decreases the amount of pain your brain thinks you’re having.
Travel
When traveling with your medication: Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag. Don’t worry about airport X-ray machines. They can’t harm your medication. You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you. Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold. Self-management Don’t presoak, lick, or wet the tablet before placing it in your mouth. Clinical monitoring You and your doctor should monitor certain health issues. This can help make sure you stay safe while you take this drug. These issues include: Breathing rate: Your doctor will monitor for any changes in your breathing pattern. This is especially important when you first start taking oxycodone and after any dosage increases. Blood pressure: You and your doctor should check your blood pressure regularly using a blood pressure monitor. Your doctor will tell you where to buy this device and how to use it. Kidney function: Blood tests can check how well your kidneys are working. If your kidneys aren’t working well, your doctor may lower your dosage of this drug. Liver function: Blood tests can check how well your liver is working. If your liver isn’t working well, your doctor may lower your dosage of this drug. Risk of misuse or addiction: Before prescribing oxycodone for you, your doctor will assess your risk of misusing or becoming addicted to opioid drugs. Your doctor may prescribe naloxone, which is a drug used to treat an oxycodone overdose. Availability Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead to make sure your pharmacy carries it. Prior authorization Many insurance companies require a prior authorization for this drug. This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription. Are there any alternatives? There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you. Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
Examples of drugs that can cause interactions with oxycodone are listed below.
Drugs you should not use with oxycodone Do not take these drugs with oxycodone. Doing so can cause dangerous effects in your body. Examples of these drugs include: Buprenorphine. Using this drug with oxycodone can decrease the effect of oxycodone. This means it won’t work as well. Buprenorphine can also cause withdrawal symptoms. Anesthesia drugs such as butorphanol, nalbuphine, and pentazocine. Using these drugs with oxycodone can decrease the effect of oxycodone. This means it won’t work as well. These drugs can also cause withdrawal symptoms. Interactions that increase your risk of side effects Increased side effects from other drugs: Taking oxycodone with certain medications raises your risk of side effects from these drugs. Examples of these drugs include: Benzodiazepines such as diazepam, lorazepam, clonazepam, temazepam, or alprazolam. Increased side effects can include severe drowsiness, slowed or stopped breathing, coma, or death. If you need to take one of these drugs with oxycodone, your doctor will monitor you closely for side effects. Monoamine oxidase inhibitors (MAOIs), a type of antidepressant, such as tranylcypromine, isocarboxazid, phenelzine, or selegiline. Increased side effects can include anxiety, confusion, slowed breathing, or coma. Do not take oxycodone if you’re taking an MAOI, or have taken an MAOI within the last 14 days. Antidepressants such as doxepin, fluvoxamine, duloxetine, or venlafaxine. Increased side effects can include higher levels of serotonin in your body. This can lead to a condition called serotonin syndrome. Symptoms can include agitation, restlessness, fast heartbeat, increased body temperature, nausea, or vomiting. Muscle relaxants such as baclofen, cyclobenzaprine, or methocarbamol. Increased side effects can include breathing problems. Hypnotics such as zolpidem, temazepam, or estazolam. Increased side effects can include breathing problems, low blood pressure, extreme drowsiness, or coma. Your doctor may prescribe a lower dosage of oxycodone for you. Antipsychotic drugs, such as chlorpromazine, prochlorperazine, or thioridazine. Increased side effects can include breathing problems, low blood pressure, extreme drowsiness, or coma. Your doctor may prescribe a lower dosage of oxycodone for you. Anticholinergic drugs, such as atropine, scopolamine, or benztropine. Increased side effects can include problems urinating. They can also include severe constipation, which could lead to more serious bowel problems. Increased side effects from oxycodone: Taking oxycodone with certain medications raises your risk of side effects from oxycodone. This is because the amount of oxycodone in your body may be increased. Examples of these drugs include: Antifungal drugs such as voriconazole or ketoconazole. If you take these drugs with oxycodone, your doctor may monitor you more often. They may adjust your dosage as needed. Antibiotics such as erythromycin or clarithromycin. If you take these drugs with oxycodone, your doctor may monitor you more often. They may adjust your dosage as needed. HIV drugs such as ritonavir, darunavir, or atazanavir. If you take these drugs with oxycodone, your doctor may monitor you more often. They may adjust your dosage as needed. Drugs such as bupropion. If you take bupropion with oxycodone, your doctor may monitor you more often. They may adjust your dosage as needed. Anti-arrhythmia drugs such as amiodarone or quinidine. If you take these drugs with oxycodone, your doctor may monitor you more often. They may adjust your dosage as needed. Interactions that can make oxycodone less effective When oxycodone is used with certain drugs, it may not work as well to treat your pain. This is because the amount of oxycodone in your body may be decreased. Examples of these drugs include: Antibiotics such as rifampin, rifabutin, or rifapentine. If you take these drugs with oxycodone, your doctor may monitor you more often. They may adjust your dosage as needed. Anticonvulsants such as carbamazepine and phenytoin. If you take these drugs with oxycodone, your doctor may monitor you more often. They may adjust your dosage as needed. Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.
How to take oxycodone
All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on: your age the condition being treated how severe your condition is other medical conditions you have how you react to the first dose Drug forms and strengths Generic: Oxycodone Form: oral immediate-release tablet Strengths: 5 milligrams (mg), 10 mg, 15 mg, 20 mg, 30 mg Brand 1: Oxaydo Form: oral immediate-release tablet Strengths: 5 mg, 7.5 mg Brand 2: Roxicodone Form: oral immediate-release tablet Strengths: 5 mg, 15 mg, 30 mg Brand 3: OxyContin Form: oral extended-release tablet Strengths: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg Dosage for moderate to severe pain Oxycodone immediate-release tablets Adult dosage (ages 18–64 years) Typical starting dosage: If you haven’t been treated with opioid medications before, your starting dosage can range from 5 mg to 15 mg taken every 4–6 hours as needed. Dosage increases: Based on your body’s response to the drug, your doctor will decide what dosage is right for you. Child dosage (ages 0–17 years) It hasn’t been confirmed that this drug is safe and effective for use in children. It shouldn’t be used in people younger than 18 years. Senior dosage (ages 65 years and older) The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, a higher amount of a drug stays in your body for a longer time. This raises your risk of side effects. Your doctor may start you on a lowered dose or a different dosing schedule. This can help keep levels of this drug from building up too much in your body. Oxycodone extended-release tablets Adult dosage (ages 18–64 years) Typical starting dosage: If you haven’t been treated with opioid medications before, your starting dosage should be 10 mg taken every 12 hours. Dosage increases: Based on your body’s response to the drug, your doctor will decide what dosage is right for you. Child dosage (ages 11–17 years) Oxycodone extended-release tablets can only be used for certain children in this age range. These are children who have taken and tolerated opioid medications for at least five days in a row. Your child’s doctor will determine their dosage based on the opioid drug your child had already taken. Child dosage (ages 0–10 years) It hasn’t been confirmed that this drug is safe and effective for use in children younger than 11 years. Senior dosage (ages 65 years and older) The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, a higher amount of a drug stays in your body for a longer time. This raises your risk of side effects. Your doctor may start you on a lowered dose or a different dosing schedule. This can help keep levels of this drug from building up too much in your body. Dosage warnings Stopping therapy: When stopping treatment after using oxycodone for a long time, your doctor should slowly lower your dosage. They should monitor for symptoms of withdrawal. Symptoms can include restlessness, tearfulness, runny nose, or yawning. They can also include sweating, chills, muscle pain, or dilated pupils (enlarged dark centers of your eyes). Switching from another opioid therapy or a combination opioid/non-opioid therapy: Your doctor will determine the equivalent (matching) dosage of oxycodone. This will be based on the strength of your previous opioid medication. It will also be based on your body’s response to oxycodone. Special dosage considerations For people with liver disease: If you’re taking the extended-release tablets, your doctor may start you on one-third to one-half of the usual starting dosage. Your dosage may be changed based on your body’s response to this drug. Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.
Oxycodone warnings
FDA warnings This drug has boxed warnings. These are the most serious warnings from the Food and Drug Administration (FDA). Boxed warnings alert doctors and patients about drug effects that may be dangerous. Addiction and misuse warning: Use of all forms of oxycodone can lead to addiction and misuse. This can result in overdose or death. Risk Evaluation and Mitigation Strategy (REMS): Because of this drug’s risk of abuse and addiction, the FDA requires that the drug’s manufacturer provide a REMS program. Under the requirements of this REMS program, the drug manufacturer must develop educational programs for your doctor regarding the safe and effective use of opioids. Decreased breathing rate warning: Any form of oxycodone can change your body’s natural breathing pattern. Your risk is higher if you’re a senior (65 years or older), have lung disease, or take large initial doses. It’s also higher if you take oxycodone extended-release tablets with other medications that affect your breathing pattern. Talk with your doctor to find out if other drugs you’re taking can cause breathing problems. Accidental ingestion warning: For certain people, accidentally taking even one dose of any form of oxycodone can lead to overdose or death. This applies to children, as well as people including seniors (ages 65 years and older), those who’ve never taken opiates before, and those with kidney or liver disease. Pregnancy warning: Using any form of oxycodone for a prolonged period during pregnancy can lead to withdrawal symptoms in your newborn child. Symptoms include irritability, overactive behaviors, or an abnormal sleep pattern. They also include high-pitched crying, tremors, vomiting, diarrhea, or failure to gain weight. Drug interaction warning: Using any form of oxycodone with certain drugs can increase the levels of oxycodone in your body. This can lead to an increase in side effects, or death. Benzodiazepine drug interaction warning: Taking oxycodone together with drugs that affect the nervous system or drugs called benzodiazepines may cause severe drowsiness, breathing problems, coma, or death. Examples of benzodiazepines include lorazepam, clonazepam, and alprazolam. Other warnings The drug comes with several other warnings. Allergy warning Oxycodone can cause a severe allergic reaction. Symptoms can include: trouble breathing swelling of your throat or tongue rash hives (itchy welts) If you develop these symptoms, call 911 or go to the nearest emergency room. Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death). Alcohol interaction warning Do not drink alcohol while taking oxycodone. The use of drinks that contain alcohol raises your risk of serious side effects from oxycodone. It may even result in coma or death. Warnings for people with certain health conditions For people with breathing problems: Oxycodone may slow down your breathing or cause you to have shallow breathing. If you have a breathing problem such as asthma or COPD (chronic obstructive pulmonary disease), talk with your doctor about whether this drug is safe for you. Certain people should never take oxycodone: These include people who already have slow or shallow breathing, or who have too much carbon dioxide in their blood due to poor breathing. They also include people with acute or severe asthma. For all of these people, taking this drug could harm their breathing too much and cause death. For people with gastrointestinal (GI) problems: Oxycodone can worsen certain stomach or bowel problems. This is because this drug makes it harder for food to move through your digestive tract. It can also make it harder for doctors to diagnose or find the cause of these problems. If you have a condition called a paralytic ileus, you should not take oxycodone. Or if you have any type of GI obstruction, you should not take extended-release oxycodone. The immediate-release version may be used cautiously. For people with head injury: Oxycodone may cause increased pressure in your brain. It may also cause breathing problems. Both of these issues raise your risk of complications, and can cause death. For people with liver problems: Your body may process drugs more slowly. As a result, a higher amount of a drug stays in your body for a longer time. This raises your risk of side effects. Your doctor may start you on a lower dosage. This can help keep levels of this drug from building up too much in your body. For people with kidney problems: If you have kidney problems or a history of kidney disease, you may not be able to clear this drug from your body well. This may increase the levels of oxycodone in your body and cause more side effects. This medication may also decrease your kidney function, making your kidney disease worse. For people with seizure problems: Oxycodone may cause or worsen seizures. If you have epilepsy, talk with your doctor about whether this drug is safe for you. For people with adrenal gland problems: If you have Addison’s disease, talk with your doctor about whether this drug is safe for you. Oxycodone may make your condition worse. Also, you’re at higher risk of side effects from this drug. Your doctor may prescribe a lower dosage of this drug. For people with hypothyroidism (low thyroid levels): Talk with your doctor about whether this drug is safe for you. Oxycodone could make your condition better or worse. You’re also at higher risk of side effects from this drug. Your doctor may prescribe a lower dosage of this drug. For people with urination problems: If you have trouble urinating due to certain problems, talk with your doctor about whether this drug is safe for you. These problems include an enlarged prostate, a bladder obstruction, or kidney problems. Oxycodone can make it even harder for you to urinate, or make you unable to urinate. Your doctor may prescribe a lower dosage of this drug. For people with pancreas and gallbladder problems: Oxycodone raises your risk of pancreatitis. If you have acute or chronic pancreatitis, this drug may worsen your condition. If you have a history of pancreatitis or gallbladder problems, you’re at higher risk of acute pancreatitis. Talk with your doctor about whether this drug is safe for you. Warnings for other groups For pregnant women: Using oxycodone long term during pregnancy may cause withdrawal symptoms in your newborn child. Symptoms include irritability, overactive behaviors, or an abnormal sleep pattern. They also include high-pitched crying, tremors, vomiting, diarrhea, or failure to gain weight. Talk to your doctor if you’re pregnant or planning to become pregnant. This drug should only be used in pregnancy if clearly needed. If you become pregnant while taking this drug, call your doctor right away. For women who are breastfeeding: Oxycodone is present in breast milk and may cause side effects in a child who is breastfed. Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication. For seniors: The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, a higher amount of a drug stays in your body for a longer time. This raises your risk of side effects. For people at risk of misuse, addiction, or overdose: Using oxycodone can lead to addiction and misuse, which can result in overdose or death. Your doctor may prescribe naloxone, which is a drug used to treat an oxycodone overdose. Talk with your doctor or pharmacist about how to get or use naloxone. For children: Oxycodone immediate-release tablet: It’s not known if this drug is safe and effective for children. It shouldn’t be used in people younger than 18 years. Oxycodone extended-release tablet: It’s not known if this drug is safe and effective for children younger than 11 years. It shouldn’t be used in children younger than 11 years. Take as directed Oxycodone oral tablet is used for short-term or long-term treatment. The length of treatment depends on how severe your pain is. This drug comes with risks if you don’t take it as prescribed. If you stop taking the drug suddenly or don’t take it at all: If you don’t take this drug at all, your pain may continue. If you stop taking the drug suddenly, you may have symptoms of withdrawal, which can include: restlessness feeling irritable or anxious trouble sleeping increased blood pressure fast breathing rate fast heart rate dilated pupils (enlargement of the dark centers of your eyes) teary eyes runny nose yawning nausea, vomiting, or a loss of appetite diarrhea and stomach cramps sweating chills muscle aches and backache If you miss doses or don’t take the drug on schedule: Your medication may not work as well or may stop working completely. For this drug to work well, a certain amount needs to be in your body at all times. If you take too much: You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include: slowed breathing or changes in your normal breathing pattern trouble speaking confusion irritability extreme drowsiness cold and clammy skin bluish skin color muscle weakness pinpoint pupils (shrinking of the dark centers of your eyes) slow heart rate heart failure low blood pressure coma If you think you’ve taken too much oxycodone, call your doctor or seek guidance from the American Association of Poison Control Centers at 800-222-1222 or through their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away. If you think you might be at risk of misuse or overdose, talk with your doctor about naloxone. It’s a drug used in the emergency treatment of an oxycodone overdose. What to do if you miss a dose: Take your dose as soon as you remember. But if you remember just a few hours before your next scheduled dose, skip the missed dose and go back to your regular dosing schedule. Never try to catch up by taking two doses at once. This could result in dangerous side effects. How to tell if the drug is working: You should have less pain. Important considerations for taking oxycodone Keep these considerations in mind if your doctor prescribes oxycodone for you. General You can take the tablets with or without food. Taking them with food may help to reduce upset stomach. Take this drug at the time(s) recommended by your doctor. You must swallow your tablet whole. You can’t cut or crush the immediate-release or extended-release tablet. And be sure to take it with enough water. This will help make sure that you’ve completely swallowed it after placing it in your mouth. Storage Store oxycodone tablets at room temperature between 59°F and 86°F (15°C and 30°C). The ideal temperature is 77°F (25°C). Keep all forms of this drug in a tightly closed container. Keep the container away from light. Don’t store this medication in moist or damp areas, such as bathrooms. Protect oxycodone from theft. Keep it in a locked cabinet or drawer. Refills A prescription for this medication is not refillable. You or your pharmacy will have to contact your doctor for a new prescription if you need this medication refilled.
