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Mafenide topical Pregnancy and Breastfeeding Warnings

Mafenide topical is also known as: Sulfamylon

Medically reviewed by Drugs.com. Last updated on Sep 17, 2019.

Mafenide topical Pregnancy Warnings

Animal studies (using oral doses) have failed to reveal evidence of fetal harm. Animal studies with the topical cream have not been reported. 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.

Topical cream: This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
Topical solution: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned.

Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-The topical cream is not recommended in women of childbearing potential unless the burned area covers more than 20% of the total body surface area or when benefits of treatment (according to physician judgment) outweigh possible risk to fetus.

See references

Mafenide topical 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: Data not available

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Sulfamylon cream (mafenide topical)." Dow Hickam Pharmaceuticals Inc, Sugar Land, TX.
  2. "Product Information. Sulfamylon (mafenide topical)." Bertek Pharmaceuticals Inc, Sugar Land, TX.

References for breastfeeding information

  1. "Product Information. Sulfamylon cream (mafenide topical)." Dow Hickam Pharmaceuticals Inc, Sugar Land, TX.
  2. "Product Information. Sulfamylon (mafenide topical)." Bertek Pharmaceuticals Inc, Sugar Land, TX.

Further information

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

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