Clomethiazole oral solution
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral solution containing clomethiazole.
Drugs List
Therapeutic Indications
Uses
Acute alcohol withdrawal
Restlessness/agitation in the elderly
Severe insomnia (short-term treatment)
Dosage
Adults
Alcohol withdrawal states
Alcohol withdrawal should be treated in hospital, or in exceptional circumstances, on an outpatient basis by specialist units when the daily dose must be closely monitored by community health staff. Dosage should be adjusted to patient response. The patient should be sedated but rousable. A suggested dosage regimen is:
Initial dose: 10 to 20ml, repeated if necessary after some hours
Day 1: 45 to 60ml divided into 3 or 4 doses
Day 2: 30 to 40ml divided into 3 or 4 doses
Day 3: 20 to 30ml divided into 3 or 4 doses
Days 4 to 6: A gradual reduction until the final dose
Administration for more than 9 days is not recommended.
Elderly
Restlessness and agitation in the elderly
5ml three times daily.
Severe insomnia in the elderly
5ml to 10ml before going to bed. The lower dose should be tried first. Treatment should be kept to a minimum, reviewed regularly, and discontinued as soon as possible.
Elderly patients should be treated with caution as there may be increased bioavailability and delayed elimination of clomethiazole.
Patients with Hepatic Impairment
Dosage may need to be reduced due to increased systemic availability and delayed elimination of the drug. Care should be taken as sedation may mask the onset of hepatic coma.
Additional Dosage Information
Before administration, the solution should be diluted with juice or water and taken immediately.
Contraindications
Children under 18 years
Acute respiratory impairment
Hereditary fructose intolerance
Pregnancy
Precautions and Warnings
Elderly
Alcoholism
Breastfeeding
Cardiac disorder
Chronic hepatic disorder
Chronic renal disorder
Hepatic cirrhosis
History of drug misuse
Personality disorder
Respiratory impairment
Sleep apnoea
Advise ability to drive/operate machinery may be affected by side effects
Correct hypoxia prior to treatment
Contains alcohol
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Monitor patients with hepatic impairment for toxic effects
Prolonged or excessive use may result in dependence
Maintain treatment at the lowest effective dose
Avoid prolonged use
Advise patient that the effects of alcohol may be potentiated
Advise patient to avoid alcohol during treatment
Advise patients to seek medical advice if confusion occurs
Hepatic impairment - Moderate liver disorders associated with alcoholism do not preclude the use of clomethiazole, though an associated increase in systemic availability of oral doses and delayed elimination of the drug may require reduced dosage. Great caution should be observed in patients with gross liver damage and decreased liver function, particularly as sedation can mask the onset of liver coma.
Cardiac and/or respiratory disease - confusional state may indicate hypoxia. Recognition and specific treatment of the cause is essential in these patients, and in such cases sedatives/hypnotics should be avoided.
Due to the risk of respiratory depression in patients with cirrhosis, alcoholics must not be prescribed clomethiazole if they continue to drink alcoholic beverages.
Pregnancy and Lactation
Pregnancy
Clomethiazole is contraindicated during pregnancy.
Use of clomethiazole during pregnancy is contraindicated by the manufacturer.
At the time of writing there is limited published information regarding the use of clomethiazole during pregnancy. Potential risks are unknown.
Lactation
Use clomethiazole with caution during breastfeeding.
The manufacturer notes that clomethiazole should only be considered if the benefit outweighs the potential risk. Available data indicates clomethiazole is expressed in human breast milk, but the quantity is unknown. Effects on exposed infants are unknown.
Side Effects
Anaphylaxis
Bullous eruption
Confusion
Conjunctival irritation
Dependence
Excitement (paradoxical)
Gastro-intestinal disturbances
Hangover effects
Headache
Increased bronchial secretions
Increased nasopharyngeal secretions
Increases in serum transaminases (transient)
Nasal congestion
Nasal irritation
Rash
Sedation
Serum bilirubin increased
Tolerance
Urticaria
Withdrawal symptoms
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last full review date: December 2021
Reference Sources
Summary of Product Characteristics: Clomethiazole 31.5mg/ml syrup. Neon Healthcare Ltd. Revised October 2020.
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