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Hydrocortisone / pramoxine topical Pregnancy and Breastfeeding Warnings

Hydrocortisone / pramoxine topical is also known as: Analpram E, Analpram-HC, Enzone, Epifoam, HC Pram, HC Pramoxine, Hydropram, Novacort, Pramcort, Pramosone, Pramosone E, Procort, Proctofoam HC, Rectocort HC, Zone-A, Zone-A Forte, Zypram

Medically reviewed by Drugs.com. Last updated on Jun 10, 2019.

Hydrocortisone / pramoxine topical Pregnancy Warnings

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

US FDA pregnancy category: C

Comments:
-Do not use extensively, in large amounts, or for a prolonged time during pregnancy.
-Corticosteroids are generally teratogenic at relatively low doses in animal models; teratogenicity was also seen with the more potent topical corticosteroids.
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.

Animal studies are not available for this combination. Animal studies of corticosteroids show teratogenicity at relatively low doses; teratogenicity was also seen with the more potent topical corticosteroids. There are no controlled data in human pregnancy.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Hydrocortisone / pramoxine topical Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Unknown (hydrocortisone)/Data not available (pramoxine)
Excreted into animal milk: Data not available (hydrocortisone)/Data not available (pramoxine)


Comments:
-It is unknown if there is enough absorption of topical corticosteroids to achieve a detectable level in breast milk.
-Systemically administered corticosteroids appear in breast milk at levels unlikely to adversely affect the infant.

See references

References for pregnancy information

  1. "Product Information. Proctofoam HC (hydrocortisone-pramoxine topical)." Meda Pharmaceuticals, Somerset, NJ.

References for breastfeeding information

  1. "Product Information. Proctofoam HC (hydrocortisone-pramoxine topical)." Meda Pharmaceuticals, Somerset, NJ.

Further information

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

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