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IMPORTANT SAFETY INFORMATION

Opana® ER has a boxed warning as follows:

WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE.


Potential for Abuse

  • OPANA® ER contains oxymorphone, which is a morphine-like opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics.
  • Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OPANA® ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

Proper Patient Selection

  • OPANA® ER is an extended-release oral formulation of oxymorphone indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Limitations of Use

  • OPANA® ER is NOT intended for use as an as needed analgesic.
  • OPANA® ER TABLETS are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed OPANA® ER TABLETS leads to rapid release and absorption of a potentially fatal dose of oxymorphone.
  • Patients must not consume alcoholic beverages, or prescription or non-prescription medications containing alcohol, while on OPANA® ER therapy. The co-ingestion of alcohol with OPANA® ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone.

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Close Safety Info

Opana® ER has a boxed warning as follows:

WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE.

Potential for Abuse

OPANA® ER contains oxymorphone, which is a morphine-like opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics.

Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OPANA® ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

Proper Patient Selection

OPANA® ER is an extended-release oral formulation of oxymorphone indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Limitations of Use

OPANA® ER is NOT intended for use as an as needed analgesic.

OPANA® ER TABLETS are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed OPANA® ER TABLETS leads to rapid release and absorption of a potentially fatal dose of oxymorphone.

Patients must not consume alcoholic beverages, or prescription or non-prescription medications containing alcohol, while on OPANA® ER therapy. The co-ingestion of alcohol with OPANA® ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone.

CONTRAINDICATIONS

  • OPANA® ER is contraindicated in patients with a known hypersensitivity to oxymorphone hydrochloride, morphine analogs such as codeine, or any of the other ingredients of OPANA ER; in patients with moderate or severe hepatic impairment or in any situation where opioids are contraindicated such as: patients with respiratory depression (in the absence of resuscitative equipment or in unmonitored settings), acute or severe bronchial asthma, hypercarbia, and in any patient who has or is suspected of having paralytic ileus.
  • OPANA ER is not indicated for pain in the immediate post-operative period or if the pain is mild, or not expected to persist for an extended period of time. OPANA ER is only indicated for post-operative use if the patient is already receiving the drug prior to surgery or if the post-operative pain is expected to be moderate or severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate (see American Pain Society guidelines). OPANA ER is not indicated for pre-emptive analgesia (administration pre-operatively for the management of post-operative pain).

WARNINGS

  • Respiratory depression is the chief hazard of OPANA ER, particularly in elderly or debilitated patients.
  • OPANA ER should be administered with extreme caution to patients with conditions accompanied by hypoxia, hypercapnia, or decreased respiratory reserve.
  • Patients receiving other opioid analgesics, general anesthetics, phenothiazines or other tranquilizers, sedatives, hypnotics, or other CNS depressants (including alcohol) may experience additive effects resulting in respiratory depression, hypotension, profound sedation, coma or death.
  • In the presence of head injury, the respiratory depressant effects of OPANA ER and the potential to elevate cerebrospinal fluid pressure may be markedly exaggerated.
  • OPANA ER may cause severe hypotension in patients with compromised ability to maintain blood pressure. Administer with caution to patients in circulatory shock.
  • Prolonged gastric obstruction may occur in patients with gastrointestinal obstruction, especially paralytic ileus.
  • Use with caution in patients with biliary tract disease, as it may cause spasm of the sphincter of oddi.
  • Opioid analgesics impair the mental and physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.
  • OPANA ER is not recommended during labor and delivery, pregnancy, or nursing.
  • OPANA ER should be used with caution in elderly and debilitated patients and in patients who are known to be sensitive to CNS depressants, such as those with cardiovascular, pulmonary, renal, or hepatic disease. OPANA ER should be used with caution in patients with mild hepatic impairment and in patients with moderate to severe renal impairment. These patients should be started cautiously with lower doses of OPANA ER while carefully monitoring for side effects.
  • Patients and their families should be instructed to flush any OPANA ER tablets that are no longer needed.

