Call your doctor for medical advice about side effects. Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Using carisoprodol with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.
Many drugs can affect carisoprodol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Every effort has been made to ensure that the information provided by Cerner Multum, Inc. Drug information contained herein may be time sensitive.
Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise.
Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient.
Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.
If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist. This information does not replace the advice of a doctor. Healthwise, Incorporated disclaims any warranty or liability for your use of this information.
Your use of this information means that you agree to the Terms of Use and Privacy Policy. Learn how we develop our content. Healthwise, Healthwise for every health decision, and the Healthwise logo are trademarks of Healthwise, Incorporated. Parent Information. Carisoprodol slide 2 of 11, Carisoprodol,. Carisoprodol slide 3 of 11, Carisoprodol,. Carisoprodol slide 4 of 11, Carisoprodol,. Carisoprodol slide 5 of 11, Carisoprodol,. Carisoprodol slide 6 of 11, Carisoprodol,. Carisoprodol slide 7 of 11, Carisoprodol,.
Carisoprodol slide 8 of 11, Carisoprodol,. Carisoprodol slide 9 of 11, Carisoprodol,. Soma slide 10 of 11, Soma,. Soma slide 11 of 11, Soma,. What is the most important information I should know about carisoprodol? What is carisoprodol? Carisoprodol is a muscle relaxer that blocks pain sensations between the nerves and the brain. Carisoprodol may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking carisoprodol? Carisoprodol is not approved for use by anyone younger than 16 years old. How should I take carisoprodol?
What happens if I miss a dose? What happens if I overdose? What should I avoid while taking carisoprodol? Do not drink alcohol. Data from published literature report that carisoprodol and its metabolite, meprobamate, are present in breastmilk. There are no data on the effect of carisoprodol on milk production.
There is one report of sedation in an infant who was breastfed by a mother taking carisoprodol see Clinical Considerations. Infants exposed to carisoprodol through breast milk should be monitored for sedation. The efficacy, safety, and pharmacokinetics of carisoprodol in pediatric patients less than 16 years of age have not been established. The efficacy, safety, and pharmacokinetics of carisoprodol in patients over 65 years old have not been established.
The safety and pharmacokinetics of carisoprodol in patients with renal impairment have not been evaluated. Since carisoprodol is excreted by the kidney, caution should be exercised if carisoprodol is administered to patients with impaired renal function. Carisoprodol is dialyzable by hemodialysis and peritoneal dialysis.
The safety and pharmacokinetics of carisoprodol in patients with hepatic impairment have not been evaluated. Since carisoprodol is metabolized in the liver, caution should be exercised if carisoprodol is administered to patients with impaired hepatic function.
Patients with reduced CYP2C19 activity have higher exposure to carisoprodol. Therefore, caution should be exercised in administration of carisoprodol to these patients [ see Clinical Pharmacology Carisoprodol tablets contain carisoprodol, a Schedule IV controlled substance.
Carisoprodol has been subject to abuse, misuse, and criminal diversion for nontherapeutic use [ see Warnings and Precautions 5. Abuse of carisoprodol poses a risk of overdosage which may lead to death, CNS and respiratory depression, hypotension, seizures and other disorders [ see Warnings and Precautions 5. Patients at high risk of carisoprodol abuse may include those with prolonged use of carisoprodol, with a history of drug abuse, or those who use carisoprodol tablets in combination with other abused drugs.
Prescription drug abuse is the intentional non-therapeutic use of a drug, even once, for its rewarding psychological effects. Drug addiction, which develops after repeated drug abuse, is characterized by a strong desire to take a drug despite harmful consequences, difficulty in controlling its use, giving a higher priority to drug use than to obligations, increased tolerance, and sometimes physical withdrawal.
Drug abuse and drug addiction are separate and distinct from physical dependence and tolerance for example, abuse or addiction may not be accompanied by tolerance or physical dependence [ see Drug Abuse and Dependence 9. Physical dependence is characterized by withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug. Both tolerance and physical dependence have been reported with the prolonged use of carisoprodol tablets. Reported withdrawal symptoms with carisoprodol include insomnia, vomiting, abdominal cramps, headache, tremors, muscle twitching, anxiety, ataxia, hallucinations, and psychosis.
Instruct patients taking large doses of carisoprodol tablets or those taking the drug for a prolonged time to not abruptly stop carisoprodol tablets [ see Warnings and Precautions 5. Overdosage of carisoprodol commonly produces CNS depression. Serotonin syndrome has been reported with carisoprodol intoxication. Many of the carisoprodol overdoses have occurred in the setting of multiple drug overdoses including drugs of abuse, illegal drugs, and alcohol. The effects of an overdose of carisoprodol and other CNS depressants e.
