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HIGHLIGHTS OF PRESCRIBING INFORMATION
WARNINGS AND PRECAUTIONS
These highlights do not include all the information needed to use SOMA
• Due to sedative properties, may impair ability to perform hazardous tasks such safely and effectively. See full prescribing information for SOMA.
SOMA (carisoprodol) Tablets for Oral use
• Additive sedative effects when used with other CNS depressants including Initial U.S. Approval: 1959
• Cases of Drug Dependence, Withdrawal, and Abuse (5.2) RECENT MAJOR CHANGES
Warnings and Precautions, Sedation (5.1) 10/2009 Warnings and Precautions, Drug Dependence, Withdrawal, and Abuse (5.2) 10/2009 ADVERSE REACTIONS
INDICATIONS AND USAGE
Most common adverse reactions (incidence > 2%) are drowsiness, dizziness, SOMA is indicated for the relief of discomfort associated with acute, painful To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc.
at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Important Limitations: • Should only be used for acute treatment periods up to two or three weeks (1) DRUG INTERACTIONS
• CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic anti- • Not recommended in pediatric patients less than 16 years of age (8.4) depressants) - additive sedative effects (5.1 and 7.1) DOSAGE AND ADMINISTRATION
See 17 for PATIENT COUNSELING INFORMATION
• Recommended dose is 250 mg to 350 mg three times a day and at bedtime. (2) Revised 10/09
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
• Hypersensitivity reactions to a carbamate such as meprobamate (4) FULL PRESCRIBING INFORMATION: CONTENTS*
DRUG ABUSE AND DEPENDENCE
OVERDOSAGE
INDICATIONS AND USAGE
DESCRIPTION
DOSAGE AND ADMINSTRATION
CLINICAL PHARMACOLOGY
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
NONCLINICAL TOXICOLOGY
ADVERSE REACTIONS
CLINICAL STUDIES
HOW SUPPLIED/STORAGE AND HANDLING
DRUG INTERACTIONS
PATIENT COUNSELING INFORMATION
17.2 Avoidance of Alcohol and Other CNS Depressants17.3 SOMA Should Only Be Used for Short-Term Treatment USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
* Sections or subsections omitted from the full prescribing FULL PRESCRIBING INFORMATION
6.2 Postmarketing Experience
INDICATIONS AND USAGE
The following events have been reported during postapproval use of SOMA.
SOMA is indicated for the relief of discomfort associated with acute, painful Because these reactions are reported voluntarily from a population of uncertain musculoskeletal conditions in adults.
size, it is not always possible to reliably estimate their frequency or establish acausal relationship to drug exposure.
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 Cardiovascular: Tachycardia, postural hypotension, and facial flushing [see been established and because acute, painful musculoskeletal conditions are generally of short duration. [see Dosage and Administration (2)]. Central Nervous System: Drowsiness, dizziness, vertigo, ataxia, tremor, DOSAGE AND ADMINISTRATION
agitation, irritability, headache, depressive reactions, syncope, insomnia, and The recommended dose of SOMA is 250 mg to 350 mg three times a day and seizures [see Overdosage (10)]. at bedtime. The recommended maximum duration of SOMA use is up to two or Gastrointestinal: Nausea, vomiting, and epigastric discomfort.
Hematologic: Leukopenia, pancytopenia.
DOSAGE FORMS AND STRENGTHS
DRUG INTERACTIONS
250 mg Tablets: round, convex, white tablets, inscribed with SOMA 250 7.1 CNS Depressants
350 mg Tablets: round, convex, white tablets, inscribed with SOMA 350 The sedative effects of SOMA and other CNS depressants (e.g., alcohol, CONTRAINDICATIONS
benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, SOMA is contraindicated in patients with a history of acute intermittent caution should be exercised with patients who take more than one of these CNS porphyria or a hypersensitivity reaction to a carbamate such as meprobamate.
