FLEXERIL- cyclobenzaprine hydrochloride tablet, film coated
Ortho-McNeil-Janssen Pharmaceuticals, Inc
DESCRIPTION
Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula C20 H21 N�HCl and a molecular weight of 311.9. It has a melting point of 217�C, and a pKa 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,
FLEXERIL 5 mg (Cyclobenzaprine HCl) is supplied as a 5 mg tablet for oral administration. FLEXERIL 10 mg (Cyclobenzaprine HCl) is supplied as a 10 mg tablet for oral administration.
FLEXERIL 5 mg (Cyclobenzaprine HCl) tablets contain the following inactive ingredients: lactose hydrous, pre-gelatinized starch, corn starch, magnesium stearate, hydroxypropyl cellulose, hypromellose, titanium dioxide, Yellow D&C #10 Aluminum Lake HT, Yellow FD&C #6 Aluminum Lake, and carnauba wax.
FLEXERIL 10 mg (Cyclobenzaprine HCl) tablets contain the following inactive ingredients: lactose hydrous, pre-gelatinized starch, corn starch, magnesium stearate, hydroxypropyl cellulose, hypromellose, titanium dioxide, yellow iron oxide, and carnauba wax.
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 (?) and alpha (?) motor systems.
INDICATIONS AND USAGE
FLEXERIL 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
