PEDIZOLPAK- ketoconazole,miconazole nitrate kit

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

NuCare Pharmaceuticals,Inc.

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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. Antifungal Cures most athlete's foot ( tinea pedis) and ringworm (tinea corporis) for effective relief of itchy,scaly skin between the toes.

Περίληψη προϊόντος:

Ketoconazole cream, 2% is supplied in 15 g (NDC 51672-1298-1). Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

unapproved drug other

Αρχείο Π.Χ.Π.

PEDIZOLPAK- KETOCONAZOLE,MICONAZOLE NITRATE
NUCARE PHARMACEUTICALS,INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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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
26
28
2
4
4
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. audouin