PENTAZOCINE HCL AND ACETAMINOPHEN- pentazocine hydrochloride and acetaminophen tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Pentazocine hydrochloride (UNII: A36BXO4PPX) (Pentazocine - UNII:RP4A60D26L), Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)

Available from:

Rebel Distributors Corp

INN (International Name):

Pentazocine hydrochloride

Composition:

Pentazocine hydrochloride 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pentazocine hydrochloride and acetaminophen tablets are indicated for the relief of mild to moderate pain. Pentazocine hydrochloride and acetaminophen tablets should not be administered to patients who are hypersensitive to either pentazocine or acetaminophen. Controlled Substance. The combination of pentazocine hydrochloride and acetaminophen tablets is a Schedule IV controlled substance. Abuse and Dependence. There have been some reports of dependence and of withdrawal symptoms with orally administered pentazocine. There have been recorded instances of psychological and physical dependence in patients using parenteral pentazocine. Abrupt discontinuance following the extended use of parenteral pentazocine has resulted in withdrawal symptoms. Patients with a history of drug dependence should be under close supervision while receiving pentazocine hydrochloride and acetaminophen tablets. There have been rare reports of possible abstinence syndromes in newborns after prolonged use of pentazocine during pregnan

Product summary:

Pentazocine Hydrochloride and Acetaminophen Tablets, 25 mg base/650 mg are light aqua, capsule-shaped, scored tablets, debossed 396 to the left of the score, 25 over 650 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 30276-4 Revised: February 2004 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PENTAZOCINE HCL AND ACETAMINOPHEN- PENTAZOCINE HYDROCHLORIDE AND
ACETAMINOPHEN TABLET
REBEL DISTRIBUTORS CORP
----------
PENTAZOCINE HCL
AND
ACETAMINOPHEN
TABLETS C-IV
RX ONLY
30276-4
DESCRIPTION
Pentazocine hydrochloride and acetaminophen tablets are a combination
of pentazocine hydrochloride
USP, equivalent to 25 mg base and acetaminophen USP, 650 mg.
Pentazocine is a member of the benzazocine series (also known as the
benzomorphan series).
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•HCL
MOLECULAR WEIG HT: 321.88
Chemically, acetaminophen is 4’-hydroxyacetanilide-. It has the
following structural formula:
C H NO
MOLECULAR WEIG HT: 151.16
Pentazocine is an analgesic and acetaminophen is an analgesic and
antipyretic.
Each tablet for oral administration contains 25 mg of pentazocine as
the hydrochloride and 650 mg of
acetaminophen. In addition, each tablet contains the following
inactive ingredients: colloidal silicon
dioxide, crospovidone, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No.
1 Aluminum Lake,
microcrystalline cellulose, povidone, pregelatinized starch, sodium
starch glycolate, and stearic acid.
CLINICAL PHARMACOLOGY
19
27
8
9
2
Pentazocine hydrochloride and acetaminophen tablets are an analgesic
possessing antipyretic actions.
Pentazocine is an analgesic with agonist/antagonist action which when
administered orally is
approximately equivalent on a mg for mg basis in analgesic effect to
codeine.
Acetaminophen is an analgesic and antipyretic.
Onset of significant analgesia with pentazocine usually occurs between
15 and 30 minutes after oral
administration, and duration of action is usually three hours or
longer. Onset and duration of action and
the degree of pain relief are related both to dose and the severity of
pretreatment pain. Pentazocine
weakly antagonizes th