depressants simultaneously. Concomitant use of SOMA and meprobamate, a WARNINGS AND PRECAUTIONS
metabolite of SOMA, is not recommended [see Warnings and Precautions (5.1)]. 5.1 Sedation
7.2 CYP2C19 Inhibitors and Inducers
SOMA has sedative properties (in the low back pain trials, 13% to 17% of Carisoprodol is metabolized in the liver by CYP2C19 to form meprobamate patients who received SOMA experienced sedation compared to 6% of patients [see Clinical Pharmacology (12.3)]. Co-administration of CYP2C19 inhibitors, who received placebo) [see ADVERSE REACTIONS (6.1)] and may impair the such as omeprazole or fluvoxamine, with SOMA could result in increased exposure mental and/or physical abilities required for the performance of potentially of carisoprodol and decreased exposure of meprobamate. Co-administration of hazardous tasks such as driving a motor vehicle or operating machinery. There CYP2C19 inducers, such as rifampin or St. John’s Wort, with SOMA could result have been post-marketing reports of motor vehicle accidents associated with the in decreased exposure of carisoprodol and increased exposure of meprobamate.
Low dose aspirin also showed induction effect on CYP2C19. The full pharma- Since the sedative effects of SOMA and other CNS depressants (e.g., alcohol, cological impact of these potential alterations of exposures in terms of either benzodiazepines, opioids, tricyclic antidepressants) may be additive, appropriate efficacy or safety of SOMA is unknown.
caution should be exercised with patients who take more than one of these CNS USE IN SPECIFIC POPULATION
8.1 Pregnancy: Pregnancy Category C.
5.2 Drug Dependence, Withdrawal, and Abuse
There are no data on the use of SOMA during human pregnancy. Animal In the postmarketing experience with SOMA, cases of dependence, with- studies indicate that carisoprodol crosses the placenta and results in adverse drawal, and abuse have been reported with prolonged use. Most cases of depend- effects on fetal growth and postnatal survival. The primary metabolite of ence, withdrawal, and abuse occurred in patients who have had a history of addiction carisoprodol, meprobamate, is an approved anxiolytic. Retrospective, post- or who used SOMA in combination with other drugs with abuse potential.
marketing studies do not show a consistent association between maternal use of However, there have been post-marketing adverse event reports of SOMA- meprobamate and an increased risk for particular congenital malformations.
associated abuse when used without other drugs with abuse potential. Withdrawal Teratogenic effects: Animal studies have not adequately evaluated the symptoms have been reported following abrupt cessation after prolonged use. To teratogenic effects of carisoprodol. There was no increase in the incidence of con- reduce the chance of SOMA dependence, withdrawal, or abuse, SOMA should be genital malformations noted in reproductive studies in rats, rabbits, and mice used with caution in addiction-prone patients and in patients taking other CNS treated with meprobamate. Retrospective, post-marketing studies of meproba- depressants including alcohol, and SOMA should not be used more than two to mate during human pregnancy were equivocal for demonstrating an increased risk three weeks for the relief of acute musculoskeletal discomfort. of congenital malformations following first trimester exposure. Across studies SOMA, and one of its metabolites, meprobamate (a controlled substance), that indicated an increased risk, the types of malformations were inconsistent.
may cause dependence [see Clinical Pharmacology (12.3)]. Nonteratogenic effects: In animal studies, carisoprodol reduced fetal weights, 5.3 Seizures
postnatal weight gain, and postnatal survival at maternal doses equivalent to 1-1.5 There have been postmarketing reports of seizures in patients who received times the human dose (based on a body surface area comparison). Rats exposed SOMA. Most of these cases have occurred in the setting of multiple drug over- to meprobamate in-utero showed behavioral alterations that persisted into doses (including drugs of abuse, illegal drugs, and alcohol) [see Overdosage 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 ADVERSE REACTIONS
used during pregnancy only if the potential benefit justifies the risk to the fetus.
6.1 Clinical Studies Experience
8.2 Labor and Delivery
Because clinical studies are conducted under widely varying conditions, There is no information about the effects of SOMA on the mother and the 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 8.3 Nursing Mothers
Very limited data in humans show that SOMA is present in breast milk and may The data described below are based on 1387 patients pooled from two double reach concentrations two to four times the maternal plasma concentrations. In one blind, randomized, multicenter, placebo controlled, one-week trials in adult case report, a breast-fed infant received about 4-6% of the maternal daily dose patients with acute, mechanical, lower back pain [see Clinical Studies (14)]. In through breast milk and experienced no adverse effects. However, milk production these studies, patients were treated with 250 mg of SOMA, 350 mg of SOMA, or was inadequate and the baby was supplemented with formula. In lactation studies placebo three times a day and at bedtime for seven days. The mean age was about in mice, female pup survival and pup weight at weaning were decreased. This infor- 41 years old with 54% females and 46% males and 74% Caucasian, 16% Black, mation 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 There were no deaths and there were no serious adverse reactions in these be exercised when SOMA is administered to a nursing woman.
two trials. In these two studies, 2.7%, 2%, and 5.4%, of patients treated with 8.4 Pediatric Use
placebo, 250 mg of SOMA, and 350 mg of SOMA, respectively, discontinued due The efficacy, safety, and pharmacokinetics of SOMA in pediatric patients less to adverse events; and 0.5%, 0.5%, and 1.8% of patients treated with placebo, than 16 years of age have not been established.
