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Nitrofurantoin Pregnancy and Breastfeeding Warnings

Nitrofurantoin is also known as: Furadantin, Macrobid, Macrodantin, Nitro Macro

Nitrofurantoin Pregnancy Warnings

FDA pregnancy category: B Nitrofurantoin should be used during pregnancy only if clearly needed; use of nitrofurantoin is contraindicated at term (38 to 42 weeks gestation), during labor and delivery, and when onset of labor is imminent. Comments: Contraindicated because of possibility of hemolytic anemia due to immature erythrocyte enzyme systems (glutathione instability)

Animal studies have failed to reveal evidence of fetotoxicity or teratogenicity except when administered in very high doses. There are no controlled data in human pregnancy. Nitrofurantoin-induced congenital anomalies have not been reported to date. One retrospective review of 91 pregnancies involving nitrofurantoin use reported no evidence of association to fetal adverse effects. In a review of 229,101 deliveries to Michigan Medicaid patients, there were 1292 first-trimester exposures to nitrofurantoin and 9998 exposures anytime during pregnancy. A total of 52 birth defects (55 expected) was reported with first-trimester exposure and included (observed/expected) 15/12 cardiovascular defects, 1/0 oral clefts, 4/3 polydactyly, 3/2 limb reductions, and 5/3 hypospadias. FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

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Nitrofurantoin Breastfeeding Warnings

Nitrofurantoin is excreted into human milk. Nitrofurantoin is considered compatible with breast-feeding by the American Academy of Pediatrics, although there is a theoretical risk of hemolytic anemia in neonates and G-6-PD-deficient infants. The manufacturer recommends that due to the potential for serious adverse effects in infants less than one month old, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

A study of 4 lactating women indicated that nitrofurantoin is actively transported into breast milk, achieving a milk-to-serum ratio of 6.21. The infant dose was estimated to be approximately 6% of the maternal dose or 0.2 mg/kg/day (based on a maternal dose of 100 mg nitrofurantoin macrocrystals twice daily).

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References for pregnancy information

  1. "Product Information. Macrodantin (nitrofurantoin)." Procter and Gamble Pharmaceuticals, Cincinnati, OH.
  2. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  3. "Product Information. Macrobid (nitrofurantoin)." Procter and Gamble Pharmaceuticals, Cincinnati, OH.
  4. Hailey FJ, Fort H, Williams JC, Hammers B "Foetal safety of nitrofurantoin macrocrystals therapy during pregnancy: a retrospective analysis." J Int Med Res 11 (1983): 364-9

References for breastfeeding information

  1. "Product Information. Macrobid (nitrofurantoin)." Procter and Gamble Pharmaceuticals, Cincinnati, OH.
  2. Pons G, Rey E, Richard MO, et al "Nitrofurantoin excretion in human milk." Dev Pharmacol Ther 14 (1990): 148-52
  3. Gerk PM, Kuhn RJ, Desai NS, McNamara PJ "Active transport of nitrofurantoin into human milk." Pharmacotherapy 21 (2001): 669-75
  4. Varsano I, Fischl J, Shochet SB "The excretion of orally ingested nitrofurantoin in human milk." J Pediatr 82 (1973): 886-7
  5. "Product Information. Macrodantin (nitrofurantoin)." Procter and Gamble Pharmaceuticals, Cincinnati, OH.
  6. "American Academy of Pediatrics. Committee on Drugs. The transfer of drugs and other chemicals into human milk." Pediatrics 108 (2001): 776-89
  7. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):

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