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Chloral hydrate Pregnancy and Breastfeeding Warnings

Chloral hydrate is also known as: Aquachloral Supprettes, Somnote

Chloral hydrate Pregnancy Warnings

AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

Safety has not been established; use during pregnancy is not recommended unless clearly needed.

AU TGA pregnancy category: A

Comments:
-Chronic use of this drug during pregnancy may cause withdrawal symptoms in the neonate.
-This drug, which crosses the placenta, and the clinically active metabolite trichloroethanol have been detected in the umbilical cord blood, foetal blood, and amniotic fluid.

See references

Chloral hydrate Breastfeeding Warnings

-In a study of 50 women who were given 1.3 grams rectally on day 3 postpartum, peak drug milk levels of about 10 mg/L occurred within the first hour and fluctuated between 6 and 10 mg/L for 10 hours after the dose. Milk levels of the active metabolite trichloroethanol reached a peak of about 40 mg/L 45 minutes after the dose and gradually decreased to about 12 mg/L over the next 23 hours. This study did not find any adverse effects on the breastfed newborn infants of these women.
-After administration of 1.3 grams of dichloralphenazone (equivalent to about 1 gram of this drug) in one woman, trichloroethanol levels were found to range from 1.3 to 3.2 mg/L in the mother's milk, and this active metabolite was detected in the breastfed infant's plasma 21 hours later.

Use is not recommended during breastfeeding unless clearly needed.

Excreted into human milk: Yes

Comments:
-Small amounts of clinically active metabolite trichloroethanol are distributed into breast milk following therapeutic doses of this drug, which may lead to sedation in breastfed infants; monitor infants for excessive drowsiness.
-Some experts believe short-term or occasional use of this drug during breastfeeding is unlikely to adversely affect the nursing infant, especially if the infant is older than 2 months; however, other hypnotic-sedative drugs are preferred for long-term use due to the long half-life of trichloroethanol.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Canadian Pharmacists Association "e-CPS. Available from: URL: http://www.pharmacists.ca/function/Subscriptions/ecps.cfm?link=eCPS_quikLink."
  4. "PDR Generics." Montvale, NJ: Medical Economics (1995):

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Canadian Pharmacists Association "e-CPS. Available from: URL: http://www.pharmacists.ca/function/Subscriptions/ecps.cfm?link=eCPS_quikLink."
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. "PDR Generics." Montvale, NJ: Medical Economics (1995):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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