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:

Padagis Israel Pharmaceuticals Ltd

INN (International Name):

CICLOPIROX OLAMINE

Composition:

CICLOPIROX 7.7 mg in 1 g

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 available as follows: 15 g tube (NDC 45802-138 -35) 30 g tube (NDC 45802-138 -11) 90 g tube (NDC 45802-138 -18)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CICLOPIROX OLAMINE- CICLOPIROX OLAMINE CREAM
PADAGIS ISRAEL PHARMACEUTICALS LTD
----------
CICLOPIROX OLAMINE CREAM USP, 0.77%
FOR TOPICAL 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 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 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 has a pH of 7.
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 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 human cadaverous skin showed that
ciclopirox
penetrates into the ha