Formulary
Clomethiazole: Indications, Dosing, Side Effects and Interactions
Clomethiazole clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 3 min read
Clomethiazole: Indications, Dosing, Side Effects and Interactions
Clomethiazole clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Severe insomnia (short-term use)**
- **Elderly** (By Mouth Using Capsules): 192-384 mg once daily, dose to be taken at bedtime.
- **Elderly** (By Mouth Using Oral Solution): 5-10 mL once daily, dose to be taken at bedtime.
**Restlessness and agitation**
- **Elderly** (By Mouth Using Capsules): 192 mg 3 times a day.
- **Elderly** (By Mouth Using Oral Solution): 5 mL 3 times a day.
**Alcohol withdrawal**
- **Adult** (By Mouth Using Capsules): Initially 2-4 capsules, to be repeated if necessary after some hours. 9-12 capsules daily in 3-4 divided doses on day 1 (first 24 hours), then 6-8 capsules daily in 3-4 divided doses on day 2, then 4-6 capsules daily in 3-4 divided doses on day 3, dose then to be gradually reduced over days 4-6, total duration of treatment for no more than 9 days.
- **Adult** (By Mouth Using Oral Solution): Initially 10-20 mL, to be repeated if necessary after some hours, then 45-60 mL daily in 3-4 divided doses on day 1 (first 24 hours), then 30-40 mL daily in 3-4 divided doses on day 2, then 20-30 mL daily in 3-4 divided doses on day 3, dose then to be gradually reduced over days 4-6, total duration of treatment for no more than 9 days.
Cautions
Avoid prolonged use (and abrupt withdrawal thereafter); cardiac disease (confusional state may indicate hypoxia); chronic pulmonary insufficiency; elderly; excessive sedation may occur (particularly with higher doses); history of drug abuse; marked personality disorder; respiratory disease (confusional state may indicate hypoxia); sleep apnoea syndrome
Contraindications
Acute pulmonary insufficiency; alcohol-dependent patients who continue to drink
Side effects
Frequency not known Agitation; bronchial secretion increased; confusion; conjunctival irritation; drug dependence; excessive sedation; gastrointestinal disorder; hangover; nasal complaints; skin reactions; upper airway secretion increased
Interactions
**Other interactions (12):**
- Clomethiazole is an inhibitor of CYP2A6 and CYP2E1.
- The plasma clearance of CYP2E1 substrates may be decreased by clomethiazole.
- An influence on the metabolism is also possible for more clinically relevant CYP2El substrates including sedatives, anaesthetics, analgesics, antidepressants, antiepileptics and antibacterials.
- Co-administration of clomethiazole with CYP2E1 Substrates may influence the pharmacokinetics of such drugs resulting in altered metabolism and therapeutic plasma levels.
- Therefore, a continuous and close monitoring of drug plasma levels is strongly recommended and potential dose adjustments of CYP2El-metabolized drugs may be required when used concomitantly with...
- A combination of clomethiazole and diazoxide should be avoided as an adverse neonatal reaction suspected to be due to the maternal administration of this combination has been reported.
Pregnancy
Avoid if possible-especially during the first and third trimesters.
Breast feeding
Use only if benefit outweighs risk-present in breast milk but effects unknown.
Hepatic impairment
Manufacturer advises caution in moderate to severe impairment (risk of increased exposure). Dose adjustments Manufacturer advises consider dose reduction in moderate hepatic disorders associated with alcoholism.
Renal impairment
Use with caution. M Increased cerebral sensitivity.
Medicinal forms
Capsule,Solution
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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