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.
See Full Prescribing Information.
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.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:
To the extent any statements made in this news release contain information that is not historical; these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the Company's future results, performance, or achievements to differ significantly from the results, performance, or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to: fluctuations in revenues and operating income; the Company's ability to successfully develop and commercialize pharmaceutical products in a timely manner; reductions or loss of business with any significant customer; the substantial portion of the Company's total revenues derived from sales of a limited number of products; the impact of consolidation of the Company's customer base; the impact of competition; the Company's ability to sustain profitability and positive cash flows; any delays or unanticipated expenses in connection with the operation of the Company's manufacturing facilities; the effect of foreign economic, political, legal, and other risks on the Company's operations abroad; the uncertainty of patent litigation and other legal proceedings; the increased government scrutiny on the Company's agreements with brand pharmaceutical companies; product development risks and the difficulty of predicting FDA filings and approvals; consumer acceptance and demand for new pharmaceutical products; the impact of market perceptions of the Company and the safety and quality of the Company's products; the Company's determinations to discontinue the manufacture and distribution of certain products; the Company's ability to achieve returns on its investments in research and development activities; changes to FDA approval requirements; the Company's ability to successfully conduct clinical trials; the Company's reliance on third parties to conduct clinical trials and testing; the Company's lack of a license partner for commercialization of NUMIENTTM (IPX066) outside of the United States; impact of illegal distribution and sale by third parties of counterfeits or stolen products; the availability of raw materials and impact of interruptions in the Company's supply chain; the Company's policies regarding returns, allowances and chargebacks; the use of controlled substances in the Company's products; the effect of current economic conditions on the Company's industry, business, results of operations and financial condition; disruptions or failures in the Company's information technology systems and network infrastructure caused by third party breaches or other events; the Company's reliance on alliance and collaboration agreements; the Company's reliance on licenses to proprietary technologies; the Company's dependence on certain employees; the Company's ability to comply with legal and regulatory requirements governing the healthcare industry; the regulatory environment; the effect of certain provisions in the Company's government contracts; the Company's ability to protect its intellectual property; exposure to product liability claims; risks relating to goodwill and intangibles; changes in tax regulations; the Company's ability to manage growth, including through potential acquisitions and investments; the risks related to the Company's acquisitions of or investments in technologies, products or businesses; the restrictions imposed by the Company's credit facility and indenture; the Company's level of indebtedness and liabilities and the potential impact on cash flow available for operations; uncertainties involved in the preparation of the Company's financial statements; the Company's ability to maintain an effective system of internal control over financial reporting; the effect of terrorist attacks on the Company's business; the location of the Company's manufacturing and research and development facilities near earthquake fault lines; expansion of social media platforms and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.
Investor Relations and Corporate Communications
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SOURCE Impax Laboratories, Inc.