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What Is Oxycodone
Oxycodone belongs to a group of medications known as opioid analgesics (narcotic pain relievers). It is used to relieve moderate-to-severe pain. It decreases pain by working on the central nervous system.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here. Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor. Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
5 mg Each blue, round, scored tablet, debossed with "5" over "OXY" on one side and scored on the other side, contains oxycodone 5 mg (as oxycodone hydrochloride). Nonmedicinal ingredients: croscarmellose sodium, dibasic calcium phosphate, FD&C Blue No. 1 Aluminum Lake, magnesium stearate, and microcrystalline cellulose. 10 mg Each white, round, scored tablet, debossed with "10" over "OXY" on one side and scored on the other side, contains oxycodone 10 mg (as oxycodone hydrochloride). Nonmedicinal ingredients: croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, and microcrystalline cellulose. 20 mg Each white, oval, scored tablet, debossed with "20 OXY" on one side and scored on the other side, contains oxycodone 20 mg (as oxycodone hydrochloride). Nonmedicinal ingredients: croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, and microcrystalline cellulose. How should I use this medication? The dose of oxycodone varies widely depending on the cause and severity of pain, individual medical history, age, and body weight. For people who are not taking opioid pain medications when oxycodone is started, the usual starting dose of immediate-release tablets and suppositories is 5 mg or 10 mg every 6 hours, as needed for the pain. Your doctor can adjust your dose until a dose that controls your pain with tolerable side effects is reached. For people who are currently taking other opioid pain medications when oxycodone is started, the recommended starting dose will depend on the type and dose of opioid that is currently being taken. Your doctor will determine the appropriate dose for you. Oxycodone should be taken with a glass of water. It can be taken with or without food. Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor. It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose of the controlled-release tablets, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice. Store this medication in its original packaging at room temperature and protect it from moisture. Keep this medication in a safe place away from children or pets, and to prevent theft. Accidental use by a child or pet may result in death, so if this occurs, get immediate medical attention for the child or pet. Do not take this medication in front of children. Return any unused medication to your pharmacy for safe disposal. Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take oxycodone if you: are allergic to oxycodone, other opioids (e.g., codeine, hydrocodone, morphine), or any ingredients of the medication are pregnant or breast-feeding, or during labour and delivery are taking or have taken (within the last 14 days) MAO inhibitors (e.g., phenelzine, tranylcypromine) have a head injury have a seizure disorder have acute alcoholism have acute asthma or other obstructive airway diseases (e.g., chronic bronchitis, emphysema) have cor pulmonale (heart failure caused by chronic high blood pressure in the arteries of the lungs) have delirium tremens (e.g., confusion, diarrhea, shaking, fever, hallucinations, disorientation) associated with alcohol withdrawal have increased cerebral spinal fluid pressure have increased levels of carbon dioxide in the blood have or may have appendicitis or pancreatitis have or may have bowel or digestive system problems (e.g., paralytic ileus) have or may have a blockage in the digestive system have respiratory depression (slowed breathing) have severe central nervous system depression (slowed nervous system) have mild pain that can be managed with other medications What side effects are possible with this medication? Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time. Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects. abnormal dreams anxiety constipation decreased interest or ability for sexual activity diarrhea dizziness drowsiness dry mouth headache heartburn lack of energy or tiredness nausea stomach pain sweating trouble sleeping vomiting weakness Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention. Check with your doctor as soon as possible if any of the following side effects occur: chest tightness or wheezing confusion decreased coordination fast, slow, or irregular heartbeat itching facial redness or flushing fever low blood pressure (e.g., fainting, dizziness when rising from a sitting or lying position) signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide) tremor vision changes Stop taking the medication and seek immediate medical attention if any of the following occur: convulsions (seizures) symptoms of serotonin syndrome (e.g., confusion, fast heartbeat, hallucinations, restlessness, shaking, shivering, sudden jerking of muscles, sweating) signs of a bowel blockage (abdominal pain, nausea, severe constipation) signs of a severe allergic reaction (hives; difficulty breathing; swelling of the face, throat, or tongue) weak or shallow breathing Seek immediate medical attention if any of the following symptoms of overdose occur: blue tinge to lips cold, clammy skin confusion dizziness extreme drowsiness floppy muscles hallucinations inability to walk normally pinpoint pupils slow or troubled breathing slow heartbeat Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication. Are there any other precautions or warnings for this medication? Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication. Abdominal (stomach) conditions: Oxycodone and other narcotic medications may make the diagnosis of abdominal conditions more difficult or it may worsen these conditions. If you have abdominal problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Accidental Use: When oxycodone is used by anyone other than the person for whom it was prescribed, the effects of the medication may be fatal. Children are especially at risk. Keep this medication out of sight and reach of children. Alcohol and other medications that cause drowsiness: Do not consume alcohol while taking this medication, as this may lead to dangerous and even fatal side effects. Other medications that cause drowsiness or slow down your breathing (e.g., antidepressants, sleeping pills, anxiety medications) and should be avoided if possible as additive side effect may occur and can be dangerous and possibly fatal. Constipation: Constipation happens frequently while taking opioid (narcotic) pain relievers on a regular basis. Your doctor will discuss the use of stimulant laxatives, stool softeners, and other measures to be used as required. Dependence and withdrawal: As with other opioid medications (narcotics), this medication may become habit-forming if taken for long periods of time. Misuse of oxycodone is usually not a problem when it is used appropriately for pain relief. Physical dependence, or tolerance (a need to take regular doses to prevent physical symptoms) has been associated with narcotic analgesics such as oxycodone. Withdrawal symptoms may be experienced if the dose is significantly reduced or suddenly discontinued. Reducing the dose gradually under medical supervision can help prevent or decrease these withdrawal symptoms when this medication is no longer required for pain control. Withdrawal symptoms (e.g., body aches, diarrhea, nervousness, restlessness, runny nose, sneezing, goose bumps, shaking, shivering, nausea, stomach cramps, fast heart rate, fever, sweating) may occur if oxycodone is stopped suddenly. If you have been taking this medication for a long time and no longer require it for pain control, you should stop the medication gradually as directed by your doctor. Difficulty breathing: Oxycodone can cause serious breathing problems, particularly for people having an acute asthma attack or those with chronic obstructive pulmonary disease (chronic bronchitis, emphysema) or other conditions that affect breathing. If you experience slowed breathing or difficulty breathing, seek immediate medical attention. If you have lung problems, or are taking other medications that can slow breathing, you are more at risk for experiencing this. If you have asthma or other breathing disorders, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Drowsiness/reduced alertness: Oxycodone may impair the mental or physical abilities needed for activities such as driving or operating machinery. Do not drive or perform other potentially hazardous tasks if this medication affects your ability to do these safely. Head injury: Oxycodone can cause increased pressure inside the head. If you have an acute head injury or any other condition that increases the pressure inside your head, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Kidney function: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. If you have severely reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have severely reduced liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Medical conditions: If you have abnormal heart rhythms, low blood pressure, reduced adrenal function (e.g., Addison's disease), low thyroid, inflammation of the pancreas, enlarged prostate, urethral strictures, or depression or other psychiatric problems, oxycodone may cause increased symptoms or your condition to become worse. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Serotonin Syndrome: Although rare, severe reactions are possible when oxycodone is combined with other medications that act on serotonin, such as tricyclic antidepressants and serotonin reuptake inhibitors, medications used to treat depression. These combinations should be avoided if possible. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, changes in mental state including delirium and agitation. Coma and death are possible. If you are taking antidepressants, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Stopping the medication: Do not suddenly stop taking this medication since withdrawal symptoms may occur. These symptoms may include body aches, diarrhea, nervousness, restlessness, runny nose, sneezing, goose bumps, shaking, shivering, nausea, stomach cramps, fast heart rate, fever, sweating, and confusion. Your doctor will advise you on how to safely stop taking this medication if you no longer require it for pain control. Uncontrolled Pain: If you experience pain that is not relieved by a normal dose of oxycodone, speak to your doctor. Do not increase the amount of this medication you are taking without medical advice. Pregnancy: This medication should not be used during pregnancy. Infants born to mothers who have taken oxycodone during pregnancy have been born with signs of narcotic withdrawal. If you become pregnant while taking this medication, contact your doctor immediately. Breast-feeding: It is not known if oxycodone passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding. Children: The safety and effectiveness of using this mediation have not been established for children under the age of 18 years. Accidental ingestion of this medication by children may lead to severe and even fatal consequences. Keep this medication out of the reach of children.
Seniors: Seniors may be more sensitive to the effects of this medication.
What other drugs could interact with this medication? There may be an interaction between oxycodone and any of the following: aclidinium alcohol amiodarone amphetamines (e.g., dextroamphetamine, lisdexamphetamine) antihistamines (e.g., chlorpheniramine, diphenhydramine, hydroxyzine) antipsychotics (e.g., chlorpromazine, haloperidol, olanzapine, quetiapine, risperidone) antiseizure medications (e.g., carbamazepine, clobazam, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide) aprepitant atropine azelastine "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole) barbiturates (e.g., secobarbital, phenobarbital) benzodiazepines (e.g., diazepam, lorazepam) benztropine beta-blockers (e.g., metoprolol, propranolol) bicalutamide bosentan brimonidine buprenorphine buspirone calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil) cannabis chloral hydrate ciprofloxacin cimetidine clonidine cobicistat conivaptan cyclosporine darifenacin deferasirox desmopressin dextromethorphan dimenhydrinate disopyramide diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene) domperidone dronedarone entacapone enzalutamide ergot alkaloids (e.g., ergotamine, dihydroergotamine) flavoxate grapefruit juice guanfacine HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine) HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir) ipratropium kava kava ketotifen lithium macrolide antibiotics (e.g., clarithromycin, erythromycin) metoclopramide mifepristone mirtazapine mitotane modafinil monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine) muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine) other narcotic pain relievers (e.g., codeine, fentanyl, hydromorphone, morphine) nefazodone norfloxacin octreotide olopatadine oxybutynin pegvisomant pramipexole pregabalin rifabutin rifampin ropinirole St. John's wort scopolamine selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline) serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine) siltuximab simeprevir thalidomide tiotropium tocilizumab tolterodine tramadol trazodone tricyclic antidepressants (e.g., amitriptyline, desipramine, imipramine, trimipramine) "triptan" migraine medications (e.g., eletriptan, sumatriptan) tryptophan tyrosine kinase inhibitors (e.g., dasatinib, imatinib, nilotinib, sunatinib) umeclidinium zolpidem zopiclone If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to: stop taking one of the medications, change one of the medications to another, change how you are taking one or both of the medications, or leave everything as is. An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed. Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Purchase Oxycodone 30mg Medicine Online
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What Is Oxycodone
Oxycodone is an opioid pain medication used to treat moderate to severe pain.
The extended-release form of oxycodone is for around-the-clock treatment of pain and should not be used on an as-needed basis for pain. Oxycodone may also be used for purposes not listed in this medication guide.
What are the possible side effects of oxycodone?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up. Call your doctor at once if you have: noisy breathing, sighing, shallow breathing, breathing that stops during sleep; a slow heart rate or weak pulse; a light-headed feeling, like you might pass out; confusion, unusual thoughts or behavior; seizure (convulsions); or low cortisol levels-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness. Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, confusion, fever, sweating, fast heart rate, chest pain, feeling short of breath, muscle stiffness, trouble walking, or feeling faint. Serious side effects may be more likely in older adults and those who are malnourished or debilitated. Long-term use of opioid medication may affect fertility in men or women. It is not known whether opioid effects on fertility are permanent. Common side effects may include: drowsiness, headache, dizziness, tiredness; or constipation, stomach pain, nausea, vomiting. What is the most important information I should know about oxycodone? MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
What should I discuss with my healthcare provider before using oxycodone?
You should not use oxycodone if you are allergic to it, or if you have: severe asthma or breathing problems; or a blockage in your stomach or intestines. You should not use oxycodone unless you are already using a similar opioid medicine and are tolerant to it. Most brands of oxycodone are not approved for use in people under 18. OxyContin should not be given to a child younger than 11 years old. Tell your doctor if you have ever had: breathing problems, sleep apnea; a head injury, or seizures; drug or alcohol addiction, or mental illness; liver or kidney disease; urination problems; or problems with your gallbladder, pancreas, or thyroid. If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks. Do not breast-feed. Oxycodone can pass into breast milk and may cause drowsiness, breathing problems, or death in a nursing baby.
How should I use oxycodone?
Follow the directions on your prescription label and read all medication guides. Never use oxycodone in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of this medicine. Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law. Stop taking all other around-the-clock narcotic pain medicines when you start taking extended-release oxycodone. Take oxycodone with food. Swallow the capsule or tablet whole to avoid exposure to a potentially fatal overdose. Do not crush, chew, break, open, or dissolve. Never crush or break an oxycodone pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This can cause in death. Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon). You should not stop using oxycodone suddenly. Follow your doctor's instructions about tapering your dose. Store at room temperature, away from heat, moisture, and light. Keep track of your medicine. Oxycodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription. Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.
What happens if I miss a dose?
