CLOTIC (clotrimazole) otic solution

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE CLOTIC is indicated for the treatment of fungal otitis externa (otomycosis) due to Aspergillus species and Candida species in patients 18 years of age and older. Limitations of Use CLOTIC has only been studied in patients with intact tympanic membranes. The use of CLOTIC is not recommended for the treatment of otomycosis in patients with perforated tympanic membranes. CLOTIC is an azole antifungal indicated for the treatment of fungal otitis externa (otomycosis) due to Aspergillus species and Candida species in patients 18 years of age and older. ( 1 ) Limitations of Use CLOTIC has only been studied in patients with intact tympanic membranes. The use of CLOTIC is not recommended for the treatment of otomycosis in patients with perforated tympanic membranes Dosage and administration 2 DOSAGE AND ADMINISTRATION CLOTIC is for otic use only. ( 2 ) 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. ( 2 ) See full prescribing information for preparation and administration instructions 2.1 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. 2.2 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 ]. Warnings and cautions 5 WARNINGS AND PRECAUTIONS None. None. ( 5 ) 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.