CICLOPIROX OLAMINE cream

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Dispensing Solutions, Inc.

INN (nume internaţional):

CICLOPIROX OLAMINE

Compoziție:

CICLOPIROX 7.7 mg in 1 g

Calea de administrare:

TOPICAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Ciclopirox olamine cream 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) vesicolor due to Malassezia furfur. Ciclopirox olamine cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

Rezumat produs:

Ciclopirox olamine cream USP, 0.77% is supplied in 15 gram (NDC 68462-297-17), 30 gram (NDC 68462-297-35) and 90 gram (NDC 68462-297-92) tubes.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

CICLOPIROX OLAMINE- CICLOPIROX OLAMINE CREAM
DISPENSING SOLUTIONS, INC.
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CICLOPIROX OLAMINE CREAM USP, 0.77%
FOR DERMATOLOGIC USE ONLY.
NOT FOR USE IN EYES.
DESCRIPTION
Ciclopirox olamine cream USP, 0.77% is for topical use. Each gram of
ciclopirox olamine cream USP
contains 7.70 mg of ciclopirox (as ciclopirox olamine USP) in a water
miscible vanishing cream base
consisting of purified water USP, cetyl alcohol NF, light mineral oil
NF, octyldodecanol NF, stearyl
alcohol NF, polysorbate 60 NF, myristyl alcohol NF, sorbitan
monostearate NF, lactic acid USP, and
benzyl alcohol NF (1%) as preservative.
Ciclopirox olamine cream USP contains a synthetic, broad-spectrum,
antifungal agent ciclopirox (as
ciclopirox olamine USP). 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:
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, Microsporum canis_, 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 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
concentration.
Autoradiographic studies with human cadaverous skin showed tha