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Cyclobenzaprine
Generic Name: Cyclobenzaprine Hydrochloride
Drug Category: Muscle Relaxant
Litigation Alert Level: Low
This drug has been approved for use by males and females over the age of 15 years old for a maximum duration of 3 weeks.
| Approved Uses |
|
Indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy. Cyclobenzaprine hydrochloride tablets 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 associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets are contraindicated in patients:
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. Tricyclic antidepressants 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, cyclobenzaprine 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. Cyclobenzaprine hydrochloride should be used with caution in subjects with mild hepatic impairment starting with a 5 mg dose and titrating slowly upward. Due to the lack of data in subjects with more severe hepatic insufficiency, the use of cyclobenzaprine in subjects with moderate to severe impairment is not recommended. Cyclobenzaprine may enhance the effects of alcohol, barbiturates, and other CNS depressants. Cyclobenzaprine, 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 the elderly, the frequency and severity of adverse events associated with the use of cyclobenzaprine, with or without concomitant medications, is increased. In elderly patients, cyclobenzaprine hydrochloride should be initiated with a 5 mg dose and titrated slowly upward. The elderly may also be more at risk for CNS adverse events such as hallucinations and confusion, cardiac events resulting in falls or other sequelae, drug-drug and drug-disease interactions. For these reasons, in the elderly, cyclobenzaprine should be used only if clearly needed. Do not use with 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. The development of a potentially life-threatening serotonin syndrome has been reported with cyclobenzaprine hydrochloride when used in combination with other drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or (MAO) inhibitors. The concomitant use of cyclobenzaprine hydrochloride with MAO inhibitors is contraindicated. Tricyclic antidepressants may block the antihypertensive action of guanethidine and similarly acting compounds. Tricyclic antidepressants may enhance the seizure risk in patients taking tramadol. There are no adequate and well-controlled studies in pregnant women. It is not known whether this drug is excreted in human milk. Because cyclobenzaprine is closely related to the tricyclic antidepressants, some of which are known to be excreted in human milk, caution should be exercised when cyclobenzaprine hydrochloride is administered to a nursing woman. |
| Off-label Uses |
|
• Adult dosage greater than 10 mg three times a day. GoToSource • Use in patients under the age of 15. GoToSource • Use longer than 3 weeks. GoToSource • Fibromyalgia. GoToSource • Tension headache. GoToSource • Sleep disturbance in breast cancer patients. GoToSource • Temporomandibular joint pain. GoToSource • Tinnitus. GoToSource • Parkinson’s disease and depression. GoToSource • Fibrositis syndrome. GoToSource • Levator ani syndrome. GoToSource • Rheumatoid arthritis. GoToSource • Chronic fatigue syndrome. GoToSource |
| Adverse Events |
|
Serotonin syndrome (severe drug reaction). GoToSource Sedation, confusion and increased risk of falls and injuries in elderly patients. GoToSource Delirium and hyperkinetic movement disorders. GoToSource Torticollis (abnormal, asymmetrical head or neck position). GoToSource Neuroleptic malignant syndrome (life-threatening drug reaction). GoToSource Blurred vision, anxiety, agitation, psychosis, hallucinations, increased heart rate and palpitations. GoToSource |
| Litigation |
|
No major injury lawsuits reported. |
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