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:

DIRECT RX

INN (International Name):

PENTAZOCINE HYDROCHLORIDE

Composition:

PENTAZOCINE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pentazocine Hydrochloride and Naloxone Hydrochloride Tablets, USP is indicated for the relief of moderate to severe pain. Pentazocine Hydrochloride and Naloxone Hydrochloride Tablets, USP is indicated for oral use only. Pentazocine hydrochloride and naloxone hydrochloride tablets is contraindicated in patients who are hypersensitive to either pentazocine or naloxone. Pentazocine can cause a physical and psychological dependence. (See DRUG ABUSE AND DEPENDENCE.) Use In Head Injury and Increased Intracranial Pressure In the presence of head injury, intracranial lesions or a preexisting increase in intracranial pressure, the possible respiratory depressant effects of pentazocine and its potential to elevate cerebrospinal fluid pressure (resulting from vasodilation following CO2 retention) may be markedly increased. Furthermore, pentazocine can produce effects on pupillary response and consciousness, which may obscure neurologic signs of further increases in intracranial pressure in patients with head injuries. I

Product summary:

Pentazocine Hydrochloride and Naloxone Hydrochloride Tablets, USP is available as light yellow, capsule shaped tablet debossed “NL” on left side and “680” on the right side of the bisect and plain on the other side. Each tablet contains pentazocine hydrochloride equivalent to 50 mg base and naloxone hydrochloride equivalent to 0.5 mg base. Bottles of 100 (NDC 43386-680-01). Store at 20° C -25° C (68° - 77° F); See USP Controlled Room Temperature. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Distributed by: GAVIS Pharmaceuticals, LLC Somerset, NJ 08873 GIN-680-01 Rev: 04/2011

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE- PENTAZOCINE
HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET
DIRECT RX
----------
PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
BOXED WARNING SECTION
WARNING: Pentazocine Hydrochloride and Naloxone Hydrochloride Tablets,
USP is intended
for oral use only. Severe, potentially lethal, reactions may result
from misuse of Pentazocine
Hydrochloride and Naloxone Hydrochloride Tablets, USP by injection
either alone or in
combination with other substances. (See DRUG ABUSE AND DEPENDENCE
section.)
DESCRIPTION SECTION
Pentazocine Hydrochloride and Naloxone Hydrochloride Tablets contains
pentazocine hydrochloride,
USP, equivalent to 50 mg base and is a member of the benzazocine
series (also known as the
benzomorphan series), and naloxone hydrochloride, USP, equivalent to
0.5 mg base.
Pentazocine Hydrochloride and Naloxone Hydrochloride Tablets, USP is
an analgesic for oral
administration.
Chemically, pentazocine hydrochloride is
(2R*,6R*,11R*)-1,2,3,4,5,6-Hexahydro-6,11dimethyl-3-(3-
methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol hydrochloride, a
white, crystalline substance soluble
in acidic aqueous solutions, and has the following structural formula:
Chemically, naloxone hydrochloride is
Morphinan-6-one,4,5-epoxy-3,14-dihydroxy-17-(2propenyl)-,
hydrochloride, (5α)-. It is a slightly off-white powder, and is
soluble in water and dilute acids, and has
the following structural formula:
CLINICAL PHARMACOLOGY SECTION
Pentazocine is a Schedule IV opioid analgesic which when administered
orally in a 50 mg dose appears
equivalent in analgesic effect to 60 mg of codeine.
Pentazocine weakly antagonizes the analgesic effects of morphine and
meperidine; in addition, it
produces incomplete reversal of cardiovascular, respiratory, and
behavioral depression induced by
morphine and meperidine. Pentazocine has about 1/50 the antagonistic
activity of nalorphine. It also has
sedative activity.
Onset of significant analgesia usually occurs between 15 and 30
minutes after oral admi