Exposure of carisoprodol is higher in female than in male subjects (approximay 30-50% on a weight adjusted basis). Overall exposure of meprobamate is comparable between female and male subjects.
The major pathway of carisoprodol metabolism is via the liver by cytochrome enzyme CYP2C19 to form meprobamate. This enzyme exhibits genetic polymorphism (see Patients with Reduced CYP2C19 Activity below ).
The degree to which these properties of meprobamate contribute to the safety and efficacy of SOMA is unknown. A metabolite of carisoprodol, meprobamate, has anxiolytic and sedative properties.
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. Vomiting should not be induced because of the risk of CNS and respiratory depression, and subsequent aspiration. Basic life support measures should be instituted as dictated by the clinical presentation of the SOMA overdose. In cases of severe CNS depression, airway protective reflexes may be compromised and tracheal intubation should be considered for airway protection and respiratory support.
350 mg Tablets: round, convex, white tablets, inscribed with SOMA 350.
Cardiac Arrest vs. Heart Disease Heart Attack vs. Heart Failure.
The proportion of patients who used concomitant acetaminophen, NSAIDs, tramadol, opioid agonists, other muscle relaxants, and benzodiazepines was similar in the treatment groups.
The recommended dose of SOMA is 250 mg to 350 mg three times a day and at bedtime. The recommended maximum duration of SOMA use is up to two or three weeks.
Other ingredients in the SOMA drug product include alginic acid, magnesium stearate, potassium sorbate, starch, and tribasic calcium phosphate.
Table 1: Patients with Adverse Reactions in Controlled Studies Adverse Reaction Placebo (n=560) n (%) SOMA 250 mg (n=548) n (%) SOMA 350 mg (n=279) n (%) Drowsiness 31 (6) 73 (13) 47 (17) Dizziness 11 (2) 43 (8) 19 (7) Headache 11 (2) 26 (5) 9 (3).
The sedative effects of SOMA and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants ) may be additive. Concomitant use of SOMA and meprobamate, a metabolite of SOMA, is not recommended. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously.
250 mg Tablets: round, convex, white tablets, inscribed with SOMA 250.
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Absolute bioavailability of carisoprodol has not been determined. Therefore, SOMA may be administered with or without food. The mean time to peak plasma concentrations (Tmax) of carisoprodol was approximay 1.5 to 2 hours. Co-administration of a high-fat meal with SOMA (350 mg tablet) had no effect on the pharmacokinetics of carisoprodol.
Gastrointestinal: Nausea, vomiting, and epigastric discomfort.
Animal studies indicate that carisoprodol crosses the placenta and results in adverse effects on fetal growth and postnatal survival. Retrospective, post-marketing studies do not show a consistent association between maternal use of meprobamate and an increased risk for particular congenital malformations. There are no data on the use of SOMA during human pregnancy. The primary metabolite of carisoprodol, meprobamate, is an approved anxiolytic.
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.
Central Nervous System: Drowsiness, dizziness, vertigo, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, insomnia, and seizures.
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.
Patients should be advised to contact their physician if they experience any adverse reactions to SOMA.
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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.
Soma contains carisoprodol, a Schedule IV controlled substance. Carisoprodol has been subject to abuse, misuse, and criminal diversion for nontherapeutic use.
This information suggests that maternal use of SOMA may lead to reduced or less effective infant feeding (due to sedation) and/or decreased milk production. Caution should be exercised when SOMA is administered to a nursing woman. Very limited data in humans show that SOMA is present in breast milk and may reach concentrations two to four times the maternal plasma concentrations. However, milk production was inadequate and the baby was supplemented with formula. In one case report, a breast-fed infant received about 4-6% of the maternal daily dose through breast milk and experienced no adverse effects. In lactation studies in mice, female pup survival and pup weight at weaning were decreased.
