Soma - Carisoprodol is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Soma - Carisoprodol should only 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.

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Sedation

Soma - Carisoprodol may have sedative properties (in the low back pain trials, 13% to 17% of patients who received Soma - Carisoprodol experienced sedation compared to 6% of patients who received placebo) and may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a motor vehicle or operating machinery.

Carisoprodol is a centrally acting skeletal muscle relaxant that does not directly relax skeletal muscles. A metabolite of carisoprodol, meprobamate, has anxiolytic and sedative properties. The degree to which these properties of meprobamate contribute to the safety and efficacy of SOMA is unknown.

Since the sedative effects of Soma - Carisoprodol and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive, appropriate caution should be exercised with patients who take more than one of these CNS depressants simultaneously.

Drug Dependence, Withdrawal, and Abuse

In the postmarketing experience with Soma - Carisoprodol, cases of dependence, withdrawal, and abuse have been reported with prolonged use. Most cases of dependence, withdrawal, and abuse occurred in patients who have had a history of addiction or who used Soma - Carisoprodol in combination with other drugs with abuse potential. Withdrawal symptoms have been reported following abrupt cessation after prolonged use. To reduce the chance of Soma - Carisoprodol dependence, withdrawal, or abuse, Soma - Carisoprodol should be used with caution in addiction-prone patients and in patients taking other CNS depressants including alcohol, and Soma - Carisoprodol should be not be used more than two to three weeks for the relief of acute musculoskeletal discomfort.

One of the metabolites of Soma - Carisoprodol, meprobamate (a controlled substance), may cause dependence

Seizures

There have been postmarketing reports of seizures in patients who received Soma - Carisoprodol. Most of these cases have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol)

NonClinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies in animals have not been performed to evaluate the carcinogenic potential of carisoprodol.

The safety and efficacy of SOMA for the relief of acute, idiopathic mechanical low back pain was evaluated in two, 7-day, double blind, randomized, multicenter, placebo controlled, U.S. trials (Studies 1 and 2). Patients had to be 18 to 65 years old and had to have acute back pain (≤ 3 days of duration) to be included in the trials. Patients with chronic back pain; at increased risk for vertebral fracture (e.g., history of osteoporosis); with a history of spinal pathology (e.g., herniated nucleus pulposis, spondylolisthesis or spinal stenosis); with inflammatory back pain, or with evidence of a neurologic deficit were excluded from participation. Concomitant use of analgesics (e.g., acetaminophen, NSAIDs, tramadol, opioid agonists), other muscle relaxants, botulinum toxin, sedatives (e.g., barbiturates, benzodiazepines, promethazine hydrochloride), and anti-epileptic drugs was prohibited.

Soma - Carisoprodol was not formally evaluated for genotoxicity. In published studies, carisoprodol was mutagenic in the in vitro mouse lymphoma cell assay in the absence of metabolizing enzymes, but was not mutagenic in the presence of metabolizing enzymes. Carisoprodol was clastogenic in the in vitro chromoSoma - Carisoprodoll aberration assay using Chinese hamster ovary cells with or without the presence of metabolizing enzymes. Other types of genotoxic tests resulted in negative findings. Carisoprodol was not mutagenic in the Ames reverse mutation assay using S. typhimurium strains with or without metabolizing enzymes, and was not clastogenic in an in vivo mouse micronucleus assay of circulating blood cells.

In rare cases, the first dose of Soma - Carisoprodol may cause unusual symptoms that appear within minutes or hours of taking the medication. Symptoms reported include: agitation, confusion, disorientation, dizziness, double vision, enlargement of pupils, extreme weakness, exaggerated feeling of well-being, lack of coordination, speech problems, temporary loss of vision, and temporary paralysis of arms and legs. These symptoms usually subside within a few hours. If you experience any of them, contact your doctor immediately.

Soma - Carisoprodol may impair the mental or physical abilities you need to drive a car or operate dangerous machinery. Do not participate in hazardous activities until you know how Soma - Carisoprodol affects you.

If you have a history of drug dependence, make sure your doctor is aware of it before you start taking Soma - Carisoprodol.

Withdrawal symptoms, including abdominal cramps, chilliness, headache, insomnia, and nausea, have occurred in people who suddenly stop taking Soma - Carisoprodol.

Take Soma - Carisoprodol cautiously if you have any kidney or liver problems.

Treatment of Overdosage: Basic life support measures should be instituted as dictated by the clinical presentation of the SOMA overdose. Induced emesis is not recommended due to the risk of CNS and respiratory depression, which may increase the risk of aspiration pneumonia. Gastric lavage should be considered soon after ingestion (within one hour). 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.
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