Fungal Infections - Patient's guide

Ciclopirox

Antifungal, topical. Ciclopirox olamine is a hydroxypyridone antifungal that is structurally unrelated to other antifungal agents.
It was first introduced in 1975 and has been accepted and used in Europe for many years. It was approved by the FDA in 1982 for the treatment of superficial fungal infections. A new lacquer formulation was approved in 1999.

Trade Name:

• Penlac*   Dermik
• Loprox*   Dermik

Dosage Forms:

• Nail lacquer solution: Ciclopirox olamine 8% Penlac Nail Lacquer*
• Topical Gel: Ciclopirox olamine 1% Loprox*
• Cream: Ciclopirox olamine 1% Loprox*
• Lotion: Ciclopirox olamine 1% Loprox*

The topical application of this drug was one of the first effective antifungals for superficial dermatophyte, yeast, and fungal infections. The most recent formulation, a lacquer, has made ciclopirox convenient in the treatment of nail infections.

Used for

• Tinea corporis
• Tinea cruris
• Tinea pedis
• Tinea versicolor
• Candidiasis, cutaneous
• Nail lacquer-
• Onychomycosis

Therapeutic Regimen

Safety Information

Adverse Effects
Cutaneous effects may include local irritation or burning when first applied.

FDA Pregnancy Category B Adequate human studies have not been completed. Animal studies have not shown adverse fetal effects. It is not known if ciclopirox is distributed in breast milk.

General References

Abrams BB, Hanel H, Hoehler T : Ciclopirox olamine : A Hydroxypyridine Antifungal Agent. In Clinics in Dermatology. Parish LC (Ed) Philadelphia, JB Lippencott 1992 : pages 471 - 477

Jue SG, Dawson GW, Brogden RN : Ciclopirox olamine 1% cream. A preliminary review of its antimicrobial activity and therapeutic use. Drugs 1985 : 29 (4) : 330 - 341

Gupta AK, Baran R : Ciclopirox nail lacquer solution 8% in the 21st century Jour. Am. Acad. Derm. 2000 : 43 : S96 - S102 Bohn M, Kraemer KT : Dermatopharmacology of ciclopirox nail lacquer topical r solution 8% in the treatment of onychomycosis Jour. Am. Acad. Derm. 2000 : 43 : S57 - S59

Gupta AK : Pharmacoeconomic analysis of ciclopirox nail lacquer solution 8% and the new oral antifungal agents used to treat dermatophyte toe onychomycosis in the US. Jour. Am. Acad. Derm. 2000 : 43 : S81 - S95

Gupta AK, Fleckman P, Baran R : Ciclopirox nail lacquer topical solution 8% in the treatment of toenail onychomycosis. Jour. Am. Acad. Derm. 2000 : 43 : S70 - S80

Tosti A, Piraccini BM, Lorenzi S : Onychomycosis caused by non-dermatophyte moulds : Clinical features and response to treatment of 59 cases. Jour. Am. Acad. Derm. 2000 : 42 : 217 - 224

Vardy DA, Zvulunov A, Tchetov T, et al : A double-blind placebo-controlled trial of a ciclopirox olamine 1% shampoo for the treatment of scalp Seborrehic dermatitis. Jour. Derm. Treat. 2000 : 11 : 73 - 77

Wu TC, Chuan MT, Lu YC : Efficacy of ciclopirox olamine 1% cream in onychomycosis and tinea pedis. Mycoses 1991 : 34 : 93 - 95

Penlac® (Ciclopirox)

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• INTRODUCTION
  Penlac is the first topical anti-fungal preparation approved specifically for the treatment of onychomycosis. The product was available for use in Canada in...   |   Read more ...



• DRUG
  Ciclopiroxs' mechanism of action is fungicidal by affecting intracellular metabolic processes reducing the organisms ability to process nutrients and detoxify toxic metabolites...   |   Read more ...



• DELIVERY SYSTEM
  Ciclopirox is incorporated into a clear nail lacquer at an 8% concentration which is applied directly onto the nail plate.This transungual delivery system is unique allowing...   |   Read more ...



• PHARMACOKINETICS
  The penetration of ciclopirox through the nail plate is well documented by invitro studies utilizing cow horn and sheep and bovine nailplate. Studies of penetration in human finger and...   |   Read more ...



• APPLICATION TECHNIQUE
  Ciclopirox nail lacquer (Penlac) is applied evenly by brush to the entire nail plate including the undersurface at the distal end and at the sites of onycholysis...   |   Read more ...



• CLINICAL EFFICACY
  The two pivotal US trials were double blind placebo controlled trials involving 549 patients randomized 1:1, placebo:drug who applied ciclopirox daily for 48 weeks to their great toenails...   |   Read more ...



• SAFETY
  The data gathered from clinical trials and post-marketing reports have not shown any significant systemic side effects related to the topical application of Penlac nail lacquer...   |   Read more ...



• PATIENT SELECTION
  In my experience, the patients most likely to have the best experience and be most successful with the use of Penlac are...   |   Read more ...

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