ADVERSE REACTIONS

  • Adverse reactions reported at (≥2%) in placebo-controlled trials were: nausea, constipation, dizziness, somnolence, vomiting, pruritus, headache, sweating increased, dry mouth, sedation, diarrhea, insomnia, fatigue, appetite decreased, and abdominal pain.
  • In clinical trials there were several adverse events that were more frequently observed in subjects 65 and over compared to younger subjects. These adverse events included dizziness, somnolence, confusion, and nausea.

DRUG INTERACTIONS

  • CNS depressants: Increased risk of respiratory depression, hypotension, profound sedation, coma or death. When combined therapy with CNS depressant is contemplated, the dose of one or both agents should be reduced. Mixed agonist/antagonist opioids (i.e., pentazocine, nalbuphine, and butorphanol): May reduce analgesic effect and/or precipitate withdrawal symptoms. Cimetidine: Combination use may precipitate confusion, disorientation, respiratory depression, apnea, seizures. Anticholinergics: May result in urinary retention and/or severe constipation, which may lead to paralytic ileus. Monoamine oxidase inhibitors (MAOIs): Potentiate the action of opioids. OPANA ER should not be used in patients taking MAOIs or within 14 days of stopping such treatment.

Please see full Prescribing Information, including boxed WARNING for Opana® ER.

Oxymorphone is also available in immediate release tablets and injectable form. For more information, please see full Prescribing Information for Opana® Tablets and Opana® Injection.

Vermont prescribers, please see additional information for Opana® ER.



ABOUT OPANA® ER

The challenges of treating chronic pain are complex. Opana ER has been developed to help manage many of those challenges. Read the Patient Information that comes with Opana® ER before you start taking it and each time you get a new prescription. There may be new information. This information does not take the place of talking with your healthcare professional about your medical condition or your treatment. Share the important information on this website with members of your household. For a complete list of questions and precautions for Opana® ER, please review the full Prescribing Information.

IMPORTANT: Keep Opana® ER in a safe place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidentally takes Opana® ER, get emergency help right away.

What is the most important information I should know about Opana® ER?

  • Opana® ER can cause trouble breathing (hypoventilation), which can lead to death, if used differently than the way you were told to use it by your healthcare provider (see "What are the possible side effects of Opana ER?").
  • Swallow Opana® ER tablets whole. Do not break, crush, dissolve, or chew Opana ER tablets before swallowing. If a tablet is broken, crushed, dissolved, or chewed, the full 12 hour dose can be taken into your body all at once. This is very dangerous. You could die from an overdose of the medicine. Use Opana ER exactly the way your healthcare provider prescribes. If you cannot swallow tablets whole, tell your healthcare provider. You may need a different medicine.
  • Do not consume alcoholic beverages, or prescription or non-prescription medications containing alcohol, while taking Opana® ER.

What is Opana® ER?

  • Opana ER is a prescription medicine that contains the opioid (narcotic pain medicine) oxymorphone. Opana ER is used to treat adults with constant pain (around the clock) that is moderate to severe and is expected to last for an extended period of time. Opana® ER is not for occasional ("as needed") use.
  • Opana® ER can cause physical dependence. Do not stop taking Opana ER all of a sudden if you have been taking it for more than a few days. You could become sick with uncomfortable withdrawal symptoms because your body has become used to the medicine. Talk to your healthcare provider about slowly stopping Opana ER to avoid getting sick with withdrawal symptoms. Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.
  • Opana® ER is a controlled substance (CII) because it contains a narcotic painkiller that can be a target for people who abuse prescription medicines or street drugs. Keep your tablets in a safe place to protect them from being stolen. Never give your tablets to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others, even causing death, and is against the law.

Who should not take Opana® ER?

