Adjunct to rest and physical therapy for the relief of muscular spasm associated with acute, painful musculoskeletal conditions.
For low back pain, generally reserve skeletal muscle relaxants for adjunctive treatment when pain is unresponsive to OTC analgesics (e.g., NSAIAs).
Skeletal muscle relaxants less well tolerated than NSAIAs, and clinical superiority to NSAIAs not established for low back pain.
Various skeletal muscle relaxants appear to have comparable efficacy for low back pain relief and are more effective than placebo.
Initially, symptomatic control of acute low back pain focuses on providing sufficient comfort to allow maximum possible activity while awaiting spontaneous recovery; later, as aid to overcome specific activity intolerance.
Because of rapid spontaneous recovery rate, efficacy of various therapies may be difficult to establish; improvement of low back pain usually occurs within 2 weeks, substantial improvement within 4 weeks.
Insufficient evidence to indicate whether cyclobenzaprine enhances the effects of aspirin or other analgesics, or vice versa, in the management of painful musculoskeletal conditions.
Ineffective for the treatment of cerebral or spinal disease-associated spasticity or in children with cerebral palsy.
Shares the toxic potentials of tricyclic antidepressants; observe the usual precautions associated with tricyclic antidepressant therapy.
Cardiac Effects
Arrhythmias, sinus tachycardia, prolongation of the conduction time leading to MI, and stroke reported with tricyclic antidepressants.
CNS Effects
May cause serious CNS effects, especially when recommended dosage is exceeded.
Performance of activities requiring mental alertness or physical coordination may be impaired.
Concurrent use of other CNS depressants may potentiate CNS depression. (See Interactions: Specific Drugs.)
General Precautions
Anticholinergic Effects
Potential for adverse anticholinergic effects. Use with caution in patients with history of urinary retention, angle-closure glaucoma, or increased intraocular pressure or in patients receiving anticholinergic drugs.
Specific Populations
Pregnancy
Category B.
Lactation
Not known whether cyclobenzaprine is distributed into milk; however, distribution into milk is likely, since other tricyclic drugs distribute into milk. Use with caution.
Pediatric Use
Safety and efficacy not established in children <15 years of age.
Geriatric Use
Increased plasma concentrations.
Increased frequency and severity of adverse effects (with or without concomitant drug therapy). Increased risk of adverse CNS effects (e.g., hallucinations, confusion, sedation), adverse cardiovascular effects resulting in falls or other sequelae, and interactions with other drugs or diseases.
Use only if clearly needed. Cautious dosing recommended. (See Geriatric Patients under Dosage and Administration.)
Hepatic Impairment
Increased plasma concentrations and susceptibility to sedation.
Initiate with caution in patients with mild hepatic impairment. (See Hepatic Impairment under Dosage and Administration.)
Use not recommended in patients with moderate or severe hepatic impairment.
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