Last update July 4, 2022

Clomethiazole

High Risk

Poorly safe. Evaluate carefully. Use safer alternative or interrupt breastfeeding 3 to 7 T ½ (elimination half-lives). Read the Comment.

It is a short-acting sedative-hypnotic with anticonvulsant effect. Indicated in states of insomnia, alcohol withdrawal symptoms and status epilepticus. Oral administration.

It is excreted in breast milk in clinically insignificant amount. (Tunstall 1979)

Its pharmacokinetic data (low molecular weight and low percentage of plasma protein binding) makes it likely that significant amounts will pass into breast milk.

Until there is more published data on this drug in relation to breastfeeding, safer known alternatives may be preferable, especially during the neonatal period and in cases of prematurity.

Alternatives

  • Lorazepam ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Oxazepam ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Zolpidem Tartrate ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Zopiclone ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

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Other names

Clomethiazole is also known as


Clomethiazole in other languages or writings:

Group

Clomethiazole belongs to this group or family:

Tradenames

Main tradenames from several countries containing Clomethiazole in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 19 (5 - 60) %
Molecular weight 162 daltons
Protein Binding 60 %
VD 0.13 - l/Kg
Tmax 0.25 - 1.5 hours
T½ 4 hours
M/P ratio 0.45- 1.97 -
Theoretical Dose 0.03 - 0.48 mg/Kg/d
Relative Dose 0.045 - 0.72 %

References

  1. Cheplapharm. Clometiazol. Ficha técnica. 2020 Full text (in our servers)
  2. Tunstall ME, Campbell DM, Dawson BM, Jostell KG. Chlormethiazole treatment and breast feeding. Br J Obstet Gynaecol. 1979 Oct;86(10):793-8. Abstract
  3. Jostell KG, Agurell S, Allgén LG, Kuylenstierna B, Lindgren JE, Aberg G, Osterlöf G. Pharmacokinetics of clomethiazole in healthy adults. Acta Pharmacol Toxicol (Copenh). 1978 Sep;43(3):180-9. Abstract

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