Carisoprodol

• There are no adequate studies of carisoprodol in pregnant women.
• Carisoprodol accumulates in breast milk in concentrations twice those of the mother's blood. The effects of carisoprodol on the infants of lactating mothers are unknown. Therefore, caution should be used when using carisoprodol in women who are breastfeeding.

SOMA is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.

SOMA should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see DOSAGE AND ADMINISTRATION].

Dosage Forms And Strengths

250 mg Tablets: round, convex, white tablets, inscribed with SOMA 250

350 mg Tablets: round, convex, white tablets, inscribed with SOMA 350

Storage And Handling

250 mg Tablets: round, convex, white tablets, inscribed with SOMA 250; available 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; available in bottles of 100 (NDC 0037-2001-01).

Store at controlled room temperature 20° - 25°C (68° - 77°F).

Meda Pharmaceuticals Meda Pharmaceuticals Inc. Somerset, New Jersey 08873-4120. Revised: 1/2013

Mechanism of Action

Not clearly known; may block interneural activity and depress polysynaptic neuron transmission

Absorption

Onset: 30 min

Duration: 4-6 hr

Peak plasma time: 1.5-2 hr

Metabolism

Metabolized by liver microsomal enzymes (CYP2C19)

Elimination

Half-life: 2 hr; meprobamate (8 hr)

Dialyzable: Yes (HD, PD)

Excretion: Urine

Serious side effects have been reported with carisoprodol including:

• Drug dependence, withdrawal, and abuse: Carisoprodol should be taken for a maximum of 3 weeks and should not be taken with alcohol or CNS depressants such as benzodiazepines, opioids, or tricyclic antidepressants.
• Seizures: Tell your doctor if you have a history of seizures. Only take the prescribed amount of carisoprodol.
• Hypersensitivity (allergic) reaction: An allergic reaction to carisoprodol can occur. Call your doctor if you experience one or more of the following:
  • difficulty breathing or swallowing
  • hoarseness
  • rash or hives

Do not take carisoprodol if you:

• are allergic to carisoprodol (Soma) or meprobamate
• have a history of acute intermittent porphyria (a disease affecting red blood cells)

Carisoprodol can cause drowsiness and dizziness. Do not drive or operate machinery until you know how carisoprodol affects you. Alcohol may intensify this side effect.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Carisoprodol falls into category C. This medication may be given to a pregnant woman if her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn baby.

• Store carisoprodol at room temperature.
• Keep in a tight, light-resistant container.
• Keep this and all medicines out of the reach of children.

Your pharmacist can provide more information about carisoprodol.

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.

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Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Carisoprodol is usually taken 3 times per day and at bedtime. Follow your doctor's dosing instructions very carefully.

This medicine should be used for only a short time; up to 2 or 3 weeks unless your doctor tells you otherwise.

Carisoprodol may be habit-forming. Never share carisoprodol with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Misuse of habit-forming medicine can cause addiction, overdose, or death.

Do not stop using carisoprodol suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Carisoprodol is only part of a complete program of treatment that may also include rest, physical therapy, or other pain relief measures. Follow your doctor's instructions.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Carisoprodol is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with carisoprodol.

Carisoprodol may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Muscular Conditions

Short-term (i.e., up to 2–3 weeks) relief of discomfort associated with acute, painful musculoskeletal conditions.100 101 102 Indicated for short-term use only;100 prolonged use not adequately studied and may increase risk of abuse, dependence, and tolerance.100 113 114 117

If pharmacologic therapy is required for acute low back pain (usually a benign and self-limiting condition105 106 108 ), an analgesic (i.e., acetaminophen, NSAIA) generally is recommended.104 105 106 108 117 Skeletal muscle relaxants may be used alone or in combination with analgesics for short-term relief; however, consider high incidence of adverse effects (e.g., CNS effects).104 106 107 108 Use skeletal muscle relaxants with caution and weigh risks against benefits.104 106 107 108

Various skeletal muscle relaxants appear to have comparable efficacy for low back pain relief.103 104 106 108

Carisoprodol is ineffective for treatment of skeletal muscle hyperactivity secondary to chronic neurologic disorders (e.g., cerebral palsy) and other dyskinesias.a

Administration

Administer orally with or without food.100

Dosage

Adults

250–350 mg 3 times daily and at bedtime.100

Prescribing Limits

Adults

Do not administer for more than 2–3 weeks.100

Metabolized by CYP2C19.100

Drugs Affecting Hepatic Microsomal Enzymes

CYP2C19 inhibitors: Potential pharmacokinetic interaction (increased exposure to carisoprodol and decreased exposure to meprobamate).100 Clinical importance unknown.100

CYP2C19 inducers: Potential pharmacokinetic interaction (decreased exposure to carisoprodol and increased exposure to meprobamate).100 Clinical importance unknown.100

Specific Drugs

Storage

Oral

20–25°C.100

Fixed-combination preparation with aspirin and codeine: Tight, light-resistant containers at 15–30°C; protect from moisture.123

Fixed-combination preparation with aspirin: Tight containers at 20–25°C; protect from moisture.124

The recommended dose of Carisoprodol tablets is 250 mg to 350 mg three times a day and at bedtime. The recommended maximum duration of Carisoprodol tablets use is up to two or three weeks.

