15 Mar 2012

Welldorm Tablets (Cloral betaine) - United Kingdom

Updated: 15 Mar 2012

Welldorm Tablets

Welldorm tablets are 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.

The use of hypnotics in adolescents is not generally recommended and if used should be under the supervision of a medical specialist.

 

Welldorm Tablets Description, Presentation and Dosage

Welldorm Tablets Description

Welldorm Tablets Drug Class Description

chloral hydrate derivative

Welldorm Tablets Drug Description

Tablets contain 707mg cloral betaine, equivalent to 414mg of Chloral Hydrate

Welldorm Tablets Generic Name

Cloral betaine

Welldorm Tablets Presentation

Welldorm Tablets Presentation

Elongated oval, bluish purple, film coated tablets

Welldorm Tablets Manufacturer

Marlborough Pharmaceuticals Ltd

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Welldorm Tablets Dosage

Welldorm Tablets 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 one to two tablets (414 – 828 mg). Higher doses should not exceed a maximum of 4 tablets (2g chloral hydrate) per dose.

Welldorm Tablets Child Dosage

 Welldorm tablets are not suitable for use in children under 12 years of age; for children between 2 and 11 years Welldorm Elixir is recommended.

Welldorm Tablets Elderly Dosage

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

 

Welldorm Tablets Precautions, Reactions and Contraindications

Welldorm Tablets Special Precautions

Welldorm Tablets 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. (See 4.2 Posology and method of administration)

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

Welldorm Tablets Adverse Reactions

Welldorm Tablets Adverse 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.

Welldorm Tablets Contraindications

Welldorm Tablets Contraindications

Welldorm Tablets 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.

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