Summary of Use during Lactation

Limited information indicates that maternal doses of propafenone up to 900 mg daily produce low levels in milk. If propafenone is required by the mother it is not a reason to discontinue breastfeeding. Until more data become available, propafenone should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.

Drug Levels

Maternal Levels. On the third postpartum day, one woman taking propafenone 300 mg orally 3 times daily had milk levels just before the morning dose of 32 and 47 mcg/L of propafenone and hydroxypropafenone, respectively. The authors estimated that a fully breastfed would receive a dose of propafenone and its metabolite of about 0.03% of the mother's weight-adjusted dosage.[1]

One mother (time postpartum not stated) took a single dose of propafenone 150 mg orally. The highest milk propafenone level was 37.4 mcg/L at 2 hours after the dose. By 6 hours after the dose, the drug was undetectable (<10 mcg/L). The highest milk 5-hydroxypropafenone level was 102 mcg/L at 2 hours after the dose. By 6 hours after the dose, the level was 19.8 mcg/L and by 12 hours it was undetectable (<10 mcg/L) in milk. The authors estimated that an exclusively breastfed infant would receive 0.1% of the maternal weight-adjusted dosage of propafenone as drug and metabolite.[2]

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

Effects in Breastfed Infants

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

Effects on Lactation and Breastmilk

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

References

1.

Libardoni M, Piovan D, Busato E et al. Transfer of propafenone and 5-OH-propafenone to foetal plasma and maternal milk. Br J Clin Pharmacol. 1991;32:527-8. [PMC free article: PMC1368620] [PubMed: 1958453]

2.

Wakaumi M, Tsuruoka S, Sakamoto K et al. Pilsicainide in breast milk from a mother: comparison with disopyramide and propafenone. Br J Clin Pharmacol. 2005;59:120-2. [PMC free article: PMC1884966] [PubMed: 15606453]

Substance Name

Propafenone

CAS Registry Number

54063-53-5

Drug Class

• Breast Feeding
• Lactation
• Antiarrhythmics