KETOCONAZOLE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Ketoconazole Cream, 2% is supplied in NDC: 70518-3367-00 PACKAGING: 1 in 1 CARTON, 30 g in 1 TUBE TYPE 0 Store at 20° to 25°C (68° to 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

KETOCONAZOLE- KETOCONAZOLE CREAM
REMEDYREPACK INC.
----------
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%.
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 thos