Total Cost
Free shipping on all orders

Powered by GeniusRx

carisoprodol 250 mg tablet generic soma

In stock Manufacturer RISING PHARM 64980038001
Create order for price
Prescription is required
  • Buy 60 for $2.81 $0.00 each and save 6%
  • Buy 90 for $2.68 $0.00 each and save 11%

Uses

Muscular Conditions

Carisoprodol is used for the short-term relief of discomfort associated with acute, painful musculoskeletal conditions. The drug is indicated for short-term use only (i.e., up to 2-3 weeks) because adequate evidence of efficacy for more prolonged use has not been established and because acute, painful musculoskeletal conditions generally are of short duration. In addition, long-term use of carisoprodol may increase the risk of abuse, dependence, and tolerance.

Skeletal muscle relaxants generally appear to be more effective than placebo in providing symptomatic relief of acute low back pain, but are associated with a high incidence of adverse effects. Although comparative studies are limited, available data suggest that various skeletal muscle relaxants generally have similar efficacy for such use. Acute low back pain usually is a benign and self-limiting condition that improves spontaneously over time; if pharmacologic therapy is required, an analgesic agent such as acetaminophen or a nonsteroidal anti-inflammatory agent (NSAIA) generally is recommended as first-line therapy for most patients. Skeletal muscle relaxants (alone or in combination with analgesics) may be used as an option for short-term relief of acute low back pain; however, the possibility of adverse effects, particularly adverse CNS effects, should be considered. In general, skeletal muscle relaxants should be used with caution after weighing the potential risks against the benefits in individual patients.

Efficacy of carisoprodol for the relief of acute, painful musculoskeletal conditions was evaluated in 2 randomized, placebo-controlled studies in adults 18-65 years of age with acute, idiopathic low back pain of no more than 3 days' duration. In these studies, patients were randomized to receive carisoprodol (250 or 350 mg) or placebo 3 times daily and at bedtime for 7 days. In both studies, carisoprodol was found to be more effective than placebo, as measured by patient-rated relief from starting backache and patient-rated global impression of change. The 250-mg dosage of carisoprodol was similar in efficacy to the 350-mg dosage, but was associated with a lower incidence of adverse events. Patients receiving carisoprodol in these studies also experienced an improvement in functional status compared with those receiving placebo (as measured by the Roland-Morris Disability Questionnaire score), and clinical improvement was observed regardless of whether patients reported sedation.

Well-controlled clinical studies have not conclusively demonstrated whether relief of musculoskeletal pain by carisoprodol results from skeletal muscle relaxant effects, sedative effects, or a placebo effect of the drug. Most authorities attribute the beneficial effects of carisoprodol to its sedative properties. The drug is ineffective in the treatment of skeletal muscle hyperactivity secondary to chronic neurologic disorders, such as cerebral palsy, and other dyskinesias.

Dosage and Administration

Administration

Carisoprodol is administered orally with or without food.

Dosage

Muscular Conditions

Adult Dosage

The recommended dosage of carisoprodol in adults is 250-350 mg 3 times daily and at bedtime. Treatment should be limited to short periods (i.e., up to 2-3 weeks) because adequate evidence of efficacy for more prolonged periods has not been established and because acute, painful musculoskeletal conditions generally are of short duration.

Cautions

Nervous System Effects

The most frequent adverse effects of carisoprodol are drowsiness and dizziness. In clinical studies of carisoprodol in patients with acute low back pain, sedation was reported in 13-17% of patients receiving the drug compared with 6% of those receiving placebo. Other adverse CNS effects include vertigo, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, and insomnia. In addition, seizures have been reported during postmarketing experience in patients receiving carisoprodol, mostly in the setting of multiple-drug overdoses (including drugs of abuse, illicit drugs, and alcohol). Use of carisoprodol also has been implicated as a factor in motor vehicle accidents.

Sensitivity Reactions

Allergic or idiosyncratic reactions have been reported in patients receiving mebrobamate, a metabolite of carisoprodol. These events have ranged from mild (e.g., pruritus, urticaria, erythematous maculopapular rash) to more severe hypersensitivity reactions, including hyperpyrexia, chills, angioedema, bronchospasm, anaphylaxis, stomatitis, proctitis, oliguria, anuria, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, and bullous dermatitis. Leukopenia, acute nonthrombocytopenic purpura, petechiae, ecchymoses, eosinophilia, adenopathy, peripheral edema, fever, and fixed drug eruptions with a cross-reaction to carisoprodol also have occurred in association with meprobamate use.

Other Adverse Effects

Adverse GI effects of carisoprodol include nausea, vomiting, and epigastric distress. Adverse cardiovascular effects include tachycardia, postural hypotension, and facial flushing. Although a causal relationship to carisoprodol has not been established, leukopenia and pancytopenia have occurred rarely in patients receiving carisoprodol along with other drugs.

