Class: Centrally Acting Skeletal Muscle Relaxants
VA Class: MS200
CAS Number: 78-44-4
Brands: Soma, Soma Compound, Soma Compound with Codeine, Vanadom
Introduction
Skeletal muscle relaxant; structurally and pharmacologically related to meprobamate, mebutamate, and tybamate.a
Uses for Carisoprodol
Muscular Conditions
Adjunct to rest, physical therapy, analgesics, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions.a b
For low back pain, generally reserve skeletal muscle relaxants for adjunctive treatment when pain is unresponsive to OTC analgesics (e.g., NSAIAs).f g h i j k
Skeletal muscle relaxants less well tolerated than NSAIAs, and clinical superiority to NSAIAs not established for low back pain.f g h i j k
Various skeletal muscle relaxants appear to have comparable efficacy for low back pain reliefe f and are more effective than placebo.f h j
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.j
Because of rapid spontaneous recovery rate, efficacy of various therapies may be difficult to establish;j improvement of low back pain usually occurs within 2 weeks, substantial improvement within 4 weeks.i
Ineffective for treatment of skeletal muscle hyperactivity secondary to chronic neurologic disorders, (e.g., cerebral palsy) and other dyskinesias.a
Carisoprodol Dosage and Administration
Administration
Administer orally.a b
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.a b
Adults
Muscular Conditions
Oral
350 mg 3 times daily and at bedtime.a b
Reduce dosage if severe adverse CNS effects occur.a
Cautions for Carisoprodol
Contraindications
Acute intermittent porphyria.a b
Known hypersensitivity (allergic or idiosyncratic reactions) to carisoprodol, any ingredient in the formulation, or related compounds (e.g., meprobamate, mebutamate, or tybamate).a b
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.a b Rarely, idiosyncratic reactions may occur in minutes or hours after the first dose.b c
Idiosyncratic reactions are characterized by extreme weakness, transient quadriplegia, dizziness, ataxia, temporary loss of vision, diplopia, mydriasis, dysarthria, agitation, euphoria, confusion, and disorientation.a b
If idiosyncratic reactions occur, discontinue the drug.a b c Symptoms usually subside within several hours; symptomatic and supportive therapy (e.g., epinephrine, antihistamine, corticosteroids in severe cases) including hospitalization may be necessary.a b c
Severe allergic reactions have been characterized by asthmatic episodes, fever, weakness, dizziness, angioedema, smarting eyes, hypotension, and anaphylactic shock.a b c
Cross-sensitivity
Rash, erythema multiforme, pruritus, urticaria, eosinophilia, and fixed drug eruption have occurred in patients receiving carisoprodol who previously had similar reactions to meprobamate.a b
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.a
General Precautions
CNS Effects
Possible CNS effects (e.g., drowsiness); may require dosage reduction.b c Dizziness, vertigo, and ataxia are reported less frequently and tremor, agitation, irritability, headache, depressive reaction, syncope, and insomnia are reported rarely.b
Performance of activities requiring mental alertness or physical coordination may be impaired.b
Concurrent use of other CNS depressants may potentiate CNS effects.b (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).a b Psychological dependence and abuse are reported rarely.a b
Use with caution in patients with histories of drug abuse.a b
GI Effects
Nausea, vomiting, hiccups, increased bowel activity, and epigastric distress have been reported.a b
Cardiovascular Effects
Tachycardia, postural hypotension, and facial flushing have been reported.a b
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.d
Lactation
Distributed into milk.a b c d Use with caution, if at all; monitor infant closely for sedation or change in behavior or functions.d
Pediatric Use
Safety and efficacy not established in children <12 years of age.a b
Geriatric Use
Use with caution in geriatric or debilitated patients.c
Hepatic Impairment
Use with caution; metabolized by the liver.a b c
Renal Impairment
Use with caution; excreted by the kidneys.a b c
Common Adverse Effects
Drowsiness, dizziness.a b
Interactions for Carisoprodol
May induce liver microsomal enzymes.a
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
Alcohol | Potential additive CNS depression a b c | Use concomitantly with cautiona b c |
CNS depressants | Potential additive CNS depression a b c | Use concomitantly with cautiona b c |
Psychotropic agents | Potential additive effectsb c | Use concomitantly with cautionb c |
