PENTAZOCINE HCL AND NALOXONE HCL- 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:

STAT RX USA LLC

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 exten

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 supplied in bottles of 100. 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 30158-4

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PENTAZOCINE HCL AND NALOXONE HCL - PENTAZOCINE HYDROCHLORIDE AND
NALOXONE
HYDROCHLORIDE TABLET
STAT RX USA LLC
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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:
PENTAZOCINE
STRUCTURE IMAGE
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:
NALOXONE STRUCTURE IMAGE
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 and
C Yellow No. 10 Al-lake, FD and C Blue No. 1 Al-lake, FD and C Yellow
No. 6 Al-lake, magnesium
stearate, microcrystalline cellulose, pregelatinized starch, and
sodium lauryl sulfate.
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. Onset of significant
analgesia usually occurs be