देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
PENTAZOCINE HYDROCHLORIDE (UNII: A36BXO4PPX) (PENTAZOCINE - UNII:RP4A60D26L), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
GAVIS Pharmaceuticals, LLC
PENTAZOCINE HYDROCHLORIDE
PENTAZOCINE HYDROCHLORIDE 25 mg
ORAL
PRESCRIPTION DRUG
Pentazocine Hydrochloride and Acetaminophen Tablets are indicated for the relief of mild to moderate pain. Pentazocine hydrochloride and acetaminophen tablets are contraindicated in patients who are hypersensitive to either pentazocine or acetaminophen.
Pentazocine Hydrochloride and Acetaminophen Tablets are light blue capsule shaped, tablets debossed “NL” on left side and “670” on right side of bisect and plain on the other side. Bottles of 100 (NDC 43386-670-01). Bottles of 100 (NDC 43386-670-05) Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). [See USP.] Dispense in a tight, light-resistant container as defined in the USP. DEA Order Form Required. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Distributed by: GAVIS Pharmaceuticals, LLC Somerset, NJ 08873 GIN-670-02 Rev: 06/2011
Abbreviated New Drug Application
PENTAZOCINE HYDROCHLORIDE AND ACETAMINOPHEN - PENTAZOCINE HYDROCHLORIDE AND ACETAMINOPHEN TABLET GAVIS PHARMACEUTICALS, LLC ---------- PENTAZOCINE HYDROCHLORIDE AND ACETAMINOPHEN TABLETS HEPATOTOXICITY Pentazocine Hydrochloride and Acetaminophen Tablets contain acetaminophen and pentazocine hydrochloride. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. DESCRIPTION Pentazocine Hydrochloride and Acetaminophen Tablets are a combination of pentazocine hydrochloride, USP, equivalent to 25 mg base and acetaminophen, USP, 650 mg. Pentazocine is a member of the benzazocine series (also known as the benzomorphan series). Chemically, pentazocine is (2R*,6R*,11R*)1,2,3,4,5,6-hexahydro-6,11-dimethyl-3-(3-methyl-2- butenyl)-2,6-methano-3-benzazocin-8-ol, a white, crystalline substance soluble in acidic aqueous solutions, and has the following structural formula: C H NO HCl M.W. 321.88 Chemically, acetaminophen is Acetamide, _N_-(4-hydroxyphenyl)-, and has the following structural formula: C H NO M.W. 151.16 Pentazocine is an analgesic and acetaminophen is an analgesic and antipyretic. Inactive ingredients: colloidal silicon dioxide, FD&C Blue # 1 aluminum lake, microcrystalline 19 27 8 9 2 cellulose, sodium lauryl sulfate, sodium starch glycolate, and stearic acid. CLINICAL PHARMACOLOGY Pentazocine is a Schedule IV opioid analgesic with agonist/antagonist action which when administered orally is approximately equivalent on a mg for mg basis in analgesic effect to codeine. Acetaminophen is an analgesic and antipyretic. Pentazocine weakly antagonizes the analgesic effects of morphine, meperidine, and phenazocine; in addition, it produces incomplete reversal of cardiovascular, respiratory, and behavioral depression induced by morphine and meperidine. Pentazocine has about पूरा दस्तावेज़ पढ़ें