EXELDERM- sulconazole nitrate cream

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

SULCONAZOLE NITRATE (UNII: 1T89100D5U) (SULCONAZOLE - UNII:5D9HAA5Q5S)

Предлага се от:

Sun Pharmaceutical Industries, Inc.

Начин на приложение:

TOPICAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is an antifungal agent indicated for the treatment of tinea pedis (athlete’s foot), tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis ,* and for the treatment of tinea versicolor. EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is contraindicated in patients who have a history of hypersensitivity to any of its ingredients.

Каталог на резюме:

EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is a smooth glossy white to off-white cream having slight characteristic odor. It is supplied as follows: 15 g tube - NDC 10631-101-15 30 g tube - NDC 10631-101-30 60 g tube - NDC 10631-101-60 Avoid excessive heat, above 40°C (104°F). To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 www.fda.gov/medwatch . Manufactured by: DPT Laboratories Inc. San Antonio, TX 78215 Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Revised May 2018

Статус Оторизация:

New Drug Application

Данни за продукта

EXELDERM- SULCONAZOLE NITRATE CREAM
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
EXELDERM (SULCONAZOLE NITRATE, USP)
CREAM, 1.0%
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION
EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is a broad-spectrum
antifungal agent intended
for topical application. Sulconazole nitrate, USP the active
ingredient in EXELDERM CREAM, is an
imidazole derivative with _in vitro _antifungal and antiyeast
activity. Its chemical name is (±)-1-[2,4-
Dichloro-β-[(_p_chlorobenzyl)thio]phenethyl]imidazole mononitrate and
it has the following chemical
structure:
Sulconazole nitrate, USP is a white to off-white crystalline powder
with a molecular weight of 460.77.
It is freely soluble in pyridine; slightly soluble in ethanol,
acetone, and chloroform; and very slightly
soluble in water. It has a melting point of about 130°C.
EXELDERM CREAM contains sulconazole nitrate, USP 10 mg/g in an
emollient cream base consisting
of propylene glycol, stearyl alcohol, isopropyl myristate, cetyl
alcohol, polysorbate 60, sorbitan
monostearate, glyceryl stearate (and) PEG-100 stearate, ascorbyl
palmitate, and purified water, with
sodium hydroxide and/or nitric acid added to adjust the pH.
CLINICAL PHARMACOLOGY
Sulconazole nitrate is an imidazole derivative with broad-spectrum
antifungal activity that inhibits the
growth _in vitro _of the common pathogenic dermatophytes including
_Trichophyton rubrum, Trichophyton_
_mentagrophytes, Epidermophyton floccosum _and _Microsporum canis_. It
also inhibits (_in vitro_) the organism
responsible for tinea versicolor, _Malassezia furfur_. Sulconazole
nitrate has been shown to be active _in_
_vitro _against the following microorganisms, although clinical
efficacy has not been established:
_Candida albicans _and certain gram positive bacteria.
A modified Draize test showed no allergic contact dermatitis and a
phototoxicity study showed no
phototoxic or photoallergic reaction to sulconazole nitrate cream.
Maximization tests with sulconazole
nitrate cream showed no e