Do not take Opana® ER if:
  • You had surgery within the past day (24 hours) and you were not taking Opana ER before your surgery.
  • Your pain is mild or will go away in a few days.
  • Your pain can be controlled by the occasional use of other pain medicines.
  • You are having an asthma attack or have severe asthma, trouble breathing, or lung problems.
  • You have liver problems.
  • You are allergic to Opana ER or anything in it. See the end of this section for a complete list of ingredients in Opana ER.
  • You have had severe allergic reactions to other narcotic pain medicines (such as morphine or codeine). A severe allergic reaction includes a severe rash, hives, breathing problems, or dizziness.

Opana® ER is not for children under 18 years of age.

What should I tell my healthcare provider before starting Opana® ER?

Tell your healthcare provider about all of your medical problems, especially if you:
  • have trouble breathing or lung problems
  • have a head injury or brain problems
  • have liver or kidney problems
  • have adrenal gland problems, such as Addison's disease
  • have convulsions or seizures
  • have thyroid problems
  • have problems urinating or prostate problems
  • have pancreas problems
  • have a drinking problem or alcoholism
  • have severe mental problems or hallucinations (see or hear things that are not really there)
  • have past or present drug abuse or drug addiction problems
  • are pregnant or plan to become pregnant. Opana ER may harm your unborn baby.
  • are breastfeeding. Opana ER may pass through your milk and may harm your baby. You should not breastfeed while taking Opana ER.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may cause serious problems when taken with Opana ER, especially if they cause sleepiness (like sleeping pills, anxiety medicines, antihistamines, or tranquilizers).

Do not take any new medicines while using Opana® ER until you have talked to your healthcare provider or pharmacist and they have told you it is safe.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.

How should I take Opana® ER?

  • Follow your healthcare provider's directions exactly. Your healthcare provider may change your dose based on your reactions to the medicine. Do not change your dose unless your healthcare provider tells you to change it. Do not take Opana ER more often than prescribed.
  • Swallow Opana® ER tablets whole. Do not break, crush, dissolve, or chew Opana® ER tablets before swallowing. If a tablet is broken, crushed, dissolved, or chewed, the full 12 hour dose can be taken into your body all at once. This is very dangerous. You could die from an overdose of the medicine. If you cannot swallow tablets whole, tell your healthcare provider. You may need a different medicine.
  • Take Opana ER every 12 hours or as instructed by your healthcare provider. Opana ER should be taken on an empty stomach, at least one hour before or two hours after meals. Talk to your healthcare provider if you feel sick taking Opana ER on an empty stomach.
  • If you miss a dose, 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 unless your healthcare provider tells you to. If you are not sure about your dosing call your healthcare provider.
  • If you take too much Opana® ER or overdose, call your local emergency number or poison control center right away.
  • Talk to your healthcare provider often about your pain. Your healthcare provider can decide if you still need Opana ER.
  • If you have side effects that bother you or if you continue to have pain, call your healthcare provider.
  • Stopping Opana® ER. If your healthcare provider decides you no longer need Opana ER, ask how to slowly reduce the dose of your medicine so you don't get uncomfortable (withdrawal) symptoms such as nausea, sweating, and pain. You should not stop taking Opana ER all at once if you have been taking it for more than a few days without talking to your healthcare provider.
    Opana ER can cause physical dependence. You can get sick with withdrawal symptoms if you stop Opana ER all at once, because your body has become used to it.

After you stop taking Opana® ER, flush the unused tablets down the toilet. Safely dispose of Opana® ER out of the reach of children and pets.

What should I avoid while taking Opana® ER?

  • Do not drive, operate heavy machinery, or participate in any other possibly dangerous activities until you know how you react to this medicine.
    Opana ER can make you sleepy. Ask your healthcare provider to tell you when it is okay to do these activities.
  • Do not drink alcohol while using Opana® ER. It may increase the chance of having dangerous side effects including overdose and death.

What are the possible side effects of Opana® ER?

Opana® ER can cause trouble breathing.

