Ciclopirox

Ciclopirox may be found in some form under the following brand names:

• Ciclodan

• Cnl8

• Loprox

• Pedipirox-4

• Penlac Nail Lacquer

Ciclopirox Olamine Cream USP, 0.77% 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.

Gently massage Ciclopirox Olamine Cream USP, 0.77% 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 USP, 0.77% the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

• Antifungal Agent, Topical

Inhibiting transport of essential elements in the fungal cell disrupting the synthesis of DNA, RNA, and protein

Absorption

Cream, suspension: 1.3% through intact skin; increased with gel; <5% with lacquer

Distribution

Scalp application: To epidermis, corium (dermis), including hair, hair follicles, and sebaceous glands

Metabolism

Conjugated with glucuronic acid

Excretion

Urine (Gel: 3% to 10%; Shampoo: <0.5%; Cream, suspension: 0.01%); feces (small amounts)

Half-Life Elimination

Biologic: Cream, suspension: 1.7 hours; Elimination: Gel: 5.5 hours

Refer to adult dosing.

Topical: For topical use only; not for ophthalmic, oral, or intravaginal use.

Cream: Gently massage into affected areas and surrounding skin in the morning and evening.

Gel: Gently massage into clean, affected areas or to scalp and adjacent skin in the morning and evening.

Lacquer (solution): Apply evenly over nail (apply evenly over entire nail plate, and if possible to nail bed and under nail plate surface) and surrounding skin at bedtime (or allow 8 hours before washing); apply daily over previous coat for 7 days; after 7 days, may remove with alcohol and continue cycle. Every 7 days after ciclopirox is removed with alcohol, file away (with emery board) loose nail material and trim nails, as required or as directed by a health care professional.

Shampoo: Wet hair and apply to the scalp; lather and leave on hair and scalp for ~3 minutes; rinse. Avoid contact with eyes.

Suspension: Shake well before use; gently massage into affected areas and surrounding skin in the morning and evening.

Cream, gel, shampoo: Store at 15°C to 30°C (59°F to 86°F).

Nail lacquer (solution): Store at 15°C to 30°C (59°F to 86°F). Protect from light. Flammable; keep away from heat and flame.

Suspension: Store at 5°C to 25°C (41°F to 77°F).

There are no known significant interactions.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience hair discoloration or skin or nail changes. Have patient report immediately to prescriber edema, skin sores, blisters, oozing, bleeding, burning, redness, skin irritation, or scalp irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.