Clotrimazole (otic)
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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.
Preparation and administration
Recommended Dosage and Administration CLOTIC is for otic use only. Instill the contents of one single-dose CLOTIC vial into the affected ear canal twice daily morning and evening, preferably 12 hours apart, for 14 consecutive days.
Preparation and Administration Instructions Warm the solution by holding the vial in the hand for 1 to 2 minutes. This is to avoid dizziness which may result from the instillation of a cold solution into the ear canal. The patient should lie with the affected ear upward, and then instill the medication. Gently pull the outer ear lobe upward and outward.
This will allow the ear drops to flow down into the ear canal. Maintain this position for 1 minute after the drug administration. Repeat, if necessary, for the opposite ear [see Instructions for Use ].
Contraindications
4 CONTRAINDICATIONS CLOTIC is contraindicated in patients with known hypersensitivity to clotrimazole. CLOTIC is contraindicated in patients with known hypersensitivity to clotrimazole. ( 4 )
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
8.1 Pregnancy Risk Summary Systemic absorption of clotrimazole following topical administration appears to be minimal, and maternal use of CLOTIC is not expected to result in fetal exposure to the drug. The background risk of major birth defects and miscarriage for the indicated population is unknown All pregnancies have a background risk of major birth defects, loss, and other adverse outcomes. The background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.
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
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