KETOCONAZOLE cream

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

REMEDYREPACK INC.

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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.

Produktbesonderheiten:

Ketoconazole Cream 2% is supplied as follows: NDC: 70518-1637-00 PACKAGING: 1 in 1 CARTON, 30 g in 1 TUBE Store below 77°F (25°C). Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

KETOCONAZOLE- KETOCONAZOLE CREAM
REMEDYREPACK INC.
----------
KETOCONAZOLE CREAM 2%
RX ONLY
DESCRIPTION
Ketoconazole Cream 2%, for topical administration only, contains the
broad-spectrum synthetic antifungal
agent, ketoconazole 2%, formulated in an aqueous cream vehicle
consisting of propylene glycol, stearyl and
cetyl alcohols, sorbitan monostearate, polysorbate 60, isopropyl
myristate, sodium sulfite anhydrous,
polysorbate 80 and purified water.
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:
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 ovale)_and
_C. tropicalis;_and the organism responsible for tinea versicolor,
_Malassezia furfur (Pityrosporum orbiculare)_.
Only those organisms listed in the INDICATIONS AND USAGE Section have
been proven to be clinically
affected. Devel