Sulconazole

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Sulconazole
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]

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Overview

Sulconazole is an antifungal that is FDA approved for the treatment of tinea pedis (athlete’s foot), tinea cruris, tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis and tinea versicolor. Common adverse reactions include pruritus.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • Sulconazole nitrate, 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.
  • A small amount of cream should be gently massaged into the affected and surrounding skin areas once or twice daily, except in tinea pedis, where administration should be twice daily.
  • Early relief of symptoms is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, tinea corporis/cruris and tinea versicolor should be treated for 3 weeks and tinea pedis for 4 weeks to reduce the possibility of recurrence.
  • If significant clinical improvement is not seen after 4 to 6 weeks of treatment, an alternate diagnosis should be considered.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sulconazole in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sulconazole in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Sulconazole in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sulconazole in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sulconazole in pediatric patients.

Contraindications

  • Sulconazole nitrate, 1.0% is contraindicated in patients who have a history of hypersensitivity to any of its ingredients.

Warnings

General
  • Sulconazole nitrate, 1.0% is for external use only. Avoid contact with the eyes. If irritation develops, the cream should be discontinued and appropriate therapy instituted.
Information for Patients
  • Patients should be told to use sulconazole nitrate as directed by the physician, to use it externally only, and to avoid contact with the eyes.
Carcinogenesis and Mutagenesis and Impairment of Fertility
  • Long-term animal studies to determine carcinogenic potential have not been performed. In vitro studies have shown no mutagenic activity.
  • Efficacy for this organism in the organ system was studied in fewer than ten infections.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Sulconazole in the drug label.

Postmarketing Experience

  • There were no systemic effects and only infrequent cutaneous adverse reactions in 1185 patients treated with sulconazole nitrate cream in controlled clinical trials. Approximately 3% of these patients reported itching, 3% burning or stinging, and 1% redness. These complaints did not usually interfere with treatment.

Drug Interactions

There is limited information regarding Sulconazole Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

  • There are no adequate and well controlled studies in pregnant women. Sulconazole nitrate should be used during pregnancy only if clearly needed. Sulconazole nitrate has been shown to be embryotoxic in rats when given in doses of 125 times the adult human dose (in mg/kg). The drug was not teratogenic in rats or rabbits at oral doses of 50 mg/kg/day.
  • Sulconazole nitrate given orally to rats at a dose 125 times the human dose resulted in prolonged gestation and dystocia. Several females died during the prenatal period, most likely due to labor complications.


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sulconazole in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Sulconazole during labor and delivery.

Nursing Mothers

It is not known whether sulconazole nitrate is excreted in human milk. Caution should be exercised when sulconazole nitrate is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children have not been established.

  • Efficacy for this organism in the organ system was studied in fewer than ten infections.

Geriatic Use

  • Clinical studies of sulconazole nitrate, 1.0%, did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients.

Gender

There is no FDA guidance on the use of Sulconazole with respect to specific gender populations.

Race

There is no FDA guidance on the use of Sulconazole with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Sulconazole in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Sulconazole in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Sulconazole in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Sulconazole in patients who are immunocompromised.

Administration and Monitoring

Administration

Monitoring

There is limited information regarding Monitoring of Sulconazole in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Sulconazole in the drug label.

Overdosage

There is limited information regarding Sulconazole overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

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Sulconazole
Systematic (IUPAC) name
1-(2-{[(4-Chlorophenyl)methyl]sulfanyl}-2-(2,4-dichlorophenyl)ethyl)-1H-imidazole
Identifiers
CAS number 61318-90-9
ATC code D01AC09
PubChem 5318
Chemical data
Formula C18H15Cl3N2S 
Mol. mass 397.749 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life ?
Excretion ?
Therapeutic considerations
Pregnancy cat.

?

Legal status
Routes Topical

Mechanism of Action

There is limited information regarding Sulconazole Mechanism of Action in the drug label.

Structure

  • Sulconazole nitrate, 1.0% is a broad-spectrum antifungal agent intended for topical application. Sulconazole nitrate, USP the active ingredient in sulconazole nitrate, is an imidazole derivative with in vitro antifungal and antiyeast activity. Its chemical name is (±)-1-[2,4-Dichloro-β-[(pchlorobenzyl)thio]phenethyl]imidazole mononitrate and it has the following chemical structure:
This image is provided by the National Library of Medicine.
  • 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 contains sulconazole nitrate 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.

Pharmacodynamics

There is limited information regarding Sulconazole Pharmacodynamics in the drug label.

Pharmacokinetics

  • 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 evidence of contact sensitization or irritation.

Nonclinical Toxicology

There is limited information regarding Sulconazole Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Sulconazole Clinical Studies in the drug label.

How Supplied

There is limited information regarding Sulconazole How Supplied in the drug label.

Storage

There is limited information regarding Sulconazole Storage in the drug label.

Images

Drug Images

Package and Label Display Panel

Sul 01.jpg
This image of the FDA label is provided by the National Library of Medicine.
Sul 02.jpg
This image of the FDA label is provided by the National Library of Medicine.
Sul 03.jpg
This image of the FDA label is provided by the National Library of Medicine.
Sul 04.jpg
This image of the FDA label is provided by the National Library of Medicine.
Sul 05.jpg
This image of the FDA label is provided by the National Library of Medicine.
Sul 06.jpg
This image of the FDA label is provided by the National Library of Medicine.

Patient Counseling Information

There is limited information regarding Sulconazole Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Sulconazole interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Sulconazole Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Sulconazole Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.







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