Adult: 500-1,000 mg as a single dose, to be given 30 minutes prior to the procedure. Doses must be diluted well or taken with plenty of water or other liquids. Dosage and treatment recommendations may vary among individual products and local guidelines (refer to specific product or country guidelines). Child: 25-50 mg/kg as a single dose, to be given 30 minutes before the procedure. Max: 1,000 mg per dose. Doses must be diluted well or taken with plenty of water or other liquids. Dosage and treatment recommendations may vary among individual products and local guidelines (refer to specific product or country guidelines).
Oral Hypnotic, Insomnia
Adult: Short-term treatment of severe cases that interfere with normal daily life and when other therapies (behavioural and pharmacologic) have failed: 430-860 mg as a single daily dose, to be taken 15-30 minutes before bedtime. Alternatively, 500-1,000 mg as a single dose, to be taken 15-30 minutes before bedtime. Max: 2,000 mg daily. Max treatment duration: 2 weeks. Doses must be diluted well or taken with plenty of water or other liquids. Dosage and treatment recommendations may vary among individual products and local guidelines (refer to specific product or country guidelines). Elderly: Dose reduction may be required (particularly in frail elderly). Child: Short-term treatment of severe cases in patients with suspected or definite neurodevelopmental disorder, when insomnia interferes with normal daily life and other therapies (behavioural and pharmacologic) have failed: 2-11 years 30-50 mg/kg as a single daily dose, to be taken 15-30 minutes before bedtime. Max: 1,000 mg daily. Max treatment duration: 2 weeks; ≥12 years Same as adult dose. Doses must be diluted well or taken with plenty of water or other liquids. Dosage and treatment recommendations may vary among individual products or local guidelines (refer to specific product or country guidelines).
Renal Impairment
Marked or severe: Contraindicated.
Hepatic Impairment
Hypnotic; Insomnia:
Mild to moderate: Dose adjustments may be needed. Marked or severe: Contraindicated.
Preoperative sedation:
Marked or severe: Contraindicated.
Reconstitution
Oral solution: Dilute with water or other liquids (e.g. fruit juice, ginger ale, milk, infant formula) to minimise unpleasant taste or gastric irritation.
Incompatibility
Incompatible with alkalis, alkali carbonates, alkaline earth, borax, soluble barbiturates, tannin, iodides, permanganates, oxidising agents, and alcohol.
Contraindications
Severe cardiac disease, acute porphyria; active gastritis, oesophagitis, gastric or duodenal ulcer or perforation. Marked or severe hepatic or renal impairment. Children with obstructive sleep apnoea (when used for sedation). Pregnancy and lactation.
Special Precautions
Patient with history of gastritis, oesophagitis, gastric or duodenal ulceration or perforation; respiratory insufficiency; low K levels, bradyarrhythmia, congenital long QT syndrome, and other heart disorders (particularly arrhythmia); depression, suicidal tendency; history of alcohol or drug abuse. Avoid prolonged use and abrupt withdrawal. Mild to moderate hepatic or renal impairment. Neonates, children, and elderly.
Adverse Reactions
Significant: May precipitate attacks of acute intermittent porphyria; precipitation of arrhythmias and hypotension (high doses), CNS depression; skin or mucous membrane irritation; drug tolerance, dependence, and withdrawal symptoms. Cardiac disorders: QT prolongation. Gastrointestinal disorders: Nausea, vomiting, abdominal distension, diarrhoea, flatulence, gastritis, gastric irritation, gastric perforation or necrosis. Immune system disorders: Hypersensitivity reactions. Injury, poisoning and procedural complications: Falls and injuries (particularly in the elderly). Nervous system disorders: Headache, drowsiness, ataxia. Psychiatric disorders: Confusion, anxiety, hyperactivity, hallucination. Renal and urinary disorders: Ketonuria, parenchymatous renal injury. Respiratory, thoracic and mediastinal disorders: Dyspnoea, respiratory depression. Potentially Fatal: Respiratory obstruction, particularly in children with obstructive sleep apnoea (when used for sedation); delirium tremens (due to abrupt withdrawal).
Patient Counseling Information
This drug may cause drowsiness, if affected, do not drive or operate machinery.
Monitoring Parameters
Monitor vital signs, blood pressure, oxygen saturation, and respiratory function. Closely monitor the level of sedation especially in children.
Overdosage
Symptoms: Hypothermia, pin-point pupils, vomiting, gastric irritation or necrosis, hypotension, arrhythmias, respiratory depression, and coma. Management: Symptomatic and supportive treatment. Maintain adequate airway, assisted respiration, oxygen administration, and body temperature and circulation. Administer activated charcoal within 1 hour of ingestion, provided the airway can be protected. Perform gastric lavage or induce vomiting to empty the stomach. Haemodialysis and haemoperfusion may be effective in the elimination of trichloroethanol.
Drug Interactions
May enhance the CNS depressive effect with anxiolytics/sedatives, hypnotics, antipsychotics, antidepressant agents, antiepileptic drugs, centrally-acting muscle relaxants, narcotic analgesics, anaesthetics and sedative antihistamines. May increase the plasma concentration of warfarin. May result in a hypermetabolic state with IV furosemide. May cause delirium (particularly in the elderly) with anticholinergics or psychotropics. May lead to cardiac arrhythmias with agents known to prolong QT interval (e.g. class IA or III antiarrhythmics, antibiotics, antimalarial agents, antipsychotics, drugs known to cause hypokalaemia or hypomagnesaemia).
Food Interaction
Sedative effect may be enhanced with alcohol.
Lab Interference
May interfere with tests for urinary glucose using copper sulfate, urinary 17-hydroxycorticosteroid (e.g. Reddy, Jenkins, and Thorn procedure), and fluorometric tests for urine catecholamine. May also interfere with thyroid function tests.
Action
Description: Mechanism of Action: Chloral hydrate is a sedative and hypnotic with properties similar to paraldehyde and barbiturates. Its exact mechanism of action is unknown; however, the CNS depressant effect is believed to be due to its active metabolite, trichloroethanol. Onset: Within 30 minutes. Duration: 4-8 hours. Pharmacokinetics: Absorption: Rapidly absorbed from the gastrointestinal tract. Distribution: Widely distributed throughout the body, including in the CSF, umbilical cord blood, amniotic fluid, and fetal blood. Crosses the placenta; enters breast milk (small amounts). Plasma protein binding: 35-40% (trichloroethanol); approx 94% (trichloroacetic acid). Metabolism: Rapidly metabolised in the liver, erythrocytes, and other tissues by alcohol dehydrogenase to form trichloroethanol (active metabolite), which further undergoes glucuronidation in the liver and kidneys into trichloroacetic acid (inactive metabolite). Excretion: Via urine (as metabolites) and faeces (small amounts). Elimination half-life: 8-12 hours (trichloroethanol); 67 hours (trichloroacetic acid).
Chemical Structure
Chloral hydrate Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 2707, Chloral Hydrate. https://pubchem.ncbi.nlm.nih.gov/compound/Chloral-Hydrate. Accessed Aug. 18, 2023.
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