HAYWARD, Calif., Dec. 22, 2016 /PRNewswire/ -- Impax Laboratories, Inc. (NASDAQ: IPXL), a specialty pharmaceutical company, today announced the launch of a generic version of Kadian (morphine sulfate) Extended Release Capsules, USP CII 20, 30, 50, 60, 80, 100 mg.
Morphine sulfate extended release capsules had annual combined brand and generic sales of approximately $98.4 million in the United States, according to IMS Health (NSP) for 12 months ending October 2016.
IMPORTANT SAFETY INFORMATION
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION;
ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and INTERACTION WITH ALCOHOL
Addiction, Abuse, and Misuse
Morphine sulfate extended release capsules exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing KADIAN, and monitor all patients regularly for the development of these behaviors or conditions.
Life-threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of morphine sulfate extended-release capsules. Monitor for respiratory depression, especially during initiation of morphine sulfate extended release capsules or following a dose increase. Instruct patients to swallow morphine sulfate extended release capsules whole; crushing, chewing, or dissolving morphine sulfate extended release capsules can cause rapid release and absorption of a potentially fatal dose of morphine.
Accidental ingestion of even one dose of morphine sulfate extended release capsules , especially by children, can result in a fatal overdose of morphine.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of morphine sulfate extended release capsules during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Interaction with Alcohol
Instruct patients not to consume alcoholic beverages or us e prescription or non-prescription products that contain alcohol while taking morphine sulfate extended release capsules. The co-ingestion of alcohol with morphine sulfate extended release capsules may result in increased plasma levels and a potentially fatal overdose of morphine.
INDICATIONS AND USAGE
Morphine sulfate extended-release capsules, USP are an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve morphine sulfate extended-release capsules, USP for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Morphine sulfate extended-release capsules, USP are not indicated as an as-needed (prn) analgesic.
- Significant respiratory depression
- Acute or severe bronchial asthma
- Known or suspected paralytic ileus
- Hypersensitivity to morphine
WARNINGS AND PRECAUTIONS
- Interaction with CNS depressants: Concomitant use may cause profound sedation, respiratory depression, and death. If co-administration is required, consider dose reduction of one or both drugs because of additive pharmacological effects.
- Elderly, cachectic, debilitated patients and those with chronic pulmonary disease: Monitor closely because of increased risk for life-threatening respiratory depression.
- Hypotensive effect: Monitor during dose initiation and titration
- Patients with head injury or increased intracranial pressure: Monitor for sedation and respiratory depression and avoid use of morphine sulfate extended-release capsules in patients with impaired consciousness or coma susceptible to intracranial effects of CO2 retention.
Most common adverse reactions (>10%): constipation, nausea, and somnolence.
- Mixed agonist/antagonist opioid analgesics: Avoid use with morphine sulfate extended-release capsules because they may reduce analgesic effect of morphine sulfate extended-release capsules or precipitate withdrawal symptoms.
- Monoamine oxidase inhibitors (MAOIs): Avoid morphine sulfate extended-release capsules in patients taking MAOIs or within 14 days of stopping such treatment.
USE IN SPECIFIC POPULATIONS
- Pregnancy: Based on animal data, may cause fetal harm.
- Nursing mothers: Morphine has been detected in human milk. Closely monitor infants of nursing women receiving morphine sulfate extended-release capsules.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit FDA MedWatch or call 1-800-FDA-1088. To report SUSPECTED ADVERSE REACTIONS contact Impax Laboratories, Inc. at 1-877-994-6729.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. (Impax) is a specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of central nervous system disorder branded products. Impax markets its generic products through its Impax Generics division and markets its branded products through the Impax Specialty Pharma division. Additionally, where strategically appropriate, Impax develops marketing partnerships to fully leverage its technology platform and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams, and ointments. For more information, please visit the Company's Web site at: www.impaxlabs.com.
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SOURCE Impax Laboratories, Inc.