Cyclobenzaprine HCL ER

FDA Drug Profile — Cyclobenzaprine HCL ER

Drug Details

Generic Name
Cyclobenzaprine HCL ER
Brand Names
Cyclobenzaprine HCL ER
Application Number
NDA021777
Sponsor
Direct_Rx
NDC Codes
2
Dosage Forms
CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients
CYCLOBENZAPRINE HYDROCHLORIDE

Indications and Usage

Cyclobenzaprine hydrochloride extended-release capsules 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, and limitation of motion. Limitations of Use: Cyclobenzaprine hydrochloride extended-release capsules 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 extended-release capsules have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy.