Is Primaquine safe while breastfeeding?
Here is what NIH LactMed, the U.S. National Library of Medicine's authority on medicines and breastfeeding, reports about Primaquine. This is a summary of that source — not our own verdict.
Effects on the breastfed infant
Twenty-one mothers with vivax malaria were given a dosage of primaquine 0.5 mg/kg daily for 14 days while breastfeeding their infants who were at least 28 days old. No alterations in hematocrit, Heinz body counts, serum bilirubin, oxygen saturation, or methemoglobinemia were seen in any of the infants.[ 7 ] A woman with vivax malaria who was 5 months postpartum was given a dose of primaquine of 0.52 mg/kg daily for 7 days, then 0.46 mg/kg daily for 7 days after rechecking the patient s weight. She was found to be heterozygous for glucose-6-phosphate dehydrogenase (G6PD) deficiency and experienced some hemolysis and anemia. Her female infant was being breastfed (extent not stated) during treatment and was found to be heterozygous for the G6PD Mahidol variant, but had no apparent hemolysis. The child s vaccination schedule was completed, and the 6-month motor milestones were normal.[ 9 ]
Effects on milk supply
Relevant published information was not found as of the revision date.
Levels in milk
Primaquine s major metabolite is carboxyprimaquine, which has unknown activity against malaria. Primaquine s half-life is about 6 hours and carboxyprimaquine s half-life is 22 to 30 hours. Maternal Levels . Twenty-one mothers with vivax malaria were given a dosage of primaquine 0.5 mg/kg daily for 14 days. Milk samples were taken on days 0 (first day of therapy), 3, 7, and 13 of therapy at various times after the dose. Peak breastmilk primaquine concentrations occurred about 1 hour after peak plasma concentrations (usually 3.4 to 3.9 hours after the dose) and averaged 44 mcg/L. Average peak breastmilk carboxyprimaquine concentrations 0f 7.2 mcg/L occurred 19 hours after the dose on day 0, and 12.1 mcg/L at hours 4 hours after the dose on day 13.[ 7 ] These data and infant blood levels of primaquine and its metabolite were incorporated into a population pharmacokinetic model. The model showed that primaquine and carboxyprimaquine weight-adjusted relative infant dosages ranged from 0.47% to 0.51% with maternal doses ranging from 0.25 mg/kg to 1 mg/kg daily. The authors concluded that even in infants with the most severe G6PD deficiency variants, it is highly unlikely that standard doses of primaquine (0.25 to 1 mg base/kg once daily given to the mother for 1 to 14 days) would cause clinically important hemolysis.[ 3 ] A physiologically based pharmacokinetic model was constructed to simulate breastmilk and infant serum levels and compared to published milk level data. Results indicate that the relative infant dosage in infants would be less than 0.13%. the absolute infant dosage would be less than the dosage that might cause hemolysis in infants over 28 days of age with G-6-PD deficiency.[ 2 ] A physiologically based pharmacokinetic model has been developed that adequately predicts primaquine excretion into breastmilk.[ 8 ] Infant Levels . Twenty-one mothers with vivax malaria were given a dosage of primaquine 0.5 mg/kg daily for 14 days. Capillary blood samples were t
Alternatives LactMed lists
Source: NIH LactMed (National Library of Medicine).
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.