The Basics

What is Clarithromycin?

Antibiotic used to treat various bacterial infections, including strep throat, pneumonia, skin infections, H. pylori infection, and Lyme disease, among others.

Brand names for Clarithromycin

Biaxin

How Clarithromycin is classified

Anti-Bacterial Agents, Anti-Infective Agents, Macrolides

Clarithromycin During Pregnancy

Clarithromycin pregnancy category

Category CNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Clarithromycin while pregnant

Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate. If pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus . Four teratogenicity studies in rats (three with oral doses and one with intravenous doses up to 160 mg/kg/day administered during the period of major organogenesis) and two in rabbits at oral doses up to 125 mg/kg/day (approximately twice the recommended maximum human dose based on mg/m²) or intravenous doses of 30 mg/kg/day administered during gestation days 6 to 18 failed to demonstrate any teratogenicity from clarithromycin. Two additional oral studies in a different rat strain at similar doses and similar conditions demonstrated a low incidence of cardiovascular anomalies at doses of 150 mg/kg/day administered during gestation days 6 to 15. Plasma levels after 150 mg/kg/day were twice the human serum levels. Four studies in mice revealed a variable incidence of cleft palate following oral doses of 1000 mg/kg/day (2 and 4 times the recommended maximum human dose based on mg/m², respectively) during gestation days 6 to 15. Cleft palate was also seen at 500 mg/kg/day. The 1000 mg/kg/day exposure resulted in plasma levels 17 times the human serum levels. In monkeys, an oral dose of 70 mg/kg/day produced fetal growth retardation at plasma levels that were twice the human serum levels.

Taking Clarithromycin While Breastfeeding

What are recommendations for lactation if you're taking Clarithromycin?

Because of the low levels of clarithromycin in breastmilk and safe administration directly to infants, it is acceptable in nursing mothers. The small amounts in milk are unlikely to cause adverse effects in the infant. Monitor the infant for possible effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash). Unconfirmed epidemiologic evidence indicates that the risk of infantile hypertrophic pyloric stenosis might be increased by maternal use of macrolide antibiotics during the first two weeks of breastfeeding, but others have questioned this relationship.

Maternal / infant drug levels

Because of the low levels of clarithromycin in breastmilk and safe administration directly to infants, it is acceptable in nursing mothers. The small amounts in milk are unlikely to cause adverse effects in the infant. Monitor the infant for possible effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash). Unconfirmed epidemiologic evidence indicates that the risk of infantile hypertrophic pyloric stenosis might be increased by maternal use of macrolide antibiotics during the first two weeks of breastfeeding, but others have questioned this relationship.

Possible effects of Clarithromycin on milk supply

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

Possible alternatives to Clarithromycin

Azithromycin, Erythromycin.

List of References

Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Sedlmayr T, Peters F, Raasch W et al. [Clarithromycin, a new macrolide antibiotic. Effectiveness in puerperal infections and pharmacokinetics in breast milk]. Geburtshilfe Frauenheilkd. 1993;53:488-91. PMID: 8370491
2. Sorensen HT, Skriver MV, Pedersen L et al. Risk of infantile hypertrophic pyloric stenosis after maternal postnatal use of macrolides. Scand J Infect Dis. 2003;35:104-6. PMID: 12693559
3. Goldstein LH, Berlin M, Tsur L et al. The safety of macrolides during lactation. Breastfeed Med. 2009;4:197-200. PMID: 19366316
4. Lund M, Pasternak B, Davidsen RB et al. Use of macrolides in mother and child and risk of infantile hypertrophic pyloric stenosis: Nationwide cohort study. BMJ. 2014;348:g1908. PMID: 24618148
5. Abdellatif M, Ghozy S, Kamel MG et al. Association between exposure to macrolides and the development of infantile hypertrophic pyloric stenosis: a systematic review and meta-analysis. Eur J Pediatr. 2019;178:301-14. PMID: 30470884
6. Almaramhy HH, Al-Zalabani AH. The association of prenatal and postnatal macrolide exposure with subsequent development of infantile hypertrophic pyloric stenosis: A systematic review and meta-analysis. Ital J Pediatr. 2019;45:20. PMID: 30717812

Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.

Read This Next

Telavancin

Telavancin and pregnancy or breastfeeding: Is it safe?

Read More

Delavirdine

Delavirdine and pregnancy or breastfeeding: Is it safe?

Read More

As seen in

Join our mailing list

Sign up for access to exclusive promotions, latest news and opportunites to test new pre-release products