Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
CICLOPIROX (UNII: 19W019ZDRJ) (CICLOPIROX - UNII:19W019ZDRJ)
Padagis US LLC
CICLOPIROX
CICLOPIROX 7.7 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
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 . Seborrheic Dermatitis Ciclopirox Gel, 0.77% is indicated for the topical treatment of seborrheic dermatitis of the scalp. Ciclopirox Gel, 0.77% is contraindicated in individuals who have shown hypersensitivity to any of its components.
Ciclopirox Gel, 0.77% is supplied in 30 g tubes (NDC 0574-2061 -30), 45 g tubes (NDC 0574-2061 -45) and 100 g tubes (NDC 0574-2061 -01). Store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]. Manufactured By Perrigo® Minneapolis, MN 55427 2201422 : 8D700 RC J1 Rev 10-13 B
Abbreviated New Drug Application
CICLOPIROX- CICLOPIROX GEL PADAGIS US LLC ---------- CICLOPIROX GEL, 0.77% FOR DERMATOLOGIC USE ONLY. NOT FOR USE IN EYES. RX ONLY DESCRIPTION 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(1_H_)- pyridinone, with the empirical formula C H NO and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is: CLINICAL PHARMACOLOGY 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 12 17 2 3+ 3+ polyvalent cations (Fe or Al ), resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell. PHARMACOKINETICS 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 C for total ciclopirox in ser Կարդացեք ամբողջական փաստաթուղթը