CICLOPIROX OLAMINE suspension

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 7.70 mg in 100 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w) (Lotion) 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; cutaneous candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur . Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w) (Lotion) is contraindicated in individuals who have shown hypersensitivity to any of its components.

Product summary:

Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w) (Lotion) is available as follows: 30 mL bottle (NDC 45802-400 -49) 60 mL bottle (NDC 45802-400 -46) Bottle space provided to allow for vigorous shaking before each use.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CICLOPIROX OLAMINE- CICLOPIROX OLAMINE SUSPENSION
PADAGIS ISRAEL PHARMACEUTICALS LTD
----------
CICLOPIROX OLAMINE TOPICAL SUSPENSION USP, 0.77%
(W/W) (LOTION)
RX ONLY
FOR DERMATOLOGIC USE ONLY.
NOT FOR USE IN EYES.
DESCRIPTION
Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w) (Lotion) is for
topical use.
Each gram of Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w)
(Lotion) contains
7.70 mg of ciclopirox (as ciclopirox olamine) in a water miscible
suspension 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 Topical Suspension USP, 0.77% (w/w) (Lotion)
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.
Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w) (Lotion) has a
pH of 7. The
chemical structure is:
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,_
_Epidermophyton floccosum, Microsporum canis, _and _Candida albicans._
Pharmacokinetic studies in men with radiolabeled ciclopirox solution
in polyethylene
glycol 400, showed an average of 1.3% absorption of the dose when it
was applied
2
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.
Autoradiographic studies with human cadaver skin showed that
ciclopirox penetrates
into the hair and through the epidermis and hair follicles into the
sebaceous glands and
dermis,