SULCONAZOLE NITRATE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Sulconazole Nitrate (UNII: 1T89100D5U) (SULCONAZOLE - UNII:5D9HAA5Q5S)

Available from:

JG Pharma

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SULCONAZOLE NITRATE 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 mentagro- phytes, Epidermophyton floccosum , and Microsporum canis ,* and for the treatment of tinea versicolor. SULCONAZOLE NITRATE cream 1.0% is contraindicated in patients who have a history of hypersensitivity to any of its ingredients.

Product summary:

SULCONAZOLE NITRATE cream 1.0% is a smooth, glossy white to off-white cream having a slight characteristic odor. It is supplied as follows:             60 g tube - NDC 72143-311-60 Avoid excessive heat, above 40° C (104° F). To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Manufactured for: JG Pharma Scottsdale, AZ 85258 www.JGPharmainc.com 141079 September 2019

Authorization status:

New Drug Application

Summary of Product characteristics

SULCONAZOLE NITRATE- SULCONAZOLE NITRATE CREAM
JG PHARMA
----------
SULCONAZOLE NITRATE
CREAM 1.0%
RX ONLY
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION
SULCONAZOLE NITRATE cream 1.0% is a broad-spectrum antifungal agent
intended for topical
application. Sulconazole nitrate, USP, the active ingredient in
SULCONAZOLE NITRATE 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.
SULCONAZOLE NITRATE 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_
_mentagro- phytes, 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 evidence of cont