NORGESIC FORTE- orphenadrine citrate, aspirin and caffeine tablet, multilayer

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ORPHENADRINE CITRATE (UNII: X0A40N8I4S) (ORPHENADRINE - UNII:AL805O9OG9), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)

Available from:

Poly Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Norgesic Forte 50 mg/770mg/60 mg Tablets are indicated in: - Symptomatic relief of mild to moderate pain of acute musculoskeletal disorders. - The orphenadrine component is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. The mode of action of orphenadrine has not been clearly identified, but may be related to its analgesic properties. Norgesic Forte Tablets do not directly relax tense skeletal muscles in man. The mode of action of orphenadrine has not been clearly identified, but may be related to its analgesic properties. Norgesic Forte Tablets do not directly relax tense skeletal muscles in man. Because of the mild anti-cholinergic effect of orphenadrine, Norgesic Forte Tablets should not be used in patients with glaucoma, pyloric or duodenal obstruction, achalasia, prostatic hypertrophy, or obstructions at the bladder neck. Norgesic Forte Tablets are also contraindicated in patients with myasthenia gravis and in patients known to be sensitive to aspirin or caffeine. The drug is contraindicated in patients who have demonstrated a previous hypersensitivity to the drug.

Product summary:

Norgesic Forte Tablets (Orphenadrine Citrate 50mg, Aspirin 770mg, and Caffeine 60mg) Two-layered, white/green capsule shaped, bisected tablets debossed "GA" and "473" with bisect on the white side and plain on the green side are available in bottles of 60 tablets (NDC 50991-999-60). Store below 30°C (86°F) Rx Only Store at 20°-25°C (68°-77° F) (see USP Controlled Room Temperature). Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NORGESIC FORTE- ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLET,
MULTILAYER
POLY PHARMACEUTICALS, INC.
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NORGESIC FORTE
DESCRIPTION
Each Norgesic Forte tablet, for oral administration, contains
Orphenadrine Citrate 50
mg, Aspirin 770 mg, Caffeine 60 mg.
In addition, each tablet contains the following inactive ingredients,
anhydrous lactous,
colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, zinc
stearate, providone,
pregetanized starch, and stearic acid.
Orphenadrine citrate, (2-dimethylaminoethyl 2-methybenzhydryl ether
citrate). It is as a
white, practically odorless, crystalline powder, having a bitter
taste. It is sparingly soluble
in water, slightly soluble in alcohol. It has the following structural
formula:
Aspirin, salicylic acid acetate, is a non-opiate analgesic,
anti-inflammatory and antipyretic
agent. It occurs as a white, crystalline tabular or needle like powder
and is odorless or
has a faint odor. It is sparingly soluble in water, freely soluble in
alcohol and chloroform.
It has the following structural formula:
Caffeine is a central nervous system stimulant which occurs as a white
powder or white
glistening needles, usually matted together. It is sparingly soluble
in alcohol, and freely
soluble in chloroform. The chemical name for caffeine is
1,3,7-Trimethylxanthine. It has
the following structural formula:
CLINICAL PHARMACOLOGY
Orphenadrine citrate is a centrally acting (brain stem) compound which
in animals
selectively blocks facilitatory functions of the reticular
formulation. Orphenadrine does
not produce myoneural block, nor does it affect crossed extensor
reflexes.
Orphenadrine prevents nicotine-induced convulsions but not those
produced by
strychnine.
Chronic administration of Orphenadrine Citrate, Aspirin, and Caffeine
to dogs and rats
has revealed no drug-related toxicity. No blood or urine changes were
observed, nor
were there any macroscopic or microscopic pathological changes
detected. Extensive
experience with combinations containing aspirin and caffeine has
establish