Oxymorphone extended-release tabletsPronunciation
Generic Name: oxymorphone (OX-i-MOR-fone)
Brand Name: Opana ER
Oxymorphone extended-release tablets are 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.
Oxymorphone extended-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 oxymorphone extended-release tablets whole. Do NOT break, crush, cut, dissolve, or chew oxymorphone extended-release tablets before swallowing it. Do NOT inject or snort oxymorphone extended-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 even one dose of oxymorphone extended-release tablets may be fatal, especially in children. Keep oxymorphone extended-release tablets out of the reach of children. Seek emergency medical care right away if another person swallows oxymorphone extended-release tablets.
Do NOT drink alcohol or take medicines (prescription or nonprescription) that contain alcohol while you are taking oxymorphone extended-release tablets. This could cause a fatal overdose. If you are unsure if any of your medicines contain alcohol, check with your doctor or pharmacist.
Long-term use of oxymorphone extended-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.
Oxymorphone extended-release tablets are used for:
Managing severe pain. Oxymorphone extended-release tablets are only for use when continuous (around-the-clock) treatment is needed for a long time. It is also only for use when other pain treatments do not treat your pain well enough or you cannot take them. It is NOT for use right after surgery if you have not already been using narcotic pain medicines, if you need only occasional or as-needed pain relief, or if the pain is mild or is not expected to last for a long time.
Oxymorphone extended-release tablets are a narcotic (opioid) pain medicine. 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, shallow, or slowed breathing, high levels of carbon dioxide in the blood (hypercapnia or hypercarbia), or severe lung problems (eg, severe asthma), or if you are having an asthma attack
- you have moderate to severe liver problems
- you have narrowing of the stomach or bowels, or known or suspected stomach or bowel blockage (eg, paralytic ileus)
- you are taking buprenorphine, a mixed agonist/antagonist pain medicine (eg, butorphanol, nalbuphine, pentazocine), or 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.
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 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), hypercapnia or hypercarbia, or low levels of oxygen in the blood (hypoxia)
- if you have severe drowsiness, a recent head injury, growths in the brain (eg, lesions, tumors), increased pressure in the brain, or a history of seizures (eg, epilepsy)
- if you have a history of liver or kidney problems, gallbladder problems, pancreas problems (eg, pancreatitis), thyroid problems, a urinary blockage or trouble urinating, esophagus or colon cancer, or stomach or bowel problems (eg, inflammation, blockage)
- if you have low blood pressure, dehydration, low blood volume, constipation, stomach pain, poor health, or trouble swallowing
- 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 mental or mood 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 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 constipation and trouble urinating may be increased
- MAOIs (eg, phenelzine) because the risk of a severe reaction, including fever, seizures, and coma, may be increased
- Other narcotic pain medicines (eg, morphine, oxycodone) because they may increase the risk of oxymorphone extended-release tablets's side effects
- Buprenorphine, mixed agonist/antagonist pain medicines (eg, butorphanol, nalbuphine, 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. Do not inject or snort oxymorphone extended-release tablets.
- Swallow oxymorphone extended-release tablets whole. Do not break, cut, crush, dissolve, or chew the tablet before swallowing it. 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.
- Do not suddenly stop taking oxymorphone extended-release tablets. You may have an increased risk of withdrawal symptoms (eg, nausea, vomiting, diarrhea, anxiety, shivering). If you need to stop oxymorphone extended-release tablets, your doctor will gradually lower your dose.
- Oxymorphone extended-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 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. Do not take more than your prescribed dose in 24 hours.
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, 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 (prescription or nonprescription) that contain alcohol while you take oxymorphone extended-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 oxymorphone extended-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.
- 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.
- Do NOT take more than the recommended dose, take for longer than prescribed, or take more often than prescribed without checking with your doctor.
- Oxymorphone extended-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 oxymorphone extended-release tablets, talk with your doctor or pharmacist.
- You may notice undissolved parts of oxymorphone extended-release tablets in your stool. This is normal and not a cause for concern.
- 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 think you may be 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 this medicine is 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. If you suddenly stop taking oxymorphone extended-release tablets, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea and vomiting; pain; rapid heartbeat; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; decreased appetite; diarrhea; dizziness; drowsiness; dry mouth; headache; mild itching; mild stomach pain; nausea; tiredness; trouble sleeping; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); abnormal sighing; chest pain; confusion; fainting; fast, slow, or irregular heartbeat; fever; hallucinations; memory problems; mental or mood changes (eg, agitation, depression); seizure; severe or persistent constipation, stomach pain, or vomiting; severe or persistent dizziness, drowsiness, headache, or light-headedness; 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.
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; difficult, shallow, or slow breathing; fainting; limp muscles; pinpoint or enlarged pupils; severe drowsiness, dizziness, or light-headedness; shortness of breath; slow or irregular heartbeat.Proper storage of oxymorphone extended-release tablets:
Store oxymorphone extended-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 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.
- 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 should not be used to decide whether or not to take oxymorphone extended-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 oxymorphone extended-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to oxymorphone extended-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 oxymorphone extended-release tablets.
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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