Land: Canada
Sprog: engelsk
Kilde: Health Canada
CICLOPIROX
STERIMAX INC
D01AE14
CICLOPIROX
8%
SOLUTION
CICLOPIROX 8%
TOPICAL
6.6ML
Prescription
HYDROXYPYRIDONES
Active ingredient group (AIG) number: 0150022001; AHFS:
CANCELLED POST MARKET
2021-02-18
PRODUCT MONOGRAPH PR CICLOPIROX TOPICAL SOLUTION (Ciclopirox Topical Solution, House Std) 8% W/W NAIL LACQUER Topical Antifungal Agent SteriMax Inc. 1-2735 Matheson Blvd. East Mississauga ON L4W 4M8 Date of Preparation: August 6, 2013 Submission Control No: 151805 PRODUCT MONOGRAPH PR CICLOPIROX TOPICAL SOLUTION Ciclopirox Topical Solution, House Std 8% w/w NAIL LACQUER Topical Antifungal Agent ACTION AND CLINICAL PHARMACOLOGY Ciclopirox free acid is an antimycotic agent that inhibits the growth of a number of fungi _in vitro _ including _Trichophyton mentagrophytes_ , _Trichophyton rubrum_ , _Microsporum canis_ , _Epidermophyton floccosum_ , _Candida albicans_ , _Candida tropicalis _ and _Candida_ _pseudotropicalis_ . The mechanism of action of ciclopirox has been investigated using various _in vitro _ and _in vivo _ infection models. One _in vitro _ study suggested that ciclopirox acts by chelation of polyvalent cations (Fe +3 or Al +3 ) resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell. The clinical significance of this observation is not known. PHARMACOKINETICS As demonstrated in pharmacokinetic studies in animals and man, ciclopirox olamine is rapidly absorbed after oral administration and completely eliminated in all species via feces and urine. Most of the compound is excreted either unchanged or as glucuronide. After oral administration of 10 mg of radiolabelled drug ( 14 C-ciclopirox) to healthy volunteers, approximately 96% of the radioactivity was excreted renally within 12 hours of administration. Ninety-four percent of the renally excreted radioactivity was in the form of glucuronides. Thus, glucuronidation is the main metabolic pathway of this compound. Systemic absorption of ciclopirox was determined in 5 patients with dermatophytic onychomycoses after application of ciclopirox topical solution, 8% w/w nail laquer, to all 20 digits and adjacent 5 mm of skin once daily for six months. Random serum concentrations an Læs hele dokumentet