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:

Tasman Pharma 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) ; in the  treatment of cutaneous candidiasis caused by Candida spp. and in 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 (NDC 72641-005-15), 30 (NDC 72641-005-30), and 60 (NDC 72641-005-60) gram tubes.  Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F.) [see USP Controlled Room Temperature]. Manufactured For:  Tasman Pharma Inc.  Warminster, PA 18974 Made in Canada Rev. 07/2021   

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

KETOCONAZOLE CREAM, 2%- KETOCONAZOLE CREAM, 2% CREAM
TASMAN PHARMA INC.
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KETOCONAZOLE CREAM, 2%
DESCRIPTION
Ketoconazole cream, 2% 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, butylated hydroxyanisole, 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:
Molecular Formula: C
H
Cl
N O
Molecular Weight: 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
Ketaconozole is a boad spectrum synthetic anti-fungal 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
US