John's Wort, with SOMA could result in decreased exposure of carisoprodol and increased exposure of meprobamate. The full pharmacological impact of these potential alterations of exposures in terms of either efficacy or safety of SOMA is unknown. Co-administration of CYP2C19 inducers, such as rifampin or St. Carisoprodol is metabolized in the liver by CYP2C19 to form meprobamate. Co-administration of CYP2C19 inhibitors, such as omeprazole or fluvoxamine, with SOMA could result in increased exposure of carisoprodol and decreased exposure of meprobamate. Low dose aspirin also showed an induction effect on CYP2C19.
Stop using carisoprodol and call your doctor at once if you have any of these serious side effects:
The efficacy, safety, and pharmacokinetics of SOMA in patients over 65 years old have not been established.
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Table 2: Pharmacokinetic Parameters of Carisoprodol and Meprobamate (Mean ± SD, n=24) 250 mg SOMA 350 mg SOMA Carisoprodol Cmax (μg/mL) 1.2 ± 0.5 1.8 ± 1.0 AUCinf (μg*hr/mL) 4.5 ± 3.1 7.0 ± 5.0 Tmax (hr) 1.5 ± 0.8 1.7 ± 0.8 T½ (hr) 1.7 ± 0.5 2.0 ± 0.5 Meprobamate Cmax (μg/mL) 1.8 ± 0.3 2.5 ± 0.5 AUCinf (μg*hr/mL) 32 ± 6.2 46 ± 9.0 Tmax (hr) 3.6 ± 1.7 4.5 ± 1.9 T½ (hr) 9.7 ± 1.7 9.6 ± 1.5.
Published studies indicate that patients who are poor CYP2C19 metabolizers have a 4-fold increase in exposure to carisoprodol, and concomitant 50% reduced exposure to meprobamate compared to normal CYP2C19 metabolizers. SOMA should be used with caution in patients with reduced CYP2C19 activity. The prevalence of poor metabolizers in Caucasians and African Americans is approximay 3-5% and in Asians is approximay 15-20%.
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Carisoprodol is eliminated by both renal and non-renal routes with a terminal elimination half-life of approximay 2 hours. The half-life of meprobamate is approximay 10 hours.
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Overdosage of SOMA commonly produces CNS depression. Fatal accidental and non-accidental overdoses of SOMA have been reported alone or in combination with CNS depressants. 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. Many of the carisoprodol overdoses have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol). 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 SOMA overdosage. Serotonin syndrome has been reported with carisoprodol intoxication.
round, white, imprinted with DAN, 5513.
SOMA was not formally evaluated for genotoxicity. Other types of genotoxic tests resulted in negative findings. typhimurium strains with or without metabolizing enzymes, and was not clastogenic in an in vivo mouse micronucleus assay of circulating blood cells. 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. Carisoprodol was not mutagenic in the Ames reverse mutation assay using S.
SOMA is contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate.
For more information on the management of an overdose of SOMA, contact a Poison Control Center.
Patients treated with SOMA experienced improvement in function as measured by the Roland-Morris Disability Questionnaire (RMDQ) score on Days 3 and 7.
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.
Included as part of the PRECAUTIONS section.
SOMA is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Animal studies have not adequay 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. Across studies that indicated an increased risk, the types of malformations were inconsistent. Retrospective, post-marketing studies of meprobamate during human pregnancy were equivocal for demonstrating an increased risk of congenital malformations following first trimester exposure.
Therefore, caution should be exercised in administration of SOMA to these patients. Patients with reduced CYP2C19 activity have higher exposure to carisoprodol.
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 SOMA, and 350 mg of SOMA, respectively, discontinued due to adverse events; and 0.5%, 0.5%, and 1.8% of patients treated with placebo, 250 mg of SOMA, and 350 mg of SOMA, respectively, discontinued due to central nervous system adverse reactions.
In both studies, the no effect level was 750 mg/kg/day, corresponding to approximay 2.6 times the human equivalent dosage of 350 mg four times a day, based on a body surface area comparison. 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. SOMA was not formally evaluated for effects on fertility. The significance of these findings for human fertility is not known.
