KETOCONAZOLE- ketoconazole cream, 2% cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Encube Ethicals Private Limited

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 . 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.

Product summary:

Ketoconazole Cream, 2% is supplied in 15, 30, and 60 gram tubes. 15 g tube (21922- 025-04) 30 g tube (21922- 025-05) 60 g tube (21922- 025-07) STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Mfg Lic No. : 361 Manufactured by : Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India.   Distributed by: Encube Ethicals, Inc. 200 Meredith Avenue, Suite 101A Durham, NC 27713 USA Rev: 03 May 2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

KETOCONAZOLE- KETOCONAZOLE CREAM, 2% CREAM
ENCUBE ETHICALS PRIVATE LIMITED
----------
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-(1H-imidazol-1-ylmethyl)-1,3-
dioxolan-4-yl]methoxy]phenyl] piperazine and has the following
structural formula:
M. 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
26
28
2
4
4
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 orbi