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Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-.
CASRN: 8001-54-5

Drug Levels and Effects
Summary of Use during Lactation
Topical maternal application of benzalkonium chloride or benzethonium chloride or their presence as a preservative in pharmaceuticals would not be expected to cause any adverse effects in breastfed infants.
Drug Levels
Maternal Levels. Four women using tampons containing benzalkonium chloride 60 mg provided breast milk samples 15 min prior to tampon application and 3 and 24 h after application. Benzalkonium chloride was not detected in the blood or breastmilk in any of the four subjects using HPLC analysis (assay limit not stated).[1]
Infant Levels. Relevant published information was not found as of the revision date.
Effects in Breastfed Infants
A study in Japan randomized 80 consecutive term patients into 4 groups who received either povidone-iodine or benzethonium chloride as a skin disinfectant before delivery and one of these for postpartum vaginal lacerations. Prepartum doses were about 7 mL and postpartum doses were about 0.5 mL of solution. Infant thyrotropin levels were elevated in the infants whose mothers received topical povidone-iodine pre- and postpartum compared to infants whose mothers received benzethonium chloride.[2]
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
Alternate Drugs to Consider
References
- 1.
- Johnson W Jr. Final report on the safety assessment of benzalkonium chloride. J Am Coll Toxicol. 1989;8:589-625.
- 2.
- Koga Y, Sano H, Kikukawa Y et al. Affect on neonatal thyroid function of povidone-iodine used on mothers during perinatal period. J Obstet Gynaecol. 1995;21:581-5. [PubMed: 8640469]
Substance Identification
Substance Name
Benzalkonium Chloride
CAS Registry Number
8001-54-5
Drug Class
- Breast Feeding
- Anti-Infective Agents, Local
- Antibacterial Agents
- Detergents
- Preservatives, Pharmaceutical
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- [Optimization of benzalkonium chloride concentration in 0.0015% tafluprost ophthalmic solution from the points of ocular surface safety and preservative efficacy].[Yakugaku Zasshi. 2010][Optimization of benzalkonium chloride concentration in 0.0015% tafluprost ophthalmic solution from the points of ocular surface safety and preservative efficacy].Asada H, Takaoka-Shichijo Y, Nakamura M, Kimura A. Yakugaku Zasshi. 2010 Jun; 130(6):867-71.
- Evaluation of the cytotoxic effects of ophthalmic solutions containing benzalkonium chloride on corneal epithelium using an organotypic 3-D model.[BMC Ophthalmol. 2009]Evaluation of the cytotoxic effects of ophthalmic solutions containing benzalkonium chloride on corneal epithelium using an organotypic 3-D model.Khoh-Reiter S, Jessen BA. BMC Ophthalmol. 2009 Jul 28; 9:5. Epub 2009 Jul 28.
- Application of the HPLC method for benzalkonium chloride determination in aerosol preparations.[J Pharm Biomed Anal. 2004]Application of the HPLC method for benzalkonium chloride determination in aerosol preparations.Dudkiewicz-WilczyĆska J, Tautt J, Roman I. J Pharm Biomed Anal. 2004 Mar 10; 34(5):909-20.
- Benzalkonium Chloride - Drugs and Lactation Database (LactMed)Benzalkonium Chloride - Drugs and Lactation Database (LactMed)
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