KETOCONAZOLE cream

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

REMEDYREPACK INC.

administration_route:

TOPICAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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.

leaflet_short:

Ketoconazole cream, 2% is supplied in NDC: 70518-0762-00 1 in 1 CARTON, 30g in 1 TUBE Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

authorization_status:

Abbreviated New Drug Application

SPC

KETOCONAZOLE- KETOCONAZOLE CREAM
REMEDYREPACK INC.
----------
KETOCONAZOLE
CREAM, 2%
RX ONLY
DESCRIPTION
Ketoconazole cream, 2% contains the broad-spectrum synthetic
antifungal agent,
ketoconazole 2%, formulated in an aqueous cream vehicle consisting of
butylated
hydroxyanisole (BHA), cetyl alcohol, isopropyl myristate, polysorbate
60, polysorbate
80, propylene glycol, purified water, sorbitan monostearate and
stearyl alcohol.
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:
Molecular Formula: C
H
Cl
N
O
Molecular Weight: 531.43
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%.
26
28
2
4
4
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