Carisoprodol tablets USP, 250 mg are white colored, round shaped, biconvex, uncoated tablets, identified with ‘H 94’ debossed on one side and other side plain.

Carisoprodol tablets USP, 350 mg are white colored, round shaped, biconvex, uncoated tablets, identified with ‘D’ debossed on one side and ‘31’ on the other side.

Carisoprodol tablets are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate.

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in practice.

The data described below are based on 1387 patients pooled from two double blind, randomized, multicenter, placebo controlled, one-week trials in adult patients with acute, mechanical, lower back pain [see Clinical Studies (14)]. In these studies, patients were treated with 250 mg of Carisoprodol, 350 mg of Carisoprodol, or placebo three times a day and at bedtime for seven days. The mean age was about 41 years old with 54% females and 46% males and 74% Caucasian, 16% Black, 9% Asian, and 2% other.

There were no deaths and there were no serious adverse reactions in these two trials. In these two studies, 2.7%, 2%, and 5.4%, of patients treated with placebo, 250 mg of Carisoprodol, and 350 mg of Carisoprodol, respectively, discontinued due to adverse events; and 0.5%, 0.5%, and 1.8% of patients treated with placebo, 250 mg of Carisoprodol, and 350 mg of Carisoprodol, respectively, discontinued due to central nervous system adverse reactions.

 Table 1 displays adverse reactions reported with frequencies greater than 2% and more frequently than placebo in patients treated with Carisoprodol in the two trials described above. 

Post-marketing Experience

The following events have been reported during postapproval use of Carisoprodol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular: Tachycardia, postural hypotension, and facial flushing [see Overdosage (10)]. 

Central Nervous System: Drowsiness, dizziness, vertigo, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, insomnia, and seizures [see Overdosage (10)]. 

Gastrointestinal: Nausea, vomiting, and epigastric discomfort.

Hematologic: Leukopenia, pancytopenia.

Pregnancy

Pregnancy Category C.

There are no data on the use of Carisoprodol 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 to 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. Carisoprodol should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

Labor and Delivery

There is no information about the effects of Carisoprodol on the mother and the fetus during labor and delivery. 

Nursing Mothers

Very limited data in humans show that Carisoprodol is present in breast milk and may reach concentrations two to four times the maternal plasma concentrations. In one case report, a breast-fed infant received about 4 to 6% of the maternal daily dose through breast milk and experienced no adverse effects. However, milk production was inadequate and the baby was supplemented with formula. In lactation studies in mice, female pup survival and pup weight at weaning were decreased. This information suggests that maternal use of Carisoprodol may lead to reduced or less effective infant feeding (due to sedation) and/or decreased milk production. Caution should be exercised when Carisoprodol is administered to a nursing woman. 

Pediatric Use

The efficacy, safety, and pharmacokinetics of Carisoprodol in pediatric patients less than 16 years of age have not been established. 

Geriatric Use

The efficacy, safety, and pharmacokinetics of Carisoprodol in patients over 65 years old have not been established. 

Renal Impairment

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. 

Hepatic Impairment

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

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 (12.3)]. 

Overdosage of Carisoprodol commonly produces CNS depression. Death, coma, respiratory depression, hypotension, seizures, delirium, hallucinations, dystonic reactions, nystagmus, blurred vision, mydriasis, euphoria, muscular incoordination, rigidity, and/or headache have been reported with Carisoprodol overdosage. 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.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) can be additive even when one of the drugs has been taken in the recommended dosage. Fatal accidental and non-accidental overdoses of Carisoprodol have been reported alone or in combination with CNS depressants.

Treatment of Overdosage: 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. 

Carcinogenesis, Mutagenesis, Impairment of Fertility

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. typhimurium strains with or without metabolizing enzymes, and was not clastogenic in an in vivo mouse micronucleus assay of circulating blood cells.

Carisoprodol 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.

Rising® NDC 64980-381-01
Carisoprodol
Tablets, USP CIV
350 mg
100 Tablets     Rx only

Musculoskeletal conditions: Oral: 250 to 350 mg 3 times daily and at bedtime for a maximum recommended duration of 2 to 3 weeks.

Discontinuation in patients on long-term therapy: Although carisoprodol should only be used for short periods (2 to 3 weeks), in patients with a history of long term use or high doses, carisoprodol should be tapered off slowly (eg, over 14 days) to avoid withdrawal symptoms such as anxiety, insomnia, or irritability (Eleid 2010).

May be administered with or without food.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, dizziness, or fatigue. Have patient report immediately to prescriber seizures or severe loss of strength and energy (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Use with caution

• Used to relieve pain associated with muscle spasm or musculoskeletal conditions in adults.
• Generic carisoprodol is available.

Animal studies have reported that this drug crosses the placenta and results in adverse effects on fetal growth and postnatal survival. Animal studies have not adequately evaluated the teratogenic effects. The primary active metabolite, meprobamate, has not been shown to have a consistent association between maternal use and increased risk for particular congenital malformations. There are no controlled data in human pregnancy. Animal studies have shown reduced testes weight and sperm motility at a dose of 1200 mg/kg/day. The significance of these findings for human fertility is unknown. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Benefit should outweigh risk. US FDA pregnancy category: C

LactMed Record Number

340

Last Revision Date

20170411

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