Pediclor Syrup

Insomnia, Sedation, Anxiety

Oral Insomnia Short-term treatment (maximum 2 weeks) of severe insomnia which is interfering with normal daily life and where other therapies (behavioural and pharmacologic) have failed Adult: The usual dose is 430-860 mg (15-30 ml of the 143mg/5ml strength). Higher doses should not exceed a maximum of 2 g chloral hydrate (70 ml of the 143mg/5ml strength) per dose.

Oral Insomnia Short-term treatment (maximum 2 weeks) of severe insomnia in children and adolescents with suspected or definite neurodevelopmental disorder, when the insomnia is interfering with normal daily life and other therapies (behavioural and pharmacologic) have failed Child: Children 12 years and over: The usual dose is 430-860 mg (15-30 ml of the 143mg/5ml strength). Higher doses should not exceed a maximum of 2 g chloral hydrate (70 ml of the 143mg/5ml strength) per dose. Children (between 2 and 11 years): 30-50 mg/kg (1-1.75 ml/kg of the 143mg/5ml strength) of bodyweight. The dose should not exceed 1 g chloral hydrate (35 ml of the 143 mg/5ml strength) per dose. Children under 2 years: Chloral hydrate should not be used because the safety and efficacy of chloral hydrate in children aged under 2 years has not been established

Renal Impairment Contraindicated in moderate-severe renal impairment

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

Hepatic Impairment Contraindicated in moderate-severe hepatic impairment

Upon discontinuation withdraw gradually over 2 weeks if patient maintained on high doses for prolong periods of time; abrupt discontinuation may result in delirium. Dilute w/ water or other liquids (e.g. fruit juice, ginger ale).

Hypersensitivity/idiosyncrasy to chloral derivatives. Severe cardiac disease, acute porphyria, gastritis, oesophagitis, gastric/duodenal ulcer; obstructive sleep apnoea in childn. Marked hepatic or renal impairment. Lactation.

Patient w/ resp insufficiency, sleep apnoea, depression, suicidal tendency, history of drug or alcohol abuse. Childn, elderly. Pregnancy. Potential toxic dose <6 years old: 50 mg/kg Use with caution in porphyria Use caution in long term care patients, elderly, and neonates Use not recommended for >2 weeks Abrupt discontinuation may cause withdrawal symptoms

C Pregnancy Category: C Lactation: small amount secreted into breast milk

Enhanced sedative effect w/ opiates, barbiturates, TCAs, antipsychotics, antihistamines, and other sedatives. May cause hot flushes, sweating, and HTN w/ IV furosemide. May cause delirium w/ anticholinergics or psychotropic. May produce a transient increase in hypoprothrombinemic response to warfarin. Contraindicated (2) calcium/magnesium/potassium/sodium oxybates sodium oxybate Serious (14) benzhydrocodone/acetaminophen fentanyl fentanyl intranasal fentanyl transdermal fentanyl transmucosal hydrocodone lemborexant mefloquine metoclopramide intranasal olopatadine intranasal selinexor sufentanil SL valerian zuranolone

Significant: Gastric irritation (e.g. nausea, vomiting, diarrhoea), abdominal distention, flatulence, tolerance, dependence. Nervous: Drowsiness, light-headedness, headache, paradoxical excitement, hallucination, nightmares, confusion, ataxia. GI: Gastritis, unpleasant taste. Genitourinary: Ketonuria, parenchymatous renal injury. Dermatologic: Erythema multiforme, Stevens-Johnson syndrome. Potentially Fatal: Delirium tremens.

Chloral hydrate is a sedative and hypnotic w/ properties similar to paraldehyde and barbiturates. Its exact mechanism of action is unknown, however, it is believed that its CNS depressant effects are due to its active metabolite, trichloroethanol.

Pediclor 143.3 mg Syrup manufactured by Beacon Pharmaceuticals Ltd.. Its generic name is Chloral Hydrate.