Clotrimazole
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From MedlinePlus, U.S. National Library of Medicine
Azole Antifungal
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Contraindications
Clotrimazole Lozenges are contraindicated in patients who are hypersensitive to any of its components.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
ELikelihood score E: Unlikely cause of clinically apparent liver injury.
Clotrimazole is an imidazole antifungal agent used primarily in the treatment of skin, oral and vaginal candida infections. Clotrimazole is typically given topically or as oral or vaginal troches and has only modest systemic absorption. Nevertheless, clotrimazole given orally or as troches has been associated with transient and asymptomatic serum aminotransferase elevations during therapy, but it has not been linked to instances of clinically apparent acute liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
Use In Pregnancy Pregnancy Category C: Clotrimazole has been shown to be embryotoxic in rats and mice when given in doses 100 times the adult human dose (in mg/kg), possibly secondary to maternal toxicity. The drug was not teratogenic in mice, rabbits, and rats when given in doses up to 200, 180, and 100 times the human dose. Clotrimazole given orally to mice from nine weeks before mating through weaning at a dose 120 times the human dose was associated with impairment of mating, decreased number of viable young, and decreased survival to weaning. No effects were observed at 60 times the human dose.
When the drug was given to rats during a similar time period at 50 times the human dose, there was a slight decrease in the number of pups per litter and decreased pup viability. There are no adequate and well controlled studies in pregnant women. Clotrimazole lozenges should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Breastfeeding (LactMed)
Because has poor absorption from the skin and vagina and has poor oral bioavailability, it is unlikely to adversely affect the breastfed infant, including after topical application to the nipples. It has been used orally in infants with thrush, sometimes successfully after nystatin has failed. Any excess cream or ointment should be removed from the nipples before nursing. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.