CICLOPIROX OLAMINE cream

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

CICLOPIROX OLAMINE (UNII: 50MD4SB4AP) (CICLOPIROX - UNII:19W019ZDRJ)

Tersedia dari:

Bryant Ranch Prepack

Rute administrasi :

TOPICAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Ciclopirox Olamine Cream USP, 0.77% is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur. Ciclopirox Olamine Cream USP, 0.77% is contraindicated in individuals who have shown hypersensitivity to any of its components.

Ringkasan produk:

Ciclopirox Olamine Cream USP, 0.77% is available as follows: 30 g tube (NDC 63629-8625-1)

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

CICLOPIROX OLAMINE- CICLOPIROX OLAMINE CREAM
BRYANT RANCH PREPACK
----------
CICLOPIROX OLAMINE CREAM USP, 0.77%
FOR DERMATOLOGIC USE ONLY
NOT FOR USE IN EYES
RX ONLY
DESCRIPTION
Ciclopirox Olamine Cream USP, 0.77% is for topical use. Each gram of
Ciclopirox
Olamine Cream USP, 0.77% contains 7.70 mg of ciclopirox (as ciclopirox
olamine) in a
water miscible, vanishing cream base consisting of benzyl alcohol (1%
as a
preservative), cetyl alcohol, lactic acid, light mineral oil, myristyl
alcohol, octyldodecanol,
polysorbate 60, purified water, sorbitan monostearate, and stearyl
alcohol.
Ciclopirox Olamine Cream USP, 0.77% contains a synthetic,
broad-spectrum, antifungal
agent ciclopirox (as ciclopirox olamine). The chemical name is
6-cyclohexyl-1-hydroxy-4-
methyl-2(1 _H_)-pyridone,2-aminoethanol salt.
The CAS Registry Number is 41621-49-2. The chemical structure is _:_
Ciclopirox Olamine Cream USP, 0.77% has a pH of 7.
CLINICAL PHARMACOLOGY
Ciclopirox is a broad-spectrum, antifungal agent that inhibits the
growth of pathogenic
dermatophytes, yeasts, and _Malassezia furfur._Ciclopirox exhibits
fungicidal activity _in_
_vitro_against isolates of _Trichophyton rubrum, Trichophyton
mentagrophytes,_
_Epidermophyton floccosum, Microsporumcanis, and Candida albicans._
Pharmacokinetic studies in men with tagged ciclopirox solution in
polyethylene glycol 400
showed an average of 1.3% absorption of the dose when it was applied
topically to 750
cm
on the back followed by occlusion for 6 hours. The biological
half-life was 1.7 hours
2
and excretion occurred via the kidney. Two days after application only
0.01% of the
dose applied could be found in the urine. Fecal excretion was
negligible.
Penetration studies in human cadaverous skin from the back, with
ciclopirox olamine
cream with tagged ciclopirox showed the presence of 0.8 to 1.6% of the
dose in the
stratum corneum 1.5 to 6 hours after application. The levels in the
dermis were still 10
to 15 times above the minimum inhibitory concentrations.
Autoradiographic studies with