Ciclopirox Olamine

Prescription

Brand names: Ciclopirox olamine

Dosage Form

Topical

Route

TOPICAL

Manufacturer

Padagis Israel Pharmaceuticals Ltd

About This Medication

DESCRIPTION Ciclopirox Olamine Cream USP, 0.77% is for topical use. Each gram of ciclopirox olamine cream contains 7.70 mg of ciclopirox (as ciclopirox olamine) in a water miscible, vanishing cream base consisting of benzyl alcohol (1% as a preservative), cetyl alcohol, lactic acid, light mineral oil, myristyl alcohol, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate, and stearyl alcohol. Ciclopirox olamine cream contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine). The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1 H )-pyridone, 2-aminoethanol salt. The CAS Registry Number is 41621-49-2. The chemical structure is: Ciclopirox olamine cream has a pH of 7. Chemical Structure Image

Active Ingredients

Ingredient	Strength
Ciclopirox Olamine	-

Indications & Usage

INDICATIONS AND USAGE Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.

Dosage & Administration

DOSAGE AND ADMINISTRATION Gently massage ciclopirox olamine cream into the affected and surrounding skin areas twice daily, in the morning and evening. Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment. If a patient shows no clinical improvement after four weeks of treatment with ciclopirox olamine cream the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

Side Effects Overview

ADVERSE REACTIONS In all controlled clinical studies with 514 patients using ciclopirox olamine cream and in 296 patients using the vehicle cream, the incidence of adverse reactions was low. This included pruritus at the site of application in one patient and worsening of the clinical signs and symptoms in another patient using ciclopirox olamine cream and burning in one patient and worsening of the clinical signs and symptoms in another patient using the vehicle cream.

Warnings & Precautions

WARNINGS Ciclopirox olamine cream is not for ophthalmic use. Keep out of reach of children.

Contraindications

CONTRAINDICATIONS Ciclopirox olamine cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

Frequently Asked Questions

INDICATIONS AND USAGE Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.

DOSAGE AND ADMINISTRATION Gently massage ciclopirox olamine cream into the affected and surrounding skin areas twice daily, in the morning and evening. Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment. If a patient shows no clinical improvement after four weeks of treatment with ciclopirox olamine cream the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

WARNINGS Ciclopirox olamine cream is not for ophthalmic use. Keep out of reach of children.

CONTRAINDICATIONS Ciclopirox olamine cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

Ciclopirox Olamine is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

References & Data Sources

• DailyMed — Ciclopirox Olamine drug label (National Library of Medicine)
• openFDA — Ciclopirox Olamine label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 309289 (NLM Normalized Drug Names)
• NDC Directory — Ciclopirox Olamine (FDA National Drug Code)

Medical Disclaimer

The information on this page is intended for educational purposes only and should not be used as a substitute for professional medical advice, diagnosis, or treatment.

Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication.

Data sources: DailyMed (NLM), openFDA, MFDS