Albendazole and its metabolites in the breast milk of lactating women following a single oral dose of albendazole.
OBJECTIVE
Albendazole (ABZ) is used in several anthelminthic drug programs. ABZ side-effects are generally mild, but ABZ-induced pancytopenia may be serious. In filariasis programmes, it may be necessary to administer ABZ to breastfeeding women. Few data are available on safety of ABZ for breastfed infants. In addition, the pharmacokinetics of ABZ and its metabolites in human milk is insufficiently investigated. The aim was to study pharmacokinetics of ABZ and its metabolites [ABZ sulphoxide (ABSX) and ABZ sulphone] in the breast milk lactating women after one single oral dose of ABZ.


METHODS
Thirty-three lactating women (age 18-40 years) participated in the study. They received a single oral 400-mg dose of ABZ. Five milk samples were taken at 0, 6, 12, 24 and 36 h. One serum sample was taken after 6 h. Samples were analysed using high-performance liquid chromatography and pharmacokinetic analysis was performed.


RESULTS
ABZ was detectable in milk samples 6 h after the oral dose. The mean concentration of serum ABZ was 63.7 +/- 11.9 ng ml(-1). The pharmacokinetic parameters for ABSX were calculated as follows: 351.9 +/- 32.4 ng ml(-1), 6.9 +/- 0.5 h, 12.4 +/- 2.2 h and 5190.3 +/- 482.8 ng*h ml(-1) for C(max), T(max), t((1/2)) and AUC(0-36), respectively. The milk-to-serum ratios (range) for ABZ and ABSX were 0.9 (0.2-6.5) and 0.6 (0.1-1.5), respectively.


CONCLUSIONS
After an oral dose of 400 mg, ABZ and ABSX attain low concentrations in breast milk that are unlikely to be considered harmful for the breastfed infant.
Abdel-tawab
Ahmed M
AM
Department of Pharmacology, Faculty of Medicine, Ain Shams University, Cairo, Egypt. amtawab@yahoo.com
Bradley
Mark
M
Ghazaly
Essam A
EA
Horton
John
J
el-Setouhy
Maged
M
D000293:Adolescent; D000328:Adult; D015766:Albendazole / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000494:pharmacology*; D000871:Anthelmintics / Q000493:pharmacokinetics / Q000494:pharmacology*; D001942:Breast Feeding; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004534:Egypt; D005260:Female; D006801:Humans; D007223:Infant; D008895:Milk, Human / Q000187:drug effects*; D012044:Regression Analysis; D055815:Young Adult
D000871:Anthelmintics; D015766:Albendazole; C027186:albendazole sulfoxide