Albendazole

Drug Levels and Effects:




Summary of Use during Lactation:


Albendazole and its active metabolite are minimally excreted into breastmilk. An informal consultation group to the World Health Organization concluded that a single oral dose of albendazole can be given to lactating women.[1]


Drug Levels:


Albendazole is poorly absorbed orally and is extensively metabolized to the active metabolite albendazole sulfoxide via extensive first-pass metabolism by CYP3A4. It is further metabolized to the inactive metabolite, albendazole sulfone.

Maternal Levels.

Thirty-three women who were breastfeeding infants between 2 weeks and 6 months of age were given a single dose of albendazole 400 mg orally. Milk samples were obtained before the dose and 6, 12, 24 and 36 h after drug administration. Maternal blood samples were obtained 6 hours after drug administration. Albendazole, albendazole sulfoxide, and albendazole sulfone were measured in maternal blood and milk samples. Pharmacokinetic parameters for albendazole sulfoxide were calculated using data from 20 of the women who provided 3 or more milk samples. The mean peak milk concentration was 352 mcg/L which occurred at a mean of 6.9 hours. It had a half-life in breastmilk of 12.4 hours. Albendazole sulfoxide concentration 36 hours after the dose averaged 57 mcg/L; both albendazole and albendazole sulfone were undetectable (<661 mcg/L) in milk at this time. The authors estimated that a fully breastfed infant would be exposed to less than 0.1 mg/kg of albendazole sulfoxide over a 36-hour period following a maternal dose of 400 mg and even less of albendazole.[2] This translates into an infant dosage of less than 1.5% of the weight-adjusted maternal dosage.

Infant Levels.

Relevant published information was not found as of the revision date.


Effects in Breastfed Infants:


Two mothers with intestinal parasites were given a single 400 mg oral dose of albendazole while exclusively breastfeeding their infants who were between 1 and 6 months of age. No mention was made of adverse reactions in the breastfed infants.[3]


Possible Effects on Lactation:


Relevant published information was not found as of the revision date.


Alternate Drugs to Consider:


Mebendazole


References:


1. Allen HE, Crompton DW, de Silva N et al. New policies for using anthelmintics in high risk groups. Trends Parasitol. 2002 ;18:381-2. PMID:12377247
2. Abdel-tawab AM , Bradley M, Ghazaly EA et al. Albendazole and its metabolites in the breast milk of lactating women following a single oral dose of albendazole. Br J Clin Pharmacol. 2009;68:737-42. PMID:19916998
3. Dhonukshe-Rutten RA, Vossenaar M, West CE et al. Day-to-day variations in iron, zinc and copper in breast milk of Guatemalan mothers. J Pediatr Gastroenterol Nutr. 2005;40:128-34. PMID:15699684



Substance Identification:




Substance Name:

Albendazole

CAS Registry Number:

54965-21-8

Drug Class:


  • Antiinfective Agents

  • Anticestodal Agents

  • Antiparasitic Agents

  • Antiprotozoal Agents


  • Administrative Information:




    LactMed Record Number:


    491


    Last Revision Date:


    Disclaimer:Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.