Since oxycodone is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An oxycodone overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose can cause severe muscle weakness, pinpoint pupils, very slow breathing, extreme drowsiness, or coma. What should I avoid while using oxycodone? Do not drink alcohol. Dangerous side effects or death could occur. Avoid driving or operating machinery until you know how oxycodone will affect you. Dizziness or severe drowsiness can cause falls or other accidents. Avoid medication errors. Always check the brand and strength of oxycodone you get from the pharmacy. What other drugs will affect oxycodone? You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C. Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use: cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill"); medicines for motion sickness, irritable bowel syndrome, or overactive bladder; other narcotic medications--opioid pain medicine or prescription cough medicine; a sedative like Valium--diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others; drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or drugs that affect serotonin levels in your body--a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting. This list is not complete and many other drugs may affect oxycodone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here. Buy Oxycodone 40mg Medicine Online
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What Is Oxycodone
Oxycodone is a strong narcotic pain-reliever and cough suppressant similar to morphine, codeine, and hydrocodone. The precise mechanism of action (how it works) is not known, but it may involve stimulation of opioid receptors in the brain. Oxycodone does not eliminate the sensation of pain but decreases discomfort by increasing the tolerance to pain. In addition to tolerance to pain, oxycodone also causes sedation and depression of respiration.
The FDA approved oxycodone in 1976.
What are the uses for oxycodone?
Oxycodone is prescribed for the management of pain severe enough to require daily, around-the-clock, long-term treatment with a narcotic, and for which alternative treatment options are inadequate for the relief of moderate to severe pain.
What are the side effects of oxycodone?
The most frequent side effects of oxycodone include: Lightheadedness Dizziness Sedation Nausea Vomiting Headache Rash Constipation Dry mouth Sweating Other side effects of oxycodone include: Faintness Heart attack Rash Itching Depression Abnormal heartbeats Agitation Seizures Urinary retention Oxycodone is used with caution in the elderly, debilitated patients, and in patients with serious lung disease because it can depress breathing. Oxycodone can impair thinking and the physical abilities required for driving or operating machinery. Oxycodone is habit forming. Mental and physical dependence can occur but are unlikely when used for short-term pain relief. If oxycodone is suddenly withdrawn after prolonged use, symptoms of withdrawal may develop. The dose of oxycodone should be gradually reduced in order to avoid withdrawal symptoms.
What is the dosage for oxycodone?
The usual starting dose using immediate release oxycodone tablets is 5 to 30 mg every 4 to 6 hours. Patients who have never received opioids should start with 5-15 mg every 4 to 6 hours. Some patients may require 30 mg or more every 4 hours. The usual starting dose using extended release tablets is 10 mg every 12 hours. Extended release tablets are used when around-the-clock treatment is required for an extended period. Extended release tablets should be swallowed whole, broken, crushed, or chewed. Breaking, crushing, or chewing extended release tablets may lead to rapid absorption of the drug and dangerous levels of oxycodone. Patients who have been using opioids and have become tolerant to opioid therapy should only use the 60 and 80 tablets or single doses greater than 40 mg. Administration of large doses to opioid-naïve patients may lead to profound depressed breathing. The usual adult dose for the oral solution (5 mg/5 ml) is 10-30 mg every 4 hours. Surprising Reasons You're in Pain Slideshow Take the Pain Quiz Joint-Friendly Exercises to Reduce RA Pain Slideshow What is oxycodone, and how does it work (mechanism of action)? What are the uses for oxycodone? What are the side effects of oxycodone? What is the dosage for oxycodone? Which drugs or supplements interact with oxycodone? Is oxycodone safe to take if I'm pregnant or breastfeeding? What else should I know about oxycodone? What is oxycodone, and how does it work (mechanism of action)? Oxycodone is a strong narcotic pain-reliever and cough suppressant similar to morphine, codeine, and hydrocodone. The precise mechanism of action (how it works) is not known, but it may involve stimulation of opioid receptors in the brain. Oxycodone does not eliminate the sensation of pain but decreases discomfort by increasing the tolerance to pain. In addition to tolerance to pain, oxycodone also causes sedation and depression of respiration. The FDA approved oxycodone in 1976. What are the uses for oxycodone? Oxycodone is prescribed for the management of pain severe enough to require daily, around-the-clock, long-term treatment with a narcotic, and for which alternative treatment options are inadequate for the relief of moderate to severe pain.
What are the side effects of oxycodone?
The most frequent side effects of oxycodone include: Lightheadedness Dizziness Sedation Nausea Vomiting Headache Rash Constipation Dry mouth Sweating Other side effects of oxycodone include: Faintness Heart attack Rash Itching Depression Abnormal heartbeats Agitation Seizures Urinary retention Oxycodone is used with caution in the elderly, debilitated patients, and in patients with serious lung disease because it can depress breathing. Oxycodone can impair thinking and the physical abilities required for driving or operating machinery. Oxycodone is habit forming. Mental and physical dependence can occur but are unlikely when used for short-term pain relief. If oxycodone is suddenly withdrawn after prolonged use, symptoms of withdrawal may develop. The dose of oxycodone should be gradually reduced in order to avoid withdrawal symptoms. What is the dosage for oxycodone? The usual starting dose using immediate release oxycodone tablets is 5 to 30 mg every 4 to 6 hours. Patients who have never received opioids should start with 5-15 mg every 4 to 6 hours. Some patients may require 30 mg or more every 4 hours. The usual starting dose using extended release tablets is 10 mg every 12 hours. Extended release tablets are used when around-the-clock treatment is required for an extended period. Extended release tablets should be swallowed whole, broken, crushed, or chewed. Breaking, crushing, or chewing extended release tablets may lead to rapid absorption of the drug and dangerous levels of oxycodone. Patients who have been using opioids and have become tolerant to opioid therapy should only use the 60 and 80 tablets or single doses greater than 40 mg. Administration of large doses to opioid-naïve patients may lead to profound depressed breathing. The usual adult dose for the oral solution (5 mg/5 ml) is 10-30 mg every 4 hours. SLIDESHOW Rheumatoid Arthritis Exercises: Joint-Friendly Workouts See Slideshow Which drugs or supplements interact with oxycodone? Oxycodone, like other narcotic pain-relievers, increases the effects of drugs that slow brain function, such as: Alcohol Barbiturates Skeletal muscle relaxants, for example, carisoprodol (Soma), cyclobenzaprine (Flexeril) Benzodiazepines, for example, lorazepam (Ativan) Combined use of the above drugs and oxycodone may lead to increased respiratory depression. Oxycodone should not be taken with any of the monoamine oxidase inhibitor (MAOI) class of antidepressants, for example, isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), selegiline (Eldepryl), and procarbazine (Matulane) or other drugs that inhibit monoamine oxidase, for example, linezolid (Zyvox). Such combinations may lead to confusion, high blood pressure, tremor, hyperactivity, coma, and death. Oxycodone should not be administered within 14 days of stopping an MAOI. Since oxycodone causes constipation, the use of antidiarrheals, for example, diphenoxylate and atropine (Lomotil) and loperamide (Imodium), in persons taking oxycodone, can lead to severe constipation. Drugs that stimulate and block opioid receptors for example, pentazocine, nalbuphine (Nubain), butorphanol (Stadol), and buprenorphine (Subutex) may reduce the effect of oxycodone and may precipitate withdrawal symptoms. Combining oxycodone with drugs that affect activity of certain liver enzymes or discontinuing such drugs may result in fatal oxycodone overdose. A fatty meal may increase the absorption of oxycodone by 27%. Get Oxycodone 60mg Medicine Online
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What Is Oxycodone
Each red, round, biconvex, film-coated tablet, engraved "APO" on one side and "OCD" over "60" on the other, contains 60 mg of oxycodone hydrochloride. Nonmedicinal ingredients: anhydrous lactose, ethylcellulose, magnesium stearate, colloidal silicon dioxide, hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyethylene glycol, and red iron oxide.
How should I use this medication?
The dose of oxycodone controlled release varies widely depending on the cause and severity of pain, individual medical history, and body weight. For people who are not taking opioid pain medications when oxycodone is started, the usual starting dose of controlled-release tablets is 10 mg or 20 mg every 12 hours. Your doctor can adjust your dose until a dose that controls your pain with tolerable side effects is reached. For people who are currently taking other opioid pain medications when oxycodone controlled release is started, the recommended starting dose will depend on the type and dose of opioid that is currently being taken. Your doctor will determine the appropriate dose for you. Oxycodone controlled release should be taken with a glass of water. It can be taken with or without food. The controlled-release tablets are for people who require continuous use of a pain killer for several days or more. It is taken every 12 hours (and is not taken "as needed"). The controlled-release tablets should be swallowed whole and should not be broken, cut, chewed, dissolved, or crushed. Taking broken, cut or chewed tablets can lead to the rapid release of oxycodone. This large amount of medication being absorbed into the body can be fatal. To avoid difficulty swallowing, take only one tablet at a time and take the controlled-release tablet with enough water so that you are able to completely swallow the tablet immediately after placing it in your mouth. Do not lick, pre-soak, or wet the tablet before you place it in your mouth. You may notice what appears to be a tablet in your stool. This is normal and occurs because the tablet does not completely dissolve after all the medication has been released in the body. Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor. It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose of the controlled-release tablets, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice. Store this medication at room temperature and protect it from moisture. Keep this medication in a safe place away from children or pets, and to prevent theft. Accidental use by a child or pet may result in death. If accidental use occurs, get immediate medical attention for the child or pet. Do not take this medication in front of children. Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
What side effects are possible with this medication?Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor. The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time. Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
Check with your doctor as soon as possible if any of the following side effects occur:
Are there any other precautions or warnings for this medication?Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Abdominal (stomach) conditions: Oxycodone and other narcotic medications may make the diagnosis of abdominal conditions more difficult or it may worsen these conditions. If you have abdominal problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Accidental Use: When oxycodone is used by anyone other than the person for whom it was prescribed, the effects of the medication may be fatal. Children are especially at risk. Keep this medication out of sight and reach of children. Alcohol and other medications that cause drowsiness: Do not consume alcohol while taking this medication, as this may lead to dangerous side effects. Other medications that cause drowsiness or slow down your breathing (e.g., antidepressants, sleeping pills, anxiety medications) should be avoided if possible as additive side effects may occur and can be dangerous. Constipation: Constipation happens frequently while taking opioid (narcotic) pain relievers on a regular basis. Your doctor will discuss the use of stimulant laxatives, stool softeners, and other measures to be used as required. Controlled-release: Controlled-release forms of this medication are designed to work over 12 hours when swallowed whole. If a tablet is broken, cut, crushed, dissolved, or chewed, the entire 12-hour dose will be absorbed rapidly into your body. This can be very dangerous, causing serious problems such as slowed breathing and overdose, which can be fatal. Dependence and withdrawal: As with other opioid medications (narcotics), this medication may become habit-forming if taken for long periods of time. Misuse of oxycodone is usually not a problem when it is used appropriately for pain relief. Physical dependence, or tolerance (a need to take regular doses to prevent physical symptoms) has been associated with narcotic analgesics such as oxycodone. Withdrawal symptoms may be experienced if the dose is significantly reduced or suddenly discontinued. Reducing the dose gradually under medical supervision can help prevent or decrease these withdrawal symptoms when this medication is no longer required for pain control. Withdrawal symptoms (e.g., body aches, diarrhea, nervousness, restlessness, runny nose, sneezing, goose bumps, shaking, shivering, nausea, stomach cramps, fast heart rate, fever, sweating) may occur if oxycodone is stopped suddenly. If you have been taking this medication for a long time and no longer require it for pain control, you should stop the medication gradually as directed by your doctor. Difficulty breathing: Oxycodone can cause serious breathing problems, particularly for people having an acute asthma attack or for those with chronic obstructive pulmonary disease (chronic bronchitis, emphysema) or other conditions that affect breathing. If you experience slowed breathing or difficulty breathing, seek immediate medical attention. If you have lung problems, or are taking other medications that can slow breathing, you are more at risk for experiencing this. If you have asthma or other breathing disorders, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Difficulty swallowing: There have been reports of choking and difficulty swallowing the controlled-release form of oxycodone. To avoid difficulty swallowing, take only one tablet at a time and take the controlled-release tablet with enough water so that you are able to completely swallow the tablet immediately after placing it in your mouth. Do not lick, pre-soak, or wet the tablet before you place it in your mouth. If you experience difficulty swallowing or pain after taking controlled-release oxycodone, contact your doctor immediately. Drowsiness/reduced alertness: Oxycodone may impair the mental or physical abilities needed for activities such as driving or operating machinery. Do not drive or perform other potentially hazardous tasks if this medication affects your ability to do these safely. Head injury: Oxycodone can cause increased pressure inside the head. If you have an acute head injury or any other condition which increases the pressure inside your head, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Kidney function: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. If you have severely reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have severely reduced liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Medical conditions: If you have abnormal heart rhythms, reduced adrenal function (e.g., Addison's disease), low thyroid, inflammation of the pancreas, enlarged prostate, or urethral strictures, oxycodone may cause increased symptoms or your condition to become worse. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Stopping the medication: Do not suddenly stop taking this medication since withdrawal symptoms may occur. These symptoms may include body aches, diarrhea, nervousness, restlessness, runny nose, sneezing, goose bumps, shaking, shivering, nausea, stomach cramps, fast heart rate, fever, sweating, and confusion. Your doctor will advise you on how to safely stop taking this medication if you no longer require it for pain control. Uncontrolled Pain: If you experience pain that is not relieved by a normal dose of oxycodone, speak to your doctor. Do not increase the amount of this medication you are taking without medical advice. Pregnancy: This medication should not be used during pregnancy. Infants born to mothers who have taken oxycodone during pregnancy have been born with signs of narcotic withdrawal. If you become pregnant while taking this medication, contact your doctor immediately. Breast-feeding: It is not known if oxycodone passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding. Children: The safety and effectiveness of using this mediation have not been established for children. Accidental ingestion of this medication by children may lead to severe and even fatal consequences. Keep this medication out of the reach of children. Seniors: Seniors may be more sensitive to the effects of this medication.
What other drugs could interact with this medication?There may be an interaction between oxycodone and any of the following:
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
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What Is Oxycodone
Oxycodone for pain relief
Abtard, Longtec, OxyContin, OxyNorm, Shortec Authored by Michael Stewart, Reviewed by Sid Dajani | Last edited 19 Feb 2020 | Meets Patient’s editorial guidelines This medicine is an opioid painkiller. There is a serious risk of addiction when taking this medicine, especially if used long-term. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance for people prescribed an opioid painkiller. If you have any questions or concerns about taking opioids safely please speak with your doctor or a pharmacist.
Oxycodone is prescribed to treat severe pain.
