1. SOMA [package insert]. Somerset, NJ: Meda Pharmaceuticals Inc.; 2007
2. Data on file. Meda Pharmaceuticals Inc.
Important Safety 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 2 or 3 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.
- SOMA is contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate.
- Patients should be advised that SOMA may cause drowsiness and/or dizziness and has been associated with motor vehicle accidents. Patients should advised to avoid using SOMA before engaging in potentially hazardous activities.
- 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 accompanying full Prescribing Information
SOMA® 250 mg is manufactured by Meda Pharmaceuticals Inc.
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