NORGESIC- orphenadrine citrate, aspirin and caffeine tablet

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Galt Pharmaceuticals, LLC

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Norgesic TM (orphenadrine citrate, aspirin and caffeine 25 mg/ 385 mg/ 30 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 TM Tablets do not directly relax tense muscles in man. Because of the mild anticholinergic effect of orphenadrine, Norgesic TM Tablets should not be used in patients with glaucoma, pyloric or duodenal obstruction, achalasia, prostatic hypertrophy or obstructions at the bladder neck. Norgesic TM 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.

পণ্য সারাংশ:

Norgesic TM Tablets (orphenadrine citrate 25 mg, aspirin 385 mg, and caffeine 30 mg): Two-layered, white/green round flat faced beveled edge tablet debossed “OAC” over “472” on the white side and plain on the green side. They are available in bottles of 60 tablets (NDC 61825-305-60). Store below 30°C (86°F). Rx Only Manufactured for: Galt Pharmaceuticals Atlanta, GA  30339 GLT.305.99 Rev. 05/2022

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

NORGESIC- ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLET
GALT PHARMACEUTICALS, LLC
----------
NORGESIC
(ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLETS)
DESCRIPTION
Each Norgesic
Tablet, for oral administration contains Orphenadrine Citrate 25 mg,
Aspirin 385 mg and Caffeine 30 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:
TM
TM
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.
Extensive
experience with combinations containing aspiri