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Indications and Dosage
Oral
Insomnia Adult: As 192 mg capsule: 1-2 capsules before going to bed. As 31.5 mg/mL syrup: 5-10 mL before going to bed. Oral Alcohol withdrawal syndrome Adult: Per cap contains 192 mg clomethiazole base. On the 1st day, 9-12 capsules, or the equivalent, divided into 3 or 4 doses. Gradually reduce dosage over the following 5 days. Not to be used for >9 days. Oral Sedation Adult: As 192 mg capsule: 1 capsule tid. As 31.5 mg/mL syrup: 5 mL tid.
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Renal Impairment
Dose reduction may be needed.
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Hepatic Impairment
Dose reduction may be needed.
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Contraindications
Acute pulmonary insufficiency; alcohol-dependent patients.
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Special Precautions
Chronic pulmonary insufficiency, cardiac and respiratory disease, hepatic or renal impairment, history of drug abuse, marked personality disorder. Excessive sedation may occur and drowsiness may persist the next day. Maintain airway integrity during parenteral administration. Avoid prolonged use or use in 1st and 3rd trimester of pregnancy. Elderly, children.
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Adverse Reactions
Nasal congestion and irritation; conjunctival irritation, headache. Rarely, paradoxical excitement, confusion, dependence, GI disturbances, rash, urticaria, bullous eruption, anaphylaxis, and alterations in liver enzymes.
Potentially Fatal: Respiratory depression. |
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Overdosage
Coma, respiratory depression, hypotension, hypothermia, pneumonia may follow increased respiratory secretion. Endotracheal intubation may be required if the patient is unconscious. Admin of activated charcoal in patients if present within 1 hr of ingestion. Treatment is supportive with close monitoring of electrolytes, CV, respiratory and renal functions. If no improvement after 24 hr of supportive care, consider charcoal haemoperfusion.
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Drug Interactions
Cimetidine inhibits metabolism. Sedation is enhanced by simultaneous admin of CNS depressants such as alcohol, barbiturates and antipsychotics. Diazoxide; calcium-channel blockers; clonidine; disulfiram; clozapine; diuretics; moxonidine; nabilone; nitrates; esomeprazole and omeprazole; muscle relaxants, dopaminergics; lofexidine; hydralazine; minoxidil and nitroprusside; antifungals; angiotensin II-receptor antagonist; antiepileptics; β-blockers; antibacterials.
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Action
Description:
Mechanism of Action: Clomethiazole is a hypnotic and sedative with anticonvulsant effects. It is used in the treatment of disturbed behaviour e.g. agitation and restlessness, short-term management of severe insomnia in the elderly and treatment of acute alcohol withdrawal symptoms. It is also used to control status epilepticus, usually to prevent seizure recurrence once they have been brought under control. It has been used for the initial control of impending or actual eclampsia. Pharmacokinetics: Absorption: Rapidly absorbed from the GI tract. Distribution: Widely distributed in the body. 65% bound to plasma proteins. Crosses the placenta and is distributed into breast milk. Metabolism: Extensively metabolised in the liver. Excretion: Elimination half-life: about 4 hr. |
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Storage
Store at 2-8°C.
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MIMS Class
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