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:

GAVIS Pharmaceuticals, LLC

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 are contraindicated in patients who are hypersensitive to either pentazocine or acetaminophen.

Product summary:

Pentazocine Hydrochloride and Acetaminophen Tablets are light blue capsule shaped, tablets debossed “NL” on left side and “670” on right side of bisect and plain on the other side. Bottles of 100 (NDC 43386-670-01). Bottles of 100 (NDC 43386-670-05) Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). [See USP.] Dispense in a tight, light-resistant container as defined in the USP. DEA Order Form Required. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Distributed by: GAVIS Pharmaceuticals, LLC Somerset, NJ 08873 GIN-670-02 Rev: 06/2011

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PENTAZOCINE HYDROCHLORIDE AND ACETAMINOPHEN - PENTAZOCINE
HYDROCHLORIDE
AND ACETAMINOPHEN TABLET
GAVIS PHARMACEUTICALS, LLC
----------
PENTAZOCINE HYDROCHLORIDE AND ACETAMINOPHEN TABLETS
HEPATOTOXICITY
Pentazocine Hydrochloride and Acetaminophen Tablets contain
acetaminophen and pentazocine
hydrochloride. Acetaminophen has been associated with cases of acute
liver failure, at times resulting
in liver transplant and death. Most of the cases of liver injury are
associated with the use of
acetaminophen at doses that exceed 4000 milligrams per day, and often
involve more than one
acetaminophen-containing product.
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 is
(2R*,6R*,11R*)1,2,3,4,5,6-hexahydro-6,11-dimethyl-3-(3-methyl-2-
butenyl)-2,6-methano-3-benzazocin-8-ol, a white, crystalline substance
soluble in acidic aqueous
solutions, and has the following structural formula:
C
H NO HCl M.W. 321.88
Chemically, acetaminophen is Acetamide, _N_-(4-hydroxyphenyl)-, and
has the following structural
formula:
C H NO M.W. 151.16
Pentazocine is an analgesic and acetaminophen is an analgesic and
antipyretic.
Inactive ingredients: colloidal silicon dioxide, FD&C Blue # 1
aluminum lake, microcrystalline
19
27
8
9
2
cellulose, sodium lauryl sulfate, sodium starch glycolate, and stearic
acid.
CLINICAL PHARMACOLOGY
Pentazocine is a Schedule IV opioid 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.
Pentazocine weakly antagonizes the analgesic effects of morphine,
meperidine, and phenazocine; in
addition, it produces incomplete reversal of cardiovascular,
respiratory, and behavioral depression
induced by morphine and meperidine. Pentazocine has about