Oxymorphone Tablets

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Oxymorphone


Generic Name: Oxymorphone Tablets (OX-i-MOR-fone)
Brand Name: Opana

Oxymorphone is used for:

Treating moderate to severe pain in certain patients.

Oxymorphone is an opioid (narcotic) analgesic. It works by binding to certain receptors in the brain and nervous system to reduce pain.

Do NOT use Oxymorphone if:

  • you are allergic to any ingredient in Oxymorphone or any other codeine- or morphine-related medicine (eg, morphine, codeine, 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 severe diarrhea, bowel problems caused by antibiotics or food poisoning, or certain other severe bowel problems (eg, paralytic ileus)
  • you are taking sodium oxybate (GHB) or an agonist/antagonist analgesic (eg, pentazocine)

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

Before using Oxymorphone:

Some medical conditions may interact with Oxymorphone. 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), an underactive thyroid, an enlarged prostate, a urinary blockage, or stomach or bowel problems (eg, inflammation), or if you have had recent stomach or bowel surgery.
  • if you drink alcohol regularly, have symptoms of alcohol withdrawal, or have a history of suicidal thoughts or attempts
  • if you have a personal or family 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, or will be having surgery

Some MEDICINES MAY INTERACT with Oxymorphone. 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
  • Barbiturate anesthetics (eg, thiopental), 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
  • Monoamine oxidase (MAO) inhibitors (eg, phenelzine) because the risk of a severe reaction including fever, seizures, and coma may be increased
  • Agonist/antagonist analgesics (eg, pentazocine) or naltrexone because they may decrease Oxymorphone"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 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:

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

  • Take Oxymorphone on an empty stomach at least 1 hour before or 2 hours after eating.
  • Oxymorphone must only be taken by mouth.
  • If you are taking Oxymorphone for persistent pain, take it on a regular schedule to help control the pain more effectively.
  • Do not change your dose or suddenly stop taking Oxymorphone without checking with your doctor.
  • If you miss a dose of Oxymorphone and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

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

Important safety information:

  • Oxymorphone may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol, other opiate pain medicines, or certain other medicines. Use Oxymorphone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you take Oxymorphone; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Oxymorphone may cause dizziness, lightheadedness, 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 may be habit forming. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Misuse or abuse of Oxymorphone may cause severe side effects, including severe breathing problems, seizures, coma, and possibly death.
  • Constipation is a common side effect of Oxymorphone. Talk to your doctor about using laxatives or stool softeners to prevent or treat constipation while you use Oxymorphone.
  • 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 before you receive any medical or dental care, emergency care, or surgery.
  • Use Oxymorphone with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness, dizziness, confusion, and nausea.
  • Oxymorphone 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: Oxymorphone may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Oxymorphone while you are pregnant. It is unknown if Oxymorphone is found in breast milk. Do not breast-feed while taking Oxymorphone.

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

Some people who use Oxymorphone 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 regularly, do not suddenly stop taking it without checking with your doctor. WITHDRAWAL symptoms have occurred when Oxymorphone is 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.

Possible side effects of Oxymorphone:

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:

Anxiety; constipation; dizziness; drowsiness; dry mouth; gas; headache; lightheadedness; nausea; sweating; vomiting.

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); confusion; fainting; fast, slow, or irregular heartbeat; fever; hallucinations; mental or mood changes; seizure; severe or persistent dizziness or drowsiness; severe or persistent headache or vomiting; shallow, slowed, or difficult breathing; trouble urinating; unusual swelling; vision changes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include bluish skin; chest pain; cold/clammy skin; coma; difficult or slow breathing; limp muscles; numbness of an arm or leg; pinpoint pupils; severe drowsiness or dizziness; slow or irregular heartbeat.

Proper storage of Oxymorphone:

Store Oxymorphone at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store Oxymorphone in the bathroom. Keep Oxymorphone out of the reach of children and away from pets. Once Oxymorphone is no longer needed, dispose of it by flushing it down the toilet.

General information:

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

This information is a summary only. It does not contain all information about Oxymorphone. 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.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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