ORPHENGESIC FORTE- orphenadrine citrate, aspirin and caffeine tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
09-01-2020

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Galt Pharmaceuticals, LLC

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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

Bidhaa muhtasari:

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 61825-999-60). Store below 30°C (86°F). Rx Only Manufactured for: Galt Pharmaceuticals, LLC Atlanta, GA  30339 500503-01 Rev. 09/2018

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

                                ORPHENGESIC FORTE- ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLET
GALT PHARMACEUTICALS, LLC
----------
ORPHENGESIC FORTE TABLETS
(ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLETS 50MG/ 770MG/ 60MG
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 detected.
                                
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