"The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.
(hydromorphone HCl) Extened-release Tablets
ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and INTERACTION WITH ALCOHOL
Addiction, Abuse, and Misuse
PALLADONE 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 PALLADONE, and monitor all patients regularly for the development of these behaviors or conditions [see WARNINGS AND PRECAUTIONS].
Life-threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of PALLADONE. Monitor for respiratory depression, especially during initiation of PALLADONE or following a dose increase. Instruct patients to swallow PALLADONE capsules whole; crushing, chewing, or dissolving PALLADONE capsules can cause rapid release and absorption of a potentially fatal dose of hydromorphone [see WARNINGS AND PRECAUTIONS].
Accidental ingestion of even one dose of PALLADONE, especially by children, can result in a fatal overdose of hydromorphone [see WARNINGS AND PRECAUTIONS].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of PALLADONE 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 [see WARNINGS AND PRECAUTIONS].
Interaction with Alcohol
Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking PALLADONE. The co-ingestion of alcohol with PALLADONE may result in increased plasma levels and a potentially fatal overdose of hydromorphone [see WARNINGS AND PRECAUTIONS].
PALLADONE extended-release capsules are for oral use and contain hydromorphone hydrochloride, a mu-opioid.
Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methlymorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C17H19NO3•HCl. The compound has the following structural formula:
(C17H19NO3•HCl) MW 321.80
PALLADONE also contains the following inactive ingredients: ammonio methacrylate copolymer type B, ethylcellulose, and stearyl alcohol, synthetic black iron oxide, gelatin, red iron oxide (12 mg & 16 mg only), FD&C Blue No. 2 (24 mg only), and titanium dioxide.
Last reviewed on RxList: 5/1/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Palladone Information
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