PENTAZOCINE AND NALOXONE hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

pentazocine hydrochloride (UNII: A36BXO4PPX) (pentazocine - UNII:RP4A60D26L)

Available from:

Golden State Medical Supply, Inc.

INN (International Name):

pentazocine hydrochloride

Composition:

pentazocine 50 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PENTAZOCINE AND NALOXONE- PENTAZOCINE HYDROCHLORIDE AND NALOXONE
HYDROCHLORIDE TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
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PENTAZOCINE AND NALOXONE HYDROCHLORIDE TABLETS, USP
RX ONLY
CIV
ANALGESIC FOR ORAL USE ONLY
Pentazocine and naloxone hydrochlorides tablets are intended
for oral use only. Severe, potentially lethal, reactions may result
from misuse of pentazocine and naloxone hydrochlorides tablets
by injection either alone or in combination with other
substances. (See DRUG ABUSE AND DEPENDENCE
section.)
DESCRIPTION
Pentazocine and naloxone hydrochlorides 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 hydrochlorides 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 WEIG HT 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 WEIG HT 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 appea