![]() Report to the FDA if a breastfeeding infant experiences any adverse effects. The oral troches should be used only when needed, as this may be systemically absorbed. Instruct mothers not to apply clotrimazole topically to the breast during times of breastfeeding. ![]() Topical clotrimazole poses little risk to nursing infants as topical clotrimazole is not expected to result in significant maternal absorption. No data is available about the excretion of clotrimazole in breast milk. The use of clotrimazole during breastfeeding has not been studied. There are well-controlled studies in humans hence the use of oral clotrimazole lozenges during pregnancy should only be an option if the potential benefit justifies the potential risk to the fetus. In animal studies with dosing up to 200 times the human dose, doses of 100 times the adult human dose have been embryotoxic in rats and mice. There have been no teratogenic effects demonstrated after clotrimazole therapy in pregnancy. There are no adequate, well-controlled studies for oral clotrimazole in pregnant women. FDA classifies clotrimazole as a class C drug in pregnancy risk classification. Ĭlotrimazole is not known to cross the placenta. However, clinical trials showed intravaginal clotrimazole to be safe in clinical trials during the second and the third trimester of pregnancy and are recommended for use. There are inadequate well-controlled human studies with the use of topical or intravaginal clotrimazole during the first trimester of pregnancy clotrimazole should only be used if indicated. Only topical preparations are recommended in pregnancy. Therefore, fungal nail infections usually require treatment with an oral (systemic) antifungal drug.Ĭlotrimazole demonstrates poor absorption after dermal or intravaginal administration. Topical clotrimazole is not effective for onychomycosis. Such action of clotrimazole on different cell targets accounts for other effects of this drug that are separate from its antimycotic activities. These include the inhibition of sarcoplasmic reticulum ca2+ ATPase, depletion of intracellular calcium, and blocking of calcium-dependent potassium channels and voltage-dependent calcium channels. Though clotrimazole exerts its anti-fungal action by decreasing ergosterol biosynthesis, clotrimazole exerts other pharmacological actions. Ergosterol also directly promotes the growth of fungal cells in a hormone-like fashion therefore, the rapid onset of the above events leads to a dose-dependent inhibition of fungal growth. When ergosterol synthesis becomes inhibited, the cell can no longer construct an intact and functional cell membrane. ![]() Clotrimazole thereby inhibits the biosynthesis of ergosterol in a concentration-dependent manner by inhibiting the demethylation of 14 alpha lanosterol. Clotrimazole exerts its action primarily by damaging the permeability barrier in the fungal cytoplasmic membrane.
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