|Drug Name:||Cyclobenzaprine Hydrochloride|
|Manufacturer:||Actavis Totowa LLC|
VALIUM® (diazepam, Roche)ULTRAM® (tramadol HCl tablets, Ortho-McNeil Pharmaceutical) ULTRACET®(tramadol HCl and acetaminophen tablets, Ortho-McNeil Pharmaceutical)Note: Cyclobenzaprine HCl tablets, USP 10 mg data are from one clinical trial.Cyclobenzaprine HCl tablets, USP 5 mg and placebo data are from two studies.
Hypersensitivity to any component of this product.Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation.Hyperpyretic crisis seizures, and deaths have occurred in patients receiving cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitor drugs.Acute recovery phase of myocardial infarction, and patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.Hyperthyroidism.
Cyclobenzaprine is closely related to the tricyclic antidepressants, e.g., amitriptyline and imipramine.In short term studies for indications other than muscle spasm associated with acute musculoskeletal conditions, and usually at doses somewhat greater than those recommended for skeletal muscle spasm, some of the more serious central nervous system reactions noted with the tricyclic antidepressants have occurred (see WARNINGS, below, and ADVERSE REACTIONS).Tricyclic antidepressants have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke.Cyclobenzaprine HCl may enhance the effects of alcohol, barbiturates, and other CNS depressants.