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Primaquine use while Breastfeeding

Primaquine Levels and Effects while Breastfeeding

Summary of Use during Lactation

Primaquine is poorly excreted into breastmilk of nursing mothers and undetectable in the serum of their breastfed infants. Breastfed infants beyond the neonatal period have shown no evidence of hemolysis, but neonates and those with glucose-6-phosphate dehydrogenase (G6PD) deficiency have not been studied. If primaquine is required, the mother and infant should be tested for G6PD deficiency before primaquine is given to a nursing mother.

United Kingdom malaria treatment guidelines recommend that primaquine be avoided in nursing mothers with malaria and that weekly chloroquine 500 mg be given until breastfeeding is completed.[1] However, these guidelines were developed before information on the excretion of primaquine into breastmilk and safety in breastfed infants was published. The Centers for Disease Control and Prevention guidelines state that primaquine may be used in breastfeeding mothers and infants with normal G6PD levels.[2] Because the small amounts of primaquine transferred in breast milk are insufficient to provide adequate protection or treatment of malaria, infants who require chemoprophylaxis or therapy must receive the recommended dosages of primaquine.

Drug Levels

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 give 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.[3]

Infant Levels. Twenty-one mothers with vivax malaria were give a dosage of primaquine 0.5 mg/kg daily for 14 days. Capillary blood samples were taken from the infants on days 0 (first day of therapy), 3, 7, and 13 of therapy at various times after the dose and after breastfeeding. All infant blood samples had unmeasurable amounts of primaquine (<1.14 mcg/L) and only 1 infant blood sample contained a measurable amount of carboxychloroquine of 2.59 mcg/L on day 7 hour 0. Based on milk concentrations, the authors calculated median total cumulative primaquine dose expected to be ingested by the infant over the 14-day course based on measured breast milk concentrations to be approximately 0.042 mg/kg, corresponding to 2.98 mcg/kg daily (0.6% of a hypothetical infant daily dose of 0.5 mg/kg). The highest cumulative infant dose was estimated at 0.127 mg/kg, or 9.07 mcg/kg daily, which is 1.8% of a hypothetical infant daily dose of 0.5 mg/kg.[3]

Effects in Breastfed Infants

Twenty-one mothers with vivax malaria were give 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.[3]

Effects on Lactation and Breastmilk

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

Alternate Drugs to Consider

Atovaquone and Proguanil, Chloroquine, Doxycycline, Mefloquine

References

1. Lalloo DG, Shingadia D, Bell DJ et al. UK Malaria Treatment Guidelines 2016. J Infect. 2016;72:635-49. PMID: 26880088

2. Centers for Disease Control and Prevention. CDC Yellow Book 2018: Health Information for International Travel. New York: Oxford University Press. 2017. https://wwwnc.cdc.gov/travel/page/2018-yellow-book-about

3. Gilder ME, Hanpithakphong W, Hoglund RM et al. Primaquine pharmacokinetics in lactating women and breastfed infant exposures. Clin Infect Dis. 2018. PMID: 29590311

Primaquine Identification

Substance Name

Primaquine

CAS Registry Number

90-34-6

Drug Class

Anti-Infective Agents

Antimalarials

Administrative Information

LactMed Record Number

801

Last Revision Date

20180402

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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