This medication should not be used if you have a certain medical condition. Before using this medication, tell your doctor if you have: acute intermittent porphyria.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, history of regular alcohol/drug abuse, asthma, seizure disorder.

To reduce dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving, swimming or using machinery. Avoid alcoholic beverages.

This medication is not recommended for use during pregnancy. It may rarely harm an unborn baby. Consult your doctor for more details and to discuss reliable forms of birth control. If you become pregnant while taking this medication, tell your doctor immediately.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Do not take Carisoprodol if you have acute intermittent porphyria. Before taking Carisoprodol, tell your doctor if you have kidney or liver disease. You may need a lower dose or special monitoring during your therapy. It is not known whether Carisoprodol will harm an unborn baby. Do not take Carisoprodol without first talking to your doctor if you are pregnant. It is also not known whether Carisoprodol passes into breast milk. Do not take Carisoprodol without first talking to your doctor if you are breast-feeding a baby. Carisoprodol is not approved for use in children younger than 12 years of age.

PRECAUTIONS
Sedation
SOMA may have sedative properties (in the low back pain trials, 13% to 17% of patients who received SOMA experienced sedation compared to 6% of patients who received placebo) [see ADVERSE REACTIONS] 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.

Since the sedative effects of SOMA 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, 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 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 dependence, withdrawal, or abuse, SOMA should be used with caution in addiction-prone patients and in patients taking other CNS depressants including alcohol, and SOMA should be not be used more than two to three weeks for the relief of acute musculoskeletal discomfort.

One of the metabolites of SOMA, meprobamate (a controlled substance), may cause dependence [see CLINICAL PHARMACOLOGY].

Seizures
There have been postmarketing reports of seizures in patients who received SOMA. Most of these cases have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol) [see OVERDOSAGE].

NonClinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long term studies in animals have not been performed to evaluate the carcinogenic potential of carisoprodol.

SOMA 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 chromosomal 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.

SOMA was not formally evaluated for effects on fertility. Published reproductive studies of carisoprodol in mice found no alteration in fertility although an alteration in reproductive cycles characterized by a greater time spent in estrus was observed at a carisoprodol dose of 1200 mg/kg/day. In a 13-week toxicology study that did not determine fertility, mouse testes weight and sperm motility were reduced at a dose of 1200 mg/kg/day. In both studies, the no effect level was 750 mg/kg/day, corresponding to approximately 2.6 times the human equivalent dosage of 350 mg four times a day, based on a body surface area comparison. The significance of these findings for human fertility is not known.

Use In Specific Population
Pregnancy: Pregnancy Category C.
There are no data on the use of SOMA during human pregnancy. Animal studies indicate that carisoprodol crosses the placenta and results in adverse effects on fetal growth and postnatal survival. The primary metabolite of carisoprodol, meprobamate, is an approved anxiolytic. Retrospective, post-marketing studies do not show a consistent association between maternal use of meprobamate and an increased risk for particular congenital malformations.

Teratogenic effects: Animal studies have not adequately evaluated the teratogenic effects of carisoprodol. There was no increase in the incidence of congenital malformations noted in reproductive studies in rats, rabbits, and mice treated with meprobamate. Retrospective, post-marketing studies of meprobamate during human pregnancy were equivocal for demonstrating an increased risk of congenital malformations following first trimester exposure. Across studies that indicated an increased risk, the types of malformations were inconsistent.

Nonteratogenic effects: In animal studies, carisoprodol reduced fetal weights, postnatal weight gain, and postnatal survival at maternal doses equivalent to 1-1.5 times the human dose (based on a body surface area comparison). Rats exposed to meprobamate in-utero showed behavioral alterations that persisted into adulthood. For children exposed to meprobamate in-utero, one study found no adverse effects on mental or motor development or IQ scores. SOMA should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

SIDE EFFECTS:
Dizziness, drowsiness, headache, unusually fast heartbeat, low blood pressure, or face flushing may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Sometimes carisoprodol may cause a very rare but serious reaction (idiosyncratic) that occurs within minutes or hours of the first dose of this medication. Seek immediate medical attention and do not take more of the medication if you experience: extreme weakness, inability to move your legs/arms, shaky/unsteady movement, pain in your joints, vision changes (double vision, inability to see), widened pupils, mental/mood changes (e.g., agitation, restlessness, unexplained mood swings, confusion).

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

carisoprodol

Other ingredients in the SOMA drug product include alginic acid, magnesium stearate, potassium sorbate, starch, and tribasic calcium phosphate.

This medication is used to treat pain and discomfort from muscle injuries such as strains, sprains, and spasms. It is usually used along with rest, physical therapy, and other treatments (e.g., anti-inflammatory medication).

Carisoprodol is called a centrally acting muscle relaxant. It works on the nerves to relieve muscle pain. It may also relieve pain by calming your nervous system.

Carisoprodol is a muscle relaxant used to relieve the pain and stiffness of muscle spasms and discomfort due to strain and sprain.

Carisoprodol is taken orally. The usual adult dosage of Carisoprodol is one 350 mg tablet, three times daily and at bedtime. Usage in patients under age 12 is not recommended. It is recommended that you take Carisoprodol with food, or with milk, to minimize the likelihood that you will suffer an upset stomach as a result of taking the medication.