KETOCONAZOLE cream

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

A-S Medication Solutions

Droga podania:

TOPICAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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.

Podsumowanie produktu:

Product: 50090-0720 NDC: 50090-0720-0 30 g in a TUBE / 1 in a CARTON

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

KETOCONAZOLE- KETOCONAZOLE CREAM
A-S MEDICATION SOLUTIONS
----------
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 clinicall