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Oxycodone sustained-release tablets


Generic Name: oxycodone (OX-i-KOE-done)
Brand Name: OxyContin

Oxycodone sustained-release tablets are a narcotic pain reliever that is similar to morphine and is used for around-the-clock treatment of moderate or severe pain. It should not be used to treat occasional pain; mild, short-term pain after surgery; or pain that occurs immediately after surgery or injuries.

Oxycodone sustained-release tablets should only be used by patients who have already been taking narcotic pain medicine and are tolerant to its effect. Use of oxycodone sustained-release tablets by people who are not used to taking narcotic pain medicine may cause severe and sometimes fatal breathing problems.

Swallow oxycodone sustained-release tablets whole. Do NOT break, crush, chew, dissolve, or split oxycodone sustained-release tablets. Doing so may cause the release of too much medicine into the bloodstream, which could be fatal.

Oxycodone sustained-release tablets may cause severe breathing problems. These effects may be worse if you take it with certain other medicines. Ask your doctor or pharmacist if you have questions about which medicines may add to this effect. Contact your doctor right away if you experience slow or shallow breathing.

Oxycodone sustained-release tablets are used for:

Treating moderate to severe pain when around-the-clock pain medicine is needed for an extended period of time.

Oxycodone sustained-release tablets are a narcotic (opioid) pain reliever. It works in the brain and nervous system to reduce pain.

Do NOT use oxycodone sustained-release tablets if:

  • you are allergic to any ingredient in oxycodone sustained-release tablets
  • you have known or suspected bowel blockage (eg, paralytic ileus)
  • you have very slow or difficult breathing, severe asthma, or you are having an asthma attack
  • you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
  • you are taking another around-the-clock opioid pain medicine

Contact your doctor or health care provider right away if any of these apply to you.

Before using oxycodone sustained-release tablets:

Some medical conditions may interact with oxycodone sustained-release tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, especially other narcotic pain relievers (eg, morphine, hydromorphone); foods; or other substances
  • if you have a history of asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems
  • if you have a history of recent head injury, increased pressure in the brain, growths in the brain (eg, tumors, lesions), or seizures
  • if you have a history of heart problems, low blood pressure, liver problems, kidney problems, thyroid problems, adrenal gland problems (eg, Addison disease), curvature of the spine, gallbladder problems, prostate problems, trouble urinating, or the blood disease porphyria
  • if you have a history of stomach or bowel problems (eg, inflammation, blockage, esophagus or colon cancer) or surgery
  • if you have difficulty swallowing, severe drowsiness, constipation, low blood oxygen levels, high blood carbon dioxide levels, low blood volume, inflammation of the pancreas, a certain type of severe or persistent diarrhea (pseudomembranous colitis), or stomach pain
  • if you have a history of mood or mental problems (eg, depression, hallucinations), suicidal thoughts or behavior, drug or alcohol abuse, or if you are in alcohol or drug withdrawal
  • if a member of your family has a history of mental or mood problems or drug or alcohol abuse

Some MEDICINES MAY INTERACT with oxycodone sustained-release tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Azole antifungals (eg, ketoconazole), cimetidine, furazolidone, macrolide antibiotics (eg, erythromycin), MAOIs (eg, phenelzine), nefazodone, phenothiazines (eg, chlorpromazine), protease inhibitors (eg, boceprevir, ritonavir), sodium oxybate (GHB), telithromycin, or certain medicines for nausea and vomiting (eg, ondansetron) because the risk of side effects, such as severe drowsiness, slow or difficult breathing, confusion, and seizures, may be increased
  • Carbamazepine, mixed narcotic agonists/antagonists (eg, buprenorphine, butorphanol, pentazocine), naltrexone, phenytoin, or rifamycins (eg, rifampin) because they may decrease oxycodone sustained-release tablets's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if oxycodone sustained-release tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use oxycodone sustained-release tablets:

