Exelderm

Patients should be told to use EXELDERM (sulconazole) SOLUTION as directed by the physician, to use it externally only, and to avoid contact with the eyes.

Exelderm is part of the drug class:

• Imidazole and triazole derivatives

Sulconazole topical is an antifungal medication. Sulconazole topical prevents fungus from growing on your skin.

Sulconazole topical is used to treat skin infections such as athlete's foot (cream only), jock itch, and ringworm.

Sulconazole topical may also be used for other purposes not listed in this medication guide.

Administration

Topical Administration

Apply topically to the skin as a 1% cream or solution.1 3

Do not apply to the eye or administer orally or intravaginally.1 3 19

Apply a sufficient amount of cream or solution; rub gently into affected area and immediately surrounding healthy skin.1 3 14 15 26

Dosage

Adults

Apply 1% cream or solution once or twice daily1 3 14 15 26 for 3 weeks.1 3

If clinical improvement does not occur after 4–6 weeks of treatment, reevaluate diagnosis.3 58

Apply 1% cream twice daily3 14 15 26 for 4 weeks.1 3 58

If clinical improvement does not occur after 4–6 weeks of treatment, reevaluate diagnosis.3 58 Chronic moccasin-type (dry-type) tinea pedis may require 4–8 weeks or longer.15 40

Apply 1% cream or solution once or twice daily1 3 14 15 26 for 3 weeks.1 3

If clinical improvement does not occur after 4–6 weeks of treatment, reevaluate diagnosis.1 3

Special Populations

No special population dosage recommendations at this time.1 3

Absorption

Bioavailability

Low amounts of sulconazole are absorbed systemically following topical application to skin.2 16 19 34

Distribution

Extent

Not known whether sulconazole is distributed into milk.1 3

Elimination

Elimination Route

Systemically absorbed drug is excreted in urine (6.7%) and feces (2%).16

• Importance of completing full course of treatment, even if symptoms improve.1 3

• Importance of contacting clinician if skin condition worsens during treatment or if improvement does not occur after completing full course of therapy.1 3

• Importance of discontinuing use and consulting clinician if treated area becomes irritated.1 3

• Importance of applying to affected areas as directed1 3 and avoiding contact with eyes and not applying intravaginally.1 3 19

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1 3

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 3

• Importance of informing patients of other important precautionary information.1 3 (See Cautions.)

• Tell all of your health care providers that you take Exelderm. This includes your doctors, nurses, pharmacists, and dentists.
• If you use this medicine too often, your skin problem may become worse.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Exelderm while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Exelderm, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Exelderm. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Exelderm.

Review Date: October 4, 2017

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.

Exelderm (sulconazole nitrate, USP) CREAM, 1.0% is contraindicated in patients who have a history of hypersensitivity to any of its ingredients.

In a vehicle-controlled study for the treatment of tinea pedis (moccasin type) due to T. rubrum, after 4-6 weeks of treatment 69% of patients on the active drug and 19% of patients on the drug vehicle had become KOH and culture negative. In addition, 68% of patients on the active drug and 20% of patients on the drug vehicle showed a good or excellent clinical response.

Summary of Use during Lactation

Topical sulconazole has not been studied during breastfeeding. About 11% of a dose is absorbed after topical application. It is considered a low risk to the nursing infant;[1] however, other antifungal agents with less absorption may be preferred, especially while nursing a newborn or preterm infant. Avoid application to the nipple area and ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.[2]

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Clotrimazole, Miconazole

References

1. Leachman SA, Reed BR. The use of dermatologic drugs in pregnancy and lactation. Dermatol Clin. 2006;24:167-97. PMID: 16677965

2. Noti A, Grob K, Biedermann M et al. Exposure of babies to C(15)-C(45) mineral paraffins from human milk and breast salves. Regul Toxicol Pharmacol. 2003;38:317-25. PMID: 14623482

LactMed Record Number

544

Last Revision Date

20130907

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.