AMRIX (Cyclobenzaprine Hydrochloride Extended-Release Capsules) is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. AMRIX should be used only for short periods (up to two or three weeks). AMRIX has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy.

AMRIX is contraindicated in patients who are hypersensitive to any of its components. AMRIX is contraindicated with concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation. AMRIX may have life-threatening interactions with MAO inhibitors. AMRIX is contraindicated during the acute recovery phase of myocardial infarction; in patients with arrhythmias, heart block conduction disturbances, or congestive heart failure; or in patients with hyperthyroidism. AMRIX may enhance the effects of alcohol, barbiturates, and other CNS depressants. AMRIX should not be used in elderly patients or in patients with impaired hepatic function.

AMRIX is closely related to tricyclic antidepressants, which have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction, and stroke.

Because of its atropine-like action, AMRIX should be used with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic medication. AMRIX, especially when used with alcohol or other CNS depressants, may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle.

In clinical trials, the most commonly reported adverse reactions (≥3%) with AMRIX were dry mouth, dizziness, fatigue, nausea, dyspepsia, and constipation.

The recommended adult dose of AMRIX for most patients is one (1) AMRIX 15-mg capsule taken once daily. Some patients may require up to 30 mg/day, given as one (1) AMRIX 30-mg capsule taken once daily or as two (2) AMRIX 15-mg capsules taken once daily. AMRIX should be taken at approximately the same time each day.

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