CARISOPRODOL — 350 mg / 500 mg tablets
📦 Product Snapshot
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🧠 Overview
Carisoprodol is a centrally acting skeletal muscle relaxant indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. First approved in the United States in 1959, it remains widely prescribed, with over 3.4 million prescriptions in 2017. The drug should always be used as part of a comprehensive treatment plan including rest and physical therapy.
Unique pharmacology: Carisoprodol itself has muscle relaxant properties, but it is rapidly metabolized in the liver by the CYP2C19 enzyme to meprobamate — a schedule IV controlled substance with significant anxiolytic and sedative effects. Meprobamate has a half-life of approximately 10 hours (compared to 2 hours for carisoprodol) and is believed to contribute substantially to both therapeutic effects and abuse potential. This metabolic pathway creates a complex pharmacokinetic profile with accumulation of the active metabolite during repeated dosing.
Critical limitations: Carisoprodol is approved for short-term use only (up to two or three weeks). There is no evidence of effectiveness for longer periods, and acute musculoskeletal conditions are generally self-limiting. In 2007, the European Medicines Agency suspended marketing authorizations for carisoprodol across Europe, concluding that risks (particularly abuse, dependence, and intoxication) no longer outweighed benefits. The drug remains available in the United States as a schedule IV controlled substance following federal scheduling in 2011.
Regulatory status: In the US, carisoprodol is DEA Schedule CIV. Risk of abuse, dependence, and withdrawal is well-documented, particularly with prolonged use or in patients with history of substance abuse. Some patients abuse carisoprodol alone, though most cases involve polysubstance abuse. Withdrawal symptoms can be severe, including insomnia, vomiting, hallucinations, and psychosis.
🏷️ Strengths & Brand Examples
- 250 mg tablets (Mylan, generic)
- 350 mg tablets (Oxford, generic, multiple manufacturers)
- Soma® 250 mg / 350 mg (original brand, now generic)
- Vanadom®
- Carisoma® 350 mg (Wallace Pharmaceuticals Pvt Ltd) — ₹48/strip
- Pain O Soma 350mg / 500 mg (HAB Pharma)
- Korisuma® (Holy Evolution Pharma) — ₹150/strip
- Carisol® 350 mg (Jocund India Ltd) — ₹30/strip
- Aciprodol® (Allied Chemicals & Pharmaceuticals Pvt Ltd) — ₹30/strip
- Carisoprodol + Aspirin + Codeine (US — discontinued by some manufacturers)
- Carisoprodol + Acetaminophen + Caffeine
⚠️ Safety, Side Effects & Monitoring
- Drowsiness / sedation (13–17% vs 6% placebo) — most frequent
- Dizziness (7–8%)
- Headache (3–5%)
- Nausea, vomiting, epigastric discomfort
- Ataxia, tremor, vertigo
- Agitation, irritability, depressive reactions
- Tachycardia, postural hypotension, facial flushing
- Leukopenia, pancytopenia (rare post-marketing)
• Sedation and impaired driving: Causes significant drowsiness. Post-marketing reports of motor vehicle accidents. Additive effects with alcohol, benzodiazepines, opioids, tricyclic antidepressants.
• Seizures: Reported post-marketing, usually in setting of multiple drug overdose.
• Contraindications: Acute intermittent porphyria; hypersensitivity to carbamates (meprobamate).
• Overdose risk: May lead to death, CNS/respiratory depression, hypotension, seizures. Meprobamate accumulation increases toxicity.
Carisoprodol is metabolized primarily by CYP2C19 to its active metabolite meprobamate. Genetic polymorphism significantly affects drug exposure:
- Poor metabolizers (3–5% of Caucasians/African Americans; 15–20% of Asians): Experience 4-fold higher carisoprodol exposure and 50% lower meprobamate exposure compared to normal metabolizers.
- Clinical implications: Increased sedation and side effects at standard doses in poor metabolizers. Consider dose adjustment or alternative therapy.
CYP2C19 inhibitors (omeprazole, fluvoxamine, ticlopidine, fluoxetine) — increase carisoprodol, decrease meprobamate.
CYP2C19 inducers (rifampin, St. John’s Wort, carbamazepine, low-dose aspirin) — decrease carisoprodol, increase meprobamate.
- Pregnancy: Limited data over decades show no consistent association with major birth defects. Animal studies show reduced fetal weight and postnatal survival at high doses. Use only if clearly needed.
- Lactation: Carisoprodol and meprobamate present in breast milk. Monitor infant for sedation. Consider alternatives, especially in newborns/preterm infants.
- Pediatric (<16 years): Safety and efficacy not established — contraindicated.
- Geriatric (>65 years): Not established — increased sensitivity to sedation, falls risk.
- Renal impairment: Caution; drug excreted renally. Dialyzable by hemodialysis/peritoneal dialysis.
- Hepatic impairment: Not studied; caution as liver metabolism is primary route.
- CNS depressants (alcohol, benzodiazepines, opioids, TCAs): Additive sedation — avoid concurrent use or use extreme caution.
- CYP2C19 inhibitors/inducers: See pharmacogenetics box above.
- Meprobamate co-administration: Not recommended (additive effects).