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 SOMA (carisoprodol) Tablets are to be had as 250 mg and 350 mg round, white tablets. Carisoprodol is a white, crystalline powder, having a mild, feature smell and a sour taste. It is barely soluble in water; freely soluble in alcohol, chloroform, and acetone; and its solubility is nearly unbiased of pH. Carisoprodol is gift as a racemic mixture. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3propanediol dicarbamate and the molecular method is C12H24N2O4, with a molecular weight of 260.33. The structural method SOMA is indicated for the comfort of pain related to acute, painful musculoskeletal situations in adults.

Limitation Of UseSOMA need to handiest be used for quick periods (up to 2 or 3 weeks) due to the fact good enough proof of effectiveness for greater extended use has now no longer been set up and due to the fact acute, painful musculoskeletal situations are normally of quick length. [see DOSAGE AND ADMINISTRATION].
DOSAGE AND ADMINISTRATIONThe advocated dose of SOMA is 250 mg to 350 mg 3 instances an afternoon and at bedtime. The advocated most length of SOMA use is up to 2 or 3 weeks.
HOW SUPPLIEDDosage Forms And Strengths250 mg Tablets: round, convex, white tablets, inscribed with SOMA 250
350 mg Tablets: round, convex, white tablets, inscribed with SOMA 350
Storage And Handling250 mg Tablets: round, convex, white tablets, inscribed with SOMA 250; to be had in bottles of 100 (NDC 0037-2250-10) and bottles of 30 (NDC 0037-2250-30).
350 mg Tablets: round, convex, white tablets, inscribed with SOMA 350; to be had in bottles of 100 (NDC 0037-2001-01).

The records defined underneath are primarily based totally on 1387 sufferers pooled from double blind, randomized, multicenter, placebo managed, one-week trials in person sufferers with acute, mechanical, decrease lower back ache [see Clinical Studies]. In those studies, sufferers have been dealt with with 250 mg of SOMA, 350 mg of SOMA, or placebo 3 instances an afternoon and at bedtime for seven days. The imply age become approximately forty one years vintage with 54% women and 46% adult males and 74 % Caucasian, 16 % Black, 9% Asian, and 2% different.
There have been no deaths and there have been no extreme unfavorable reactions in those trials. In those studies, 2.7%, 2%, and 5.4%, of sufferers dealt with with placebo, 250 mg of SOMA, and 350 mg of SOMA, respectively, discontinued because of unfavorable events; and 0.5%, 0.5%, and 1.8% of sufferers dealt with with placebo, 250 mg of SOMA, and 350 mg of SOMA, respectively, discontinued because of primary apprehensive gadget unfavorable reactions.
DRUG INTERACTIONSCNS DepressantsThe sedative consequences of SOMA and different CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) can be additive. Therefore, warning need to be exercised with sufferers who take greater than the sort of CNS depressants simultaneously. Concomitant use of SOMA and meprobamate, a metabolite of SOMA, isn't advocated [see WARNINGS AND PRECAUTIONS].
CYP2C19 Inhibitors And InducersCarisoprodol is metabolized withinside the liver through CYP2C19 to shape meprobamate [see CLINICAL PHARMACOLOGY]. Co-management of CYP2C19 inhibitors, along with omeprazole or fluvoxamine, with SOMA ought to bring about elevated publicity of carisoprodol and reduced publicity of meprobamate. Co-management of CYP2C19 inducers, along with rifampin or St. John`s Wort, with SOMA ought to bring about reduced publicity of carisoprodol and elevated publicity of meprobamate. Low dose aspirin additionally confirmed an induction impact on CYP2C19. The complete pharmacological effect of those capacity changes of exposures in phrases of both efficacy or protection of SOMA is unknown.

Drug Abuse And DependenceControlled SubstanceSoma consists of carisoprodol, a Schedule IV managed substance. Carisoprodol has been difficulty to abuse, misuse, and crook diversion for nontherapeutic use [see WARNINGS AND PRECAUTIONS].
AbuseAbuse of carisoprodol poses a threat of overdosage which might also additionally cause death, CNS and respiration depression, hypotension, seizures and different disorders [see WARNINGS AND PRECAUTIONS and OVERDOSAGE]. Patients at excessive threat of SOMA abuse might also additionally consist of people with extended use of carisoprodol, with a records of drug abuse, or individuals who use SOMA in aggregate with different abused drugs.
Prescription drug abuse is the intentional non-healing use of a drug, even once, for its worthwhile mental consequences. Drug dependancy, which develops after repeated drug abuse, is characterised through a sturdy preference to take a drug notwithstanding dangerous consequences, problem in controlling its use, giving a better precedence to drug use than to obligations, elevated tolerance, and occasionally bodily withdrawal. Drug abuse and drug dependancy are separate and wonderful from bodily dependence and tolerance (for example, abuse or dependancy might not be followed through tolerance or bodily dependence) [see Drug Abuse And Dependence].
DependenceTolerance is whilst a patient's response to a particular dosage and awareness is step by step decreased withinside the absence of ailment progression, requiring an growth withinside the dosage to keep the same. Physical dependence is characterised through withdrawal signs and symptoms after abrupt discontinuation or a big dose discount of a drug. Both tolerance and bodily dependence were said with the extended use of SOMA. Reported withdrawal signs and symptoms with SOMA consist of insomnia, vomiting, belly cramps, headache, tremors, muscle twitching, anxiety, ataxia, hallucinations, and psychosis. Instruct sufferers taking massive doses of SOMA or the ones taking the drug for a extended time to now no longer all of sudden forestall SOMA 
WARNINGSIncluded as a part of the PRECAUTIONS section.
PRECAUTIONSSedationSOMA has sedative properties (withinside the low lower back ache trials, 13% to 17% of sufferers who obtained SOMA skilled sedation as compared to 6% of sufferers who obtained placebo) [see ADVERSE REACTIONS] and can impair the intellectual and/or bodily capabilities required for the overall performance of doubtlessly dangerous obligations along with using a motor automobile or running machinery. There were post-advertising reviews of motor automobile injuries related to the usage of SOMA.