PENTAZOCINE AND NALOXONE- pentazocine hydrochloride and naloxone hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PENTAZOCINE HYDROCHLORIDE (UNII: A36BXO4PPX) (PENTAZOCINE - UNII:RP4A60D26L), NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N)

Available from:

Keltman Pharmaceuticals Inc.

INN (International Name):

PENTAZOCINE HYDROCHLORIDE

Composition:

PENTAZOCINE HYDROCHLORIDE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pentazocine and naloxone hydrochlorides tablets are indicated for the relief of moderate to severe pain. Pentazocine and naloxone hydrochlorides tablets are indicated for oral use only. Pentazocine and naloxone hydrochlorides tablets should not be administered to patients who are hypersensitive to either pentazocine or naloxone. Controlled Substance. Pentazocine and naloxone hydrochlorides tablets are a Schedule IV controlled substance. There have been some reports of dependence and of withdrawal symptoms with orally administered pentazocine. Patients with a history of drug dependence should be under close supervision while receiving pentazocine orally. There have been rare reports of possible abstinence syndromes in newborns after prolonged use of pentazocine during pregnancy. There have been instances of psychological and physical dependence on parenteral pentazocine in patients with a history of drug abuse and rarely, in patients without such a history. Abrupt discontinuance following the extended use of

Product summary:

Pentazocine and Naloxone Hydrochlorides Tablets USP are light green, scored, capsule shaped tablets debossed 395 to the left of the score, 50 over 0.5 to the right of the score and WATSON on the reverse side. They are supplied by Keltman Pharmaceuticals Inc. as follows: Store at controlled room temperature 15°-30°C (59°-86°F). [See USP.] Dispense in a tight, light-resistant container as defined in the USP. Watson Laboratories, Inc. Corona, CA 92880 USA This Product was Repackaged By Sandhills Packaging For: Keltman Pharmaceuticals Inc. 1 Lakeland Square, Suite A Flowood, MS 39232 United States

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PENTAZOCINE AND NALOXONE - PENTAZOCINE HYDROCHLORIDE AND NALOXONE
HYDROCHLORIDE TABLET
KELTMAN PHARMACEUTICALS INC.
----------
PENTAZOCINE AND
NALOXONE
HYDROCHLORIDES
TABLETS USP
RX ONLY
SPL UNCLASSIFIED SECTION
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