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Drug Details

Welldorm Elixir

• Drug Class Description
  chloral hydrate derivative
• Generic Name
  Chloral hydrate
• Presentation
  Oral Solution
• Description
  Each 5ml of Welldorm Elixir contains 143.3mg of Chloral Hydrate BP.
• Indications
  

  Welldorm elixir is used for the short-term treatment of severe insomnia which is interfering with normal daily life and where other therapies have failed.

  Welldorm 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

   

• Adult Dosage
  

  Route of administration: oral. Welldorm 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 chloral hydrate) per dose.

• Child Dosage
  

  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 chloral hydrate) per dose.

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

  Children (under 2 years): not recommended

• Elderly Dosage
  

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

• Contra Indications
  

  Welldorm Elixir 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.

• Special Precautions
  

  Elderly patients are more likely 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.

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

• Interactions
  

  Alcohol potentiates the sedative effect. Chloral hydrate followed by intravenous frusemide may result in sweating, hot flushes and variable blood pressure including hypertension due to a hypermetabolic state caused by displacement of thyroid hormone from its bound state. Dilerium may occur, especially in the elderly, particularly when used in conjunction with psychotropics or anticholinergics. In patients taking anticoagulants, when chloral hydrate is added to or withdrawn from the drug regimen, or its dosage changed, careful monitoring of the prothrombin time is required.

  Chloral Hydrate may interfere with laboratory tests of thyroid function.

• Adverse Drug Reactions
  

  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 Welldorm and are therefore more susceptible to ataxia, confusion, falls and injuries.