cyclobenzaprine hydrochloride tablet film coated

INDICATIONS AND USAGE Cyclobenzaprine HCl 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 HCl 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 has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.

actavis pharma, inc.

FDA Reported Adverse Reactions
[1] drug ineffective    [2] off label use    [3] nausea    [4] diarrhoea    [5] fatigue    [6] pain    [7] toxicity to various agents    [8] headache    [9] product use in unapproved indication    [10] dyspnoea