Oxycodone sustained-release tablets

Pronunciation

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

Oxycodone sustained-release tablets is a narcotic pain medicine that may become habit-forming. Misuse or abuse can lead to overdose and death. Do NOT take more than the recommended dose, take for longer than prescribed, or take more often than prescribed without checking with your doctor.

Oxycodone sustained-release tablets may cause severe and sometimes fatal breathing problems. The risk may be greater when you first start this drug or with any increase in dose. Contact your doctor right away if you experience slow, shallow, or difficult breathing.

Be sure to swallow oxycodone sustained-release tablets whole. Do NOT break, crush, cut, dissolve, or chew oxycodone sustained-release tablets before swallowing it. Do NOT inject oxycodone sustained-release tablets. Doing any of these things could result in very serious side effects, including severe trouble breathing and death from overdose.

Accidental swallowing of oxycodone sustained-release tablets may be fatal, especially in children. Keep oxycodone sustained-release tablets out of the reach of children. Seek emergency medical care right away if another person swallows oxycodone sustained-release tablets.

Long-term use of oxycodone sustained-release tablets during pregnancy may cause dependence in the unborn baby. This can lead to withdrawal in the newborn, which can be life-threatening. Discuss any questions or concerns with your doctor.


Oxycodone sustained-release tablets is used for:

Managing moderate to severe pain when continuous (around-the-clock) treatment is needed for an extended period of time. Oxycodone sustained-release tablets is not for use right after surgery if you have not already been using narcotic pain medicines, if only occasional or "as-needed" pain relief is needed, or if the pain is mild or is not expected to last for an extended period of time.

Certain strengths of oxycodone sustained-release tablets should only be used by patients who have already been taking other narcotic pain medicine on a regular schedule and are tolerant to its effects. The use of these strengths by people who are not used to taking narcotic pain medicine may cause severe and sometimes fatal breathing problems.

Oxycodone sustained-release tablets is a narcotic (opioid) pain medicine. 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 narrowing of the stomach or bowels or known or suspected stomach or bowel blockage (eg, paralytic ileus)
  • you have slow, shallow, or difficult breathing
  • if you have severe lung problems (eg, severe asthma) or you are having an asthma attack
  • you are taking mixed agonist/antagonist pain medicines (eg, buprenorphine, butorphanol, nalbuphine, pentazocine) or sodium oxybate (GHB)
  • you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or have taken an MAOI within the last 14 days

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

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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 medicines (eg, morphine, hydromorphone); foods; or other substances
  • if you have a history of chronic obstructive pulmonary disease (COPD) or other lung or breathing problems (eg, asthma, emphysema, bronchitis), sleep apnea, curvature of the spine (scoliosis), a certain heart problem (cor pulmonale), high levels of carbon dioxide in the blood (hypercapnia or hypercarbia), or low levels of oxygen in the blood (hypoxia)
  • if you have severe drowsiness, a recent head injury, increased pressure in the brain, growths in the brain (eg, tumors, lesions), or a history of seizures
  • if you have a history of liver problems, kidney problems, thyroid problems, gallbladder problems, pancreas problems (eg, pancreatitis), urinary blockage or trouble urinating, an enlarged prostate, or stomach or bowel problems (eg, blockage, esophageal or colon cancer, inflammation)
  • if you have difficulty swallowing, constipation, low blood pressure, dehydration, low blood volume, poor health, or stomach pain
  • if you drink alcohol, have symptoms of alcohol withdrawal, or have a history of suicidal thoughts or attempts
  • if you or a member of your family has a history of mood or mental problems (eg, depression), or alcohol or other substance abuse or dependence
  • if you are very overweight, or have recently had or will be having surgery (eg, stomach or bowel surgery)
  • if you have never taken a narcotic pain medicine before
  • if you are taking carisoprodol

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:

