Exelderm (Sulconazole)
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Exelderm (Sulconazole)

Exelderm®
(sulconazole nitrate) Solution, 1.0%

For topical use only. Not for ophthalmic use.

DRUG DESCRIPTION

EXELDERM (sulconazole nitrate) SOLUTION, 1.0% is a broad-spectrum antifungal agent intended for topical application. Sulconazole nitrate, the active ingredient in EXELDERM (sulconazole) 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:

Exelderm® 
  (sulconazole nitrate) Structural Formula Illustration

Sulconazole nitrate 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 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.

What are the possible side effects of sulconazole topical (Exelderm)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using sulconazole topical and call your doctor at once if you have severe blistering, itching, redness, peeling, dryness, or irritation of treat skin areas.

Less serious side effects may include mild skin dryness or irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at...

Read All Potential Side Effects and See Pictures of Exelderm »

What are the precautions when taking sulconazole (Exelderm)?

Before using sulconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals such as clotrimazole, ketoconazole, or miconazole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Exelderm »

Last reviewed on RxList: 7/23/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

EXELDERM (sulconazole nitrate) 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 (sulconazole) SOLUTION and clinical improvement usually occurs within one week.

DOSAGE AND ADMINISTRATION

A small amount of the solution should be gently massaged into the affected and surrounding skin areas once or twice daily.

Symptomatic relief usually occurs within a few days after starting EXELDERM (sulconazole nitrate) SOLUTION, 1.0%, and clinical improvement usually occurs within one week. To reduce the possibility of recurrence, tinea cruris, tinea corporis, and tinea versicolor should be treated for 3 weeks.

If significant clinical improvement is not seen after 4 weeks of treatment, an alternate diagnosis should be considered.

HOW SUPPLIED

EXELDERM (sulconazole) SOLUTION, 1.0%

5 mL Plastic Bottle NDC 10631-100-32
(Physician Sample Not for Sale)
30 mL Plastic Bottle NDC 10631-100-30

Avoid excessive heat, above 40°C (104°F), and protect from light.

Developed by Syntex. RANBAXY Jacksonville, FL 32257 USA. Revised February 2009.

Last reviewed on RxList: 7/23/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

There were no systemic effects and only infrequent cutaneous adverse reactions in 370 patients treated with sulconazole nitrate solution in controlled clinical trials. Approximately 1% of these patients reported itching and 1% burning or stinging. These complaints did not usually interfere with treatment.

Read the Exelderm (sulconazole) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 7/23/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

No information provided.

PRECAUTIONS

General

EXELDERM (sulconazole nitrate) SOLUTION, 1.0% is for external use only. Avoid contact with the eyes. If irritation develops, the solution should be discontinued and appropriate therapy instituted.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies to determine carcinogenic potential have not been performed. In vitro studies have shown no mutagenic activity.

Pregnancy

Pregnancy Category C

Sulconazole nitrate has been shown to be embryotoxic in rats when given in doses 125 times the human dose (in mg/kg). The drug at this dose given orally to rats also resulted in prolonged gestation and dystocia. Several females died during the perinatal period, most likely due to labor complications. Sulconazole nitrate was not teratogenic in rats or rabbits at oral doses of 50 mg/kg/day.

There are no adequate and well-controlled studies in pregnant women. Sulconazole nitrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are 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.

Geriatric Use

Clinical studies of EXELDERM (sulconazole) SOLUTION, 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.

Last reviewed on RxList: 7/23/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

EXELDERM (sulconazole nitrate) SOLUTION, 1.0% is contraindicated in patients who have a history of hypersensitivity to any of the ingredients.

Last reviewed on RxList: 7/23/2009
This monograph has been modified to include the generic and brand name in many instances.

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.

Last reviewed on RxList: 7/23/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

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.

Last reviewed on RxList: 7/23/2009
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

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.

Last reviewed on RxList: 7/23/2009
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Exelderm Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

SULCONAZOLE CREAM - TOPICAL

(sul-KON-a-zole)

COMMON BRAND NAME(S): Exelderm

USES: Sulconazole is used to treat skin infections such as athlete's foot, jock itch and ringworm. This medication is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs. Sulconazole is an azole antifungal that works by preventing the growth of fungus.

HOW TO USE: Use this medication on the skin only. Clean and thoroughly dry the area to be treated. Apply this medication to the affected skin, usually once or twice a day or as directed by your doctor. Dosage and length of treatment depends on the type of infection being treated. Do not apply this more often than prescribed. Your condition will not clear faster, but side effects may be increased.

Apply enough cream to cover the affected area and some of the surrounding skin. After applying this medication, wash your hands. Do not wrap, cover or bandage the area unless directed to do so by your doctor.

Do not apply this medication in the eyes, nose, mouth, or vagina.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time(s) each day.

Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after starting sulconazole. Stopping the medication too early may allow the fungus to continue to grow, which may result in a relapse of the infection.

Inform your doctor if your condition persists after 4-6 weeks of treatment or worsens at any time.

Disclaimer

Exelderm Consumer (continued)

SIDE EFFECTS: Burning, stinging, swelling, irritation, redness, pimple-like bumps, tenderness, or flaking of the treated skin may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: blistering, oozing, open sores.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Exelderm (sulconazole) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using sulconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals such as clotrimazole, ketoconazole, or miconazole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Exelderm Consumer (continued)

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in those cases.

When treating pityriasis, this medication may not cause an immediate return to normal skin color. It may take several months after treatment is completed for your natural skin color to return.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature below 104 degrees F (40 degrees C) away from high heat and light. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised May 2010. Copyright(c) 2010 First Databank, Inc.

Exelderm Patient Information Including Side Effects

Brand Names: Exelderm

Generic Name: sulconazole topical (Pronunciation: sul KON a zole)

What is sulconazole topical (Exelderm)?

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.

What are the possible side effects of sulconazole topical (Exelderm)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using sulconazole topical and call your doctor at once if you have severe blistering, itching, redness, peeling, dryness, or irritation of treat skin areas.

Less serious side effects may include mild skin dryness or irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Exelderm (sulconazole) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about sulconazole topical (Exelderm)?

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Avoid getting this medication in your eyes, nose, or mouth.

Side Effects Centers

Exelderm Patient Information including How Should I Take

What should I discuss with my healthcare provider before using sulconazole topical (Exelderm)?

You should not use this medication if you are allergic to sulconazole.

FDA pregnancy category C. It is not known whether sulconazole is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether sulconazole passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use sulconazole topical (Exelderm)?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply the cream or solution once or twice daily as directed for 3 to 6 weeks.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

If the infection does not clear up in 3 weeks (or 4 weeks for athlete's foot), or if it appears to get worse, see your doctor.

Do not use bandages or dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.

Store sulconazole topical at room temperature away from moisture and heat.

Side Effects Centers

Exelderm Patient Information including If I Miss a Dose

What happens if I miss a dose (Exelderm)?

Apply the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to apply the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Exelderm)?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of sulconazole topical is not likely to cause life-threatening symptoms.

What should I avoid while using sulconazole topical (Exelderm)?

Avoid getting this medication in your eyes, nose, or mouth.

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Avoid using other medicated skin products unless your doctor has told you to. Other skin medications may make sulconazole topical less effective.

What other drugs will affect sulconazole topical (Exelderm)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied sulconazole. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist has additional information about sulconazole topical.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.08. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers

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