DOSAGE AND ADMINISTRATION
The usual adult dosage of `SOMA' (carisoprodol) Tablets, USP is one 350 mg tablet, three times daily and at bedtime. Usage in patients under age 12 is not recommended.

HOW SUPPLIED
`SOMA' (carisoprodol) Tablets, USP 350 mg: Round, convex, white tablets, inscribed with SOMA 350, are available in bottles of 100 (NDC 0037-2001-01).

Storage: Store at controlled room temperature 20 to 25° C (68 to 77° F).

Dispense in a tight container.

 

OVERDOSAGE
Overdosage of Soma produces CNS depression, and in severe cases coma. Shock, respiratory depression, seizures and death have also been reported rarely. The following signs and symptoms may be associated with Soma overdosage: horizontal and vertical nystagmus, blurred vision, mydriasis, mild tachycardia and hypotension, respiratory depression, euphoria, CNS stimulation, muscular incoordination, and/or rigidity, confusion, headache, hallucinations, and dystonic reactions.

The effects of an overdosage of Soma and alcohol or other CNS depressants or psychotropic agents can be additive even when one of the drugs has been taken in the usual recommended dosage. Fatal accidental and non-accidental overdoses have been reported alone or in combination with alcohol or psychotropic drugs.

 

INDICATIONS
Carisoprodol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions.

CLINICAL PHARMACOLOGY

Soma is a centrally acting skeletal muscle relaxant that does not directly relax  tense skeletal muscles in man. The mode of action of Soma in relieving acute muscle spasm of local origin has not been clearly identified, but may be related to its sedative properties. In animals, Soma has been shown to produce muscle relaxation by blocking interneuronal activity and depressing transmission of polysynaptic neurons in the spinal cord and in the descending reticular formation of the brain. The onset of action is rapid and lasts four to six hours.

Soma is metabolized in the liver and is excreted by the kidneys. One of the products of metabolism, meprobamate, is active as an anxiolytic. The degree to which it contributes to the efficacy of Soma is unknown. Soma is dialyzable by peritoneal and hemodialysis.

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Important information about Soma

These pills may be habit-forming and should be used just by the person it was prescribed for. Soma should never be given to another person, particularly someone who has a history of drug abuse or dependence. Keep the drug in a secure place where others cannot get it. You may have removal symptoms when you stop using Soma after using it a long period of time. Do not stop using Soma suddenly without first talking to your medical doctor. You may need to use less and less before you stop usage of medication completely. Soma can cause side effects that may slow your judgment or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase sleepiness and giddiness caused by Soma.

SOMA: GENERAL DESCRIPTION

Soma (Carisoprodol) is a muscle relaxant, used to relieve the pain and stiffness of muscle strains and spasms.

SOMA (carisoprodol) Tablets, USP is available as 350 mg round, white tablets.

Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate.

Soma (Carisoprodol) is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is very slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; its solubility is practically independent of pH. Soma (Carisoprodol) is present as a racemic mixture. The molecular formula is C 12 H 24 N 2 O 4 , with a molecular weight of 260.33.

The structural formula is: