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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

Medically reviewed by Drugs.com. Last updated on Jun 20, 2019.

Betamethasone topical Pregnancy Warnings

Intramuscular doses administered to rabbits have been shown to be teratogenic with abnormalities including umbilical hernias, cephalocele, and cleft palate; a relevant comparison of how systemic animal exposure relates to human dermal exposure is not available. There are no adequate and well-controlled studies in pregnant women. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

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 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.

Benefit should outweigh risk

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-Use of over 300 grams of potent or very potent topical corticosteroids during pregnancy may increase the risk of low birthweight infants.
-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

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Topical administration could potentially result in detectable quantities of this drug in human milk.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.
-Apply to the smallest area of skin for the shortest possible duration during breastfeeding.
-Topical administration should be avoided on the nipple or any area where the infant could directly ingest the drug from the skin.

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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