You may be prescribed oxycodone to take regularly, or only when it is needed for pain relief. Make sure you know which is right for you. The most common side-effects are constipation, drowsiness and feeling sick (nausea). Your doctor will be able to prescribe medicines for you to take with oxycodone to help with some of these side-effects. About oxycodone Type of medicine Strong opioid painkiller Used for Severe pain in adults Also called Abtard®; Carexil®; Ixyldone®; Longtec®; Lynlor®; Onexila®; Oxeltra®; OxyContin®; OxyNorm®; Oxypro®; Reltebon®; Renocontin®; Shortec®; Targinact® (contains oxycodone with naloxone) Available as Capsules, modified-release tablets, oral liquid medicine, and injection Strong opioids (sometimes called opiates) are medicines used to treat severe pain. Oxycodone is a type of strong opioid. It is used in particular to treat pain after a surgical operation and pain caused by cancer. It works on your nervous system and brain to reduce the amount of pain you feel. Oxycodone can be taken as capsules or as a liquid medicine, both of which start working quickly to ease pain. It can also be taken as slow-release tablets - these release oxycodone over several hours to provide a more even pain control. It is also available as an injection. Oxycodone is sometimes used in combination with another medicine called naloxone (in a brand called Targinact®). The naloxone helps to reduce some of the side-effects of oxycodone, such as constipation.
Before taking oxycodone
Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking oxycodone, it is important that your doctor knows: If you are pregnant, trying for a baby or breastfeeding. If you have heart, liver, or kidney problems. If you have prostate problems or any difficulties passing urine. If you have any breathing problems, such as asthma or chronic obstructive pulmonary disease (COPD). If you have been told you have low blood pressure (hypotension). If you have any problems with your thyroid, pancreas, or adrenal glands. If you have epilepsy. If you have a problem with your bile duct. If you have been constipated for more than a week or have an inflammatory bowel problem. If you have a condition causing muscle weakness, called myasthenia gravis. If you have a rare blood disorder called porphyria. If you have recently had a severe head injury. If you have ever had a mental health problem called psychosis. If you have ever been dependent on drugs or alcohol. If you have ever had an allergic reaction to a medicine. If you are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as as herbal and complementary medicines.
How to take oxycodone
Before you start this treatment, read the manufacturer's printed information leaflet from inside your pack. The manufacturer's leaflet will give you more information about the specific brand of oxycodone you have been prescribed, and a full list of the side-effects which you may experience from taking it. Take oxycodone exactly as your doctor tells you to. Depending on the reason you are taking it, your doctor may advise that you take regular doses or only when you need it for pain relief. Make sure you know which is right for you. If you have been prescribed the quick-acting capsules or liquid medicine, you will be asked to take a dose every 4-6 hours. If you have been given slow-release tablets, they are taken twice a day, 12 hours apart. Swallow the tablets whole with a drink of water - it is very important you do not break or crush them before they are swallowed. You can take oxycodone before or after food. If you forget to take a dose, check the manufactuter's information leaflet for advice about what to do. Depending upon when your next dose is due, you will either be recommended to take a dose when you remember or wait for your next dose. Never take two doses together to make up for a missed dose. Getting the most from your treatment Ask your doctor for advice before drinking alcohol while you are on this medicine. Your doctor may recommend you do not drink alcohol while you are on oxycodone because it increases the possibility of side-effects such as feeling dizzy and sleepy. If you are a driver, please be aware that oxycodone is likely to affect your reactions and ability to drive. It is an offence to drive while your reactions are impaired. Even if your driving ability is not impaired, should you drive, you are advised to carry with you some evidence that the medicine has been prescribed for you - a repeat prescription form or a patient information leaflet from the pack is generally considered suitable. There are several different brands and strengths of oxycodone tablets and capsules. Each time you collect a prescription, check to make sure it contains what you are expecting. Ask your pharmacist to check for you if you are unsure about anything. If you are having an operation or dental treatment, tell the person carrying out the treatment that you are taking oxycodone as a painkiller. If you buy any medicines, check with a pharmacist that they are suitable for you to take with oxycodone. Many other medicines have similar side-effects to oxycodone, and taking them together will increase the risk of unwanted effects. If you are planning a trip abroad, you are advised to carry a letter with you from your doctor to explain that you have been prescribed oxycodone. This is because it is classed as a 'controlled drug' and is subject to certain restrictions. Do not take oxycodone for longer than you have been advised by your doctor. This is because repeatedly using oxycodone may lead to your body becoming dependent on it. When you then stop taking it, it will cause withdrawal symptoms such as restlessness and irritability. If you are concerned about this, discuss it with your doctor or pharmacist.
Can oxycodone cause problems?
Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with oxycodone. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome. Common oxycodone side-effects - these affect fewer than than 1 in 10 people who take this medicine What can I do if I experience this? Feeling sick (nausea) or being sick (vomiting), indigestion, tummy (abdominal) pain Stick to simple meals - avoid rich or spicy foods. If this continues, let your doctor know Feeling dizzy, sleepy or drowsy If this happens, do not drive and do not use tools or machines. Do not drink alcohol Shallow breathing and other breathing problems Let your doctor know about this Constipation Eat a well-balanced diet and drink plenty of water each day. If this continues to be a problem, speak with your doctor Diarrhoea Drink plenty of water to replace any lost fluids Dry mouth Try chewing sugar-free gum or sucking sugar-free sweets Other common side-effects include: reduced appetite, feeling confused or disorientated, difficulty sleeping, headache, chills, itching, sweating, and rash If any of these become troublesome, speak with your doctor Important: people taking opioid medicines, and their family and friends, should be aware of the risk of accidental overdose and know when to seek medical help. The risk is higher if you also take other medicines that make you feel drowsy. Signs you have taken too much medicine include: Feeling very sleepy or dizzy. Feeling sick (nausea) or being sick (vomiting). Breathing difficulties. Loss of consciousness. If you have taken more oxycodone than you should or someone else accidentally swallows your medication, call for an ambulance and tell them the name of your medicine. If you experience any other symptoms which you think may be due to this medicine, speak with your doctor or pharmacist. How to store oxycodone Keep all medicines out of the reach and sight of children. Store in a cool, dry place, away from direct heat and light. Many liquid preparations of oxycodone only keep for a few weeks once the bottle has been opened. Check the label for further details and write on it the date you open the bottle. Important information about all medicines Never take more than the prescribed dose. If you suspect that you or someone else might have taken an overdose of this medicine, go to the accident and emergency department of your local hospital. Take the container with you, even if it is empty. This medicine is for you. Never give it to other people even if their condition appears to be the same as yours. Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you. If you have any questions about this medicine ask your pharmacist.
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What Is Oxycontin
OxyContin Neo (oxycodone hydrochloride controlled-release) is an opioid analgesic supplied in 10 mg, 20 mg, 40 mg, 60 mg and 80 mg tablets for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt.
The structural formula for oxycodone hydrochloride is: C18H21NO4·HCl. MW: 351.83. The chemical name is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. Oxycodone is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL). It is slightly soluble in alcohol (octanol water partition coefficient 0.7). OxyContin Neo 10 mg (oxycodone hydrochloride): Each contains oxycodone hydrochloride 10 mg equivalent to 9 mg oxycodone base. OxyContin Neo 20 mg (oxycodone hydrochloride): Each contains oxycodone hydrochloride 20 mg equivalent to 18 mg oxycodone base. OxyContin Neo 40 mg (oxycodone hydrochloride): Each contains oxycodone hydrochloride 40 mg equivalent to 36 mg oxycodone base. Excipients/Inactive Ingredients: Butylated hydroxytoluene (BHT), hypromellose, polyethylene glycol 400, polyethylene oxide, magnesium stearate, titanium dioxide. 10 mg: Hydroxypropyl cellulose. 20 mg: Polysorbate 80 and red iron oxide. 40 mg: Polysorbate 80 and yellow iron oxide.
Action
Pharmacology: Oxycodone is a full opiod agonist and is relatively selective for the mu receptor although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesic. Like all full opioid agonists, there is no ceiling effect to analgesia for Oxycodone. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. Mechanism of Action: Central Nervous System: The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug. Pharmacodynamics: A single-dose, double-blind, placebo- and dose-controlled study was conducted using OxyContin (10, 20, and 30 mg) in an analgesic pain model involving 182 patients with moderate to severe pain. OxyContin doses of 20 mg and 30 mg produced statistically significant pain reduction compared to placebo. Effects on the Central Nervous System: Oxycodone produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves both a reduction in the responsiveness of the brain stem respiratory centers to increases in CO2 tension and to electrical stimulation. Oxycodone depresses the cough reflex by direct effect on the cough center in the medulla. Antitussive effects may occur with doses lower than those usually required for analgesia. Oxycodone causes miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in the setting of oxycodone overdose (see Overdosage). Effects on the Gastrointestinal Tract and Other Smooth Muscle: Oxycodone causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm resulting in constipation. Other opioid-induced effects may include a reduction in gastric, biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase. Effects on the Cardiovascular System: Oxycodone may produce release of histamine with or without associated peripheral vasodilation. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension. Effects on the Endocrine System: Opioids inhibit the secretion of ACTH, cortisol, testosterone, and luteinizing hormone (LH) in humans. They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon. Effects on the Immune System: Opioids have been shown to have a variety of effects on components of the immune system in in vitro and animal models. The clinical significance of these findings is unknown. Overall, the effects of opioids appear to be modestly immunosuppressive. Concentration-Efficacy Relationships: Studies in normal volunteers and patients reveal predictable relationships between oxycodone dosage and plasma oxycodone concentrations, as well as between concentration and certain expected opioid effects, such as pupillary constriction, sedation, overall subjective "drug effect", analgesia and feelings of relaxation. The minimum effective analgesic concentration will vary widely among patients, especially among patients who have been previously treated with potent agonist opioids. As a result, patients must be treated with individualized titration of dosage to the desired effect. The minimum effective analgesic concentration of oxycodone for any individual patient may increase over time due to an increase in pain, the development of a new pain syndrome and/or the development of analgesic tolerance. Concentration-Adverse Reaction Relationships: There is a relationship between increasing oxycodone plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression. In opioid-tolerant patients, the situation may be altered by the development of tolerance to opioid-related side effects. The dose of OxyContin Neo must be individualized because the effective analgesic dose for some patients will be too high to be tolerated by other patients (see Dosage and Administration). Clinical Studies: A double-blind, placebo-controlled, fixed-dose, parallel group, two-week study was conducted in 133 patients with persistent, moderate to severe pain, who were judged as having inadequate pain control with their current therapy. In this study, OxyContin 20 mg, but not 10 mg, was statistically significant in pain reduction compared with placebo. Pharmacokinetics: The activity of OxyContin Neo is primarily due to the parent drug oxycodone. OxyContin Neo is designed to provide delivery of oxycodone over 12 hours. Cutting, breaking, chewing, crushing or dissolving OxyContin Neo impairs the controlled-release delivery mechanism and results in the rapid release and absorption of a potentially fatal dose of oxycodone. Oxycodone release from OxyContin Neo is pH independent. The oral bioavailability of oxycodone is 60% to 87%. The relative oral bioavailability of oxycodone from OxyContin Neo to that from immediate-release oral dosage forms is 100%. Upon repeated dosing with OxyContin Neo in healthy subjects in pharmacokinetic studies, steady-state levels were achieved within 24-36 hours. Oxycodone is extensively metabolized and eliminated primarily in the urine as both conjugated and unconjugated metabolites. The apparent elimination half-life (t½) of oxycodone following the administration of OxyContin Neo was 4.5 hours compared to 3.2 hours for immediate-release oxycodone. Absorption: About 60% to 87% of an oral dose of oxycodone reaches the central compartment in comparison to a parenteral dose. This high oral bioavailability is due to low pre-systemic and/or first-pass metabolism. Plasma Oxycodone Concentration over Time: Dose proportionality has been established for OxyContin Neo 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg tablet strengths for both peak plasma concentrations (Cmax) and extent of absorption (AUC) (see Table 1). Given the short elimination t½ of oxycodone, steady-state plasma concentrations of oxycodone are achieved within 24-36 hours of initiation of dosing with OxyContin Neo. In a study comparing 10 mg of OxyContin Neo every 12 hours to 5 mg of immediate-release oxycodone every 6 hours, the two treatments were found to be equivalent for AUC and Cmax, and similar for Cmin (trough) concentrations.
Food Effects: Food has no significant effect on the extent of absorption of oxycodone from OxyContin Neo.
