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Xolegel

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Xolegel

XOLEGEL®
(ketoconazole)

Xolegel

DRUG DESCRIPTION

XOLEGEL contains the antifungal agent ketoconazole USP at 2% in a topical anhydrous gel vehicle for topical administration.

Chemically, ketoconazole is (±)-cis-1-Acetyl-4-[p-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4yl]methoxy]phenyl]piperazine, with the molecular formula C26H28Cl2N4O4 and a molecular weight of 531.43.

Figure 1

XOLEGEL® (ketoconazole) Structural Formula Illustration

Each gram contains: 20 mg ketoconazole USP, dehydrated alcohol (34%), ascorbic acid, butylated hydroxytoluene, citric acid monohydrate, glycerin, hydroxypropyl cellulose, polyethylene glycol 400, PPG-15 stearyl ether, propylene glycol, FD&C yellow No. 6, and FD&C yellow No.10.

XOLEGEL is a smooth, translucent to clear, amber gel.

What are the possible side effects of ketoconazole topical (Extina, Kuric, Nizoral A-D, Nizoral Topical, Xolegel)?

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

Stop using ketoconazole topical and call your doctor if you have any of these serious side effects:

  • severe itching, burning, or irritation where the medicine is applied;
  • oily or dry scalp, mild hair loss;
  • redness, pain, or oozing of treated skin areas; or
  • eye redness, swelling, or irritation.

Less serious side effects...

Read All Potential Side Effects and See Pictures of Xolegel »

What are the precautions when taking ketoconazole (Xolegel)?

Before using ketoconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals such as clotrimazole, econazole, 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.

During pregnancy, this medication should be used only when clearly needed. 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 Xolegel »

Last reviewed on RxList: 6/22/2012
This monograph has been modified to include the generic and brand name in many instances.

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Xolegel - User Reviews

Xolegel User Reviews

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Here is a collection of user reviews for the medication Xolegel sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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