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.
Crosses the placenta; distributed into milk in concentrations 2–4 times higher than concurrent maternal plasma concentrations.
Elimination
Metabolism
Metabolized in the liver.
Elimination Route
Excreted in urine, principally as hydroxycarisoprodol and hydroxymeprobamate, and to a lesser extent as meprobamate; trace amounts excreted unchanged in urine.
CNS depressant with sedative and skeletal muscle relaxant effects.
Precise mechanism of action not known; minimal skeletal muscle relaxant effects are probably related to sedation.
No direct skeletal muscle relaxant effect; does not depress neuronal conduction, neuromuscular transmission, or muscle excitability.
In animals, blocks interneuronal activity in descending reticular formation and spinal cord.
May modify central perception of pain without abolishing peripheral pain reflexes and may have slight antipyretic activity.
Advice to Patients
Potential for drug to impair mental alertness or physical coordination; use caution when driving or operating machinery until effects on individual are known.
Potential for additive CNS depression if other CNS depressants (e.g., alcohol) are used concomitantly.
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Carisoprodol
Routes
Dosage Forms
Strengths
Brand Names
Manufacturer
Oral
Tablets
350 mg*
Soma®
Medpointe
Vanadom®
GM Pharmaceuticals
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Carisoprodol Aspirin and Codeine Phosphate Tablets ( C-III)
Eon, Rugby
Soma® Compound with Codeine ( C-III; with povidone and sodium metabisulfite)
Medpointe
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
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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