Clinical Trials Demonstrate SOMA 250 mg Efficacy and Favorable Tolerability Profile
FDA approval of Soma Carisoprodol 250 mg was based on the results from two randomized, double-blind, placebo-controlled, multi-site parallel group studies (MP502 and MP505) which included more than 1,300 patients aged 18 to 65 who suffered from acute painful muscle spasm of the lower back. Results from both studies showed that Soma Carisoprodol 250 mg provided significant and rapid relief of back pain compared to placebo (P = 0.0001) with efficacy comparable to Soma Carisoprodol 350 mg. Results from the studies also showed that Soma Carisoprodol 250 mg provided efficacy comparable to Soma Carisoprodol 350 mg with a more favorable tolerability profile, resulting in fewer discontinuations due to treatment-related adverse events. In the studies, the discontinuation rate due to adverse events for Soma Carisoprodol 250 mg was comparable to placebo and lower than that for Soma Carisoprodol 350 mg (2% versus 2.7% versus 5.4% respectively). The most common side effects associated with Soma Carisoprodol 250 mg in clinical trials included drowsiness (13%), dizziness (8%) and headache (5%). The most common side effects for Soma Carisoprodol 350 mg included drowsiness (17%), dizziness (7%) and headache (3%).This new recommended dose of Soma Carisoprodol is 250 mg three times a day and at bedtime.
Important Information
Soma Carisoprodol (carisoprodol) is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Soma Carisoprodol should be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration.
Since the effects of Soma Carisoprodol and CNS depressants (including alcohol) or psychotropic drugs may be additive, appropriate caution should be exercised with patients who take more than one of these agents simultaneously. In postmarketing experience with Soma Carisoprodol, cases of dependence, withdrawal, and abuse have been reported with prolonged use. Soma Carisoprodol should be used with caution in addiction-prone patients. There have been postmarketing reports of seizures in Soma Carisoprodol treated patients with most cases having occurred in the setting of multiple drug overdoses.