देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
orphenadrine citrate (UNII: X0A40N8I4S) (orphenadrine - UNII:AL805O9OG9), aspirin (UNII: R16CO5Y76E) (aspirin - UNII:R16CO5Y76E), caffeine (UNII: 3G6A5W338E) (caffeine - UNII:3G6A5W338E)
Jerome Stevens Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
- 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. These products do not directly relax tense skeletal muscles in man. Because of the mild anticholinergic effect of orphenadrine, these products should not be used in patients with glaucoma, pyloric or duodenal obstruction, achalasia, prostatic hypertrophy or obstructions at the bladder neck. These products 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.
Regular tablets can be identified as a round, multi-layered tablet embossed JSP 554 on one side, and contains orphenadrine citrate (2-dimethylaminoethyl 2-methylbenzhydryl ether citrate) 25 mg, aspirin 385 mg, and caffeine 30 mg. Forte tablets are exactly twice the strength of the regular. They are identified by their scored capsule shape. Each multi-layered tablet is embossed JSP 555 on one side and contains orphenadrine citrate 50 mg, aspirin 770 mg, and caffeine 60 mg. Products also contain: lactose, starch, D&C yellow #10 and FD&C blue #1. Regular: Bottles of Forte: Bottles of Store below 30°C (86°F) Caution: Federal law prohibits dispensing without prescription. Manufactured by: Jerome Stevens Pharmaceuticals, Inc. Bohemia, NY 11716 Rev. 03/21 MG # 11584
Abbreviated New Drug Application
ORPHENADRINE CITRATE ASPIRIN CAFFEINE- ORPHENADRINE CITRATE, ASPIRIN, CAFFEINE TABLET JEROME STEVENS PHARMACEUTICALS, INC. ---------- ORPHENADRINE CITRATE ASPIRIN CAFFEINE REGULAR AND FORTE TABLETS ACTIONS: 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 the regular formula 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 established them as safe agents. The addition of orphenadrine citrate does not alter the toxicity of aspirin and caffeine. The mode of therapeutic action of orphenadrine has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate also possesses anticholinergic actions. INDICATIONS: 1. Symptomatic relief of mild to moderate pain of acute musculoskeletal disorders. 2. 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. These products do not directly relax tense skeletal muscles in man. CONTRAINDICATIONS: Because of the mild anticholinergic effect of orphenadrine, these products should not be used in patients with glaucoma, pyloric or duodenal obstruction, achalasia, prostatic hypertrophy or obstructions at the bladder neck. These products 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 पूरा दस्तावेज़ पढ़ें