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:

NuCare Pharmaceuticals,Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Ciclopirox Olamine Cream USP, 0.77% is supplied in Box of 30 g (NDC 68071-4162-3) Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CICLOPIROX OLAMINE- CICLOPIROX OLAMINE CREAM
NUCARE PHARMACEUTICALS,INC.
----------
CICLOPIROX OLAMINE
CREAM USP, 0.77%
RX ONLY
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
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) in a water miscible vanishing cream base consisting of cetyl
alcohol, cocamide
DEA, lactic acid, mineral oil, myristyl alcohol, octyldodecanol,
polysorbate 60, purified
water, sorbitan monostearate, stearyl alcohol, and benzyl alcohol (1%)
as preservative.
Ciclopirox olamine 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:
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Ciclopirox is a hydroxypyridone antifungal agent that acts by
chelation of 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
Pharmacokinetic studies in men with tagged ciclopirox solution in
polyethylene glycol 400
3+
3+
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 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 showed that
ciclopirox
penetrates into the hair and through the epidermis and hair follicl