Precautions and Contraindications

Because carisoprodol is metabolized by the liver and excreted by the kidneys, the drug should be used with caution in patients with impaired hepatic or renal function. Patients should be warned that carisoprodol may impair their ability to perform hazardous activities requiring mental alertness or physical coordination such as operating machinery or driving a motor vehicle. In addition, the possibility of additive sedative effects should be considered in patients receiving other CNS depressants (e.g., alcohol, benzodiazepines, opiate agonists, tricyclic antidepressants) concomitantly. Because of the potential for abuse and dependence, carisoprodol should be used with caution in addiction-prone patients and in those receiving other CNS depressants, including alcohol; in addition, use of the drug should be limited to short periods (i.e., up to 2-3 weeks) for the relief of acute musculoskeletal discomfort. Carisoprodol also should be used with caution in patients with reduced cytochrome P-450 (CYP) 2C19 activity (i.e., poor metabolizers) because such patients may have higher than expected concentrations of the drug.

Commercially available formulations of carisoprodol (e.g., Soma Compound with Codeine) may contain sodium metabisulfite, a sulfite that may cause serious allergic-type reactions in certain susceptible individuals. The overall incidence of sulfite sensitivity in the general population is probably low, but in susceptible individuals, exposure to sulfites can result in acute bronchospasm or, less frequently, life-threatening anaphylaxis. Carisoprodol formulations containing sodium metabisulfite should be used with caution in atopic, nonasthmatic individuals.

Carisoprodol is contraindicated in patients with a history of acute intermittent porphyria and in patients with known hypersensitivity to carisoprodol or other carbamate derivatives (e.g., meprobamate).

Pediatric Precautions

Safety and efficacy of carisoprodol in children younger than 16 years of age have not been established.

Geriatric Precautions

Safety and efficacy of carisoprodol in patients older than 65 years of age have not been established.

Pregnancy and Lactation

Pregnancy

Animal studies indicate that carisoprodol may have adverse effects on fetal growth and postnatal survival; however, teratogenic effects of the drug have not been adequately evaluated. While the risk of fetal harm appears to be low in humans, experience with use of carisoprodol in pregnant women is limited. Although studies have been conducted in pregnant women receiving meprobamate (an active metabolite of carisoprodol), results have been equivocal as to whether there is an increased risk of congenital abnormalities following first trimester exposure to the drug. Carisoprodol should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. Some experts recommend that the drug be avoided, if possible, during the first trimester of pregnancy.

Lactation

Limited data indicate that carisoprodol is distributed into human milk and may reach concentrations that are 2-4 times maternal plasma concentrations. Other than mild sedation, no adverse effects have been observed in nursing infants exposed to carisoprodol; however, insufficient maternal milk production has been described in several case reports. Carisoprodol should be used with caution in nursing women, and infants should be monitored closely for sedation or other changes in behavior or function.

Drug Interactions

Drugs Affecting Hepatic Microsomal Enzymes

Carisoprodol is metabolized by cytochrome P-450 (CYP) isoenzyme 2C19; pharmacokinetic interactions are possible with drugs that affect this isoenzyme. CYP2C19 inhibitors (e.g., fluvoxamine, omeprazole) may increase exposure to carisoprodol and decrease exposure to meprobamate; conversely, CYP2C19 inducers (e.g., rifampin, St. John's wort [Hypericum perforatum]) may decrease exposure to carisoprodol and increase exposure to meprobamate. Low-dose aspirin also may have some CYP2C19-inducing effects. The clinical importance of these potential pharmacokinetic interactions is not known.

CNS Depressants

Additive CNS depression may occur when carisoprodol is used concomitantly with other CNS depressants, including alcohol, benzodiazepines, opiate agonists, and tricyclic antidepressants. If carisoprodol is used concomitantly with other CNS depressant drugs, caution should be exercised. Concomitant use of carisoprodol and meprobamate (a metabolite of carisoprodol) is not recommended.

Pharmacokinetics

Absorption

Plasma concentrations of carisoprodol required for sedative, skeletal muscle relaxant, or toxic effects are not known. Peak plasma concentrations of approximately 1.2 and 1.8 mcg/mL were attained following oral administration of single doses of 250 and 350 mg of carisoprodol, respectively, to healthy adults. Peak plasma concentrations were achieved in approximately 1.5-2 hours. Administration of a high-fat meal had no effect on the pharmacokinetics of the drug. Following usual therapeutic dosages, the onset of action is usually within 30 minutes and the duration of action is 4-6 hours.

Distribution

Animal studies indicate that carisoprodol crosses the placenta. The drug distributes into milk in concentrations 2-4 times higher than concurrent maternal plasma concentrations.

Elimination

Carisoprodol is metabolized in the liver by cytochrome P-450 (CYP) isoenzyme 2C19; several metabolites (meprobamate, hydroxycarisoprodol, hydroxymeprobamate) have been identified, among which meprobamate is the main active metabolite.Carisoprodol is eliminated via both renal and nonrenal routes; the mean elimination half-life of carisoprodol is approximately 2 hours and the mean elimination half-life of meprobamate is approximately 10 hours. Carisoprodol may be removed by hemodialysis and peritoneal dialysis.

Genetic polymorphism of the CYP2C19 isoenzyme may affect the pharmacokinetic responses of carisoprodol. Studies have shown that exposure to carisoprodol is increased (by fourfold) and exposure to meprobamate is decreased (by 50%) in individuals with genetic deficiency of the CYP2C19 isoenzyme (i.e., poor metabolizers) compared with those with normal CYP2C19 function. Approximately 15-20% of Asians and approximately 3-5% of Caucasians and African Americans exhibit the CYP2C19 poor metabolizer phenotype.

Write Your Own Review

Your meds on autopilot. Forever.