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:

Bryant Ranch Prepack

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
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.