País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI)
Mylan Institutional Inc.
CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE 10 mg
ORAL
PRESCRIPTION DRUG
Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy. Hypersensitivity to any component of this product. Concomitant use of monoamine oxidase MAO inhibitors or within
Cyclobenzaprine Hydrochloride Tablets, USP are available containing 10 mg of cyclobenzaprine hydrochloride, USP. The 10 mg tablets are butterscotch yellow film-coated, round, unscored tablets debossed with M on one side of the tablet and 751 on the other side. They are available as follows: NDC 51079-644-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). NDC 51079-644-19 – Robot Ready blister packages of 25 (25 cards of 1 tablet each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A S-12205 R1 9/15
Abbreviated New Drug Application
CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED MYLAN INSTITUTIONAL INC. ---------- DESCRIPTION Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the molecular formula C H N • HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pK of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5 _H_ -dibenzo[ _a,d_] cyclohepten-5-ylidene) _-N_, _N_- dimethyl-1-propanamine hydrochloride, and has the following structural formula: Cyclobenzaprine hydrochloride tablets, USP are available as 5 mg, 7.5 mg and 10 mg tablets for oral administration. Each 5 mg, 7.5 mg and 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin. In addition, the 5 mg tablet contains FD&C Blue No. 2 Aluminum Lake and the 10 mg tablet contains lecithin, sodium alginate and yellow iron oxide. CLINICAL PHARMACOLOGY Cyclobenzaprine hydrochloride relieves skeletal muscle spasm of local origin without interfering with muscle function. It is ineffective in muscle spasm due to central nervous system disease. Cyclobenzaprine reduced or abolished skeletal muscle hyperactivity in several animal models. Animal studies indicate that cyclobenzaprine does not act at the neuromuscular junction or directly on skeletal muscle. Such studies show that cyclobenzaprine acts primarily within the central nervous system at brain stem as opposed to spinal cord levels, although its action on the latter may contribute to its overall skeletal muscle relaxant activity. Evidence suggests that the net effect of cyclobenzaprine is a Leia o documento completo