CICLOPIROX OLAMINE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

CICLOPIROX OLAMINE

Composition:

CICLOPIROX OLAMINE 7.7 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ciclopirox olamine cream, USP 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 is contraindicated in individuals who have shown hypersensitivity to any of its components.

Product summary:

Ciclopirox olamine cream, USP is supplied in 15 gram, 30 gram, and 90 gram tubes.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CICLOPIROX OLAMINE - CICLOPIROX OLAMINE CREAM
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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CICLOPIROX OLAMINE 15G CREAM
DESCRIPTION
Ciclopirox olamine cream, USP is for topical use.
Each gram of ciclopirox olamine cream, USP contains 7.70 mg of
ciclopirox (as Ciclopirox Olamine)
in a water miscible vanishing cream base consisting of Purified Water
USP, Octyldodecanol NF, Light
Mineral Oil NF, Stearyl Alcohol NF, Cetyl 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). 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 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, Epidermorphyton
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, USP 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 human cadaverous skin sh