Ciclopirox (topical)
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From MedlinePlus, U.S. National Library of Medicine
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
DOSAGE AND ADMINISTRATION Ciclopirox topical solution, USP 8% should be used as a component of a comprehensive management program for onychomycosis. Removal of the unattached, infected nail, as frequently as monthly, by a health care professional, weekly trimming by the patient, and daily application of the medication are all integral parts of this therapy.
Nail Care By Patient Patients should file away (with emery board) loose nail material and trim nails, as required, or as directed by the health care professional, every seven days after ciclopirox topical solution, 8% is removed with alcohol. Ciclopirox topical solution, 8% should be applied once daily (preferably at bedtime or eight hours before washing) to all affected nails with the applicator brush provided.
The ciclopirox topical solution, 8% should be applied evenly over the entire nail plate. If possible, ciclopirox topical solution, 8% should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed (e.g., onycholysis). The ciclopirox topical solution, 8% should not be removed on a daily basis.
Contraindications
Ciclopirox topical solution, 8% is contraindicated in individuals who have shown hypersensitivity to any of its components.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for ciclopirox (topical). Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
Pregnancy Teratogenic Effects: Pregnancy Category B Teratology studies in mice, rats, rabbits, and monkeys at oral doses of up to 77, 23, 23, or 38.5 mg, respectively, of ciclopirox as ciclopirox olamine/kg/day (14, 8, 17, and 28 times MRHTD), or in rats and rabbits receiving topical doses of up to 92.4 and 77 mg/kg/day, respectively (33 and 55 times MRHTD), did not indicate any significant fetal malformations. There are no adequate or well-controlled studies of topically applied ciclopirox in pregnant women. Ciclopirox topical solution, 8% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation
Nursing Mothers It is not known whether this drug is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when ciclopirox topical solution, 8% is administered to a nursing woman.
Breastfeeding (LactMed)
Topical ciclopirox has not been studied during breastfeeding. Because only about 1.3% is absorbed after topical application, it is considered a low risk to the nursing infant. Avoid application to the nipple area and ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated. 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.