250 mg of SOMA, and 350 mg of SOMA, respectively, discontinued due to central 8.5 Geriatric
The efficacy, safety, and pharmacokinetics of SOMA in patients over 65 years 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 8.6 Renal
Impairment
The safety and pharmacokinetics of SOMA in patients with renal impairment have not been evaluated. Since SOMA is excreted by the kidney, caution should be Table 1. Patients with Adverse Reactions in Controlled Studies
exercised if SOMA is administered to patients with impaired renal function.
SOMA 250 mg
SOMA 350 mg
Carisoprodol is dialyzable by hemodialysis and peritoneal dialysis.
Reaction
8.7 Hepatic
Impairment
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.
8.8 Patients with Reduced CYP2C19 Activity
Patients with reduced CYP2C19 activity have higher exposure to carisoprodol.
Therefore, caution should be exercised in administration of SOMA to thesepatients. [see Clinical Pharmacology (12.3)]. DRUG ABUSE AND DEPENDENCE
CLINICAL STUDIES
SOMA is not a controlled substance [see Warnings and Precautions (5.2)].
The safety and efficacy of SOMA for the relief of acute, idiopathic mechani- Discontinuation of carisoprodol in animals or in humans after chronic cal low back pain was evaluated in two, 7-day, double blind, randomized, multi- administration can produce withdrawal signs, and there are published case center, placebo controlled, U.S. trials (Studies 1 and 2). Patients had to be 18 to reports of human carisoprodol dependence.
65 years old and had to have acute back pain (≤ 3 days of duration) to be includ-ed in the trials. Patients with chronic back pain; at increased risk for vertebral frac- In vitro studies demonstrate that carisoprodol elicits barbiturate-like effects.
ture (e.g., history of osteoporosis); with a history of spinal pathology (e.g., her- Animal behavioral studies indicate that carisoprodol produces rewarding effects.
niated nucleus pulposis, spondylolisthesis or spinal stenosis); with inflammatory Monkeys self administer carisoprodol. Drug discrimination studies using rats indi- back pain, or with evidence of a neurologic deficit were excluded from par- cate that carisoprodol has positive reinforcing and discriminative effects similar to ticipation. Concomitant use of analgesics (e.g., acetaminophen, NSAIDs, tra- barbital, meprobamate, and chlordiazepoxide.
madol, opioid agonists), other muscle relaxants, botulinum toxin, sedatives (e.g., 10 OVERDOSAGE
barbiturates, benzodiazepines, promethazine hydrochloride), and anti-epileptic Overdosage of SOMA commonly produces CNS depression. Death, coma, respiratory depression, hypotension, seizures, delirium, hallucinations, dystonic In Study 1, patients were randomized to one of three treatment groups (i.e., reactions, nystagmus, blurred vision, mydriasis, euphoria, muscular incoordina- SOMA 250 mg, SOMA 350 mg, or placebo) and in Study 2 patients were random- tion, rigidity, and/or headache have been reported with SOMA overdosage. Many ized to two treatment groups (i.e., SOMA 250 mg or placebo). In both studies, of the SOMA overdoses have occurred in the setting of multiple drug overdoses patients received study medication three times a day and at bedtime for seven (including drugs of abuse, illegal drugs, and alcohol). The effects of an overdose of SOMA and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tri-cyclic antidepressants) can be additive even when one of the drugs has been taken The primary endpoints were the relief from starting backache and the global in the recommended dosage. Fatal accidental and non-accidental overdoses of impression of change, as reported by patients, on Study Day 3. Both endpoints were SOMA have been reported alone or in combination with CNS depressants.
