CICLOPIROX OLAMINE- ciclopirox olamine cream

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc.

INN (Mezinárodní Name):

CICLOPIROX OLAMINE

Složení:

CICLOPIROX 7.7 mg in 1 g

Podání:

TOPICAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Ciclopirox 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) versicolor due to Malassezia furfur . Ciclopirox Cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

Přehled produktů:

Ciclopirox Cream 0.77% (Ciclopirox Olamine Cream USP) is supplied in: NDC 0168-0313-15  15 gram tube NDC 0168-0313-30  30 gram tube NDC 0168-0313-90  90 gram tube Store at 20°-25°C (68°-77°F). [see USP Controlled Room Temperature] E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I2313B R11/11 #99

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

CICLOPIROX OLAMINE- CICLOPIROX OLAMINE CREAM
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
----------
CICLOPIROX CREAM 0.77%
(CICLOPIROX OLAMINE CREAM USP)
RX ONLY
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Ciclopirox Cream 0.77% is for topical use.
Each gram of Ciclopirox cream 0.77% contains 7.70 mg of Ciclopirox
(as Ciclopirox Olamine) in a water miscible vanishing cream base
consisting of purified water USP,
cetyl alcohol NF, mineral oil USP, octyldodecanol NF, stearyl alcohol
NF, cocamide DEA,
polysorbate 60 NF, myristyl alcohol, sorbitan monostearate NF, lactic
acid USP, and benzyl alcohol NF
(1%) as preservative.
Ciclopirox Cream 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 Cream 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, 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 cream 0.77% 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.
Autora