KETOCONAZOLE cream

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Physicians Total Care, Inc.

INN (Rahvusvaheline Nimetus):

KETOCONAZOLE

Koostis:

KETOCONAZOLE 20 mg in 1 g

Manustamisviis:

TOPICAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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.

Toote kokkuvõte:

Ketoconazole Cream 2% is supplied as follows: Store below 77°F (25°C). E. FOUGERA & CO. a division of Altana Inc. MELVILLE, NEW YORK 11747 I299 #39 R6/02 Relabeling of "Additional" barcode label by: Physicians Total Care, Inc. Tulsa, OK       74146

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

KETOCONAZOLE - KETOCONAZOLE CREAM
PHYSICIANS TOTAL CARE, INC.
----------
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. Developm