Patients at high risk of SOMA abuse may include those with prolonged use of carisoprodol, with a history of drug abuse, or those who use SOMA in combination with other abused drugs. 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 and OVERDOSAGE ].
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Abuse of SOMA poses a risk of overdosage which may lead to death, CNS and respiratory depression, hypotension, seizures, and other disorders. Carisoprodol, the active ingredient in SOMA, has been subject to abuse, dependence, withdrawal, misuse, and criminal diversion.
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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 SOMA. Tolerance is when a patient's reaction to a specific dosage and concentration is progressively reduced in the absence of disease progression, requiring an increase in the dosage to maintain the same. Instruct patients taking large doses of SOMA or those taking the drug for a prolonged time to not abruptly stop SOMA. Reported withdrawal symptoms with SOMA include insomnia, vomiting, abdominal cramps, headache, tremors, muscle twitching, anxiety, ataxia, hallucinations, and psychosis.
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 SOMA 250 mg and placebo groups in both studies.
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.
Cardiovascular: Tachycardia, postural hypotension, and facial flushing.
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The mechanism of action of carisoprodol in relieving discomfort associated with acute painful musculoskeletal conditions has not been clearly identified.
Prescription drug abuse is the intentional non-therapeutic use of a drug, even once, for its rewarding psychological effects. 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). 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.
Long term studies in animals have not been performed to evaluate the carcinogenic potential of carisoprodol.
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. In these studies, patients were treated with 250 mg of SOMA, 350 mg of SOMA, 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.
SOMA 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 SOMA.
In both studies, patients received study medication three times a day and at bedtime for seven days. In Study 1, patients were randomized to one of three treatment groups (i.e., SOMA 250 mg, SOMA 350 mg, or placebo) and in Study 2 patients were randomized to two treatment groups (i.e., SOMA 250 mg or placebo).
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Patients should be advised that SOMA may cause drowsiness and/or dizziness, and has been associated with motor vehicle accidents. Patients should be advised to avoid taking SOMA before engaging in potentially hazardous activities such as driving a motor vehicle or operating machinery.
Patients with chronic back pain; at increased risk for vertebral fracture (e.g., history of osteoporosis ); with a history of spinal pathology (e.g., herniated nucleus pulposis, spondylolisthesis or spinal stenosis ); with inflammatory back pain, or with evidence of a neurologic deficit were excluded from participation. The safety and efficacy of SOMA for the relief of acute, idiopathic mechanical low back pain was evaluated in two, 7-day, double blind, randomized, multicenter, placebo controlled, U.S. Concomitant use of analgesics (e.g., acetaminophen, NSAIDs, tramadol, opioid agonists), other muscle relaxants, botulinum toxin, sedatives (e.g., barbiturates, benzodiazepines, promethazine hydrochloride), and anti-epileptic drugs was prohibited. trials (Studies 1 and 2). Patients had to be 18 to 65 years old and had to have acute back pain ( ≤ 3 days of duration) to be included in the trials.
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.
Patients should be advised to avoid alcoholic beverages while taking SOMA and to check with their doctor before taking other CNS depressants such as benzodiazepines, opioids, tricyclic antidepressants, sedating antihistamines, or other sedatives.
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Less serious side effects may include:
There have been post-marketing 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).
The efficacy, safety, and pharmacokinetics of SOMA in pediatric patients less than 16 years of age have not been established.