Distribution: Following intravenous administration, the steady-state volume of distribution (Vss) for oxycodone was 2.6 L/kg. Oxycodone binding to plasma protein at 37°C and a pH of 7.4 was about 45%. Once absorbed, oxycodone is distributed to skeletal muscle, liver, intestinal tract, lungs, spleen, and brain. Oxycodone has been found in breast milk (see Use in Specific Populations). Metabolism: Oxycodone is extensively metabolized by multiple metabolic pathways to produce noroxycodone, oxymorphone and noroxymorphone, which are subsequently glucuronidated. Noroxycodone and noroxymorphone are the major circulating metabolites. CYP3A mediated N-demethylation to noroxycodone is the primary metabolic pathway of oxycodone with a lower contribution from CYP2D6 mediated O-demethylation to oxymorphone. Therefore, the formation of these and related metabolites can, in theory, be affected by other drugs (see Interactions). Noroxycodone exhibits very weak anti-nociceptive potency compared to oxycodone, however, it undergoes further oxidation to produce noroxymorphone, which is active at opioid receptors. Although noroxymorphone is an active metabolite and present at relatively high concentrations in circulation, it does not appear to cross the blood-brain barrier to a significant extent. Oxymorphone is present in the plasma only at low concentrations and undergoes further metabolism to form its glucuronide and noroxymorphone. Oxymorphone has been shown to be active and possessing analgesic activity but its contribution to analgesia following oxycodone administration is thought to be clinically insignificant. Other metabolites (α- and ß-oxycodol, noroxycodol and oxymorphol) may be present at very low concentrations and demonstrate limited penetration into the brain as compared to oxycodone. The enzymes responsible for keto-reduction and glucuronidation pathways in oxycodone metabolism have not been established. Excretion: Oxycodone and its metabolites are excreted primarily via the kidney. The amounts measured in the urine have been reported as follows: free and conjugated oxycodone 8.9%, free noroxycodone 23%, free oxymorphone less than 1%, conjugated oxymorphone 10%, free and conjugated noroxymorphone 14%, reduced free and conjugated metabolites up to 18%. The total plasma clearance was approximately 1.4 L/min in adults. Special Populations: Elderly (≥ 65 years): The plasma concentrations of oxycodone are only nominally affected by age, being 15% greater in elderly as compared to young subjects (age 21-45). Gender: Across individual pharmacokinetic studies, average plasma oxycodone concentrations for female subjects were up to 25% higher than for male subjects on a body weight-adjusted basis. The reason for this difference is unknown (see Precautions). Renal Impairment: Data from a pharmacokinetic study involving 13 patients with mild to severe renal dysfunction (creatinine clearance <60 mL/min) showed peak plasma oxycodone and noroxycodone concentrations 50% and 20% higher, respectively, and AUC values for oxycodone, noroxycodone, and oxymorphone 60%, 50%, and 40% higher than normal subjects, respectively. This was accompanied by an increase in sedation but not by differences in respiratory rate, pupillary constriction, or several other measures of drug effect. There was an increase in mean elimination t½ for oxycodone of 1 hour. Hepatic Impairment: Data from a study involving 24 patients with mild to moderate hepatic dysfunction show peak plasma oxycodone and noroxycodone concentrations 50% and 20% higher, respectively, than healthy subjects. AUC values are 95% and 65% higher, respectively. Oxymorphone peak plasma concentrations and AUC values are lower by 30% and 40%. These differences are accompanied by increases in some, but not other, drug effects. The mean elimination t½ for oxycodone increased by 2.3 hours. Drug-Drug Interactions: CYP3A4 Inhibitors: CYP3A4 is the major enzyme involved in noroxycodone formation. Co-administration of OxyContin Neo (10 mg single dose) and the CYP3A4 inhibitor ketoconazole (200 mg BID) increased oxycodone AUC and Cmax by 170% and 100%, respectively (see Interactions). CYP3A4 Inducers: A published study showed that the co-administration of rifampin, a drug metabolizing enzyme inducer, decreased oxycodone AUC and Cmax values by 86% and 63%, respectively (see Interactions). CYP2D6 Inhibitors: Oxycodone is metabolized in part to oxymorphone via CYP2D6. While this pathway may be blocked by a variety of drugs such as certain cardiovascular drugs (e.g., quinidine) and antidepressants (e.g., fluoxetine), such blockade has not been shown to be of clinical significance with OxyContin Neo (see Interactions). Toxicology: Carcinogenesis: No animal studies to evaluate the carcinogenic potential of oxycodone have been conducted. Mutagenesis: Oxycodone was genotoxic in the mouse lymphoma assay at concentrations of 50 mcg/mL or greater with metabolic activation and at 400 mcg/mL or greater without metabolic activation. Clastogenicity was observed with oxycodone in the presence of metabolic activation in one chromosomal aberration assay in human lymphocytes at concentrations greater than or equal to 1250 mcg/mL at 24 but not 48 hours of exposure. In a second chromosomal aberration assay with human lymphocytes, no structural clastogenicity was observed either with or without metabolic activation; however, in the absence of metabolic activation, oxycodone increased numerical chromosomal aberrations (polyploidy). Oxycodone was not genotoxic in the following assays: Ames S. typhimurium and E. coli test with and without metabolic activation at concentrations up to 5000 μg/plate, chromosomal aberration test in human lymphocytes (in the absence of metabolic activation) at concentrations up to 1500 μg/mL, and with activation after 48 hours of exposure at concentrations up to 5000 μg/mL, and in the in vivo bone marrow micronucleus assay in mice (at plasma levels up to 48 μg/mL). Impairment of Fertility: In a study of reproductive performance, rats were administered a once daily gavage dose of the vehicle or oxycodone hydrochloride (0.5, 2, and 8 mg/kg). Male rats were dosed for 28 days before cohabitation with females, during the cohabitation and until necropsy (2-3 weeks post-cohabitation). Females were dosed for 14 days before cohabitation with males, during cohabitation and up to gestation day 6. Oxycodone hydrochloride did not affect reproductive function in male or female rats at any dose tested (≤8 mg/kg/day).
Indications/Uses
OxyContin Neo is indicated for the management of pain severe enough to require daily, around the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve OxyContin Neo for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. OxyContin Neo is not indicated as an as-needed (prn) analgesic. Dosage/Direction for Use Initial Dosing: OxyContin Neo should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. OxyContin Neo 60 mg and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established. Patients considered opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid. Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse (see Precautions). Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with OxyContin Neo (see Precautions). OxyContin Neo tablets must be taken whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth. Crushing, chewing, or dissolving OxyContin Neo tablets will result in uncontrolled delivery of oxycodone and can lead to overdose or death (see Precautions). Use of OxyContin Neo as the First Opioid Analgesic: Initiate treatment with OxyContin Neo with one 10 mg tablet orally every 12 hours. Use of OxyContin Neo in Patients who are not Opioid Tolerant: The starting dose for patients who are not opioid tolerant is OxyContin Neo 10 mg orally every 12 hours. Patients who are opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, or an equianalgesic dose of another opioid. Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression. Conversion from other Oral Oxycodone Formulations to OxyContin Neo: Patients receiving other oral oxycodone formulations may be converted to OxyContin Neo by administering one-half of the patient's total daily oral oxycodone dose as OxyContin Neo every 12 hours. It is safer to underestimate a patient's 24-hour oral oxycodone requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour oral oxycodone requirements which could result in adverse reactions. While useful tables of opioid equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products. Conversion from Methadone to OxyContin Neo: Close monitoring is of particular importance when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma. Conversion from Transdermal Fentanyl to OxyContin Neo: Eighteen hours following the removal of the transdermal fentanyl patch, OxyContin Neo treatment can be initiated. Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg every 12 hours of OxyContin Neo, should be initially substituted for each 25 mcg/hr fentanyl transdermal patch. Follow the patient closely during conversion from transdermal fentanyl to OxyContin Neo, as there is limited documented experience with this conversion. Titration and Maintenance of Therapy: Individually titrate OxyContin Neo to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving OxyContin Neo to assess the maintenance of pain control and the relative incidence of adverse reactions as well as monitoring for the development of addiction, abuse and misuse. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy, periodically reassess the continued need for the use of opioid analgesics. Patients who experience breakthrough pain may require a dose increase of OxyContin Neo or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the OxyContin Neo dose. Because steady-state plasma concentrations are approximated in 1 day, OxyContin Neo dosage may be adjusted every 1 to 2 days. If unacceptable opioid-related adverse reactions are observed, the subsequent dose may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions. There are no well-controlled clinical studies evaluating the safety and efficacy with dosing more frequently than every 12 hours. As a guideline, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose, each time an increase is clinically indicated. Patients with Hepatic Impairment: For patients with hepatic impairment, start dosing patients at 1/3 to 1/2 the usual starting dose followed by careful dose titration (see Pharmacology under Actions). Discontinuation of OxyContin Neo: When the patient no longer requires therapy with OxyContin Neo tablets, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically-dependent patient. Do not abruptly discontinue OxyContin Neo. Administration: Instruct patients to swallow OxyContin Neo tablets intact. The tablets are not to be crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of oxycodone (see Precautions). Instruct patients to take OxyContin Neo one tablet at a time and with enough water to ensure complete swallowing immediately after placing in the mouth (see Precautions).
Overdosage
Clinical Presentation: Acute overdosage with OxyContin Neo can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring and death. Marked mydriasis rather than miosis may be seen due to severe hypoxia in overdose situations. Treatment of Overdose: In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation if needed. Employ other supportive measures (including oxygen, vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life support techniques. The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to oxycodone overdose. Such agents should be administered cautiously to persons who are known, or suspected to be physically dependent on OxyContin Neo. In such cases, an abrupt or complete reversal of opioid effects may precipitate an acute withdrawal syndrome. Because the duration of reversal would be expected to be less than the duration of action of oxycodone in OxyContin Neo, carefully monitor the patient until spontaneous respiration is reliably reestablished. OxyContin Neo will continue to release oxycodone and add to the oxycodone load for 24 to 48 hours or longer following ingestion, necessitating prolonged monitoring. If the response to opioid antagonists is suboptimal or not sustained, additional antagonist should be administered as directed in the product's prescribing information. In an individual physically dependent on opioids, administration of the usual dose of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist. Contraindications Hypersensitivity to opioids and to any of the constituents or in any situation where opioids are contraindicated, acute respiratory depression, cor pulmonale, cardiac arrhythmias, severe bronchial asthma, chronic obstructive airways disease, paralytic ileus, suspected surgical abdomen, moderate to severe hepatic impairment, severe renal impairment (creatinine clearance <10 ml/min), delayed gastric emptying, acute alcoholism, brain tumor, increased cerebrospinal or intracranial pressure, head injury, severe CNS depression, convulsive disorders, delirium tremens, hypercarbia, concurrent administration of monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use. Not recommended for pre-operative use or for the first 24 hours post-operatively. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Special Precautions Addiction, Abuse, and Misuse: OxyContin Neo contains oxycodone. As an opioid, OxyContin Neo exposes users to the risks of addiction, abuse, and misuse (see Drug Abuse and Dependence). As modified-release products such as OxyContin Neo deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of oxycodone present (see Drug Abuse and Dependence). Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed OxyContin Neo. Addiction can occur at recommended doses and if the drug is misused or abused. Assess each patient's risk for opioid addiction, abuse or misuse prior to prescribing OxyContin Neo, and monitor all patients receiving OxyContin Neo for the development of these behaviors or conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed modified-release opioid formulations such as OxyContin Neo, but use in such patients necessitates intensive counseling about the risks and proper use of OxyContin Neo along with intensive monitoring for signs of addiction, abuse, and misuse. Abuse, or misuse of OxyContin Neo by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of oxycodone and can result in overdose and death (see Overdosage). Opioid agonists are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing OxyContin Neo. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug. Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression has been reported with the use modified-release opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status (see Overdosage). Carbon dioxide (CO2) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of OxyContin Neo, the risk is greatest during the initiation of therapy or following a dose increase. Closely monitor patients for respiratory depression when initiating therapy with OxyContin Neo and following dose increases. To reduce the risk of respiratory depression, proper dosing and titration of OxyContin Neo are essential (see Dosage and Administration). Overestimating the OxyContin Neo dose when converting patients from another opioid product can result in a fatal overdose with the first dose. Accidental ingestion of even one dose of OxyContin Neo, especially by children, can result in respiratory depression and death due to an overdose of oxycodone. Neonatal Opioid Withdrawal Syndrome: Prolonged use of OxyContin Neo during pregnancy can result in withdrawal signs in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Interactions with Central Nervous System Depressants: Hypotension and profound sedation, coma, or respiratory depression may result if OxyContin Neo is used concomitantly with other central nervous system (CNS) depressants (e.g., sedatives, anxiolytics, hypnotics, neuroleptics, other opioids).When considering the use of OxyContin Neo in a patient taking a CNS depressant, assess the duration of use of the CNS depressant and the patient’s response, including the degree of tolerance that has developed to CNS depression. Additionally, evaluate the patient's use of alcohol or illicit drugs that can cause CNS depression. If the decision to begin OxyContin Neo therapy is made, start with 1/3 to 1/2 the usual dose of OxyContin Neo, monitor patients for signs of sedation and respiratory depression and consider using a lower dose of the concomitant CNS depressant (see Interactions and Dosage & Administration). When considering the use of OxyContin Neo in a patient taking a CNS depressant, assess the duration of use of the CNS depressant and the patient’s response, including the degree of tolerance that has developed to CNS depression. Additionally, evaluate the patient's use of alcohol or illicit drugs that can cause CNS depression. If the decision to begin OxyContin Neo therapy is made, start with 1/3 to 1/2 the usual dose of OxyContin Neo, monitor patients for signs of sedation and respiratory depression and consider using a lower dose of the concomitant CNS depressant (see Drug Interactions and Dosage & Administration). Elderly, Cachectic, and Debilitated Patients: Respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients. Therefore, monitor such patients closely, particularly when initiating and titrating OxyContin Neo and when OxyContin Neo is given concomitantly with other drugs that depress respiration (see Precautions). Use in Patients with Chronic Pulmonary Disease: Monitor patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression for respiratory depression, particularly when initiating therapy and titrating with OxyContin Neo, as in these patients, even usual therapeutic doses of OxyContin Neo may decrease respiratory drive to the point of apnea (see Precautions). Consider the use of alternative non-opioid analgesics in these patients if possible. Hypotensive Effects: OxyContin Neo may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is an increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics) (see Interactions). Monitor these patients for signs of hypotension after initiating or titrating the dose of OxyContin Neo. In patients with circulatory shock, OxyContin Neo may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of OxyContin Neo in patients with circulatory shock. Use in Patients with Head Injury or Increased Intracranial Pressure: Monitor patients taking OxyContin Neo who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors) for signs of sedation and respiratory depression, particularly when initiating therapy with OxyContin Neo. OxyContin Neo may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of OxyContin Neo in patients with impaired consciousness or coma. Difficulty in Swallowing and Risk for Obstruction in Patients at Risk for a Small Gastrointestinal Lumen: There have been post-marketing reports of difficulty in swallowing OxyContin Neo tablets. These reports included choking, gagging, regurgitation and tablets stuck in the throat. Instruct patients not to pre-soak, lick or otherwise wet OxyContin Neo tablets prior to placing in the mouth, and to take one tablet at a time with enough water to ensure complete swallowing immediately after placing in the mouth. There have been rare post-marketing reports of cases of intestinal obstruction, and exacerbation of diverticulitis, some of which have required medical intervention to remove the tablet. Patients with underlying GI disorders such as