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clomethiazole, combinations

N05CX04

Forms & Strengths

Oral capsules: 192 mg base (equivalent to 300 mg clomethiazole edisylate)

Adult Dosing

Alcohol withdrawal syndrome: Initial 2 capsules (384 mg) orally, followed by 1 capsule as needed to control restlessness; max 12 capsules daily on the first day, tapering over subsequent days
Agitation and sleep disorders in the elderly: 1 to 2 capsules at bedtime

Pediatric Dosing

Not recommended for pediatric use due to lack of established safety and efficacy data

Indications

Management of acute alcohol withdrawal symptoms
Sedative and hypnotic in elderly patients for short-term use

Mechanism of Action

Acts as a positive allosteric modulator at the GABA-A receptor complex
Enhances inhibitory GABAergic neurotransmission, producing sedation, hypnosis, anticonvulsant, and muscle relaxant effects

Contraindications

Hypersensitivity to clomethiazole
Acute pulmonary insufficiency or severe respiratory depression
Active alcohol intoxication when combined with other CNS depressants
Severe hepatic impairment

Adverse Reactions

Drowsiness and sedation (especially upon initiation)
Nasal congestion and conjunctival irritation
Respiratory depression in high doses
Dependence, tolerance, and withdrawal symptoms with prolonged use
Hypotension and dizziness

Drug Interactions

Alcohol and other CNS depressants (opioids, barbiturates, benzodiazepines): synergistic central nervous system and respiratory depression
Cimetidine: inhibits metabolism of clomethiazole, increasing plasma concentrations and risk of toxicity

Curated Content: Needs Vetting Before Put to Clinical Use