Oxymorphone Extended-Release Tablets

Oxymorphone Extended-Release Tablets are used for:

Treating pain in adults with constant (around-the-clock), moderate to severe pain that is expected to last for an extended amount of time. Oxymorphone Extended-Release Tablets are not for use right after surgery if you have not already been using narcotic pain relievers, or if the pain is mild or not expected to last for an extended period of time.

Oxymorphone Extended-Release Tablets are an opioid (narcotic) analgesic. It works in the brain and nervous system to reduce pain.

Do NOT use Oxymorphone Extended-Release Tablets if:

• you are allergic to any ingredient in Oxymorphone Extended-Release Tablets or any other codeine- or morphine-related medicine (eg, oxycodone)
• you have difficult or slowed breathing, high levels of carbon dioxide in the blood, or severe asthma, or you are having an asthma attack
• you are in labor
• you have moderate to severe liver problems
• you have a certain severe bowel problem (paralytic ileus)
• you are taking sodium oxybate (GHB)
• you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) 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 Oxymorphone Extended-Release Tablets:

Some medical conditions may interact with Oxymorphone Extended-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, foods, or other substances
• if you have a history of lung or breathing problems (eg, asthma, emphysema, bronchitis, chronic obstructive pulmonary disease [COPD]), sleep apnea (you stop breathing when you sleep), curvature of the spine (eg, kyphoscoliosis), heart problems (eg, cor pulmonale), low blood pressure, dehydration, or low blood volume
• if you have severe drowsiness, a recent head injury, growths in the brain, increased pressure in the brain, or a history of seizures (eg, epilepsy)
• if you have liver or kidney problems, gallbladder or pancreas problems, adrenal gland problems (eg, Addison disease), thyroid problems, an enlarged prostate, a urinary blockage or trouble urinating, stomach pain, or stomach or bowel problems (eg, inflammation, blockage), or if you have had recent stomach or bowel surgery
• 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 had a history of mental or mood problems, alcohol abuse, or other substance abuse or dependence
• if you are in poor health or shock, are very overweight, have trouble swallowing, or will be having surgery

Some MEDICINES MAY INTERACT with Oxymorphone Extended-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
• Cimetidine or sodium oxybate (GHB) because the risk of severe drowsiness, coma, confusion, or slowed or difficult breathing may be increased
• Anticholinergics (eg, scopolamine, benztropine) because the risk of severe constipation or trouble urinating may be increased
• MAOIs (eg, phenelzine) because the risk of a severe reaction, including fever, seizures, and coma, may be increased
• Agonist/antagonist analgesics (eg, buprenorphine, pentazocine) or naltrexone because they may decrease Oxymorphone Extended-Release Tablets's effectiveness and withdrawal may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Oxymorphone Extended-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 Oxymorphone Extended-Release Tablets:

Use Oxymorphone Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Oxymorphone Extended-Release Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Oxymorphone Extended-Release Tablets refilled.
• Take Oxymorphone Extended-Release Tablets on an empty stomach at least 1 hour before or 2 hours after eating.
• Oxymorphone Extended-Release Tablets must only be taken by mouth.
• Swallow Oxymorphone Extended-Release Tablets whole. Do not break, cut, crush, dissolve, or chew the tablet. If you cannot swallow Oxymorphone Extended-Release Tablets whole, tell your doctor.
• Do not swallow more than 1 tablet at a time. If your dose requires more than 1 tablet, swallow each tablet separately.
• 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 Oxymorphone Extended-Release Tablets immediately after you place it in your mouth.
• Tell your doctor if your pain gets worse or if you have breakthrough pain while taking Oxymorphone Extended-Release Tablets.
• Do not suddenly stop taking Oxymorphone Extended-Release Tablets. You may have an increased risk of withdrawal symptoms (eg, nausea, sweating, pain). If you need to stop Oxymorphone Extended-Release Tablets, your doctor will gradually lower your dose.
• If Oxymorphone Extended-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 Oxymorphone Extended-Release Tablets.
• If you miss a dose of Oxymorphone Extended-Release Tablets, take it as soon as possible. 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.

Ask your health care provider any questions you may have about how to use Oxymorphone Extended-Release Tablets.

Important safety information:

• Oxymorphone Extended-Release Tablets may cause drowsiness, dizziness, blurred vision, or light-headedness. These effects may be worse if you take it with alcohol, other opiate pain medicines, or certain other medicines. Use Oxymorphone Extended-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 that contain alcohol while you take Oxymorphone Extended-Release Tablets.
• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Oxymorphone Extended-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Oxymorphone Extended-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.
• Oxymorphone Extended-Release Tablets may be habit forming. Do NOT take more than the recommended dose, change your dose, use more often than prescribed, or use for longer than prescribed without checking with your doctor. Misuse or abuse of Oxymorphone Extended-Release Tablets may cause severe side effects, including severe breathing problems, seizures, coma, and possibly death.
• Constipation is a common side effect of Oxymorphone Extended-Release Tablets. Talk to your doctor about using laxatives or stool softeners to prevent or treat constipation while you use Oxymorphone Extended-Release Tablets.
• 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 Oxymorphone Extended-Release Tablets before you receive any medical or dental care, emergency care, or surgery.
• Seek emergency medical care right away if another person swallows Oxymorphone Extended-Release Tablets. Accidental swallowing of Oxymorphone Extended-Release Tablets may be fatal, especially in children.
• Use Oxymorphone Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems, drowsiness, dizziness, confusion, and nausea.
• Oxymorphone Extended-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 Oxymorphone Extended-Release Tablets while you are pregnant. Long-term use of Oxymorphone Extended-Release Tablets during pregnancy may cause dependence in the fetus or newborn. Discuss any questions or concerns with your doctor. It is not known if Oxymorphone Extended-Release Tablets are found in breast milk. If you are or will be breast-feeding while you use Oxymorphone Extended-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Oxymorphone Extended-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 Oxymorphone Extended-Release Tablets stops working well. Do not take more than prescribed.

Some people who use Oxymorphone Extended-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. Dependence is unlikely to be an issue in terminally ill patients where comfort is more important. If you are taking Oxymorphone Extended-Release Tablets regularly, do not suddenly stop taking it without checking with your doctor. WITHDRAWAL symptoms have occurred when Oxymorphone Extended-Release Tablets are suddenly stopped and may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea and vomiting; pain; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping. Contact your doctor if you notice any of these symptoms after stopping Oxymorphone Extended-Release Tablets.

Possible side effects of Oxymorphone Extended-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; decreased appetite; diarrhea; dizziness; drowsiness; dry mouth; headache; mild stomach pain; nausea; sweating; tiredness; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; fainting; fast, slow, or irregular heartbeat; fever; hallucinations; mental or mood changes; seizure; severe or persistent constipation, stomach pain, or vomiting; severe or persistent dizziness, drowsiness, or headache; shallow, slowed, or difficult breathing; shortness of breath; trouble urinating; unusual swelling; vision changes (eg, blurred vision).

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.

See also: Oxymorphone side effects (in more detail)

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; chest, jaw, or arm pain; cold and clammy skin; coma; difficult or slow breathing; fainting; limp muscles; pinpoint pupils; severe drowsiness or dizziness; shortness of breath; slow or irregular heartbeat; sudden severe nausea or vomiting; sudden unusual sweating or weakness.

Store Oxymorphone Extended-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store Oxymorphone Extended-Release Tablets in the bathroom. Keep Oxymorphone Extended-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Oxymorphone Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Oxymorphone Extended-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 Oxymorphone Extended-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.