País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
CARISOPRODOL (UNII: 21925K482H) (CARISOPRODOL - UNII:21925K482H), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)
Rising Pharmaceuticals, Inc.
CARISOPRODOL
CARISOPRODOL 200 mg
ORAL
PRESCRIPTION DRUG
Carisoprodol and Aspirin is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol and Aspirin should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration (see DOSAGE AND ADMINISTRATION ). Carisoprodol and Aspirin is contraindicated in patients with a history of: - a serious GI complication (i.e., bleeding, perforations, obstruction) due to aspirin use - aspirin induced asthma (a symptom complex which occurs in patients who have asthma, rhinosinusitis, and nasal polyps who develop a severe, potentially fatal bronchospasm shortly after taking aspirin or other NSAIDs) - hypersensitivity reaction to carbamate such as meprobamate - acute intermittent prophyria The efficacy, safety, and pharmacokinetics of carisoprodol and Aspirin in pediatric patients less than 16 years
Carisoprodol and Aspirin Tablets, USP 200mg/325mg are red and white, round unscored convex, two layered tablets debossed on red layer with "CL" over "023" and plain on the white layer. The tablets are available in: Bottles of 100 NDC 64980-175-01. Bottles of 500 NDC 64980-175-05.
Abbreviated New Drug Application
CARISOPRODOL AND ASPIRIN- CARISOPRODOL AND ASPIRIN TABLET RISING PHARMACEUTICALS, INC. ---------- CARISOPRODOL AND ASPIRIN TABLETS, USP 200 MG/325 MG CIV RX ONLY DESCRIPTION Carisoprodol and Aspirin tablets, USP are a fixed-dose combination product containing the following two products: 200 mg of carisoprodol, a centrally-acting muscle relaxant 325 mg of aspirin, an analgesic with antipyretic and anti-inflammatory properties It is available as a two-layered, Red and White, round tablet for oral administration. _CARISOPRODOL:_ Chemically, carisoprodol is _N_-isopropyl-2-methyl-2-propyl-1,3propanediol dicarbamate and its molecular formula is C H N O , with a molecular weight of 260.33. The structural formula of carisoprodol is: _ASPIRIN:_ Chemically, aspirin (acetylsalicylic acid) is 2-(acetyloxy-, benzoic acid and its molecular formula is C H O , with a molecular weight of 180.16. The structural formula of aspirin is: Other ingredients in the Carisoprodol ·and Aspirin Tablets, drug product are Com starch, FD&C Red # 40 Aluminum Lake, Hydroxypropyl Cellulose, Lactose Anhydrous, Microcrystalline Cellulose, Magnesium Stearate, Pregelatinized Starch, Sodium Starch Glycolate and Sodium Lauryl Sulfate. CLINICAL PHARMACOLOGY 12 24 2 4 9 8 4 MECHANISM OF ACTION _CARISOPRODOL:_ The mechanism of action of carisoprodol in relieving discomfort associated with acute painful musculoskeletal conditions has not been clearly identified. In animal studies, muscle relaxation induced by carisoprodol is associated with altered interneuronal activity in the spinal cord and in the descending reticular formation of the brain. _ASPIRIN:_ The mechanism of action of aspirin in relieving pain is by inhibition of the body's production of prostaglandins, which are thought to cause pain sensations by stimulating muscle contractions and dilating blood vessels. PHARMACODYNAMICS _CARISOPRODOL:_ Carisoprodol is a centrally-acting muscle relaxant that does not directly relax tense skeletal muscles. A metabolite of carisoprodol, meprobamate, has anx Leia o documento completo