KETOCONAZOLE cream

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

DIRECT RX

INN (Internationale Bezeichnung):

KETOCONAZOLE

Zusammensetzung:

KETOCONAZOLE 20 mg in 1 g

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: 15 gram NDC 0168-0099-15 30 gram NDC 0168-0099-30 60 gram NDC 0168-0099-60 Store below 77°F (25°C). E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I299C R11/11 #39 PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER NDC 0168-0099-15 FOUGERA® KETOCONAZOLE CREAM 2% For dermatologic use only. Rx only Contains ketoconazole 20 mg/g, propylene glycol, stearyl and cetyl alcohols, sorbitan monostearate, polysorbate 60, isopropyl myristate, sodium sulfite anhydrous, polysorbate 80 and purified water. NET WT 15 grams

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

KETOCONAZOLE- KETOCONAZOLE CREAM
DIRECT RX
----------
KETOCONAZOLE
DESCRIPTION SECTION
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-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-
4-yl]methoxy]phenyl]piperazine and has the following structural
formula:
[Structural Formula]
CLINICAL PHARMACOLOGY SECTION
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