ORPHENGESIC FORTE- orphenadrine citrate, aspirin and caffeine tablet

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:

Galt Pharmaceuticals, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Orphengesic Forte (Orphenadrine Citrate, Aspirin and Caffeine 50 mg/ 770 mg/ 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. Orphengesic Forte Tablets do not directly relax tense muscles in man. Because of the mild anticholinergic effect of orphenadrine, Orphengesic Forte Tablets should not be used in patients with glaucoma, pyloric or duodenal obstruction, achalasia, prostatic hypertrophy or obstructions at the bladder neck. Orphengesic 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 h

Product summary:

Orphengesic ® Forte Tablets (Orphenadrine Citrate 50 mg, Aspirin 770 mg, and Caffeine 60 mg): 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 61825-302-60). Store below 30°C (86°F). Rx Only Manufactured for: Galt Pharmaceuticals Atlanta, GA  30339 500523-04 Rev. 04/2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ORPHENGESIC FORTE- ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLET
GALT PHARMACEUTICALS, LLC
----------
ORPHENGESIC FORTE TABLETS
(ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLETS 50 MG/ 770MG/ 60
MG
USP)
DESCRIPTION
Each Orphengesic
Forte Tablet, for oral administration contains Orphenadrine Citrate
50 mg, Aspirin 770 mg and Caffeine 60 mg.
In addition, each tablet contains the following inactive ingredients:
anhydrous lactose,
colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, zinc
stearate, povidone,
pregelatinized starch, and stearic acid.
Orphenadrine citrate is (2-dimethylaminoethyl 2-methylbenzhydryl ether
citrate). It is 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 formation.
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
detecte