Country: United States
Language: English
Source: NLM (National Library of Medicine)
PENTAZOCINE HYDROCHLORIDE (UNII: A36BXO4PPX) (PENTAZOCINE - UNII:RP4A60D26L)
Bryant Ranch Prepack
PENTAZOCINE HYDROCHLORIDE
PENTAZOCINE 50 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
PENTAZOCINE AND NALOXONE- PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET BRYANT RANCH PREPACK ---------- PENTAZOCINE AND NALOXONE TABLETS USP REVISED: JUNE 2008 RX ONLY 173017 CIV ANALGESIC FOR ORAL USE ONLY Pentazocine and naloxone tablets are intended for oral use only. Severe, potentially lethal, reactions may result from misuse of pentazocine and naloxone tablets by injection either alone or in combination with other substances. (See DRUG ABUSE AND DEPENDENCE section.) DESCRIPTION Pentazocine and naloxone tablets USP contain pentazocine hydrochloride USP, equivalent to 50 mg base, a member of the benzazocine series (also known as the benzomorphan series), and naloxone hydrochloride USP, equivalent to 0.5 mg base. Pentazocine and naloxone tablets are an analgesic for oral administration. Chemically, pentazocine hydrochloride is (2_R_*, 6_R_*, 11_R_*)-1,2,3,4,5,6-Hexahydro-6,11-dimethyl-3-(3- methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol hydrochloride, a white, crystalline substance soluble in acidic aqueous solutions. It has the following structural formula: C H NO•HCI Molecular Weight 321.88 Chemically, naloxone hydrochloride is 17-AIlyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride. It is a slightly off-white powder, and is soluble in water and dilute acids. It has the following structural formula: 19 27 C H N0 •HCI Molecular Weight 363.84 Each tablet, for oral administration, contains pentazocine hydrochloride USP, equivalent to 50 mg of pentazocine, and naloxone hydrochloride USP, equivalent to 0.5 mg of naloxone. In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, D&C Yellow No. 10 Al-lake, FD&C Blue No. 1 Al-lake, FD&C Yellow No. 6 Al-lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium lauryl sulfate. CLINICAL PHARMACOLOGY Pentazocine is a potent analgesic which when administered orally in a 50 mg dose appears equivalent in analgesic effect to 60 mg (1 grain) of codeine. Read the complete document