Consists of Beclometasone Topical, Clotrimazole Topical, Neomycin Topical
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Bestozol-NC Cream Pregnancy |
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Consists of Beclometasone Topical, Clotrimazole Topical, Neomycin Topical
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Clotrimazole Topical (Bestozol-NC Cream) has been assigned to pregnancy category B by the FDA. Systemic absorption is minimal following topical or vaginal administration. Animals given high doses intravaginally have not revealed evidence of teratogenicity. High oral doses resulted in embryotoxicity and maternal toxicity. In clinical trials involving women in their second and third trimester, clotrimazole treatment of vaginal candidiasis was not associated with fetal harm. Clotrimazole use has not been well studied during the first trimester. Clotrimazole should only be used during the first trimester when need has been clearly established.
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There are no data on the excretion of clotrimazole into human milk. However, systemic absorption is minimal after topical and vaginal administration. The manufacturer recommends that caution be used when administering Clotrimazole Topical (Bestozol-NC Cream) to nursing women.
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The manufacturer makes no recommendation regarding use during pregnancy. US FDA pregnancy category: Not formally assigned to a pregnancy category.
Animal studies have not been reported. There are no controlled data in human pregnancy.
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The manufacturer makes no recommendation regarding use during lactation. Excreted into human milk: Data not available Excreted into animal milk: Data not available Comments: -The effects in the nursing infant are unknown; negligible risk is expected, however, topical application to the nipple may increase risk for diarrhea in the infant. -Ointments should not be applied to the breast prior to breastfeeding; water miscible cream or gel products should be used if necessary.
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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