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All about: Opana ER Extended-Release Tablets

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

Opana ER Extended-Release Tablets is used to treat constant (around-the-clock), moderate to severe pain that is expected to last for an extended amount of time. Opana ER Extended-Release Tablets is not for patients who only need occasional or "as-needed" pain relief.

Opana ER Extended-Release Tablets must be swallowed whole. Do NOT break, crush, dissolve, or chew Opana ER Extended-Release Tablets before swallowing it. Do not drink alcohol or take medicines that contain alcohol while you are using Opana ER Extended-Release Tablets. Doing any of these things may cause Opana ER Extended-Release Tablets to be absorbed into the body too quickly. This could result in very serious side effects, including severe trouble breathing and death from overdose. If you are unsure if any of your medicines contain alcohol, check with your doctor or pharmacist.


Opana ER Extended-Release Tablets is used for:

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

Opana ER Extended-Release Tablets is an opioid (narcotic) analgesic. It works by binding to certain receptors in the brain and nervous system to reduce pain.

Do NOT use Opana ER Extended-Release Tablets if:

  • you are allergic to any ingredient in Opana ER Extended-Release Tablets 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 Opana ER Extended-Release Tablets:

Some medical conditions may interact with Opana ER 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), 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 Opana ER 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
  • 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 Opana ER 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 Opana ER 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 Opana ER Extended-Release Tablets:

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

  • Take Opana ER Extended-Release Tablets on an empty stomach at least 1 hour before or 2 hours after eating.
  • Opana ER Extended-Release Tablets must only be taken by mouth.
  • Swallow Opana ER Extended-Release Tablets whole. Do not break, crush, dissolve, or chew the tablet.
  • If you are taking Opana ER Extended-Release Tablets 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 Opana ER Extended-Release Tablets without checking with your doctor.
  • If you miss a dose of Opana ER Extended-Release Tablets 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 Opana ER Extended-Release Tablets.

Important safety information:

  • Opana ER Extended-Release Tablets 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 Opana ER 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, take medicines that contain alcohol, or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you take Opana ER Extended-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Opana ER Extended-Release Tablets 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.
  • Opana ER Extended-Release Tablets 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 Opana ER Extended-Release Tablets may cause severe side effects, including severe breathing problems, seizures, coma, and possibly death.
  • Constipation is a common side effect of Opana ER Extended-Release Tablets. Talk to your doctor about using laxatives or stool softeners to prevent or treat constipation while you use Opana ER 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 this medicine before you receive any medical or dental care, emergency care, or surgery.
  • Use Opana ER Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness, dizziness, confusion, and nausea.
  • Opana ER 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: Opana ER Extended-Release Tablets 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 Opana ER Extended-Release Tablets while you are pregnant. It is unknown if Opana ER Extended-Release Tablets is found in breast milk. Do not breast-feed while taking Opana ER Extended-Release Tablets.

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

Some people who use Opana ER 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 Opana ER Extended-Release Tablets regularly, do not suddenly stop taking it without checking with your doctor. WITHDRAWAL symptoms have occurred when Opana ER Extended-Release Tablets 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 Opana ER Extended-Release Tablets.

Possible side effects of Opana ER 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:

Anxiety; constipation; decreased appetite; 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 Opana ER Extended-Release Tablets:

Store Opana ER Extended-Release Tablets 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 Opana ER Extended-Release Tablets in the bathroom. Keep Opana ER Extended-Release Tablets out of the reach of children and away from pets. Once Opana ER Extended-Release Tablets is no longer needed, dispose of it by flushing it down the toilet.

General information:

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

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

Issue Date: September 5, 2007
Database Edition 07.3.1.003
Copyright © 2007 Wolters Kluwer Health, Inc.

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