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Betamethasone / clotrimazole topical Pregnancy and Breastfeeding Warnings

Betamethasone / clotrimazole topical is also known as: Lotrisone

Betamethasone / clotrimazole 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

Animal studies with this combination product have not been conducted. Clotrimazole has failed to reveal evidence of teratogenicity in animals; however, it has been shown to be fetotoxic at high oral doses. Betamethasone dipropionate has been shown to be teratogenic when given via the IM route. Topical administration of some corticosteroids to pregnant animals can cause abnormalities to fetal development including cleft palate and intrauterine growth retardation. 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

Betamethasone / clotrimazole topical Breastfeeding Warnings

It is unknown whether topically administered corticosteroids could result in sufficient systemic absorption to produce detectable levels in breast milk; however, systemically administered corticosteroids may appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production, or cause untoward effects.

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -Since only extensive application of the most potent corticosteroids may cause systemic effects in the mother, it is unlikely that short-term application of topical corticosteroids would pose a risk to the breastfed infant by passage into breast milk; however, the least potent drug should be used on the smallest area of skin possible. -Any product containing a topical corticosteroid should be wiped off thoroughly prior to nursing if it is being applied to the breast or nipple area. -Only water-miscible creams or gels should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Lotrisone (betamethasone-clotrimazole)." Schering Laboratories, Kenilworth, NJ.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Lotrisone (betamethasone-clotrimazole)." Schering Laboratories, Kenilworth, NJ.

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