KETOCONAZOLE- ketoconazole cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)

Available from:

NuCare Pharmaceuticals,Inc.

INN (International Name):

KETOCONAZOLE

Composition:

KETOCONAZOLE 20 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ketoconazole cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis. Ketoconazole cream, 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.

Product summary:

Ketoconazole cream, 2% is supplied in box of 60g . NDC 68071-1743-6 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

KETOCONAZOLE- KETOCONAZOLE CREAM
NUCARE PHARMACEUTICALS,INC.
----------
KETOCONAZOLE
CREAM, 2%
RX ONLY
DESCRIPTION
Ketoconazole cream, 2% contains the broad-spectrum synthetic
antifungal agent, ketoconazole 2%,
formulated in an aqueous cream vehicle consisting of butylated
hydroxyanisole (BHA), cetyl alcohol,
isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol,
purified water, sorbitan
monostearate and stearyl alcohol.
Ketoconazole is _cis_-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1
_H_-imidazol-1-ylmethyl)-1,3-dioxolan-
4-yl]methoxy]phenyl] piperazine and has the following structural
formula:
Molecular Formula: C
H
Cl
N
O
Molecular Weight: 531.43
CLINICAL PHARMACOLOGY
When ketoconazole cream, 2% was applied dermally to intact or abraded
skin of beagle dogs for 28
consecutive days at a dose of 80 mg, there were no detectable plasma
levels using an assay method
having a lower detection limit of 2 ng/mL.
After a single topical application to the chest, back and arms of
normal volunteers, systemic absorption
of ketoconazole was not detected at the 5 ng/mL level in blood over a
72-hour period.
Two dermal irritancy studies, a human sensitization test, a
phototoxicity study and a photoallergy study
conducted in 38 male and 62 female volunteers showed no contact
sensitization of the delayed
hypersensitivity type, no irritation, no phototoxicity and no
photoallergenic potential due to
ketoconazole cream, 2%.
MICROBIOLOGY
Ketoconazole is a broad spectrum synthetic antifungal agent which
inhibits the _in vitro_ growth of the
following common dermatophytes and yeasts by altering the permeability
of the cell membrane:
dermatophytes: _Trichophyton rubrum, T. mentagrophytes, T. tonsurans,
Microsporum canis, M. audouini,_
_M. gypseum_ and _Epidermophyton floccosum; yeasts: Candida albicans,
Malassezia ovale (Pityrosporum_
26
28
2
4
4
_ovale)_ and _C. tropicalis;_ and the organism responsible for tinea
versicolor, _Malassezia furfur_
_(Pityrosporum orbiculare)._ Only those organisms listed in the
INDICATIONS A