Call your healthcare provider or get medical help right away if:
  • your breathing slows down
  • you have shallow breathing (little chest movement with breathing)
  • you feel faint, dizzy, confused, or have any other unusual symptoms

These can be signs that you have taken too much Opana ER (overdose) or the dose is too high for you, which can be dangerous and lead to death if not treated.

Opana® ER can cause your blood pressure to drop. This can make you feel dizzy if you get up too fast from sitting or lying down. Low blood pressure is also more likely to happen if you are taking other medicines that can also lower your blood pressure.

Opana® ER can cause physical dependence. Your body will get used to
Opana ER if you take it more than a few days. You can get sick with withdrawal symptoms if you stop taking Opana ER all at once. You can avoid getting sick with withdrawal symptoms by stopping Opana ER slowly. Your healthcare provider will tell you how to do this.

There is a chance of abuse or addiction with Opana® ER. Abuse or addiction is different than a physical dependence. If you have abused prescription medicines, street drugs, or alcohol in the past, you have a higher chance of developing abuse or addiction again while using Opana ER. If you have more concerns, talk to your healthcare provider for more information about abuse and addiction.

The most common side effects of Opana® ER are nausea, constipation, dizziness, vomiting, itching, sleepiness, headache, increased sweating, and sedation. Some of these side effects may decrease with continued use. Talk to your healthcare provider if you continue to have these side effects.

These are not all the possible side effects of Opana ER. For a complete list, ask your healthcare provider or pharmacist.

Constipation (decrease in the usual number of hard bowel movements) is a common side effect of opioid medicines, including Opana ER. Talk to your healthcare provider or pharmacist about the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while taking Opana ER.

How should I store Opana® ER?

  • Store Opana ER at room temperature between 59° to 86°F (15° to 30°C).
  • Keep Opana ER in a childproof container and store in a safe place to protect it from being stolen.
  • Keep Opana® ER out of the reach of children. Accidental overdose in children is an emergency and can result in death.

General information about Opana® ER

  • Do not use Opana ER for conditions for which it was not prescribed.
  • Do not give Opana ER to other people, even if they have the same symptoms you have. It may harm them, even causing death, and it is against the law.

This section summarizes the most important information about Opana ER. If you would like more information, talk with your healthcare provider. Also, you can ask your pharmacist or healthcare provider for information about Opana ER that is written for healthcare professionals.

What are the ingredients in Opana® ER?

Active Ingredient: oxymorphone hydrochloride

Inactive Ingredients: hypromellose, methylparaben, silicified microcrystalline cellulose, sodium stearyl fumarate, TIMERx®-N, titanium dioxide, and triacetin. The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets also contain macrogol, and polysorbate 80. In addition, the 5 mg, 7.5 mg, and 30 mg tablets contain iron oxide red. The 7.5 mg tablets contain iron oxide black, and iron oxide yellow. The 10 mg tablets contain FD&C yellow No. 6. The 20 mg tablets contain FD&C blue No. 1, FD&C yellow No. 6, and D&C yellow No. 10. The 40 mg tablets contain FD&C yellow No. 6, D&C yellow No. 10, and lactose monohydrate.

CAUTION: Federal law prohibits dispensing without prescription.
IMPORTANT SAFETY INFORMATION

Opana® ER has a boxed warning as follows:

WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE.

Potential for Abuse

OPANA® ER contains oxymorphone, which is a morphine-like opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics.

Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OPANA® ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

Proper Patient Selection

OPANA® ER is an extended-release oral formulation of oxymorphone indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Limitations of Use

OPANA® ER is NOT intended for use as an as needed analgesic.

OPANA® ER TABLETS are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed OPANA® ER TABLETS leads to rapid release and absorption of a potentially fatal dose of oxymorphone.

Patients must not consume alcoholic beverages, or prescription or non-prescription medications containing alcohol, while on OPANA® ER therapy. The co-ingestion of alcohol with OPANA® ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone.

