מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
CARISOPRODOL (UNII: 21925K482H) (CARISOPRODOL - UNII:21925K482H), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)
Avet Pharmaceuticals Inc.
CARISOPRODOL
CARISOPRODOL 200 mg
ORAL
PRESCRIPTION DRUG
Carisoprodol and aspirin tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol and aspirin tablets 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 tablets are 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 a carbamate such as meprobamate - acute intermittent porphyria Controlled Substance Carisoprodol and aspirin tablets contain carisoprodol, a Sche
Carisoprodol and aspirin tablets are round, convex, two-layered and debossed on the white layer with HP 145 and plain on the light lavender layer. The tablets are available in bottles of 100 (NDC 23155-145-01). Storage: Store at 20°- 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container. MANUFACTURED FOR: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 1-866-901-DRUG (3784) MF # 0214-05 Issued 10/13
Abbreviated New Drug Application
CARISOPRODOL AND ASPIRIN- CARISOPRODOL AND ASPIRIN TABLET AVET PHARMACEUTICALS INC. ---------- CARISOPRODOL AND ASPIRIN TABLETS, USP FOR ORAL USE CIV RX ONLY DESCRIPTION Carisoprodol and aspirin tablets, USP is 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, white and lavender, round tablet for oral administration. _CARISOPRODOL:_ Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol 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 (acetylsalicyclic 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 drug product are croscarmellose sodium, D&C Red#30, FD&C Blue #1, magnesium stearate, microcrystalline cellulose, povidone, starch, and stearic acid. CLINICAL PHARMACOLOGY 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 12 24 2 4 9 8 4 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 skeletal muscles. A metabolite of carisoprodol, meprobamate, has anxiolytic and sedative properties. The degree to which these properties of meprob קרא את המסמך השלם