Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany
Clomethiazole is a short acting hypnotic and sedative with anticonvulsant effect. It is used for the: management of restlessness and agitation in the elderly, short term treatment of severe insomnia in the elderly and treatment of alcohol withdrawal symptoms where close hospital supervision is also provided.
Management of restlessness and agitation in the elderly: one capsule three times daily.
Severe insomnia in the elderly: 1-2 capsules before going to bed. The lower dose should be tried first. As with all psychotropic drugs, treatment should be kept to a minimum, reviewed regularly and discontinued as soon as possible.
Alcohol withdrawal states: Clomethiazole is not a specific ‘cure’ for alcoholism. Alcohol withdrawal should be treated in hospital or, in exceptional circumstances, on an outpatient basis by specialist units when the daily dosage of clomethiazole must be monitored closely by community health staff. The dosage should be adjusted to patient response. The patient should be sedated but rousable.
A suggested regimen is:
Initial dose: 2 to 4 capsules, if necessary repeated after some hours.
Day 1, first 24 hours: 9 to 12 capsules, divided into 3 or 4 doses.
Day 2: 6 to 8 capsules, divided into 3 or 4 doses.
Day 3: 4 to 6 capsules, divided into 3or 4 doses.
Days 4 to 6: A gradual reduction in dosage until the final dose.
Administration for more than nine (9) days is not recommended.
The safety and efficacy of Clomethiazole in children and adolescents under 18 years of age has not been established.
For oral use. The capsules must be swallowed whole with water. They should not be chewed, crushed or broken.
The main effects to be expected with overdose of clomethiazole are: coma, respiratory depression, hypotension and hypothermia.
Hypothermia is thought to be due to a direct central effect as well as a result of lying unconscious for several hours. In addition, patients have increased secretion in the upper airways, which in one series was associated with a high incidence of pneumonia. The effects of overdosage are not usually severe in patients with no evidence of alcoholic liver disease, but they may be exacerbated when clomethiazole is taken in combination with alcohol and/or CNS depressant drugs, particularly those that are metabolised by the liver. There is no specific antidote to clomethiazole. Treatment of overdosage should therefore be carried out on a symptomatic basis, applying similar principles to those used in the treatment of barbiturate overdosage.
Charcoal column haemoperfusion is not and cannot be expected to be effective in treating clomethiazole poisoning.
Amber glass bottles: 2 years.
Aluminium foil blister packs: 2 years.
Do not store above 25°C.
Store in the original container to protect from light and moisture.
Amber glass bottle with white polyethylene child resistant clic-loc closure containing 60 or 100 capsules.
Transparent plastic bag in a cardboard outer for bulk packaging of 20,000 capsules. Aluminium foil blister packs each containing 10 capsules.
Not all pack sizes may be marketed.
The capsules should remain in the container in which they are supplied.
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