esophageal cancer or colon cancer with a small gastrointestinal lumen are at greater risk of developing these complications. Consider use of an alternative analgesic in patients who have difficulty swallowing and patients at risk for underlying GI disorders resulting in a small gastrointestinal lumen. Use in Patients with Gastrointestinal Conditions: OxyContin Neo is contraindicated in patients with GI obstruction, including paralytic ileus. The oxycodone in OxyContin Neo may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms. Opioids may cause increases in the serum amylase. Use in Patients with Convulsive or Seizure Disorders: The oxycodone in OxyContin Neo may aggravate convulsions in patients with convulsive disorders, and may induce or aggravate seizures in some clinical settings. Monitor patients with a history of seizure disorders for worsened seizure control during OxyContin Neo therapy. Avoidance of Withdrawal: Avoid the use of mixed agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, and butorphanol) in patients who have received or are receiving a course of therapy with a full opioid agonist analgesic, including OxyContin Neo. In these patients, mixed agonist/antagonist analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms. When discontinuing OxyContin Neo, gradually taper the dose (see Dosage and Administration). Do not abruptly discontinue OxyContin Neo. Driving and Operating Machinery: OxyContin Neo may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of OxyContin Neo and know how they will react to the medication. Cytochrome P450 3A4 Inhibitors and Inducers: Since the CYP3A4 isoenzyme plays a major role in the metabolism of OxyContin Neo, drugs that alter CYP3A4 activity may cause changes in clearance of oxycodone which could lead to changes in oxycodone plasma concentrations. Inhibition of CYP3A4 activity by its inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may increase plasma concentrations of oxycodone and prolong opioid effects. CYP450 inducers, such as rifampin, carbamazepine, and phenytoin, may induce the metabolism of oxycodone and, therefore, may cause increased clearance of the drug which could lead to a decrease in oxycodone plasma concentrations, lack of efficacy or, possibly, development of an abstinence syndrome in a patient who had developed physical dependence to oxycodone. If co-administration is necessary, caution is advised when initiating OxyContin Neo treatment in patients currently taking, or discontinuing, CYP3A4 inhibitors or inducers. Evaluate these patients at frequent intervals and consider dose adjustments until stable drug effects are achieved (see Interactions and Pharmacology under Actions). Laboratory Monitoring: Not every urine drug test for "opioids" or "opiates" detects oxycodone reliably, especially those designed for in-office use. Further, many laboratories will report urine drug concentrations below a specified "cut-off" value as "negative". Therefore, if urine testing for oxycodone is considered in the clinical management of an individual patient, ensure that the sensitivity and specificity of the assay is appropriate, and consider the limitations of the testing used when interpreting results. Gender Differences: In pharmacokinetic studies with OxyContin Neo, opioid-naïve females demonstrate up to 25% higher average plasma concentrations and greater frequency of typical opioid adverse events than males, even after adjustment for body weight. The clinical relevance of a difference of this magnitude is low for a drug intended for chronic usage at individualized dosages, and there was no male/female difference detected for efficacy or adverse events in clinical trials. Neonatal Opioid Withdrawal Syndrome: Chronic maternal use of oxycodone during pregnancy can affect the fetus with subsequent withdrawal signs. Neonatal withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration and severity of neonatal withdrawal syndrome vary based on the drug used, duration of use, the dose of last maternal use, and rate of elimination of drug by the newborn. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening and should be treated according to protocols developed by neonatology experts. Hepatic Impairment: A study of OxyContin Neo in patients with hepatic impairment demonstrated greater plasma concentrations than those seen at equivalent doses in persons with normal hepatic function. Therefore, in the setting of hepatic impairment, start dosing patients at 1/3 to 1/2 the usual starting dose followed by careful dose titration (see Pharmacology under Actions). Renal Impairment: In patients with renal impairment, as evidenced by decreased creatinine clearance (<60 mL/min), the concentrations of oxycodone in the plasma are approximately 50% higher than in subjects with normal renal function. Follow a conservative approach to dose initiation and adjust according to the clinical situation (see Pharmacology under Actions). Drug Abuse and Dependence: Opioids: OxyContin Neo contains oxycodone, an opioid with a high potential for abuse similar to other opioids including fentanyl, hydromorphone, methadone, oxycodone, and oxymorphone. OxyContin Neo can be abused and is subject to misuse, addiction, and criminal diversion (see Precautions). The high drug content in extended-release formulations adds to the risk of adverse outcomes from abuse and misuse. Abuse: All patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Drug abuse is the intentional non-therapeutic use of an over-the-counter or prescription drug, even once, for its rewarding psychological or physiological effects. Drug abuse includes, but is not limited to, the following examples: The use of a prescription or over-the-counter drug to get "high", or the use of steroids for performance enhancement and muscle build up. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and include: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. "Drug-seeking" behavior is very common to addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated claims of loss of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). "Doctor shopping" (visiting multiple prescribers) to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction. OxyContin Neo, like other opioids, can be diverted for non-medical use into illicit channels of distribution. Careful recordkeeping of prescribing information, including quantity, frequency, and renewal requests as required by state law, is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to reduce abuse of opioid drugs. Risks Specific to Abuse of OxyContin Neo: OxyContin Neo is for oral use only. Abuse of OxyContin Neo poses a risk of overdose and death. The risk is increased with concurrent use of OxyContin Neo with alcohol and other central nervous system depressants. Taking cut, broken, chewed, crushed, or dissolved OxyContin Neo enhances drug release and increases the risk of overdose and death. With parenteral abuse, the inactive ingredients in OxyContin Neo can result in death, local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury. Parenteral drug abuse is commonly associated with transmission of infectious diseases, such as hepatitis and HIV. Abuse Deterrence Studies: OxyContin Neo is formulated with inactive ingredients intended to make the tablet more difficult to manipulate for misuse and abuse. For the purposes of describing the results of studies of the abuse-deterrent characteristics of OxyContin Neo resulting from a change in formulation, in this section, the original formulation of OxyContin, which is no longer marketed, will be referred to as "original OxyContin" and the reformulated, currently marketed product will be referred to as OxyContin Neo. In Vitro Testing: In vitro physical and chemical tablet manipulation studies were performed to evaluate the success of different extraction methods in defeating the extended-release formulation. Results support that, relative to original OxyContin Neo, there is an increase in the ability of OxyContin Neo to resist crushing, breaking, and dissolution using a variety of tools and solvents. The results of these studies also support this finding for OxyContin Neo relative to an immediate-release oxycodone. When subjected to an aqueous environment, OxyContin Neo gradually forms a viscous hydrogel (i.e., a gelatinous mass) that resists passage through a needle. Clinical Studies: In a randomized, double-blind, placebo-controlled 5-period crossover pharmacodynamic study, 30 recreational opioid users with a history of intranasal drug abuse received intranasally administered active and placebo drug treatments. The five treatment arms were finely crushed OxyContin Neo 30 mg tablets, coarsely crushed OxyContin Neo 30 mg tablets, finely crushed original OxyContin Neo 30 mg tablets, powdered oxycodone HCl 30 mg, and placebo. Data for finely crushed OxyContin Neo, finely crushed original OxyContin Neo, and powdered oxycodone HCl are described as follows. Drug liking was measured on a bipolar drug liking scale of 0 to 100 where 50 represents a neutral response of neither liking nor disliking, 0 represents maximum disliking and 100 represents maximum liking. Response to whether the subject would take the study drug again was also measured on a bipolar scale of 0 to 100 where 50 represents a neutral response, 0 represents the strongest negative response ("definitely would not take drug again") and 100 represents the strongest positive response ("definitely would take drug again"). Twenty-seven of the subjects completed the study. Incomplete dosing due to granules falling from the subjects’ nostrils occurred in 34% (n=10) of subjects with finely crushed OxyContin Neo, compared with 7% (n=2) of subjects with finely crushed original OxyContin and no subjects with powdered oxycodone HCl. The intranasal administration of finely crushed OxyContin Neo was associated with a numerically lower mean and median drug liking score and a lower mean and median score for take drug again, compared to finely crushed original OxyContin or powdered oxycodone HCl as summarized in Table 2. (See Table 2.) Figure as follows demonstrates a comparison of drug liking for finely crushed OxyContin Neo compared to powdered oxycodone HCl in subjects who received both treatments. The Y-axis represents the percent of subjects attaining a percent reduction in drug liking for OxyContin Neo vs. oxycodone HCl powder greater than or equal to the value on the X-axis. Approximately 44% (n=12) had no reduction in liking with OxyContin Neo relative to oxycodoneHCl. Approximately 56% (n=15) of subjects had some reduction in drug liking with OxyContin Neo relative to oxycodone HCl. Thirty-three percent (n=9) of subjects had a reduction of at least 30% in drug liking with OxyContin Neo compared to oxycodone HCl, and approximately 22% (n=6) of subjects had a reduction of at least 50% in drug liking with OxyContin Neo compared to oxycodone HCl (see Figure.) The results of a similar analysis of drug liking for finely crushed OxyContin Neo relative to finely crushed original OxyContin were comparable to the results of finely crushed OxyContin Neo relative to powdered oxycodone HCl. Approximately 43% (n=12) of subjects had no reduction in liking with OxyContin Neo relative to original OxyContin. Approximately 57% (n=16) of subjects had some reduction in drug liking, 36% (n=10) of subjects had a reduction of at least 30% in drug liking, and approximately 29% (n=8) of subjects had a reduction of at least 50% in drug liking with OxyContin Neo compared to original OxyContin. Summary: The in vitro data demonstrate that OxyContin Neo has physicochemical properties expected to make abuse via injection difficult. The data from the clinical study, along with support from the in vitro data, also indicate that OxyContin Neo has physicochemical properties that are expected to reduce abuse via the intranasal route. However, abuse of OxyContin Neo by these routes, as well as by the oral route is still possible. Additional data, including epidemiological data, when available, may provide further information on the impact of the current formulation of OxyContin Neo on the abuse liability of the drug. Accordingly, this section may be updated in the future as appropriate. OxyContin Neo contains oxycodone, an opioid agonist with an abuse liability similar to other opioid agonists, legal or illicit, including fentanyl, hydromorphone, methadone, morphine, and oxymorphone. OxyContin Neo can be abused and is subject to misuse, addiction, and criminal diversion (see Precautions). Dependence: Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. Physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity, e.g., naloxone, nalmefene, or mixed agonist/antagonist analgesics (pentazocine, butorphanol, nalbuphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. OxyContin Neo should not be abruptly discontinued (see Dosage and Administration). If OxyContin Neo is abruptly discontinued in a physically-dependent patient, an abstinence syndrome may occur. Some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs. Use in Children: Safety and effectiveness of OxyContin Neo in pediatric patients below the age of 18 years have not been established. Use in Elderly: In controlled pharmacokinetic studies in elderly subjects (greater than 65 years) the clearance of oxycodone was slightly reduced. Compared to young adults, the plasma concentrations of oxycodone were increased approximately 15% (see Pharmacology under Actions). Of the total number of subjects (445) in clinical studies of oxycodone hydrochloride controlled-release tablets, 148 (33.3%) were age 65 and older (including those age 75 and older) while 40 (9.0%) were age 75 and older. In clinical trials with appropriate initiation of therapy and dose titration, no untoward or unexpected adverse reactions were seen in the elderly patients who received oxycodone hydrochloride controlled-release tablets. Thus, the usual doses and dosing intervals may be appropriate for elderly patients. However, reduce the starting dose to 1/3 to 1/2 the usual dosage in debilitated, non-opioid-tolerant patients. Respiratory depression is the chief risk in elderly or debilitated patients, usually the result of large initial doses in patients who are not tolerant to opioids, or when opioids are given in conjunction with other agents that depress respiration. Titrate the dose of OxyContin Neo cautiously in these patients. Use In Pregnancy & Lactation Use in Pregnancy: Clinical Considerations: Fetal/neonatal Adverse Reactions: Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Observe newborns for symptoms of neonatal opioid withdrawal syndrome, such as poor feeding, diarrhea, irritability, tremor, rigidity, and seizures, and manage accordingly (see Precautions). Teratogenic Effects-Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. OxyContin Neo should be used during pregnancy only if the potential benefit justifies the risk to the fetus. The effect of oxycodone in human reproduction has not been adequately studied. Studies with oral doses of oxycodone hydrochloride in rats up to 8 mg/kg/day and rabbits up to 125 mg/kg/day, equivalent to 0.5 and 2.0 times an adult human dose of 160 mg/day, respectively on a mg/m2 basis, did not reveal evidence of harm to the fetus due to oxycodone. In a pre- and postnatal toxicity study, female rats received oxycodone during gestation and lactation. There were no long-term developmental or reproductive effects in the pups (see Toxicology under Actions). Non-Teratogenic Effects: Oxycodone hydrochloride was administered orally to female rats during gestation and lactation in a pre- and postnatal toxicity study. There were no drug-related effects on reproductive performance in these females or any long-term developmental or reproductive effects in pups born to these rats. Decreased body weight was found during lactation and the early post-weaning phase in pups nursed by mothers given the highest dose used (6 mg/kg/day, equivalent to approximately 0.4-times an adult human dose of 160 mg/day, on a mg/m2 basis). However, body weight of these pups recovered. Labor and Delivery: Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. OxyContin Neo is not recommended for use in women immediately prior to and during labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate. Occasionally, opioid analgesics may prolong labor through actions which temporarily reduce the strength, duration and frequency of uterine contractions. However this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor. Use in Lactation: Oxycodone has been detected in breast milk. Instruct patients not to undertake nursing while receiving OxyContin Neo. Do not initiate OxyContin Neo therapy while nursing because of the possibility of sedation or respiratory depression in the infant. Withdrawal signs can occur in breast-fed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped. Adverse Reactions Clinical Trial Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of OxyContin Neo was evaluated in double-blind clinical trials involving 713 patients with moderate to severe pain of various etiologies. In open-label studies of cancer pain, 187 patients received OxyContin Neo in total daily doses ranging from 20 mg to 640 mg per day. The average total daily dose was approximately 105 mg per day. OxyContin Neo may increase the risk of serious adverse reactions such as those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, or shock (see Overdosage). The most common adverse reactions (>5%) reported by patients in clinical trials comparing OxyContin Neo with placebo are shown in Table 3 as follows. (See Table 3.) In clinical trials, the following adverse reactions were reported in patients treated with OxyContin with an incidence between 1% and 5%: Gastrointestinal Disorders: Abdominal pain, diarrhea, dyspepsia, gastritis. General Disorders and Administration Site Conditions: Chills, fever. Metabolism and Nutrition Disorders: Anorexia. Musculoskeletal and Connective Tissue Disorders: Twitching. Psychiatric Disorders: Abnormal dreams, anxiety, confusion, dysphoria, euphoria, insomnia, nervousness, thought abnormalities. Respiratory, Thoracic and Mediastinal Disorders: Dyspnea, hiccups. Skin and Subcutaneous Tissue Disorders: Rash. Vascular Disorders: Postural hypotension. The following adverse reactions occurred in less than 1% of patients involved in clinical trials: Blood and Lymphatic System Disorders: Lymphadenopathy. Ear and Labyrinth Disorders: Tinnitus. Eye Disorders: Abnormal vision. Gastrointestinal Disorders: Dysphagia, eructation, flatulence, gastrointestinal disorder, increased appetite, stomatitis. General Disorders and Administration Site Conditions: Withdrawal syndrome (with and without seizures), edema, peripheral edema, thirst, malaise, chest pain, facial edema. Injury, Poisoning and Procedural Complications: Accidental injury. Investigations: ST depression. Metabolism and Nutrition Disorders: Dehydration. Nervous System Disorders: Syncope, migraine, abnormal gait, amnesia, hyperkinesia, hypesthesia, hypotonia, paresthesia, speech disorder, stupor, tremor, vertigo, taste perversion. Psychiatric Disorders: Depression, agitation, depersonalization, emotional lability, hallucination. Renal and Urinary Disorders: Dysuria, hematuria, polyuria, urinary retention. Reproductive System and Breast Disorders: Impotence. Respiratory, Thoracic and Mediastinal Disorders: Cough increased, voice alteration. Skin and Subcutaneous Tissue Disorders: Dry skin, exfoliative dermatitis. Postmarketing Experience: The following adverse