Carisoprodol

No boxed warning. The label prominently states "carisoprodol, the active ingredient in SOMA, has been subject to abuse, dependence, and withdrawal, misuse and criminal diversion." It also warns of sedation (reported in 13-17% of patients vs. 6% on placebo) with postmarketing reports of motor vehicle accidents, additive effects with other CNS depressants, withdrawal symptoms after abrupt cessation ("insomnia, vomiting, abdominal cramps, headache, tremors, muscle twitching, ataxia, hallucinations, and psychosis"), and postmarketing seizure reports, mostly in overdose.

4 CONTRAINDICATIONS Carisoprodol tablets are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. Acute intermittent porphyria ( 4 ) Hypersensitivity reactions to a carbamate such as meprobamate ( 4 )

10 OVERDOSAGE Clinical Presentation Overdosage of carisoprodol tablets commonly produces CNS depression. Death, coma, respiratory depression, hypotension, seizures, delirium, hallucinations, dystonic reactions, nystagmus, blurred vision, mydriasis, euphoria, muscular incoordination, rigidity, and/or headache have been reported with carisoprodol tablets overdosage. Serotonin syndrome has been reported with carisoprodol intoxication. Many of the carisoprodol overdoses have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol). The effects of an overdose of carisoprodol and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) can be additive even when one of the drugs has been taken in the recommended dosage. Fatal accidental and non-accidental overdoses of carisoprodol tablets have been reported alone or in combination with CNS depressants. Treatment of Overdosage Basic life support measures should be instituted as dictated by the clinical presentation of the carisoprodol tablets overdose. Vomiting should not be induced because of the risk of CNS and respiratory depression, and subsequent aspiration. Circulatory support should be administered with volume infusion and vasopressor agents if needed. Seizures should be treated with intravenous benzodiazepines and the reoccurrence of seizures may be treated with phenobarbital. In cases of severe CNS depression, airway protective reflexes may be compromised and tracheal intubation should be considered for airway protection and respiratory support. For decontamination in cases of severe toxicity, activated charcoal should be considered in a hospital setting in patients with large overdoses who present early and are not demonstrating CNS depression and can protect their airway. For more information on the management of an overdose of carisoprodol tablets, contact a Poison Control Center.