Cyclobenzaprine is used as an adjunct to rest and physical therapy for the relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is usually seen through reduction of muscle spasm and related symptoms such as pain, tenderness, restricted movement, and difficulty in performing daily activities.

Cyclobenzaprine is a centrally acting skeletal muscle relaxant structurally related to tricyclic antidepressants, and therefore shares some similar properties. It acts primarily at the brain stem level, reducing tonic somatic motor activity by influencing both gamma and alpha motor systems. It is used as supportive therapy for the symptomatic treatment of painful muscle spasms associated with musculoskeletal disorders.

The usual dose is 5-10 mg three times daily given by mouth. The daily dose should not exceed 60 mg. Treatment for more than 2 or 3 weeks is not recommended.

Dose in elderly: Therapy with Flexor in the elderly should be initiated with a 5 mg dose and titrated slowly upward.

Dose in hepatic impairment: Flexor should be used with caution in subjects with mild hepatic impairment starting with the 5 mg dose and titrating slowly upward. The use of Flexor in subjects with moderate to severe impairment is not recommended.

Pediatric use: Safety and effectiveness of Cyclobenzaprine Hydrochloride in pediatric patients below 15 years of age have not been established.

Cyclobenzaprine Hydrochloride may produce serious and potentially life-threatening interactions when used together with MAO inhibitors. It may also enhance the effects of alcohol, barbiturates, and other central nervous system depressants.

• Hypersensitivity to any component of this preparation
• Concurrent use of monoamine oxidase (MAO) inhibitors or use within 14 days after stopping MAO inhibitors
• Patients with a history of hyperpyretic crisis, seizures, or death related to concomitant use with MAO inhibitors
• Acute recovery phase following myocardial infarction
• Patients with arrhythmias, heart block, conduction disturbances, or congestive heart failure
• Hyperthyroidism

The most commonly reported adverse effects of Cyclobenzaprine Hydrochloride include drowsiness, dry mouth, and dizziness. These reactions are generally less frequent in post-marketing surveillance than in controlled clinical studies.

Pregnancy category B. Cyclobenzaprine Hydrochloride should be used during pregnancy only when clearly necessary. Caution is advised when administered to breastfeeding mothers.

Due to its atropine-like properties, Cyclobenzaprine Hydrochloride should be used cautiously in patients with urinary retention, angle-closure glaucoma, increased intraocular pressure, or in those receiving anticholinergic medications.

Although uncommon, overdose with Cyclobenzaprine Hydrochloride may be fatal. Symptoms of toxicity can develop rapidly after overdose; therefore, immediate hospital monitoring and medical management are recommended.

Locally acting Skeletal Muscle Relaxants

Store below 30°C, protected from light and moisture. Keep out of reach of children.