Adjunct to rest, physical therapy, analgesics, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions.
For low back pain, generally reserve skeletal muscle relaxants for adjunctive treatment when pain is unresponsive to OTC analgesics (e.g., NSAIAs).
Skeletal muscle relaxants less well tolerated than NSAIAs, and clinical superiority to NSAIAs not established for low back pain.
Various skeletal muscle relaxants appear to have comparable efficacy for low back pain relief and are more effective than placebo.
Initially, symptomatic control of acute low back pain focuses on providing sufficient comfort to allow maximum possible activity while awaiting spontaneous recovery; later, as aid to overcome specific activity intolerance.
Because of rapid spontaneous recovery rate, efficacy of various therapies may be difficult to establish; improvement of low back pain usually occurs within 2 weeks, substantial improvement within 4 weeks.
Ineffective for treatment of skeletal muscle hyperactivity secondary to chronic neurologic disorders, (e.g., cerebral palsy) and other dyskinesias.
Dosage and Administration
Administration
Administer orally.
Dosage
Pediatric Patients
Muscular Conditions
Oral
Children ≥5 years of age: 25 mg/kg or 750 mg/m2 daily in 4 divided doses has been suggested by some clinicians, although manufacturers state that safety and efficacy are not established in children <12 years of age.
Adults
Muscular Conditions
Oral
350 mg 3 times daily and at bedtime.
Reduce dosage if severe adverse CNS effects occur.
Known hypersensitivity (allergic or idiosyncratic reactions) to carisoprodol, any ingredient in the formulation, or related compounds (e.g., meprobamate, mebutamate, or tybamate).
Warnings/Precautions
Sensitivity Reactions
Hypersensitivity and Idiosyncratic Reactions
Occasionally, allergic or idiosyncratic reactions occur, usually evident by the time of the fourth dose in patients who have not received carisoprodol previously. Rarely, idiosyncratic reactions may occur in minutes or hours after the first dose.
Idiosyncratic reactions are characterized by extreme weakness, transient quadriplegia, dizziness, ataxia, temporary loss of vision, diplopia, mydriasis, dysarthria, agitation, euphoria, confusion, and disorientation.
If idiosyncratic reactions occur, discontinue the drug. Symptoms usually subside within several hours; symptomatic and supportive therapy (e.g., epinephrine, antihistamine, corticosteroids in severe cases) including hospitalization may be necessary.
Rash, erythema multiforme, pruritus, urticaria, eosinophilia, and fixed drug eruption have occurred in patients receiving carisoprodol who previously had similar reactions to meprobamate.
Sulfite Sensitivity
Some formulations (e.g., Soma® Compound with Codeine) contain sodium metabisulfite, which can cause allergic-type reactions, including anaphylaxis and life-threatening or less severe asthmatic episodes, in certain susceptible individuals.
General Precautions
CNS Effects
Possible CNS effects (e.g., drowsiness); may require dosage reduction. Dizziness, vertigo, and ataxia are reported less frequently and tremor, agitation, irritability, headache, depressive reaction, syncope, and insomnia are reported rarely.
Performance of activities requiring mental alertness or physical coordination may be impaired.
Concurrent use of other CNS depressants may potentiate CNS effects. (See Specific Drugs under Interactions.)
Drug Dependence
Mild withdrawal symptoms (e.g., abdominal cramps, insomnia, chilliness, headache, nausea) have been reported following abrupt discontinuance of large doses of carisoprodol (100 mg/kg for an unspecified number of days). Psychological dependence and abuse are reported rarely.
Use with caution in patients with histories of drug abuse.
GI Effects
Nausea, vomiting, hiccups, increased bowel activity, and epigastric distress have been reported.
Cardiovascular Effects
Tachycardia, postural hypotension, and facial flushing have been reported.
Fixed Combinations
When used in fixed combination with aspirin and/or codeine, consider the cautions, precautions, and contraindications associated with the other agent(s).
Specific Populations
Pregnancy
Category C.
Lactation
Distributed into milk. Use with caution, if at all; monitor infant closely for sedation or change in behavior or functions.
Pediatric Use
Safety and efficacy not established in children <12 years of age.
Geriatric Use
Use with caution in geriatric or debilitated patients.
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