"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.
TALWIN NX (pentazocine and naloxone hydrochlorides, USP) is indicated for the relief of moderate to severe pain.
TALWIN NX (pentazocine and naloxone) is indicated for oral use only.
DOSAGE AND ADMINISTRATION
The usual initial adult dose is 1 tablet every three or four hours. This may be increased to 2 tablets when needed. Total daily dosage should not exceed 12 tablets.
Due to the potential for withdrawal symptoms associated with abrupt discontinuation, consideration should be given to tapering patients off TALWTN NX after prolonged periods of treatment with TALWIN NX (See PRECAUTIONS, Drug Abuse and Dependence).
TALWIN NX (pentazocine and naloxone hydrochlorides, USP) is available as yellow, scored, oblong tablets, debossed with a "W" surrounded by a box on one side and "T51" on the other. Each tablet contains pentazocine hydrochloride equivalent to 50 mg base and naloxone hydrochloride equivalent to 0.5 mg base.
Bottles of 100 (NDC 0024-1951-04).
Store at 25° C (77° F); excursions permitted between 15° - 30° C (59° F to 86° F).
Manufactured for: sanofi-aventis U.S. LLC Bridgewater, NJ 08807.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/13/2011
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