  • Phenothiazines (eg, chlorpromazine) because the risk of low blood pressure may be increased
  • Sodium oxybate (GHB) because the risk of severe drowsiness, coma, confusion, or slowed or difficult breathing may be increased
  • Anticholinergics (eg, benztropine, scopolamine) because the risk of constipation and trouble urinating may be increased
  • Azole antifungals (eg, ketoconazole), macrolide antibiotics (eg, erythromycin), mifepristone, other narcotic pain medicines (eg, codeine, morphine), nefazodone, protease inhibitors (eg, boceprevir, ritonavir), or telithromycin because they may increase the risk of oxycodone sustained-release tablets's side effects
  • Carbamazepine, phenytoin, or rifamycins (eg, rifampin) because they may decrease oxycodone sustained-release tablets's effectiveness
  • Mixed agonist/antagonist pain medicines (eg, buprenorphine, butorphanol, nalbuphine, pentazocine) or naltrexone because they may decrease oxycodone sustained-release tablets's effectiveness and withdrawal may occur
  • Muscle relaxants (eg, cyclobenzaprine) because the risk of their side effects may be increased
  • Diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by oxycodone sustained-release tablets

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.
  • Oxycodone sustained-release tablets must only be taken by mouth. Do not inject oxycodone sustained-release tablets.
  • Swallow oxycodone sustained-release tablets whole. Do not break, cut, crush, chew, or dissolve the tablet before swallowing it. If you cannot swallow oxycodone sustained-release tablets whole, tell your doctor.
  • 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 presoak, 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.
  • Do not suddenly stop taking oxycodone sustained-release tablets. You may have an increased risk of withdrawal symptoms (eg, nausea, vomiting, diarrhea, anxiety, shivering). If you need to stop oxycodone sustained-release tablets, your doctor will gradually lower your dose.
  • Oxycodone sustained-release tablets works best if it is taken at the same time(s) each day. Do not miss any doses.
  • If you miss a dose of oxycodone sustained-release tablets, take it as soon as possible then take your next dose as directed by your doctor. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not take more than 1 dose in 12 hours.

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 light-headedness. 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 or take medicines (prescription or nonprescription) that contain alcohol while you are taking oxycodone sustained-release tablets. Check with your pharmacist if you have questions about whether any of your medicines contain alcohol.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking oxycodone sustained-release tablets; the risk of severe drowsiness or breathing problems may be increased. Ask your pharmacist if you have questions about which medicines may increase the risk of these effects.
  • 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 recommended dose, take for longer than prescribed, or take more often than prescribed without checking with your doctor.
  • If your pain continues or becomes worse or if you have side effects that concern you, contact 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.
  • Seek emergency medical care right away if another person swallows oxycodone sustained-release tablets. Accidental swallowing of oxycodone sustained-release tablets may be fatal, especially in children.
  • Use oxycodone sustained-release tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems.
  • Oxycodone sustained-release tablets should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in children have not been confirmed.
  • PREGNANCY AND BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using oxycodone sustained-release tablets while you are pregnant. Long-term use of oxycodone sustained-release tablets during pregnancy may cause dependence in the fetus or newborn. Discuss any questions or concerns with your doctor. Oxycodone sustained-release tablets is 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.

If you suddenly stop taking oxycodone sustained-release tablets, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid 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; mild itching; mild stomach pain; nausea; sweating; tiredness; 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, throat, or tongue); abnormal sighing; burning, numbness, or tingling; chest pain; confusion; difficulty urinating; fainting; fast, slow, or irregular heartbeat; fever or chills; hallucinations; memory problems; mental or mood changes (eg, agitation, depression); seizures; severe dizziness, drowsiness, or light-headedness; severe or persistent stomach pain, constipation, or vomiting; shortness of breath; slow, difficult, or shallow breathing; swelling of the hands, ankles, or feet; tremor; trouble talking, thinking, or walking; 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 bluish skin or nails; cold and clammy skin; coma; fainting; limp muscles; pinpoint or enlarged pupils; severe drowsiness, dizziness, or light-headedness; shortness of breath; slow or irregular heartbeat; slow, shallow, or difficult breathing.

Proper storage of oxycodone sustained-release tablets:

Store oxycodone sustained-release tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. 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 is 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 should not be used to decide whether or not to take oxycodone sustained-release tablets 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 oxycodone sustained-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to oxycodone sustained-release tablets. 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 oxycodone sustained-release tablets.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

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.

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