CICLOPIROX- ciclopirox gel
Paddock Laboratories, LLC
FOR DERMATOLOGIC USE ONLY.
NOT FOR USE IN EYES.
Ciclopirox Gel, 0.77% contains a synthetic antifungal agent, ciclopirox. It is intended for topical dermatologic use only.
Each gram of Ciclopirox Gel, 0.77% contains 7.70 mg of ciclopirox in a gel consisting of Purified Water USP, Isopropyl Alcohol USP, Octyldodecanol NF, Dimethicone Copolyol 190, Carbomer 980, Sodium Hydroxide NF, and Docusate Sodium USP.
Ciclopirox Gel, 0.77% is a white, slightly fluid gel.
The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)- pyridinone, with the empirical formula C12 H17 NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is:
Ciclopirox Gel Structural Formula
(click image for full-size original)
Mechanism of Action
Ciclopirox is a hydroxypyridone antifungal agent although the relevance of this property for the indication of seborrheic dermatitis is not known. Ciclopirox acts by chelation of polyvalent cations (Fe3+ or Al3+), resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell.
A comparative study of the pharmacokinetics of Ciclopirox Gel, 0.77% and Ciclopirox Cream (ciclopirox olamine) 0.77% in 18 healthy males indicated that systemic absorption of ciclopirox from Ciclopirox Gel, 0.77% was higher than that of Ciclopirox Cream, 0.77%. A 5 gm dose of Ciclopirox Gel, 0.77% produced a mean (±SD) peak serum concentration of 25.02 (±20.6) ng/mL total ciclopirox and 5 gm of Ciclopirox Cream, 0.77% produced 18.62 (±13.56) ng/mL total ciclopirox.
Approximately 3% of the applied ciclopirox was excreted in the urine within 48 hours after application, with a renal elimination half-life of about 5.5 hours.
In a study of Ciclopirox Gel, 0.77%, 16 men with moderate to severe tinea cruris applied approximately 15 grams/day of the gel for 14.5 days. The mean (±SD) dose-normalized values of Cmax for total ciclopirox in serum were 100 (±42) ng/mL on Day 1 and 238 (±144) ng/mL on Day 15. During the 10 hours after dosing on Day 1, approximately 10% of the administered dose was excreted in the urine.
Ciclopirox is a hydroxypyridinone antifungal agent that inhibits the growth of pathogenic dermatophytes. Ciclopirox has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section: Trichophyton rubrum , Trichophyton mentagrophytes , and Epidermophyton floccosum.
INDICATIONS AND USAGE
Superficial Dermatophyte Infections
Ciclopirox Gel, 0.77% is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum , Trichophyton mentagrophytes , or Epidermophyton floccosum.
Ciclopirox Gel, 0.77% is indicated for the topical treatment of seborrheic dermatitis of the scalp.