Exelderm® (sulconazole nitrate,USP) Solution, 1.0%

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sun Pharmaceutical Industries, Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a broad-spectrum antifungal agent indicated for the treatment of tinea cruris and tinea corporis caused by Trichophyton rubrum , Trichophyton mentagrophytes , Epidermophyton floccosum , and Microsporum canis ; and for the treatment of tinea versicolor. Effectiveness has not been proven in tinea pedis (athlete’s foot). Symptomatic relief usually occurs within a few days after starting EXELDERM SOLUTION and clinical improvement usually occurs within one week. EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is contraindicated in patients who have a history of hypersensitivity to any of the ingredients.

Product summary:

EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a clear, slightly viscous, colorless to slightly yellow liquid with a slight characteristic odor. It is supplied as follows: 30 mL        Plastic Bottle         NDC 10631-100-30 2 x 30 mL       Plastic Bottle         NDC 10631-100-04 Avoid excessive heat, above 40°C (104°F), and protect from light. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or 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

Authorization status:

New Drug Application

Summary of Product characteristics

EXELDERM- SULCONAZOLE NITRATE SOLUTION
SUN PHARMACEUTICAL INDUSTRIES, INC.
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EXELDERM
(SULCONAZOLE NITRATE,USP)
SOLUTION, 1.0%
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION
EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a broad-spectrum
antifungal agent
intended for topical application. Sulconazole nitrate, USP, the active
ingredient in EXELDERM
SOLUTION, is an imidazole derivative with 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 SOLUTION contains sulconazole nitrate, USP 10 mg/mL in a
solution of propylene
glycol, poloxamer 407, polysorbate 20, butylated hydroxyanisole, and
purified water, with sodium
hydroxide and, if necessary, nitric acid added to adjust the pH.
CLINICAL PHARMACOLOGY
Sulconazole nitrate is an imidazole derivative that inhibits the
growth of the common pathogenic
dermatophytes including _Trichophyton rubrum_, _Trichophyton
mentagrophytes_, _Epidermophyton floccosum_,
and _Microsporum canis_. It also inhibits the organism responsible for
tinea versicolor, _Malassezia furfur_,
and certain gram positive bacteria.
A maximization test with sulconazole nitrate solution showed no
evidence of irritation or contact
sensitization.
INDICATIONS AND USAGE
EXELDERM (sulconazole nitrate, USP) SOLUTION, 1.0% is a broad-spectrum
antifungal agent
indicated for the treatment of tinea cruris and tinea corporis caused
by _Trichophyton rubrum_,
_Trichophyton mentagrophytes_, _Epidermophyton floccosum_, and
_Microsporum canis_; and for the treatment of
®
tinea versicolor. Effectiveness has not been proven in tinea pedis
(athlete’s foot).
Symptomatic relief usually occurs within