Pediclor Syrup

Chloral hydrate has been used for a great many years as a sedative/hypnotic drug in human and veterinary medicine. The metabolite (trichloroethanol) is responsible for the pharmacological effect. The proposed mechanisms for the depression of the central nervous system include potentiating the function of GABAA receptors, inhibition of excitatory amino acid-activated currents mediated by N-methyl-D-aspartate, and allosteric modulation of the 5- hydroxytryptamine 3 receptor-mediated depolarization of the vagus nerve.

The treatment should be as short as possible and should not exceed the maximum treatment period of 2 weeks. Repeat courses of chloral hydrate are not recommended and can only be administered following medical specialist re-assessment since the risk of abuse and dependence increases with the duration of treatment. Following prolonged treatment with chloral hydrate the dose should be slowly tapered before discontinuation. The use of Chloral Hydrate Oral Solution in children and adolescents is not generally recommended and if used should be under the supervision of a medical specialist. Chloral Hydrate 143 mg/5 ml Oral Solution should be administered as a single daily dose, between 15 to 30 minutes before bedtime with water or milk.

Adults: The usual dose is 430-860 mg (15-30 ml of the 143 mg/5 ml strength). Higher doses should not exceed a maximum of 2 g chloral hydrate (70 ml of the 143 mg/5ml strength) 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 (see section 4.4).

Children 12 years and over: The usual dose is 430-860 mg (15-30 ml of the 143 mg/5 ml strength). Higher doses should not exceed a maximum of 2 g chloral hydrate (70 ml of the 143 mg/5 ml strength) per dose.

Children (between 2 and 11 years): 30-50 mg/kg (1-1.75 ml/kg of the 143 mg/5 ml strength) of bodyweight. The dose should not exceed 1 g chloral hydrate (35 ml of the 143 mg/5 ml 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.

• Hypersensitivity to chloral hydrate or to any of the excipients
• In patients with severe hepatic impairment
• In patients with severe renal impairment
• In patients with severe cardiac disease
• In patients with active gastritis, oesophagitis, gastric or duodenal ulcers or perforation
• In patients susceptible to acute attacks of porphyria

Pregnancy: Little information is available on the possible adverse effects of chloral hydrate on human pregnancy. Chloral hydrate is known to cross the human placenta at term, but its use during relatively few pregnancies did not cause a detectable increase in abnormal outcomes. Some data suggest that prolonged administration of sedative doses of chloral hydrate to neonates increases the likelihood of hyperbilirubinemia.

Breast Feeding: Low levels of chloral hydrate have been found in breast milk. Although breastfeeding infants may be sedated by chloral hydrate in breast milk, the highest concentration measured in the milk (about 15 µg/ml) was considerably lower than that which would be measured in blood at a clinically active dose (100 µg/ml).

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. Tolerance, dependence, withdrawal, misuse: Tolerance, dependence and withdrawal symptoms have been reported with Pediclor. Abrupt discontinuation should not be undertaken in patients receiving prolonged treatment with Pediclor. Sudden withdrawal of the drug may cause delirium and hallucinations. Slowly withdraw Pediclor. Individuals with a history of alcohol or drug abuse or dependence may be at greater risk for abuse and misuse of Pediclor. Prior to prescribing Pediclor, each patient's risk for abuse or misuse should be assessed and patients receiving Pediclor should be monitored for the development of behaviours or conditions of abuse or misuse while on therapy.

Gastrointestinal disorders: Pediclor should be used with caution in patients with history of gastritis, oesophagitis, gastric or duodenal ulceration or perforation. Pediclor is contraindicated in patients with active gastritis, oesophagitis, gastric or duodenal ulcers or perforation.

Hepatic and renal impairment: Pediclor should be used with caution in patients with mild to moderate hepatic and renal impairment and is contraindicated in patients with severe hepatic and renal impairment.

Elderly patients: 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 the lowest effective dose be administered.

QT prolongation: Pediclor should be used with caution and particular care in patients with low potassium levels, bradyarrhythmia, congenital long QT syndrome and other heart disorders (especially arrhythmia).

Pediatric population: Due to immaturity of hepatic metabolism in neonates and children <2 years of age, there is a risk of extended half-life of Pediclor and an increased risk of undesirable effects.

Hepatic impairment: Pediclor is contraindicated in patients with severe hepatic impairment. Specific guidelines for dosage adjustments in mild and moderate hepatic impairment are not available; Pediclor is extensively metabolized by the liver and, therefore, dose adjustments may be warranted.
 
Renal impairment: Pediclor is contraindicated in patients with renal failure or severe renal impairment. Specific guidelines for dosage adjustments in mild and moderate renal impairment are not available; dose adjustments may be warranted.

Store below 25°C. Keep the bottle upright in outer carton in order to protect from light.