TRIAMAZOLE- econazole nitrate ,triamcinolone acetonide kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ECONAZOLE NITRATE (UNII: H438WYN10E) (ECONAZOLE - UNII:6Z1Y2V4A7M)

Available from:

PureTek Corporation

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Econazole Nitrate Cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum, in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor Econazole Nitrate Cream is contraindicated in individuals who have shown hypersensitivity to any of its ingredients. Triamcinolone Acetonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio. HPA axis s

Product summary:

Econazole Nitrate Cream 1% is supplied in the following: 15 gram tubes (NDC 52565-022-15) 30 gram tubes (NDC 52565-022-30) 85 gram tubes (NDC 52565-022-85) Store at controlled room temperature 20° - 25°C (68° - 77°F). Triamcinolone Acetonide Ointment USP, 0.1% is supplied in the following sizes: 15 g tube – NDC 52565-014-15 80 g tube – NDC 52565-014-80 1 lb (454 g) jar – NDC 52565-014-26

Authorization status:

unapproved drug other

Summary of Product characteristics

TRIAMAZOLE- ECONAZOLE NITRATE ,TRIAMCINOLONE ACETONIDE
PURETEK CORPORATION
_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._
----------
TRIAMAZOLE
RX ONLY
FOR TOPICAL USE ONLY
DESCRIPTION
Econazole Nitrate Cream contains the antifungal agent, econazole
nitrate 1% in a water miscible base
consisting of pegoxol 7 stearate, peglicol 5 oleate, mineral oil,
benzoic acid, butylated hydroxyanisole,
and purified water. The white to off-white soft cream is for topical
use only.
Chemically, econazole nitrate is 1-[2-{(4-chloro-phenyl)
methoxy}-2-(2,4-dichlorophenyl)ethyl]-1H-
imidazole mononitrate. Its structure is as follows:
CLINICAL PHARMACOLOGY
After topical application to the skin of normal subjects, systemic
absorption of econazole nitrate is
extremely low. Although most of the applied drug remains on the skin
surface, drug concentrations
were found in the stratum corneum which, by far, exceeded the minimum
inhibitory concentration for
dermatophytes. Inhibitory concentrations were achieved in the
epidermis and as deep as the middle
region of the dermis. Less than 1% of the applied dose was recovered
in the urine and feces.
MICROBIOLOGY
Econazole nitrate has been shown to be active against most strains of
the following microorganisms,
both in vitro and in clinical infections as described in the
INDICATIONS AND USAGE section.
DERMATOPHYTES
YEAS TS
Epidermophyton floccosum
Candida albicans
Microsporum audouini
Malassezia furfur
Microsporum canis
Microsporum gypseum
Trichophyton mentagrophytes
Trichophyton rubrum
Trichophyton tonsurans
Econazole nitrate exhibits broad-spectrum antifungal activity against
the following organisms in vitro,
but the clinical significance of these data is unknown.
DERMATOPHYTES
YEAS TS
Trichophyton verrucosum Candida guillermondii
Candida parapsilosis
Candida tropicalis
INDICATIONS AND USAGE
Econazole Nitrate Cream is indicated for topical application in the