Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
CYCLOBENZAPRINE HYDROCHLORIDE (UNII: 0VE05JYS2P) (CYCLOBENZAPRINE - UNII:69O5WQQ5TI)
KAISER FOUNDATION HOSPITALS
CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE 10 mg
ORAL
PRESCRIPTION DRUG
Cyclobenzaprine HCl tablets 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 HCl tablets should be used only for short periods (up to two or three 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 HCl 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 14 days after their discont
Cyclobenzaprine HCl Tablets, USP are available in the following strength and package sizes: 10 mg (Yellow, round, film-coated, debossed with TL177 on one side and plain on the other side) Bottles of 30 (NDC 0179-0057-30) Bottles of 50 (NDC 0179-0057-50) Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Manufactured by: Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA. Revised 02/07 Repackaged by: Kaiser Foundation Hospitals Livermore, CA 94551, USA.
Abbreviated New Drug Application
CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED KAISER FOUNDATION HOSPITALS ---------- CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP RX ONLY DESCRIPTION Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula C H N•HCI and a molecular weight of 311.9. It has a melting point of 217º C, and a pKa of 8.47 at 25º 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 HCI is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N, N-dimethyl-1- propanamine hydrochloride, and has the following structural formula: Cyclobenzaprine HCl Tablets, for oral administration, are available in the following strength: 10 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, iron oxide yellow. CLINICAL PHARMACOLOGY Cyclobenzaprine HCI 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 reduction of tonic somatic motor activity, influencing both gamma (γ) and alpha (α) motor systems. Pharmacological studies in animals showed a similarity between the effects of cyclobenzaprine and the structurally rela Прочитајте комплетан документ