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Amphotericin b Pregnancy and Breastfeeding Warnings

Amphotericin b is also known as: Amphocin, Fungizone, Fungizone For Tissue Culture

Medically reviewed on March 12, 2018

Amphotericin b Pregnancy Warnings

Animal studies showed no evidence of fetal harm, however one animal model showed a higher rate of spontaneous abortions. There are no controlled data in human pregnancy. This drug crosses the placenta, with cord blood to maternal serum ratios ranging from 0.38 to 1. A small number of systemic fungal infections have been successfully treated with the injectable form of this medication without obvious fetal effects.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US 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.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: B

See references

Amphotericin b Breastfeeding Warnings

Safety has not been established; benefit to mother should outweigh risk to the infant.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-Excretion into milk is possible.
-Although gastrointestinal absorption is considered insignificant, use the oral formulations with caution in nursing women.
-It may be prudent to advise women to stop breastfeeding while on this drug.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  4. "Product Information. Amphotericin B (amphotericin B)." X-Gen Pharmaceuticals Inc, Big Flats, NY.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Amphotericin B (amphotericin B)." X-Gen Pharmaceuticals Inc, Big Flats, NY.

Further information

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

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