Use oxycodone sustained-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Oxycodone sustained-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get oxycodone sustained-release tablets refilled.
  • Take oxycodone sustained-release tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Swallow oxycodone sustained-release tablets whole. Do not break, crush, chew, dissolve, or split before swallowing.
  • Some patients have reported trouble swallowing oxycodone sustained-release tablets. These reports have included choking, gagging, spitting tablets back up, and getting tablets stuck in the throat. To decrease these risks, take oxycodone sustained-release tablets 1 tablet at a time if your dose calls for more than 1 tablet. Do not pre-soak, lick, or wet the tablet before you place it in your mouth. Take each tablet with enough water to be sure that you swallow it completely. Swallow oxycodone sustained-release tablets immediately after you place it in your mouth.
  • Take oxycodone sustained-release tablets on a regular schedule to get the most benefit from it. It is more effective in preventing pain than in treating pain after it occurs.
  • Tell your doctor if your pain gets worse or if you have breakthrough pain while taking oxycodone sustained-release tablets.
  • Do not suddenly stop taking oxycodone sustained-release tablets. You may experience withdrawal symptoms. If you need to stop oxycodone sustained-release tablets, your doctor will gradually lower your dose.
  • If oxycodone sustained-release tablets are no longer needed, dispose of it as soon as possible by flushing it down the toilet. You may also check with your pharmacist for other ways to dispose of oxycodone sustained-release tablets.
  • If you miss a dose of oxycodone sustained-release tablets, take it as soon as possible. Take your next dose 12 hours later. Do not take 2 doses at once. Call your doctor if you miss a dose and you are not sure what to do.

Ask your health care provider any questions you may have about how to use oxycodone sustained-release tablets.

Important safety information:

  • Oxycodone sustained-release tablets may cause dizziness, drowsiness, or changes in judgment. These effects may be worse if you take it with alcohol or certain medicines. Use oxycodone sustained-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol while you are taking oxycodone sustained-release tablets.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using oxycodone sustained-release tablets; they may add to oxycodone sustained-release tablets's effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Oxycodone sustained-release tablets may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Oxycodone sustained-release tablets may cause constipation. Talk with your doctor or pharmacist about using a stool softener or laxative to prevent constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation. If you become constipated while taking oxycodone sustained-release tablets, talk with your doctor or pharmacist.
  • Do NOT take more than the prescribed dose or use for longer than prescribed without checking with your doctor.
  • Tell your doctor or dentist that you take oxycodone sustained-release tablets before you receive any medical or dental care, emergency care, or surgery.
  • Use oxycodone sustained-release tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially severe breathing problems.
  • Oxycodone sustained-release tablets should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using oxycodone sustained-release tablets while you are pregnant. Oxycodone sustained-release tablets are found in breast milk. Do not breast-feed while taking oxycodone sustained-release tablets.

When used for long periods of time or at high doses, oxycodone sustained-release tablets may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if oxycodone sustained-release tablets stops working well. Do not take more than prescribed.

Some people who use oxycodone sustained-release tablets for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

Do not suddenly stop taking oxycodone sustained-release tablets. If you do, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; fast or irregular heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of oxycodone sustained-release tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; dry mouth; headache; nausea; sweating; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal snoring or sighing; confusion; difficulty urinating; fainting; fast, slow, or irregular heartbeat; hallucinations; mental or mood changes; seizures; severe dizziness, drowsiness, or light-headedness; severe or persistent stomach pain, nausea, or constipation; shortness of breath; slow or shallow breathing; tremor; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include abnormal snoring; cold and clammy skin; decreased pupil size; loss of consciousness; seizures; severe drowsiness, dizziness, or lightheadedness; severe weakness; slow heartbeat; slow, shallow, or difficult breathing.

Proper storage of oxycodone sustained-release tablets:

Store oxycodone sustained-release tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from light, heat, and moisture. Do not store in the bathroom. Keep oxycodone sustained-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about oxycodone sustained-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Oxycodone sustained-release tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about oxycodone sustained-release tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Review Date: July 5, 2017

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.