muscle spasm
† non-FDA-approved indication
Cyclobenzaprine Indications and Dosage
For the relief of muscle spasm associated with acute painful musculoskeletal conditions unrelated to central nervous system disease:
NOTE: The manufacturer reduced the dosage recommendations for cyclobenzaprine based on efficacy and safety data in February, 2003.
Oral dosage:
Adults and adolescents >= 15 years: The FDA-approved dosage for cyclobenzaprine has been reduced to 5 mg PO three times daily based on clinical efficacy and safety data (February 2003). During February 2003, cyclobenzaprine became available in both 5 mg and 10 mg tablets to accommodate the lower dosage recommendations. If needed, the dosage may be increased to 10 mg PO three times daily based on therapeutic response. The manufacturer has also reduced the recommended maximum dosage to 30 mg/day PO (prior to February 2003, the maximum dosage was 60 mg/day PO). Treatment duration beyond 2 - 3 weeks is not recommended by the manufacturer. .
Elderly: Generally not recommended for use in patients 65 years of age and older. The manufacturer recommends that cyclobenzaprine be used in the elderly only if clearly needed. If prescribed, initiate dosage with the lowest dose (5 mg PO) and titrate upward slowly. Elderly patients may respond to less frequent dosing compared to the three times daily regimen recommended for adults (See adult dosage). Adjust dosage cautiously based on clinical response. The plasma concentrations of cyclobenzaprine are elevated in elderly patients relative to younger patients. In addition, elderly patients are at higher risk for adverse CNS (e.g. hallucinations, confusion) and cardiac events, potentially leading to falls or other sequelae.
Children and adolescents < 15 years: Safe and effective use has not been established.
For the treatment of fibromyalgia † :
Oral dosage:
Adults: Cyclobenzaprine, administered initially in doses of 10 mg PO at bedtime and titrated up to 10 mg PO every morning and 20 mg PO at bedtime over a period of 12 weeks to 208 patients, was found to be superior to placebo at 1 month but not significantly better at 3 or 6 months.
Elderly: The manufacturer recommends that cyclobenzaprine be used in the elderly only if clearly needed. If prescribed, initiate dosage with the lowest dose (5 mg PO) and titrate upward slowly. Elderly patients may respond to less frequent dosing compared to the three times daily regimen recommended for adults (See adult dosage). Adjust dosage cautiously based on clinical response. The plasma concentrations of cyclobenzaprine are elevated in elderly patients relative to younger patients. In addition, elderly patients are at higher risk for adverse CNS (e.g. hallucinations, confusion) and cardiac events, potentially leading to falls or other sequelae.
Maximum Dosage Limits:
- Adults: 30 mg/day PO.
- Elderly: 30 mg/day PO. Elderly are at higher risk for adverse effects.
- Adolescents >= 15 years: 30 mg/day PO.
- Children and adolescents < 15 years: Safe and effective use has not been established.
Patients with hepatic impairment:
Not recommended for patients with moderate to severe hepatic impairment. In patients with mild hepatic impairment, begin with 5 mg PO dose and titrate upward slowly; these patients may require less frequent dosing than the three times daily schedule recommended for adults. Peak plasma concentrations and AUC of cyclobenzaprine are nearly doubled in patients with hepatic impairment (15 of 16 patients studied had mild hepatic impairment).
Patients with renal impairment:
No dosage adjustment needed.
† non-FDA-approved indication
[ Last revised: 3/9/2004 2:40:00 PM ]
References
. Carette S, Bell MJ, Reynolds WJ et al. Comparison of amitriptyline, cyclobenzaprine, and placebo in the treatment of fibromyalgia. A randomized, double-blind clinical trial. Arthritis Rheum 1994;37:32 - 40.
. Beers MH. Explicit criteria for determining potential inappropriate medication use by the elderly: an update. Arch Intern Med 1997;157:1531 - 6.
. Fick DM, Cooper JW, Wade WE, et al. Updating the Beers criteria for potentially inappropriate medication use in older adults: results of a US consensus panel of experts. Arch Intern Med 2003;163:2716 - 24.
. Douglass MA, Levine DP. Hallucinations in an elderly patient taking recommended doses of cyclobenzaprine. Arch Intern Med 2000; 160:1373.
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