Generally well tolerated³

Incidence of the Most Common Adverse Reactions Occurring in ≥3% of Subjects in Any Treatment Group in the 2 Phase 3, Double-Blind AMRIX Trials^a

• The most common adverse reactions seen in ≥3% of patients with AMRIX were dry mouth, dizziness, fatigue, nausea, dyspepsia, and constipation
• Somnolence occurred in:
• 0% of patients taking placebo
• 1% of patients taking AMRIX 15 mg
• 2% of patients taking AMRIX 30 mg
• 7% of patients taking cyclobenzaprine immediate release (IR) 10 mg 3 times daily

Daytime drowsiness³

Patient-Rated Daytime Drowsiness at Day 4 (N=504)^a

• Daytime drowsiness reported in both AMRIX groups was greater than placebo and less than cyclobenzaprine IR 10 mg 3 times daily^*

^*In clinical trials, AMRIX was dosed in the evening.

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.

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