ORION

What it is

Chloral Hydrate Mixture is an oral liquid solution containing chloral hydrate 1g/10mL. It is a clear, colourless, syrupy liquid supplied in a 200mL bottle. Chloral hydrate is a hypnotic and sedative with CNS depressant properties similar to barbiturates.

Approved indications

— Pre-operative sedation — Short term (not more than 2 weeks) use as a hypnotic to assist in sleep disorders

Dosing overview

The maximum daily dose in adults should not exceed 2g. Chloral Hydrate Mixture should be well diluted with water or another liquid (such as fruit juice or ginger ale) prior to administering, to minimise gastric irritation. Dosage may need to be reduced in patients with hepatic or renal impairment, and in elderly or debilitated patients.

Key safety warnings

Tolerance to chloral hydrate may develop and dependence may occur. It should be used with caution in patients who are mentally depressed, have suicidal tendencies, or a history of drug or alcohol abuse. Tolerance and psychological dependence may develop by the second week of continued therapy. Withdrawal symptoms similar to those of barbiturates, including delirium tremens and hallucinations, can occur if chloral hydrate is stopped abruptly. Prolonged administration and abrupt withdrawal should be avoided, and dependent persons should be hospitalised with slow drug withdrawal. Chloral hydrate may impair mental and physical abilities and cause drowsiness that may persist the next day. Patients should be cautioned about performing activities requiring mental alertness or physical coordination, such as operating machinery or driving. Deaths have occurred prior to or following diagnostic procedures in paediatric patients after chloral hydrate was administered for sedation. It should be administered only at a health care facility where appropriate monitoring can be instituted, and monitoring must continue until the child meets appropriate discharge criteria. Chloral hydrate is irritating to the skin and mucous membranes. Gastric irritation may be minimised by diluting the oral solution with water or other liquids.

Contraindications

Chloral hydrate is contraindicated in patients with marked hepatic or renal impairment, severe cardiac disease, gastritis, oesophagitis or gastric or duodenal ulcers, porphyrias, and previous history of a hypersensitivity reaction to chloral hydrate or to any of the excipients contained in the mixture. It is also contraindicated for sedation of children with obstructive sleep apnoea, due to the risk of life threatening respiratory obstruction.

Regulatory history

Chloral Hydrate Mixture 1g/10mL (ARTG 42850) was first listed on the Australian Register of Therapeutic Goods on 26 November 1992. The product was first approved on 19 September 2003.