KETOCONAZOLE- ketoconazole cream

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

A-S Medication Solutions

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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) ; and in the treatment of cutaneous candidiasis caused by Candida spp . Ketoconazole Cream, 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.

Περίληψη προϊόντος:

Product: 50090-3299 NDC: 50090-3299-0 30 g in a TUBE

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

KETOCONAZOLE- KETOCONAZOLE CREAM
A-S MEDICATION SOLUTIONS
----------
KETOCONAZOLE CREAM
RX ONLY
DESCRIPTION
Ketoconazole Cream, 2% contains the broad-spectrum synthetic
antifungal agent, ketoconazole 2%.
Each gram, for topical administration, contains ketoconazole 20 mg and
is formulated in an aqueous
cream vehicle consisting of propylene glycol, purified water, cetyl
alcohol, stearyl alcohol, isopropyl
myristate, sorbitan monostearate, polysorbate 60, polysorbate 80, and
sodium sulfite, anhydrous:
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:
C
H Cl
N O M.W. 531.44
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:
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28
2
4
4
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 th