Carisoprodol is a drug formulated to relax the muscles to relieve the ache, discomfort and stiffness of muscle spasm caused by injuries. Carisoprodol is used together with rest and physical therapy to treat injuries and other painful musculoskeletal conditions. Carisoprodol may also be used for other purposes not listed in this medication guide.
Carisoprodol is used short-term to treat muscle pain and discomfort. It is usually used along with rest, physical therapy, and other treatments. It works by helping to relax the muscles.
Take this medication by mouth with or without food as directed by your doctor, usually 4 times a day.
The dosage is based on your medical condition and response to treatment. This medication should only be used short-term (for 3 weeks or less) unless directed by your doctor. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as stomach cramps, trouble sleeping, headache, nausea) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.
Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.
Tell your doctor if your condition persists after 2 to 3 weeks or if it worsens.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using carisoprodol and call your doctor at once if you have any of these serious side effects:
paralysis (loss of feeling);
extreme weakness or lack of coordination;
feeling light-headed, fainting;
vision loss; or
Less serious side effects may include:
drowsiness, dizziness, tremor;
depression, feeling irritable;
sleep problems (insomnia); or
nausea, vomiting, hiccups, upset stomach.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
Carisoprodol has 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) 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 Carisoprodol.
Since the sedative effects of Carisoprodol 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.
Abuse, Dependence and Withdrawal
Carisoprodol, the active ingredient in Carisoprodol, has been subject to abuse, dependence, withdrawal, misuse, and criminal diversion. [see Drug Abuse and Dependence]. Abuse of SOMA poses a risk of overdosage which may lead to death, CNS and respiratory depression, hypotension, seizures, and other disorders.
Post-marketing experience cases of carisoprodol abuse and dependence have been reported in patients with prolonged use and a history of drug abuse. Although most of these patients took other drugs of abuse, some patients solely abused carisoprodol. Withdrawal symptoms have been reported following abrupt cessation of Carisoprodol after prolonged use. Reported withdrawal symptoms included insomnia, vomiting, abdominal cramps, headache, tremors, muscle twitching, ataxia, hallucinations, and psychosis. One of carisoprodol's metabolites, meprobamate (a controlled substance), may also cause dependence.
To reduce the risk of Carisoprodol 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.
There have been post-marketing reports of seizures in patients who received Carisoprodol. Most of these cases have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol).
The sedative effects of Carisoprodol 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 Carisoprodol, is not recommended [see WARNINGS AND PRECAUTIONS].
CYP2C19 Inhibitors and Inducers
Carisoprodol is metabolized in the liver by CYP2C19 to form meprobamate [see CLINICAL PHARMACOLOGY]. Co-administration of CYP2C19 inhibitors, such as omeprazole or fluvoxamine, with Carisoprodol 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 Carisoprodol 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 Carisoprodol is unknown.
Drug Abuse And Dependence
Carisoprodol contains soma, a Schedule IV controlled substance. Carisoprodol has been subject to abuse, misuse, and criminal diversion for nontherapeutic use.