Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2014 Publisher: Marlborough Pharmaceuticals Ltd, 35A High Street, Marlborough, Wiltshire, SN8 1LW
Chloral Hydrate Oral Solution is used for the short-term treatment of severe insomnia which is interfering with normal daily life and where other therapies have failed.
Chloral Hydrate Oral Solution should be used as an adjunct to non-pharmacological therapies.
In children aged 2-11 years treatment should be as an adjunct to behavioural therapy and sleep hygiene management, and usually for duration of less than 2 weeks.
The use of hypnotics in children and adolescents is not generally recommended and if used should be under the supervision of a medical specialist.
Oral.
Chloral Hydrate Oral Solution should be administered as a single daily dose, 15-30 minutes before bedtime with water or milk.
The usual dose is 15-30ml (430-860 mg). Higher doses should not exceed a maximum of 70ml of elixir (2g chloral hydrate) per dose.
Dosage as for adults except for the frail elderly or those with hepatic impairment, where a reduction in dose may be appropriate.
1-1.75 ml/kg (30-50mg/kg) of bodyweight. The dose should not exceed 35ml (1g) chloral hydrate.
Not recommended.
The signs and symptoms of overdose involve the cardiovascular, respiratory and central nervous systems. These may include: respiratory depression, arrhythmias, hypothermia, pin-point pupils, hypotension or coma. Gastric irritation may result in vomiting and even gastric necrosis. If the patient survives, icterus due to hepatic damage and albuminuria from renal damage may appear. Serious problems have arisen with doses as little as 4g and 10g can be fatal. Overdosage should be treated with gastric lavage or inducing vomiting to empty the stomach. Supportive measures must be used. Haemodialysis, and in some cases haemoperfusion, have been reported to be effective in promoting the clearance of trichloroethanol.
Shelf life: 18 months when stored below 25°C.
Store below 25°C. Protect from direct sunlight.
Amber glass bottle with child-proof plastic screw cap, containing 150ml or 30ml of Chloral Hydrate Oral Solution, presented in a carton.
Syrup BP should be used as a diluent.
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