CICLOPIROX gel

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

CICLOPIROX (UNII: 19W019ZDRJ) (CICLOPIROX - UNII:19W019ZDRJ)

זמין מ:

Bryant Ranch Prepack

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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.

leaflet_short:

Ciclopirox Gel, 0.77% is supplied in 100 g tubes (NDC 63629-8622-1). Store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

CICLOPIROX- CICLOPIROX GEL
BRYANT RANCH PREPACK
----------
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