Country: United States
Language: English
Source: NLM (National Library of Medicine)
Cyclobenzaprine Hydrochloride (UNII: 0VE05JYS2P) (Cyclobenzaprine - UNII:69O5WQQ5TI)
Mutual Pharmaceutical
Cyclobenzaprine Hydrochloride
Cyclobenzaprine Hydrochloride 5 mg
ORAL
PRESCRIPTION DRUG
Cyclobenzaprine hydrochloride is 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 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 hydrochloride has 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 dis
Cyclobenzaprine hydrochloride tablets are supplied as follows: Cyclobenzaprine hydrochloride 5 mg, capsule shaped, white, film coated tablets, debossed MP 578 on one side and plain on the other side Cyclobenzaprine hydrochloride 10 mg, round, white, film coated tablets, debossed MP 577 on one side and plain on the other side Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
Abbreviated New Drug Application
CYCLOBENZAPRINE HYDROCHLORIDE- CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED MUTUAL PHARMACEUTICAL ---------- CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP RX ONLY DESCRIPTION Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical 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 HCl 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 hydrochloride is supplied as 5 mg and 10 mg tablets for oral administration. Cyclobenzaprine hydrochloride tablets contain the following inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and propylene glycol. CLINICAL PHARMACOLOGY Cyclobenzaprine HCl 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 related tricyclic antidepressants, including Read the complete document