PENLAC SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

CICLOPIROX

Disponible des:

BAUSCH HEALTH, CANADA INC.

Codi ATC:

D01AE14

Designació comuna internacional (DCI):

CICLOPIROX

Dosis:

8%

formulario farmacéutico:

SOLUTION

Composición:

CICLOPIROX 8%

Vía de administración:

TOPICAL

Unidades en paquete:

12G

tipo de receta:

Prescription

Área terapéutica:

HYDROXYPYRIDONES

Resumen del producto:

Active ingredient group (AIG) number: 0150022001; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2012-03-05

Fitxa tècnica

PRODUCT MONOGRAPH
PR
PENLAC
®
Ciclopirox Topical Solution
8% w/w
NAIL LACQUER
TOPICAL ANTIFUNGAL AGENT
BAUSCH HEALTH, CANADA INC.
DATE OF REVISION:
2150 St-Elzear Blvd. West
February 23, 2021
Laval, Quebec
H7L 4A8
Control No.: 248363
_Pr_
_PENLAC_
_®_
_ Product Monograph Page 2 of 18_
PRODUCT MONOGRAPH
PR
PENLAC
®
Ciclopirox Topical Solution
8% w/w
ACTIONS 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 PENLAC (Ciclopirox Topical
Solution, 8% w/w) nail
lacquer, to all 20 digits and adjacent 5 mm of skin once daily for six
months. Random serum
concentrations and 24-hour urinary excretion of ciclopirox w