reactions have been identified during post-approval use of controlled-release oxycodone: abuse, addiction, amenorrhea, cholestasis, death, dental caries, increased hepatic enzymes, hyperalgesia, hyponatremia, ileus, muscular hypertonia, overdose, palpitations (in the context of withdrawal), seizures, syndrome of inappropriate antidiuretic hormone secretion, and urticaria. Anaphylaxis has been reported with ingredients contained in OxyContin Neo. Advise patients how to recognize such a reaction and when to seek medical attention. In addition to the events listed above, the following have also been reported, potentially due to the swelling and hydrogelling property of the tablet: choking, gagging, regurgitation, tablets stuck in the throat and difficulty swallowing the tablet. View ADR Monitoring Form Drug Interactions CNS Depressants: The concomitant use of OxyContin Neo and other CNS depressants including sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, other opioids, and alcohol can increase the risk of respiratory depression, profound sedation, coma, or death. Monitor patients receiving CNS depressants and OxyContin Neo for signs of respiratory depression, sedation, and hypotension. When combined therapy with any of the above medications is considered, the dose of one or both agents should be reduced (see Dosage & Administration and Precautions). Muscle Relaxants: Oxycodone may enhance the neuromuscular blocking action of true skeletal muscle relaxants and produce an increased degree of respiratory depression. Monitor patients receiving muscle relaxants and OxyContin Neo for signs of respiratory depression that may be greater than otherwise expected. Agents Affecting Cytochrome P450 Isoenzymes: Inhibitors of CYP3A4 and 2D6: Because the CYP3A4 isoenzyme plays a major role in the metabolism of oxycodone, drugs that inhibit CYP3A4 activity may cause decreased clearance of oxycodone which could lead to an increase in oxycodone plasma concentrations and result in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of CYP2D6 and 3A4 inhibitors. If co-administration with OxyContin Neo is necessary, monitor patients for respiratory depression and sedation at frequent intervals and consider dose adjustments until stable drug effects are achieved (see Pharmacology under Actions). Inducers of CYP3A4: CYP450 3A4 inducers may induce the metabolism of oxycodone and, therefore, may cause increased clearance of the drug which could lead to a decrease in oxycodone plasma concentrations, lack of efficacy or, possibly, development of an abstinence syndrome in a patient who had developed physical dependence to oxycodone. If co-administration with OxyContin Neo is necessary, monitor for signs of opioid withdrawal and consider dose adjustments until stable drug effects are achieved. After stopping the treatment of a CYP3A4 inducer, as the effects of the inducer decline, the oxycodone plasma concentration will increase which could increase or prolong both the therapeutic and adverse effects, and may cause serious respiratory depression (see Pharmacology under Actions). Mixed Agonist/Antagonist Opioid Analgesics: Mixed agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, and butorphanol) and partial agonist (buprenorphine) analgesics may reduce the analgesic effect of oxycodone or precipitate withdrawal symptoms. Avoid the use of mixed agonist/antagonist and partial agonist analgesics in patients receiving OxyContin Neo. Diuretics: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Opioids may also lead to acute retention of urine by causing spasm of the sphincter of the bladder, particularly in men with enlarged prostates. Anticholinergics: Anticholinergics or other medications with anticholinergic activity when used concurrently with opioid analgesics may result in increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Monitor patients for signs of urinary retention or reduced gastric motility when OxyContin Neo is used concurrently with anticholinergic drugs. Antihypertensive Agents: Hypotensive effects of these medications may be potentiated when used concurrently with oxycodone, leading to increased risk of orthostatic hypotension. Coumarin Derivatives: Although there is little substantiating evidence, opiate agonists have been reported to potentiate the anticoagulant activity of coumarin derivatives. Metoclopramide: Concurrent use with oxycodone may antagonise the effects of metoclopramide on gastrointestinal motility. Monoamine Oxidase Inhibitors (MAOIs): Non-selective MAOIs intensify the effects of opioid drugs which can cause anxiety, confusion and significant respiratory depression. Severe and sometimes fatal reactions have occurred in patients concurrently administered MAOIs and pethidine. Oxycodone should not be given to patients taking non-selective MAOIs or within 14 days of stopping such treatment. As it is unknown whether there is an interaction between selective MAOIs (e.g. selegiline) and oxycodone, caution is advised with this drug combination. Opioid Agonist Analgesics (including morphine, pethidine): Additive CNS depressant, respiratory depressant and hypotensive effects may occur if two or more opioid agonist analgesics are used concurrently. Caution For Usage Instructions on How Supplied/Storage and Handling: OxyContin Neo (oxycodone hydrochloride controlled-release) Tablets 10 mg are round, white-colored, bi-convex tablets debossed with OP on one side and 10 on the other and are supplied as child-resistant closure, opaque plastic bottles of 30 and 12, and unit dose packaging with 10 individually numbered tablets per card; three cards per glue end carton, two cards per glue end carton and one card per glue end carton. OxyContin Neo (oxycodone hydrochloride controlled-release) Tablets 20 mg are round, pink-colored, bi-convex tablets debossed with OP on one side and 20 on the other and are supplied as child-resistant closure, opaque plastic bottles of 30 and 12, and unit dose packaging with 10 individually numbered tablets per card; three cards per glue end carton, two cards per glue end carton and one card per glue end carton. OxyContin Neo (oxycodone hydrochloride controlled-release) Tablets 40 mg are round, yellow-colored, bi-convex tablets debossed with OP on one side and 40 on the other and are supplied as child-resistant closure, opaque plastic bottles of 30 and 12, and unit dose packaging with 10 individually numbered tablets per card; three cards per glue end carton, two cards per glue end carton and one card per glue end carton. OxyContin Neo (oxycodone hydrochloride controlled-release) Tablets 60 mg are round, red-colored, bi-convex tablets debossed with OP on one side and 60 on the other and are supplied as child-resistant closure, opaque plastic bottles of 30 and 12, and unit dose packaging with 10 individually numbered tablets per card; three cards per glue end carton, two cards per glue end carton and one card per glue end carton. OxyContin Neo (oxycodone hydrochloride controlled-release) Tablets 80 mg are round, green-colored, bi-convex tablets debossed with OP on one side and 80 on the other and are supplied as child-resistant closure, opaque plastic bottles of 30 and 12, and unit dose packaging with 10 individually numbered tablets per card; three cards per glue end carton, two cards per glue end carton and one card per glue end carton. 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What Is Oxycontin
OxyContin (oxycodone) is an opioid pain medication sometimes called a narcotic.
OxyContin is a strong prescription medicine used when an opioid medicine is needed to manage severe pain enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them. OxyContin is not to be used on an as-needed basis for pain that is not around-the-clock.
Warnings
You should not use OxyContin if you have severe asthma or breathing problems, or a blockage in your stomach or intestines. MISUSE OF OXYCONTIN CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Taking oxycodone during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Fatal side effects can occur if you use OxyContin with alcohol, or with other drugs that cause drowsiness or slow your breathing. Before taking this medicine You should not use OxyContin if you are allergic to oxycodone, or if you have: severe asthma or breathing problems; or a blockage in your stomach or intestines. You should not use OxyContin unless you are already using a similar opioid medicine and are tolerant to it. OxyContin should not be given to a child younger than 11 years old. To make sure this medicine is safe for you, tell your doctor if you have ever had: breathing problems, sleep apnea; a head injury, or seizures; drug or alcohol addiction, or mental illness; liver or kidney disease; urination problems; or problems with your gallbladder, pancreas, or thyroid. If you use OxyContin while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks. Ask a doctor before using oxycodone if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.
How should I use OxyContin?
Take OxyContin exactly as prescribed. Follow the directions on your prescription label and read all medication guides. Never use oxycodone in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of oxycodone. Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law. Stop taking all other around-the-clock opioid pain medicines when you start taking extended-release OxyContin. Swallow the extened release tablet whole to avoid exposure to a potentially fatal overdose. Do not crush, chew, break, or dissolve. Never crush or break an OxyContin tablet to inhale the powder or mix it into a liquid to inject the drug into your vein. This can result in death. You should not stop using OxyContin suddenly. Follow your doctor's instructions about tapering your dose. Store at room temperature, away from heat, moisture, and light. Keep track of your medicine. Oxycodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription. Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet. Detailed OxyContin dosage information What happens if I miss a dose? Since OxyContin is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An oxycodone overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing. Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive. Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.
What should I avoid while using OxyContin?
Do not drink alcohol. Dangerous side effects or death could occur. Avoid driving or operating machinery until you know how oxycodone will affect you. Dizziness or severe drowsiness can cause falls or other accidents. Avoid medication errors. Always check the brand and strength of oxycodone you get from the pharmacy. OxyContin side effects Get emergency medical help if you have signs of an allergic reaction to OxyContin: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up. Call your doctor at once if you have: noisy breathing, sighing, shallow breathing, breathing that stops during sleep; a slow heart rate or weak pulse; a light-headed feeling, like you might pass out; confusion, unusual thoughts or behavior; seizure (convulsions); low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or high levels of serotonin in the body - agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea. Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders. Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent. Common OxyContin side effects may include: drowsiness, headache, dizziness, tiredness; or constipation, stomach pain, nausea, vomiting. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
OxyContin side effects (more detail)
What other drugs will affect OxyContin? You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C. Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use: cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill"); medicines for motion sickness, irritable bowel syndrome, or overactive bladder; other opioids - opioid pain medicine or prescription cough medicine; a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others; drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting. This list is not complete and many other drugs may interact with oxycodone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here. Purchase Oxycontin 30mg Medicine Online
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What Is Oxycontin
OxyContin tablets contain oxycodone hydrochloride. Oxycodone belongs to a group of medicines called opioid analgesics.
OxyContin tablets are used to relieve severe pain when other forms of treatment have failed or are otherwise inappropriate to provide sufficient management of pain. Your doctor, however, may prescribe it for another purpose. Ask your doctor if you have any questions about why it has been prescribed for you. As with all strong painkillers, your body may become used to you taking OxyContin tablets. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking OxyContin tablets suddenly, so it is important to take it exactly as directed by your doctor. This medicine is only available with a doctor's prescription.
Before you take it
Long-term use of OxyContin tablets may result in a decrease in sex hormone levels which may affect sperm production in men and the menstrual cycles in females. Talk to your doctor if you have concerns. When you must not take it Do not take OxyContin tablets if you: have any breathing problems such as acute asthma, respiratory depression (breathing slows or weakens) or other obstructive airways disease are severely drowsy or have a reduced level of consciousness suffer from irregular heartbeats or changes in the way the heart beats have heart disease due to long term lung disease have just consumed a large amount of alcohol, regularly consume large amounts of alcohol or have confusion and shaking due to alcohol withdrawal suffer from convulsions, fits or seizures have a head injury, a brain tumour or have raised pressure within the head, brain or spinal cord have sudden, severe abdominal pain have a condition where your stomach empties more slowly than it should or any condition that obstructs the stomach/bowel or affects bowel transit (movement of food or ingested material along the bowel) have swallowing difficulties or narrowing of the oesophagus have severe liver or kidney disease are about to have an operation (including surgery on your spine for pain relief in the next 24 hours) or have had an operation within the last 24 hours take a medicine for depression called a 'monoamine oxidase inhibitor' or have taken any in the last two weeks. Do not take OxyContin tablets if you are allergic to oxycodone, opioid painkillers, or any of the ingredients listed at the end of this leaflet. Do not take this medicine after the expiry date (EXP) printed on the pack. If you take it after the expiry date has passed, it may not work very well. Do not take it if the packaging is torn or shows signs of tampering. Do not give this medicine to a child younger than 12 years of age. Safety and effectiveness in children younger than 12 years of age have not been established.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes. Tell your doctor if you have or have had any medical conditions, especially the following: Have sleep apnoea (temporarily stopping breathing while you sleep) low blood pressure increased prostate size or difficulty passing urine chronic lung, liver or kidney disease disease of your gall bladder or bile duct inflammation of the pancreas underactive adrenal glands underactive thyroid gland inflammatory bowel disease or recent abdominal surgery diverticulitis (inflammation of bowel wall) oesophageal, stomach or intestinal disorders (including cancer in these areas) resulting in narrowing of the oesophagus, stomach or intestines severe mental condition involving losing contact with reality, hearing voices or an inability to think clearly an addiction or history of abuse of alcohol, opioids or other drugs. Pregnancy and breastfeeding This medicine is not recommended to be taken during labour. Oxycodone given to the mother during labour may cause breathing problems and signs of withdrawal in the newborn. Tell your doctor if you are breastfeeding or planning to breastfeed. Oxycodone can pass into the breast milk and can affect the baby. Your doctor can discuss with you the risks involved. If you have not told your doctor about any of the above, tell them before you take any OxyContin tablets. Do not take this medicine if you are pregnant or intend to become pregnant whilst taking this medicine. Like most medicines of this kind, OxyContin tablets are not recommended to be taken during pregnancy. Your doctor will discuss the risks of taking it if you are pregnant.
Addiction
You can become addicted to OxyContin even if you take it exactly as prescribed. OxyContin may become habit forming causing mental and physical dependence. If abused it may become less able to reduce pain. Dependence As with all other opioid containing products, your body may become used to you taking OxyContin. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking OxyContin suddenly, so it is important to take it exactly as directed by your doctor. Tolerance Tolerance to OxyContin may develop, which means that the effect of the medicine may decrease. If this happens, more may be needed to maintain the same effect. Withdrawal Continue taking your medicine for as long as your doctor tells you. If you stop having this medicine suddenly, your pain may worsen and you may experience some or all of the following withdrawal symptoms: nervousness, restlessness, agitation, trouble sleeping or anxiety body aches, weakness or stomach cramps loss of appetite, nausea, vomiting or diarrhoea increased heart rate, breathing rate or pupil size watery eyes, runny nose, chills or yawning increased sweating. Taking other medicines Tell your doctor if you are taking any other medicines or dietary supplements, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines and OxyContin tablets may interfere with each other. These include: medicines to treat depression, psychiatric or mental disorders medicines to treat depression belonging to a group called 'monoamine oxidase inhibitors' must be stopped 14 days before OxyContin tablets are taken antidepressants e.g. fluoxetine, paroxetine medicines to help you sleep medicines to put you to sleep during an operation or procedure medicines to relax your muscles medicines to lower blood pressure quinidine and other medicines to treat the heart medicines to treat convulsions e.g. phenytoin, carbamazepine medicines to thin the blood e.g. coumarin derivatives such as warfarin cimetidine, a medicine to treat stomach ulcers or heartburn medicines to relieve stomach cramps or spasms, to prevent travel sickness or symptoms of allergies medicines to treat Parkinson's disease medicines to treat urinary incontinence medicines to stop nausea or vomiting e.g. metoclopramide other pain relievers including other opioids antifungals e.g. ketoconazole antibiotics e.g. clarithromycin, rifampin medicine to treat HIV infection and AIDS e.g. ritonavir alcohol St John's wort (a herbal preparation) grapefruit and grapefruit juice. medicines to treat epilepsy, pain, and anxiety e.g. gabapentin and pregabalin. These medicines, dietary supplements or alcohol may be affected by OxyContin tablets, may affect how well OxyContin tablets work or may increase side effects. You may need to use different amounts of your medicines, or take different medicines. Your doctor or pharmacist has more information on medicines and dietary supplements to be careful with or avoid while taking this medicine.