Fatal accidental and non-accidental overdoses of carisoprodol have been reported alone or in combination with CNS depressants. Basic life support measures should be instituted as dictated by the clinical presentation of the carisoprodol overdose. Vomiting should not be induced because of the risk of CNS and respiratory depression, and subsequent aspiration. Circulatory support should be administered with volume infusion and vasopressor agents if needed. Seizures should be treated with intravenous benzodiazepines and the reoccurrence of seizures may be treated with phenobarbital.
In cases of severe CNS depression, airway protective reflexes may be compromised and tracheal intubation should be considered for airway protection and respiratory support.
For decontamination in cases of severe toxicity, activated charcoal should be considered in a hospital setting in patients with large overdoses who present early and are not demonstrating CNS depression and can protect their airway.
For more information on the management of an overdose of carisoprodol, contact a Poison Control Center. Carisoprodol tablets are available as mg round, white tablets. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. The structural formula is:.
Other ingredients in the carisoprodol drug product include alginic acid, magnesium stearate, potassium sorbate, starch, and tribasic calcium phosphate. 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. Carisoprodol is a centrally acting skeletal muscle relaxant that does not directly relax skeletal muscles.
A metabolite of carisoprodol, meprobamate, has anxiolytic and sedative properties. The degree to which these properties of meprobamate contribute to the safety and efficacy of carisoprodol is unknown.
The pharmacokinetics of carisoprodol and its metabolite meprobamate were studied in a crossover study of 24 healthy subjects 12 male and 12 female who received single doses of mg and mg carisoprodol see Table 2.
The exposure of carisoprodol and meprobamate was dose proportional between the mg and mg doses. The C max of meprobamate was 2. Absolute bioavailability of carisoprodol has not been determined. The mean time to peak plasma concentrations T max of carisoprodol was approximately 1.
Co-administration of a high-fat meal with carisoprodol mg tablet had no effect on the pharmacokinetics of carisoprodol. Therefore, carisoprodol may be administered with or without food. The major pathway of carisoprodol metabolism is via the liver by cytochrome enzyme CYP2C19 to form meprobamate. Carisoprodol is eliminated by both renal and non-renal routes with a terminal elimination half-life of approximately 2 hours.
The half-life of meprobamate is approximately 10 hours. Overall exposure of meprobamate is comparable between female and male subjects. Carisoprodol should be used with caution in patients with reduced CYP2C19 activity. Long term studies in animals have not been performed to evaluate the carcinogenic potential of carisoprodol. Carisoprodol 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. Carisoprodol was not formally evaluated for effects on fertility. The significance of these findings for human fertility is not known. The safety and efficacy of carisoprodol for the relief of acute, idiopathic mechanical low back pain was evaluated in two, 7-day, double blind, randomized, multicenter, placebo controlled, U.
Patients with chronic back pain; at increased risk for vertebral fracture e. Concomitant use of analgesics e. In Study 1, patients were randomized to one of three treatment groups i.
In both studies, patients received study medication three times a day and at bedtime for seven days. The primary endpoints were the relief from starting backache and the global impression of change, as reported by patients, on Study Day 3. Both endpoints were scored on a 5-point rating scale from 0 worst outcome to 4 best outcome in both studies. The primary statistical comparison was between the carisoprodol mg and placebo groups in both studies.
The proportion of patients who used concomitant acetaminophen, NSAIDs, tramadol, opioid agonists, other muscle relaxants, and benzodiazepines was similar in the treatment groups. The results for the primary efficacy evaluations in the acute, low back pain studies are presented in Table 3. Patients should be advised to contact their physician if they experience any adverse reactions to carisoprodol tablets.
Patients should be advised to avoid taking carisoprodol before engaging in potentially hazardous activities such as driving a motor vehicle or operating machinery [see Warnings and Precautions 5.
Advise patients to avoid alcoholic beverages while taking carisoprodol tablets and to check with their doctor before taking other CNS depressants such as benzodiazepines, opioids, tricyclic antidepressants, sedating antihistamines, or other sedatives [see Warnings and Precautions 5. Advise patients that treatment with carisoprodol tablets should be limited to acute use up to two or three weeks for the relief of acute, musculoskeletal discomfort.
In the post-marketing experience with carisoprodol tablets, cases of dependence, withdrawal, and abuse have been reported with prolonged use. If the musculoskeletal symptoms still persist, patients should contact their healthcare provider for further evaluation. Advise nursing mothers using carisoprodol tablets to monitor neonates for signs of sedation [ see Use in Specific Populations 8.
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