These endpoints were scored on a 5-point rating scale from 0 (worst outcome) to 4 (best outcome). Table 3: Results of the Primary Efficacy Endpointsa in Studies 1 and 2 Study Parameter Placebo SOMA 250 mg SOMA 350 mg 1 Number of Patients n=269 n=264 n=273 Relief from Starting Backache, Mean (SE)b 1.4 (0.1) 1.8 (0.1) 1.8 (0.1) Difference between SOMA and Placebo, Mean (SE)b (95% CI) 0.4 (0.2, 0.5) 0.4 (0.2, 0.6) Global Impression of Change, Mean (SE)b 1.9 (0.1) 2.2 (0.1) 2.2 (0.1) Difference between SOMA and Placebo, Mean (SE)b (95% CI) 0.2 (0.1, 0.4) 0.3 (0.1, 0.4) 2 Number of Patients n=278 n=269 Relief from Starting Backache, Mean (SE)b 1.1 (0.1) 1.8 (0.1) Difference between SOMA and Placebo, Mean (SE)b (95% CI) 0.7 (0.5, 0.9) Global Impression of Change, Mean (SE)b 1.7 (0.1) 2.2 (0.1) Difference between SOMA and Placebo, Mean (SE)b (95% CI) 0.5 (0.4, 0.7) a The primary efficacy endpoints (Relief from Starting Backache and Global Impression of Change) were assessed by the patients on Study Day 3. The ANOVA model was used for the primary statistical comparison between the SOMA 250 mg and placebo groups. b Mean is the least squared mean and SE is the standard error of the mean.
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In the post-marketing experience with SOMA, 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. Patients should be advised that treatment with SOMA should be limited to acute use (up to two or three weeks) for the relief of acute, musculoskeletal discomfort.
It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone ; and its solubility is practically independent of pH. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3propanediol dicarbamate and the molecular formula is C 12 H 24 N 2 O 4, with a molecular weight of 260.33. Carisoprodol is present as a racemic mixture. SOMA (carisoprodol) Tablets are available as 250 mg and 350 mg round, white tablets. The structural formula is:. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste.
Rats exposed to meprobamate in-utero showed behavioral alterations that persisted into adulthood. 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). 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.
The safety and pharmacokinetics of SOMA in patients with hepatic impairment have not been evaluated. Since SOMA is metabolized in the liver, caution should be exercised if SOMA is administered to patients with impaired hepatic function.
Store at controlled room temperature 20° - 25°C (68° - 77°F).
The safety and pharmacokinetics of SOMA in patients with renal impairment have not been evaluated. Carisoprodol is dialyzable by hemodialysis and peritoneal dialysis. Since SOMA is excreted by the kidney, caution should be exercised if SOMA is administered to patients with impaired renal function.
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. Withdrawal symptoms have been reported following abrupt cessation of SOMA after prolonged use. Although most of these patients took other drugs of abuse, some patients solely abused carisoprodol. Post-marketing experience cases of carisoprodol abuse and dependence have been reported in patients with prolonged use and a history of drug abuse.
There is no information about the effects of SOMA on the mother and the fetus during labor and delivery.
350 mg Tablets : round, convex, white tablets, inscribed with SOMA 350; available in bottles of 100 ( NDC.
The Cmax of meprobamate was 2.5 ± 0.5 μg/mL (mean ± SD) after administration of a single 350 mg dose of SOMA, which is approximay 30% of the Cmax of meprobamate (approximay 8 μg/mL) after administration of a single 400 mg dose of meprobamate. The exposure of carisoprodol and meprobamate was dose proportional between the 250 mg and 350 mg doses. 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 250 mg and 350 mg SOMA (see Table 2).
Carisoprodol is a centrally acting skeletal muscle relaxant that does not directly relax skeletal muscles.
To reduce the risk of SOMA 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.
Hematologic: Leukopenia, pancytopenia.
250 mg Tablets : round, convex, white tablets, inscribed with SOMA 250; available in bottles of 100 ( NDC and bottles of 30 ( NDC.
The following events have been reported during postapproval use of SOMA. 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.
The results for the primary efficacy evaluations in the acute, low back pain studies are presented in Table 3.
Table 1 displays adverse reactions reported with frequencies greater than 2% and more frequently than placebo in patients treated with SOMA in the two trials described above.Carisoprodol