How to take OxyContin tablets
How much to take Your doctor will tell you exactly how much to take. Follow the instructions given to you by your doctor and pharmacist exactly. How to take it Swallow OxyContin tablets whole with a full glass of water or other fluid. OxyContin tablets should be taken one tablet at a time with enough water to ensure complete swallowing immediately after placing it in the mouth. Do not pre-soak, lick or wet the tablet before placing in your mouth. Do not break, cut, chew, crush or dissolve the tablets. OxyContin tablets are only designed to work properly if swallowed whole. The tablets may release all their contents at once if broken, cut, chewed, crushed or dissolved which can be dangerous and cause serious problems, such as an overdose, which may be fatal. If you have trouble swallowing your tablets whole, talk to your doctor. You must only take OxyContin tablets by mouth. Taking this medicine in a manner other than that prescribed by your doctor can be harmful to your health. There are no data on rectal administration of OxyContin tablets, therefore rectal administration of OxyContin tablets is not recommended. When to take it Take OxyContin tablets every 12 hours. Take OxyContin tablets regularly to control the pain. Taking them at the same time each day will assist in ensuring the best effect in improving your pain. If however, you begin to experience worsening pain and you are taking your OxyContin tablets as prescribed, contact your doctor as your dosage may have to be reviewed. How long to take it Continue taking your medicine for as long as your doctor tells you. If you stop taking this medicine suddenly, your pain may worsen and you may experience withdrawal symptoms such as: body aches loss of appetite, nausea, stomach cramps or diarrhoea fast heart rate sneezing or runny nose chills, tremors, shivering or fever trouble sleeping increased sweating and yawning weakness nervousness or restlessness. If you forget to take it If you forget to take your tablets, contact your doctor or pharmacist for advice. Do not take a double dose to make up for the dose you have missed. This will increase the chance of you getting unwanted side effects. If you have trouble remembering when to take your medicine, ask your pharmacist for hints. For example, take your medicine at the same time each morning and evening such as 8 a.m. and 8 p.m. If you take too much (overdose) If you or someone else receive too much (overdose), and experience one or more of the symptoms below, call triple zero (000) for an ambulance. Keep the person awake by talking to them or gently shaking them every now and then. You should follow the steps even if someone other than you have accidentally used OxyContin that was prescribed for you. If someone takes an overdose, they may experience one or more of the following symptoms: slow, unusual or difficult breathing drowsiness, dizziness or unconsciousness slow or weak heartbeat nausea or vomiting convulsions or fits If you think you or someone else may have taken too much OxyContin, you should immediately telephone your doctor or the Poisons Information Centre (Australia: telephone 13 11 26) , or go to Emergency Department at your nearest hospital. You should do this even if there are no signs of discomfort or poisoning. While you are taking it Things you must do Take OxyContin tablets exactly as your doctor has prescribed. Before you start on a new medicine, remind your doctor and pharmacist that you are taking OxyContin tablets. Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine. If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery. If you become pregnant while taking this medicine, tell your doctor immediately. Keep all of your doctor's appointments so that your progress can be checked. Tell your doctor if your pain is getting worse. Also tell your doctor if you are having any problems or difficulties while you are being treated with OxyContin tablets. Tolerance to oxycodone may develop which means that the effect of the medicine may decrease. If this happens, your doctor may review your dose so that you get adequate pain relief. Keep enough OxyContin tablets with you to last over weekends and holidays. Things you must not do Do not drink alcohol while you are taking OxyContin tablets. Drinking alcohol whilst taking OxyContin tablets may make you feel more sleepy and increase the risk of serious side effects, such as shallow breathing with the risk of stopping breathing and loss of consciousness. Do not take OxyContin tablets to treat any other complaint unless your doctor tells you to. Do not give your medicine to anyone else, even if they have the same condition as you. Do not stop taking your medicine, exceed the dose recommended or change the dosage without checking with your doctor. Over time your body may become used to oxycodone. If you stop taking it suddenly, your pain may worsen and you may experience unwanted side effects such as withdrawal symptoms. This is called physical dependence. If you need to stop taking this medicine, your doctor will gradually reduce the amount you take each day, if possible, before stopping the medicine completely. Things to be careful of Do not drive or operate machinery until you know how OxyContin tablets affect you. OxyContin tablets may cause drowsiness, dizziness, hallucinations, disorientation, blurred vision or other vision problems or may affect alertness. If you are affected, you should not drive or operate machinery. Discuss these effects with your doctor. Be careful if you are elderly, unwell or taking other medicines. Some people may experience side effects such as drowsiness, confusion, dizziness and unsteadiness, which may increase the risk of a fall. If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Standing up slowly will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor. Tell your doctor if you suffer from nausea or vomiting when taking OxyContin tablets. If you vomit after your dose, your pain may come back, as you may not have absorbed your medicine. If this happens, speak to your doctor. Your doctor may prescribe some medicine to help you stop vomiting. Tell your doctor if taking OxyContin tablets causes constipation. Your doctor can advise about your diet, the proper use of laxatives or alternative treatments, and suitable exercise you can do to help manage this. There is potential for abuse of oxycodone and the development of addiction to oxycodone. It is important that you discuss this issue with your doctor. Side effects All medicines may have some unwanted side effects. Sometimes they are serious but most of the time they are not. As for other medicines of this type, that is opioid analgesics, many side effects tend to reduce over time, with the exception of constipation. This means that the longer you take this medicine, the less it may cause problems for you. Your doctor has weighed the risks of this medicine against the benefits they expect it will have for you. Do not be alarmed by this list of possible side effects. Not everybody experiences them. Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking OxyContin tablets. This medicine helps most people with moderate to severe pain, but it may have unwanted side effects in a few people. Other side effects not listed here may also occur in some people. Ask your doctor or pharmacist to answer any questions you may have. Tell your doctor if you notice any of the following and they worry you: mild abdominal problems such as diarrhoea, feeling sick (nausea), decreased appetite or constipation dry mouth, hiccups, sore throat, or changes in voice excessive sweating feeling anxious or nervous, trouble sleeping or abnormal dreams trouble with your balance new problems with your eyesight skin rash, itching, chills or fever muscle problems such as spasms, twitching or tremors swelling of legs or ankles absence of menstrual periods impotence decreased sexual drive. Tell your doctor as soon as possible if you notice any of the following and they worry you: stomach discomfort, vomiting, indigestion or abdominal pain choking, gagging, regurgitation, tablets stuck in throat or trouble swallowing the tablets abnormal thinking, changes in mood or feeling deep sadness drowsiness, feeling faint or fainting, or dizziness especially when standing up slow or noticeable heartbeats headache or confusion unusual weakness, loss of strength or trouble walking fatigue, feeling of tiredness, drowsiness or lack of energy changes in passing urine such as the volume passed, pain or feeling the need to urinate urgently. The above list includes serious side effects that may require medical treatment. If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital: your breathing slows or weakens you have an allergic reaction: shortness of breath, wheezing, shallow or difficult breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin seizures, fits or convulsions fast or irregular heartbeats chest pain or chest tightness. The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. When seeking medical attention, take this leaflet and any remaining tablets with you to show the doctor. After taking it Storage Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the blister pack they may not keep as well. Keep your tablets in a cool, dry place, where the temperature stays below 25°C. Do not store it or any other medicine in the bathroom, near a sink or on a window sill. Do not leave it in the car on hot days. Heat and damp can destroy some medicines. Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines. Disposal If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal. Do not use this medicine after the expiry date. Product description What it looks like The reformulated OxyContin® tablets are round, film-coated tablets. They are available in six strengths which are as follows: 10 mg - white, marked "ON" on one side and 10 on the other 15 mg - grey, marked "ON" on one side and 15 on the other 20 mg - pink, marked "ON" on one side and 20 on the other 30 mg - brown, marked "ON" on one side and 30 on the other 40 mg - yellow, marked "ON" on one side and 40 on the other 80 mg - green, marked "ON" on one side and 80 on the other. OxyContin® tablets come in boxes containing blister packs of 28 tablets. Ingredients Active ingredients: 10 mg tablets contain 10 mg oxycodone hydrochloride 15 mg tablets contain 15 mg oxycodone hydrochloride 20 mg tablets contain 20 mg oxycodone hydrochloride 30 mg tablets contain 30 mg oxycodone hydrochloride 40 mg tablets contain 40 mg oxycodone hydrochloride 80 mg tablets contain 80 mg oxycodone hydrochloride. Inactive ingredients (reformulated tablets): polyethylene oxide butylated hydroxytoluene (BHT) magnesium stearate. In addition, the reformulated tablets also contain the ingredients listed below: 10 mg - Opadry White 15 mg - Opadry complete film coating system Grey 20 mg - Opadry Pink 30 mg - Opadry Brown 40 mg - Opadry Yellow 80 mg - Opadry Green. This medicine does not contain lactose, sucrose, gluten or tartrazine.
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What Is Oxycontin
This medication is used to help relieve severe ongoing pain (such as due to cancer). Oxycodone belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain.The higher strengths of this drug (more than 40 milligrams per tablet) should be used only if you have been regularly taking moderate to large amounts of an opioid pain medication. These strengths may cause overdose (even death) if taken by a person who has not been regularly taking opioids.Do not use the extended-release form of oxycodone to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.
Dosage Forms & Strengths
capsule, immediate-release: Schedule II 5mg tablet, immediate-release: Schedule II 5mg 10mg 15mg 20mg 30mg abuse deterrent tablet, immediate-release (Oxaydo): Schedule II 5mg 7.5mg Discourages intranasal abuse abuse deterrent tablet, immediate-release (RoxyBond): Schedule II 5mg 7.5mg Creates viscous material if mixed with liquid that does not pass through a needle abuse deterrent tablet, controlled-release (OxyContin): Schedule II 10mg 15mg 20mg 30mg 40mg 60mg 80mg abuse deterrent capsule, controlled-release (Xtampza ER): Schedule II 9mg (equivalent to 10 mg oxycodone HCl) 13.5mg (equivalent to 15 mg oxycodone HCl) 18mg (equivalent to 20 mg oxycodone HCl) 27mg (equivalent to 30 mg oxycodone HCl) 36mg (equivalent to 40 mg oxycodone HCl) Abuse-deterrent capsule utilizing DETERx technology platform to maintain its extended-release profile after being subjected to common methods of tampering oral concentrate: Schedule II 20mg/mL oral solution: Schedule II 5mg/5mL MORE... Moderate-to-Severe Pain Immediate-release Opioid-tolerant:: 10-30 mg PO q4-6hr Opioid-naïve (initial dose): 5-15 mg PO q4-6hr Chronic Severe Pain Controlled-release products (eg, OxyContin, Xtampza ER) are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Also see Administration
Initial dosing OxyContin Opioid-naïve patients: 10 mg PO q12hr initially; titrate gradually every 1-2 days, increasing by 25-50% increments, with q12hr dosing interval maintained A single dose >40 mg ER or total dose >80 mg ER are for use only in opioid-tolerant patients Xtampza ER Opioid-naïve patients: 9 mg PO q12hr with food Dosage Modifications Coadministration with other CNS depressants: Initiate long-acting oxycodone with one-third to one-half the recommended starting dose; monitor for signs of respiratory depression, sedation, and hypotension.
Conversion from other opioids to OxyContin
Provide immediate-release opioids for breakthrough pain Monitor patient closely for adverse effects or breakthrough pain during conversion and for several days following Also see Medscape reference topic - Opioid Equivalents Conversion from other oral oxycodone formulations Conversion from other oral oxycodone formulations: Administer one-half of the patient's total daily PO oxycodone dose as q12hr Conversion from fentanyl transdermal: Wait 18 hr after patch removed, then initiate conservative dose of ~10 mg q12hr oxycodone controlled-release for each 25 mcg/hr fentanyl transdermal patch Conversion from fentanyl transdermal Wait 18 hr after patch removed, then initiate conservative dose of ~10 mg q12hr oxycodone controlled-release for each 25 mcg/hr fentanyl transdermal patch Conversion from other opioids to Xtampza ER Conversion from other oral oxycodone formulations Administer one-half of the patient's total daily PO oxycodone dose as q12hr with food Because Xtampza ER is not bioequivalent to other oxycodone extended-release products Monitor patients for possible dosage adjustment Conversion from other opioids Discontinue all other around-the clock opioid drugs There are no established conversion ratios for conversion from other opioids to Xtampza ER defined by clinical trials Initiate dosing using 9 mg PO q12hr with food and provide immediate-release rescue medication while stabilizing patient on Xtampza ER Conversion from methadone Close monitoring is of particular importance when converting from methadone to other opioid agonists; the ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure and methadone has a long half-life and can accumulate in the plasma Conversion from fentanyl transdermal 18 hr following the removal of the transdermal fentanyl patch, initiate Xtampza ER; there has been no systematic assessment of such conversion, a conservative oxycodone dose, ~9 mg (equivalent to 10 mg oxycodone HCl) q12hr should be initially substituted for each 25 mcg/hr fentanyl transdermal patch Renal impairment CrCl <60 mL/min: Serum concentration may increase by 50%; adjust dosage to response Hepatic impairment Reduce dosage in liver disease; decrease dosage of extended-release form to 1/3 or 1/2 of usual starting dosage; titrate to response Alternative analgesics are recommended for patients who require a dose of Xtampza ER <9 mg Dosing Considerations Access to naloxone for opioid overdose Assess need for naloxone upon initiating and renewing treatment Consider prescribing naloxone Based on patient’s risk factors for overdose (eg, concomitant use of CNS depressants, a history of opioid use disorder, prior opioid overdose); presence of risk factors should not prevent proper pain management Household members (including children) or other close contacts at risk for accidental ingestion or overdose Consult patients and caregivers on the following: Availability of naloxone for emergency treatment of opioid overdose Ways differ on how to obtain naloxone as permitted by individual state dispensing and prescribing requirements or guidelines (eg, by prescription, directly from a pharmacist, as part of a community-based program).
Discontinuation
Use a gradual downward titration of the dosage to avoid signs and symptoms of withdrawal in the physically-dependent patient Do not abruptly discontinue Xtampza ER Opioid-tolerant definition Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression Patients who are opioid tolerant are those receiving, for 1 week or longer, at least 60 mg/day PO morphine, 25 mcg/hr transdermal fentanyl, 30 mg/day PO oxycodone, 8 mg/day PO hydromorphone, 25 mg/day PO oxymorphone, or an equianalgesic dose of another opioid Limitations of use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve for patients whom alternative treatment options (eg, nonopioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain Long-acting opioids are not indicated as a PRN analgesic. |
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