scored on a 5-point rating scale from 0 (worst outcome) to 4 (best outcome) in bothstudies. The primary statistical comparison was between the SOMA 250 mg and place- Treatment of Overdosage: Basic life support measures should be instituted
as dictated by the clinical presentation of the SOMA overdose. Induced emesis isnot recommended due to the risk of CNS and respiratory depression, which may The proportion of patients who used concomitant acetaminophen, NSAIDs, increase the risk of aspiration pneumonia. Gastric lavage should be considered tramadol, opioid agonists, other muscle relaxants, and benzodiazepines was sim- soon after ingestion (within one hour). Circulatory support should be adminis- tered with volume infusion and vasopressor agents if needed. Seizures should be The results for the primary efficacy evaluations in the acute, low back pain treated with intravenous benzodiazepines and the reoccurrence of seizures may be treated with phenobarbital. In cases of severe CNS depression, airway protectivereflexes may be compromised and tracheal intubation should be considered for Table 3. Results of the Primary Efficacy Endpointsa in Studies 1 and 2
airway protection and respiratory support. Parameter
The following types of treatment have been used successfully with an over- dose of meprobamate, a metabolite of SOMA: activated charcoal (oral or via naso- Number of Patients
gastric tube), forced diuresis, peritoneal dialysis, and hemodialysis (carisoprodolis also dialyzable). Careful monitoring of urinary output is necessary and over- Relief from Starting Backache, Mean (SE)b
hydration should be avoided. Observe for possible relapse due to incomplete gastric emptying and delayed absorption. For more information on the management of an overdose of SOMA, contact a Poison Control Center.
Global Impression of Change, Mean (SE)b
11 DESCRIPTION
SOMA (carisoprodol) Tablets are available as 250 mg and 350 mg round, white tablets. Carisoprodol is a white, crystalline powder, having a mild, charac-teristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, Number of Patients
in chloroform, and in acetone; and its solubility is practically independent of pH.
Relief from Starting Backache, Mean (SE)b
Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is N-iso- propyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formu- la is C H N O , with a molecular weight of 260.33. The structural formula is: Global Impression of Change, Mean (SE)b
a The primary efficacy endpoints (Relief from Starting Backache and Global Impression of Change) were assessed by the patients on Study Day 3.
These endpoints were scored on a 5-point rating scale from 0 (worst Table 3. Results of the Primary Efficacy Endpointsa in Studies 1 and 2
Parameter
Number of Patients
Relief from Starting Backache, Mean (SE)b
Global Impression of Change, Mean (SE)b
Number of Patients
Relief from Starting Backache, Mean (SE)b
Global Impression of Change, Mean (SE)b
Other ingredients in the SOMA drug product include alginic acid, magnesium b Mean is the least squared mean and SE is the standard error of the mean.
stearate, potassium sorbate, starch, and tribasic calcium phosphate.
The ANOVA model was used for the primary statistical comparisonbetween the SOMA 250 mg and placebo groups.
CLINCIAL PHARMACOLOGY
Patients treated with SOMA experienced improvement in function 12.1 Mechanism of Action
as measured by the Roland-Morris Disability Questionnaire (RMDQ) The mechanism of action of carisoprodol in relieving discomfort associated with acute painful musculoskeletal conditions has not been clearly identified. 16 HOW SUPPLIED/STORAGE AND HANDLING
In animal studies, muscle relaxation induced by carisoprodol is associated 250 mg Tablets: round, convex, white tablets, inscribed with with altered interneuronal activity in the spinal cord and in the descending reticular SOMA 250; available in bottles of 100 (NDC 0037-2250-10) and bottles of 12.2 Pharmacodynamics
350 mg Tablets: round, convex, white tablets, inscribed with Carisoprodol is a centrally acting skeletal muscle relaxant that does not SOMA 350; available in bottles of 100 (NDC 0037-2001-01). Storage:
A metabolite of carisoprodol, meprobamate, has anxiolytic and sedative Store at controlled room temperature 20° - 25°C (68° - 77°F). properties. The degree to which these properties of meprobamate contribute tothe safety and efficacy of SOMA is unkown.
