- Soma (carisoprodol) 250 mg and 350 mg tablets
- Soma Compound (carisoprodol 200 mg and aspirin 325 mg) tablets
- Soma Compound with Codeine (carisoprodol 200 mg, aspirin 325 mg and codeine phosphate 16 mg) tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2009
WARNINGS AND PRECAUTIONS
- There have been post-marketing reports of motor vehicle accidents associated with the use of Soma.
Drug Dependence, Withdrawal, and Abuse
- Soma, and one of its metabolites, meprobamate (a controlled substance), may cause dependence.
DRUG ABUSE AND DEPENDENCE
- Soma is not a controlled substance. Discontinuation of carisoprodol in animals or in humans after chronic administration can produce withdrawal signs, and there are published case reports of human carisoprodol dependence.
- In vitro studies demonstrate that carisoprodol elicits barbiturate-like effects. Animal behavioral studies indicate that carisoprodol produces rewarding effects. Monkeys self administer carisoprodol. Drug discrimination studies using rats indicate that carisoprodol has positive reinforcing and discriminative effects similar to barbital, meprobamate, and chlordiazepoxide.
PATIENT COUNSELING INFORMATION
- Patients should be advised that carisoprodol may cause drowsiness and/or dizziness, and has been associated with motor vehicle accidents.
Soma Should Only Be Used for Short-Term Treatment
- In the post-marketing experience with Soma, cases of dependence, withdrawal, and abuse have been reported with prolonged use. If the musculoskeletal...