Carisoprodol

SOMA is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitation of Use 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 a muscle relaxant indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitations of Use • Should only be used for acute treatment periods up to two or three weeks

The mechanism of action of carisoprodol in relieving discomfort associated with acute painful musculoskeletal conditions has not been clearly identified. In animal studies, muscle relaxation induced by carisoprodol is associated with altered interneuronal activity in the spinal cord and in the descending reticular formation of the brain.

The recommended dose of SOMA is 250 mg to 350 mg three times a day and at bedtime. The recommended maximum duration of SOMA use is up to two or three weeks. • Recommended dose is 250 mg to 350 mg three times a day and at bedtime.

SOMA is contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. • Acute intermittent porphyria. • Hypersensitivity reactions to a carbamate such as meprobamate

• Due to sedative properties, may impair ability to perform hazardous tasks such as driving or operating machinery. • Additive sedative effects when used with other CNS depressants including alcohol. • Cases of abuse, dependence and withdrawal. • Seizures

Most common adverse reactions (incidence > 2%) are drowsiness, dizziness, and headache

CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) - additive sedative effects CNS Depressants 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. Concomitant use of SOMA and meprobamate, a metabolite of SOMA, is not recommended. CYP2C19 Inhibitors and Inducers Carisoprodol is metabolized in the liver by CYP2C19 to form meprobamate. Co-administration of CYP2C19 inhibitors, such as omeprazole or fluvoxamine, with SOMA could result in increased exposure of carisoprodol and decreased exposure of meprobamate.

Store at controlled room temperature 20° - 25°C (68° - 77°F).