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ABOUT OPANA<span style='vertical-align:super;font-size:50%;'>®</span> ER ABOUT OPIOIDS RESOURCES HCP
ABOUT OPANA<span style='vertical-align:super;font-size:50%;'>®</span> ER RESOURCES TIMERx<span style='vertical-align:super;font-size:50%;'>®</span>-N DELIVERY PATIENT

Supply Shortage and Rare Tablet Mix-up

Production of certain products has been temporarily suspended by our contract manufacturer in order for the manufacturer to implement manufacturing process improvements. These improvements are intended to address rare instances of errors in the packaging of the tablets, potentially resulting in product mix-ups. As a result of the implementation of these improvements, we anticipate that there may be a short-term disruption in the supply of these products to patients. This temporary supply disruption is not related to the efficacy or safety of these products.

Endo’s primary concerns are the health, well-being, and continuity of care for patients suffering from pain.

For patients currently prescribed any of the following products, a visual guide has been provided to verify the appearance of these products. Please review the product name of your prescription to confirm the tablets in your prescription match the tablet images provided:

  • OPANA® ER (oxymorphone hydrochloride)
    Extended-Release Tablets CII
  • OPANA® (oxymorphone hydrochloride)
    Tablets CII
  • Oxymorphone Hydrochloride Tablets CII
  • PERCOCET® (oxycodone hydrochloride and
    acetaminophen USP) Tablets CII
  • PERCODAN® (oxycodone hydrochloride and
    aspirin, USP) Tablets CII
  • ENDOCET® (oxycodone hydrochloride and
    acetaminophen USP) Tablets CII
  • ENDODAN® (oxycodone hydrochloride and
    aspirin, USP) Tablets CII
  • Morphine Sulfate Extended-Release
    Tablets CII
  • ZYDONE® (hydrocodone
    bitartrate/acetaminophen tablets, USP) CIII

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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.

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.