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Rifamycin Pregnancy and Breastfeeding Warnings

Brand names: Aemcolo

Medically reviewed by Drugs.com. Last updated on Jan 18, 2024.

Rifamycin Pregnancy Warnings

Benefit should outweigh risk.

US FDA pregnancy category: Not assigned.

Risk Summary: There are no data available on use of this drug in pregnant women to inform a drug-related risk.

Comment:
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies have revealed evidence of decreased fetal weight, diaphragm formation variations, and slightly delayed fetal ossifications at maternally toxic concentrations. Animal models given lower oral doses did not reveal evidence of embryofetal toxicities, including malformations. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Rifamycin Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Yes (parenteral formulations); Unknown (oral formulations)

Comments:
-The effects of this drug on lactation and in the nursing infant are unknown.
-Some authorities state that systemic absorption of oral formulations given at recommended doses is negligible.

See references

References for pregnancy information

  1. (2018) "Product Information. Aemcolo (rifamycin)." Aries Pharmaceuticals, Inc.

References for breastfeeding information

  1. (2018) "Product Information. Aemcolo (rifamycin)." Aries Pharmaceuticals, Inc.

Further information

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