CONTRAINDICATIONS

  • OPANA® ER is contraindicated in patients with a known hypersensitivity to oxymorphone hydrochloride, morphine analogs such as codeine, or any of the other ingredients of OPANA ER; in patients with moderate or severe hepatic impairment or in any situation where opioids are contraindicated such as: patients with respiratory depression (in the absence of resuscitative equipment or in unmonitored settings), acute or severe bronchial asthma, hypercarbia, and in any patient who has or is suspected of having paralytic ileus.
  • OPANA ER is not indicated for pain in the immediate post-operative period or if the pain is mild, or not expected to persist for an extended period of time. OPANA ER is only indicated for post-operative use if the patient is already receiving the drug prior to surgery or if the post-operative pain is expected to be moderate or severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate (see American Pain Society guidelines). OPANA ER is not indicated for pre-emptive analgesia (administration pre-operatively for the management of post-operative pain).

WARNINGS

  • Respiratory depression is the chief hazard of OPANA ER, particularly in elderly or debilitated patients.
  • OPANA ER should be administered with extreme caution to patients with conditions accompanied by hypoxia, hypercapnia, or decreased respiratory reserve.
  • Patients receiving other opioid analgesics, general anesthetics, phenothiazines or other tranquilizers, sedatives, hypnotics, or other CNS depressants (including alcohol) may experience additive effects resulting in respiratory depression, hypotension, profound sedation, coma or death.
  • In the presence of head injury, the respiratory depressant effects of OPANA ER and the potential to elevate cerebrospinal fluid pressure may be markedly exaggerated.
  • OPANA ER may cause severe hypotension in patients with compromised ability to maintain blood pressure. Administer with caution to patients in circulatory shock.
  • Prolonged gastric obstruction may occur in patients with gastrointestinal obstruction, especially paralytic ileus.
  • Use with caution in patients with biliary tract disease, as it may cause spasm of the sphincter of oddi.
  • Opioid analgesics impair the mental and physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.
  • OPANA ER is not recommended during labor and delivery, pregnancy, or nursing.
  • OPANA ER should be used with caution in elderly and debilitated patients and in patients who are known to be sensitive to CNS depressants, such as those with cardiovascular, pulmonary, renal, or hepatic disease. OPANA ER should be used with caution in patients with mild hepatic impairment and in patients with moderate to severe renal impairment. These patients should be started cautiously with lower doses of OPANA ER while carefully monitoring for side effects.
  • Patients and their families should be instructed to flush any OPANA ER tablets that are no longer needed.

ADVERSE REACTIONS

  • Adverse reactions reported at (≥2%) in placebo-controlled trials were: nausea, constipation, dizziness, somnolence, vomiting, pruritus, headache, sweating increased, dry mouth, sedation, diarrhea, insomnia, fatigue, appetite decreased, and abdominal pain.
  • In clinical trials there were several adverse events that were more frequently observed in subjects 65 and over compared to younger subjects. These adverse events included dizziness, somnolence, confusion, and nausea.

DRUG INTERACTIONS

  • CNS depressants: Increased risk of respiratory depression, hypotension, profound sedation, coma or death. When combined therapy with CNS depressant is contemplated, the dose of one or both agents should be reduced. Mixed agonist/antagonist opioids (i.e., pentazocine, nalbuphine, and butorphanol): May reduce analgesic effect and/or precipitate withdrawal symptoms. Cimetidine: Combination use may precipitate confusion, disorientation, respiratory depression, apnea, seizures. Anticholinergics: May result in urinary retention and/or severe constipation, which may lead to paralytic ileus. Monoamine oxidase inhibitors (MAOIs): Potentiate the action of opioids. OPANA ER should not be used in patients taking MAOIs or within 14 days of stopping such treatment.

Please see full Prescribing Information, including boxed WARNING for Opana® ER.

Oxymorphone is also available in immediate release tablets and injectable form. For more information, please see full Prescribing Information for Opana® Tablets and Opana® Injection.

Vermont prescribers, please see additional information for Opana® ER.

About Opana ER