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:

Glenmark Pharmaceuticals Inc., USA

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 supplied in 15 grams (NDC 68462-297-17), 30 grams (NDC 68462-297-35) and 90 grams (NDC 68462-297-92) tubes.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CICLOPIROX OLAMINE- CICLOPIROX OLAMINE CREAM
GLENMARK PHARMACEUTICALS INC., USA
----------
CICLOPIROX OLAMINE CREAM USP, 0.77%
FOR DERMATOLOGIC 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, USP
contains 7.70 mg of ciclopirox (as ciclopirox olamine USP) in a water
miscible vanishing cream base
consisting of benzyl alcohol (1%) as preservative, cetyl alcohol,
lactic acid, light mineral oil, myristyl
alcohol, octyldodecanol, polysorbate 60, purified water, sorbitan
monostearate and stearyl alcohol.
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
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 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 hair
and through the epider