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SOMA® 250 mg Tolerability
SOMA 250 mg is well tolerated, with reduced drowsiness compared to SOMA® 350 mg.1
Well Tolerated
SOMA 250 mg (carisoprodol) is generally well tolerated. Two double-blind, randomized, placebo-controlled, multicenter trials with over 1,300 patients showed2
- Less drowsiness: 13% of patients reported drowsiness
- Fewer discontinuations: SOMA 250 mg had 2% discontinuations vs 5.4% for SOMA 350 mg (vs 2.7% and 2.7% for placebo, respectively)
Incidence of Drowsiness With SOMA 250 mg (n=548) 2
Common Side Effects
In clinical studies of SOMA 250 mg, the most common side effects were drowsiness, dizziness, and headache.2
Percent of Patients Reporting Side Effects in Controlled Studies 2
Awareness of Drug Abuse and Dependence
Cases of dependence, withdrawal, and abuse have been reported with prolonged use. Most cases occurred in patients who:
- Had history of addiction
- Used SOMA in combination with other drugs with abuse potential
As a result of these findings, it is recommended to:
- Use for up to 2 or 3 weeks because adequate evidence of effectivenesss for more prolonged use is not available
- Use caution in prescribing carisoprodol to addiction-prone patients and patients taking other CNS depressants, including alcohol
Reference
(1) Data on file. Meda Healthcare, Inc.
(2) SOMA [package insert]. Somerset, NJ: Meda Healthcare Inc.; 2007.
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Important Information
SOMA (carisoprodol) is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. SOMA 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 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, cases of dependence, withdrawal, and abuse have been reported with prolonged use. SOMA should be used with caution in addiction-prone patients. There have been postmarketing reports of seizures in SOMA treated patients with most cases having occurred in the setting of multiple drug overdoses.
Most common side effects include drowsiness, dizziness and headache.
Please see full Prescribing Information.
SOMA® 250 mg is distributed by Meda Pharmaceuticals.
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