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Soma

Generic Name: Carisoprodol
Drug Category: Muscle Relaxant
Litigation Alert Level: Medium
This drug has been approved for use by males and females over the age of 16 years old and under the age of 65 years old for a maximum duration of 3 weeks.

Approved Uses

Indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.

SOMA 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.

Soma is contraindicated in patients with acute intermittent porphyria.

There have been post-marketing reports of seizures in patients who received SOMA.

The safety and pharmacokinetics of SOMA in patients with renal impairment have not been evaluated. Since SOMA is excreted by the kidney, caution should be exercised if SOMA is administered to patients with impaired renal function.

The safety and pharmacokinetics of SOMA in patients with hepatic impairment have not been evaluated. Since SOMA is metabolized in the liver, caution should be exercised if SOMA is administered to patients with impaired hepatic function.

Carisoprodol, the active ingredient in SOMA, has been subject to abuse, dependence, withdrawal, misuse, and criminal diversion. To reduce the risk of SOMA abuse, assess the risk of abuse prior to prescribing. After prescribing, limit the length of treatment to three weeks for the relief of acute musculoskeletal discomfort, keep careful prescription records, monitor for signs of abuse and overdose, and educate patients and their families about abuse and on proper storage and disposal.

SOMA has sedative properties 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. There have been post-marketing reports of motor vehicle accidents associated with the use of SOMA.

The sedative effects of SOMA and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously.

Co-administration of CYP2C19 inhibitors, such as omeprazole or fluvoxamine, with SOMA could result in increased exposure of carisoprodol and decreased exposure of meprobamate. Co-administration of CYP2C19 inducers, such as rifampin or St. John’s Wort, with SOMA could result in decreased exposure of carisoprodol and increased exposure of meprobamate. Low dose aspirin also showed an induction effect on CYP2C19. The full pharmacological impact of these potential alterations of exposures in terms of either efficacy or safety of SOMA is unknown.

Data over many decades of carisoprodol use in pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Animal studies: reduced fetal weights, postnatal weight gain, and postnatal survival.

Data from published literature report that carisoprodol and its metabolite, meprobamate, are present in breastmilk.

GoToSource

Off-label Uses

• Use in patients under the age of 16 and over the age of 65. GoToSource

• Nocturnal leg cramps. GoToSource

Adverse Events

Fatal intoxication. GoToSource

Abuse and withdrawal. GoToSource

Agitation, hypertonia (increased rigidity, tension, and spasticity of muscles) and myoclonic encephalopathy. GoToSource 

Seizures and death. GoToSource

Litigation

Lawsuits filed for overdose and death. 

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 29, 2024