Carisoprodol Pharmacokinetics
Absorption
Onset
Usually within 30 minutes.a
Duration
4–6 hours.a
Distribution
Extent
Crosses the placenta; distributed into milk in concentrations 2–4 times higher than concurrent maternal plasma concentrations.a
Elimination
Metabolism
Metabolized in the liver.a c
Elimination Route
Excreted in urine,a c principally as hydroxycarisoprodol and hydroxymeprobamate, and to a lesser extent as meprobamate; trace amounts excreted unchanged in urine.a
Half-life
Approximately 8 hours.a
Special Populations
May be removed by hemodialysis or peritoneal dialysis.a c Accumulation of carisoprodol may occur in patients with hepatic or renal impairment.a b c
Stability
Storage
Oral
Tablets
Tight containers at 15–30°C.a b c
ActionsActions
CNS depressant with sedative and skeletal muscle relaxant effects.a
Precise mechanism of action not known; minimal skeletal muscle relaxant effects are probably related to sedation.a
No direct skeletal muscle relaxant effect;a b c does not depress neuronal conduction, neuromuscular transmission, or muscle excitability.a
In animals, blocks interneuronal activity in descending reticular formation and spinal cord.b c
May modify central perception of pain without abolishing peripheral pain reflexes and may have slight antipyretic activity.a
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.b c
Potential for additive CNS depression if other CNS depressants (e.g., alcohol) are used concomitantly.a b c
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.a b c
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.a b c
Importance of informing patients of other important precautionary information.a b c (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
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
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 200 mg with Aspirin 325 mg* | Soma Compound (with povidone) | Medpointe |
200 mg with Aspirin 325 mg and Codeine Phosphate 16 mg* | Carisoprodol Aspirin and Codeine Phosphate Tablets ( C-III) | Eon, Rugby | ||
Soma Compound with Codeine ( C-III; with povidone and sodium metabisulfite) | Medpointe |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Carisoprodol 350MG Tablets (QUALITEST): 30/$13.99 or 90/$31.99
Carisoprodol-Aspirin 200-325MG Tablets (SANDOZ): 30/$65.99 or 90/$169.96
Carisoprodol-Aspirin-Codeine 200-325-16MG Tablets (SANDOZ): 30/$83.37 or 90/$240.03
Soma 250MG Tablets (MEDA PHARMACEUTICALS): 100/$319.98 or 300/$925.98
Soma 350MG Tablets (MEDA PHARMACEUTICALS): 30/$189.98 or 90/$515.94
Soma Compound 200-325MG Tablets (MEDA PHARMACEUTICALS): 30/$139.99 or 90/$399.96
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions April 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
References
a. AHFS drug information 2004. McEvoy GK, ed. Carisoprodol. Bethesda, MD: American Society of Health-System Pharmacists; 2004:1328-9.
b. Medpointe Heathcare. Soma (carisoprodol) tablets prescribing information. Somerset, NJ; 2001 Oct.
c. Medpointe Heathcare. Soma Compound (carisoprodol and aspirin) tablets USP prescribing information. Somerset, NJ; 2001 Oct.
d. Carisoprodol. In: Briggs GG, Freeman RK, Yaffe SJ. Drug in pregnancy and lactation: a reference guide to fetal and neonatal risk. 6th ed. Philadelphia: Lippincott Williams & Wilkins; 2002:193-4
e. McNeil. Cyclobenzaprine hydrochloride (Flexeril) tablets prescribing information. Fort Washington, PA: 2003 Feb.
f. van Tulder MW, Touray T, Furlan AD et al. Muscle relaxants for non-specific low back pain. The Cochrane Library. From their web site (). Accessed 11/10/2003.
g. van Tulder MW, Scholten RJPM, Kowes BW, et al. Non-steroidal anti-inflammatory drugs for low back pain. The Cochrane Library. From their web site (). Accessed 11/10/2003.
h. Department of Veterans Affairs Veterans Health Administration Office of Quality & Performance. Management of Person with Low Back Pain/Sciatica in Primary Care. From the web site (). Accessed 8/25/2003.
i. Agency for Healthcare Research and Quality. Adult low back pain. From the National Guideline Clearinghouse website. (). Accessed 8/25/2003.
j. U.S. Department of Health and Human Services. Public Health Service. Agency for Halath Care Policy and Research. Acute low back problems in adults. Clinical Practice Guideline.1994; No. 14
k. U.S. Department of Health and Human Services. Public Health Service. Agency for Health Care Policy and Research. Acute low back problems in adults: Assessment and treatment. Clinical Practice Guideline. Quick Reference Guide for Clinicians.1994; No. 14
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