Chloraldurat

Chloraldurat 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.

Chloraldurat 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.

Route of administration: oral. Chloraldurat Oral Solution should be administered as a single daily dose, 15-30 minutes before bedtime with water or milk.

Adults and children 12 years and over: The usual dose is 15-30ml (430-860 mg). Higher doses should not exceed a maximum of 70ml of elixir (2g Chloraldurat) per dose.

Elderly: Dosage as for adults except for the frail elderly or those with hepatic impairment, where a reduction in dose may be appropriate.

Children (between 2 and 11 years): 1-1.75 ml/kg (30-50mg/kg) of bodyweight. The dose should not exceed 35ml (1g) Chloraldurat.

Children (under 2 years): not recommended.

Chloraldurat Oral Solution should not be used in patients with a marked hepatic or renal impairment, or in patients with severe cardiac disease. Should not be used in patients susceptible to acute attacks of porphyria.

Elderly patients are more likely to experience the undesirable effects of hypnotics such as ataxia and confusion which may lead to falls and injury. For use in the frail elderly it is recommended that a lower dose be administered. (See 4.2 Posology and method of administration)

Best avoided in the presence of gastritis and in patients who have previously exhibited an idiosyncrasy or hypersensitivity to Chloraldurat.

Patients receiving Chloraldurat Oral Solution should be warned that their ability to drive or use machinery may be impaired by drowsiness.

Gastric irritation, abdominal distension and flatulence may occur. Excitement, tolerance, allergic skin reactions, headache and ketonuria have occasionally been reported. There is a danger of abuse or chronic intoxication and the possibility that habituation may develop. In such patients gastritis and parenchymatous renal injury may develop. After long term use, sudden withdrawal may result in delirium.

Elderly patients are more susceptible to the undesirable effects of hypnotic medications such as Chloral Hydrate Oral Solution and are therefore more susceptible to ataxia, confusion, falls and injuries.

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.

Chloraldurat Oral Solution is a Chloraldurat derivative, which leads to a decrease in sleep latency and in the number of awakenings. A near natural sleep is induced and the REM/Non-REM ratio is not altered.

Chloraldurat and its metabolite trichloroethanol act as central nervous system depressants. Chloral hydrate is rapidly absorbed from the stomach, and starts to act within 30 minutes. It is widely distributed throughout the body, and is metabolised to trichloroethanol, also an active hypnotic, and trichloroacetic acid in the erythrocytes, liver and other tissues. It is excreted partly in the urine as trichloroethanol and its glucuronide, urochloralic acid, and as trichloroacetic acid. Significant amounts are also excreted in bile. Trichloroethanol has a plasma half life of the order of 8 hours. Trichloroacetic acid has a half-life of several days. In infants the half lives are longer. The value for trichloroethanol is 35 hours whilst for trichloroacetic acid the half life exceeds 6 days, with significant plasma concentrations present at 14 days.

Chloraldurat induces liver tumours in male mice, with no tumourigenic effects in rats. The mechanism of tumour induction is not known, but in the absence of clear evidence of mutagenic and clastogenic potential it is unlikely to be relevant in man.

None known.

Syrup BP should be used as a diluent.