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Betamethasone topical Pregnancy and Breastfeeding Warnings

Betamethasone topical is also known as: Alphatrex, Beta-Val, Betacort, Betaderm, Betamethacot, Betanate, Betatrex, Betnovate, Del-Beta, Diprolene, Diprolene AF, Diprosone, Luxiq, Maxivate, Sernivo, Teladar, Uticort, Valisone

Betamethasone topical Pregnancy Warnings

Animal studies have shown the more potent corticosteroids to be teratogenic after dermal application. There are no adequate and well-controlled studies in pregnant women on the teratogenic effects from topically applied corticosteroids.

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 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.

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

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

Comments: Topical corticosteroids should not be used extensively on pregnant patients, in large amounts or for extended periods of time.

See references

Betamethasone topical Breastfeeding Warnings

A decision should be made whether to discontinue breastfeeding or to 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. Petersen MC, Nation RL, Ashley JJ, McBride WG "The placental transfer of betamethasone." Eur J Clin Pharmacol 18 (1980): 245-7
  2. "Product Information. Diprolene (betamethasone topical)." Schering Laboratories, Kenilworth, NJ.
  3. Anderson AB, Gennser G, Jeremy JY, Ohrlander S, Sayers L, Turnbull AC "Placental transfer and metabolism of betamethasone in human pregnancy." Obstet Gynecol 49 (1977): 471-4

References for breastfeeding information

  1. "Product Information. Diprolene (betamethasone topical)." Schering Laboratories, Kenilworth, 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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