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:

Cosette Pharmaceuticals, Inc.

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 USP, 0.77% 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. Safety and effectiveness in pediatric patients below the age of 10 years have not been established.

Product summary:

Ciclopirox Olamine Cream USP, 0.77% is supplied in: 15-g tubes (NDC 0713-0638-15) 30-g tubes (NDC 0713-0638-31) 90-g tubes (NDC 0713-0638-18) Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc.  South Plainfield, NJ 07080 8-0638CPLNC2     VC7640 Rev. 06/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CICLOPIROX OLAMINE- CICLOPIROX OLAMINE CREAM
COSETTE PHARMACEUTICALS, INC.
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CICLOPIROX OLAMINE CREAM USP, 0.77%
(CICLOPIROX CREAM)
FOR DERMATOLOGIC USE ONLY.
NOT FOR USE IN EYES.
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 purified water
USP, octyldodecanol NF, mineral oil USP, stearyl alcohol NF, cetyl
alcohol NF, cocamide
DEA, 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:
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Ciclopirox is a hydroxypyridone antifungal agent that acts by
chelation of polyvalent
cations (Fe
or A1
), 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
3+
3+
2
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
pe