PATIENT COUNSELING INFORMATION
Patients should be advised to contact their physician if they expe-
12.3 Pharmacokinetics
The pharmacokinetics of carisoprodol and its metabolite meprobamate were studied in a crossover study of 24 healthy subjects (12 male and 12 female) who 17.1 Sedation
received single doses of 250 mg and 350 mg SOMA (see Table 2). The exposure Patients should be advised that SOMA may cause drowsiness of carisoprodol and meprobamate was dose proportional between the 250 mg and and/or dizziness, and has been associated with motor vehicle acci- 350 mg doses. The Cmax of meprobamate was 2.5 ± 0.5 ␮g/mL (mean ± SD) after dents. Patients should be advised to avoid taking SOMA before engag- administration of a single 350 mg dose of SOMA, which is approximately 30% of ing in potentially hazardous activities such as driving a motor vehicle the Cmax of meprobamate (approximately 8 ␮g/mL) after administration of a or operating machinery [see Warnings and Precautions (5.1)]. 17.2 Avoidance of Alcohol and Other CNS Depressants
Patients should be advised to avoid alcoholic beverages while taking SOMA Table 2. Pharmacokinetic Parameters of Carisoprodol and Meprobamate
and to check with their doctor before taking other CNS depressants such as ben- (Mean ± SD, n=24)
zodiazepines, opioids, tricyclic antidepressants, sedating antihistamines, or othersedatives [see Warnings and Precautions (5.1)]. 250 mg SOMA
350 mg SOMA
17.3 SOMA Should Only Be Used for Short-Term Treatment
Carisoprodol
Patients should be advised that treatment with SOMA should be limited to Cmax (g/mL)
acute use (up to two or three weeks) for the relief of acute, musculoskeletal dis- comfort. In the post-marketing experience with SOMA, cases of dependence, ␮g*hr/mL)
withdrawal, and abuse have been reported with prolonged use. If the muscu- Tmax (hr)
loskeletal symptoms still persist, patients should contact their healthcare provider Meprobamate
To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc.
at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Cmax (g/mL)
g*hr/mL)
Tmax (hr)
Absorption: Absolute bioavailability of carisoprodol has not been deter- mined. The mean time to peak plasma concentrations (Tmax) of carisoprodol was approximately 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. Therefore,SOMA may be administered with or without food.
Metabolism: The major pathway of carisoprodol metabolism is via the liver by cytochrome enzyme CYP2C19 to form meprobamate. This enzyme exhibitsgenetic polymorphism (see Patients with Reduced CYP2C19 Activity below). Elimination: Carisoprodol is eliminated by both renal and non-renal routes with a terminal elimination half-life of approximately 2 hours. The half-life ofmeprobamate is approximately 10 hours.
Gender: Exposure of carisoprodol is higher in female than in male subjects (approximately 30-50% on a weight adjusted basis). Overall exposure ofmeprobamate is comparable between female and male subjects.
Patients with Reduced CYP2C19 Activity: SOMA should be used with caution in patients with reduced CYP2C19 activity. Published studies indicate that patientswho are poor CYP2C19 metabolizers have a 4-fold increase in exposure tocarisoprodol, and concomitant 50% reduced exposure to meprobamate compared tonormal CYP2C19 metabolizers. The prevalence of poor metabolizers in Caucasiansand African Americans is approximately 3-5% and in Asians is approximately 15-20%.
NONCLINICAL TOXICOLOGY
13.1 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 theabsence of metabolizing enzymes, but was not mutagenic in the presence ofmetabolizing enzymes. Carisoprodol was clastogenic in the in vitro chromosomalaberration assay using Chinese hamster ovary cells with or without the presenceof metabolizing enzymes. Other types of genotoxic tests resulted in negative find-ings. Carisoprodol was not mutagenic in the Ames reverse mutation assay usingS. typhimurium strains with or without metabolizing enzymes, and was not clas-togenic in an in vivo mouse micronucleus assay of circulating blood cells.
SOMA was not formally evaluated for effects on fertility. Published reproduc- tive studies of carisoprodol in mice found no alteration in fertility although an alter-ation in reproductive cycles characterized by a greater time spent in estrus wasobserved at a carisoprodol dose of 1200 mg/kg/day. In a 13-week toxicologystudy that did not determine fertility, mouse testes weight and sperm motility werereduced at a dose of 1200 mg/kg/day. In both studies, the no effect level was 750mg/kg/day, corresponding to approximately 2.6 times the human equivalent dosageof 350 mg four times a day, based on a body surface area comparison. The signifi-cance of these findings for human fertility is not known.

Source: http://www.soma250.com/hcp/pdf/full_prescribing_info.pdf

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