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-(lH-imidazol-1 -ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine, with the molecular formula C26H28Cl2N4O4 and a molecular weight of 531.43.

Figure 1

KLONOPIN® 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 (ketoconazole) 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...

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 »


Xolegel Consumer (continued)

SIDE EFFECTS: Burning, redness, or dryness of the treated skin may occur. If any of these effects persist or worsen, tell 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 rare but very serious side effects occur: blisters/open sores on the treated skin, eye swelling.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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.

PRECAUTIONS: 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 breast-feeding.


Xolegel Patient Information Including Side Effects

Brand Names: Extina, Kuric, Nizoral A-D, Nizoral Topical, Xolegel

Generic Name: ketoconazole topical (Pronunciation: kee toe KOE na zole)

  • What is ketoconazole topical (Xolegel)?
  • What are the possible side effects of ketoconazole topical (Xolegel)?
  • What is the most important information I should know about ketoconazole topical (Xolegel)?
  • What should I discuss with my healthcare provider berfore using ketoconazole topical (Xolegel)?
  • How should I apply ketoconazole topical (Xolegel)?
  • What happens if I miss a dose (Xolegel)?
  • What happens if I overdose (Xolegel)?
  • What should I avoid while using ketoconazole topical (Xolegel)?
  • What other drugs will affect ketoconazole topical (Xolegel)?
  • Where can I get more information?

What is ketoconazole topical (Xolegel)?

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

Ketoconazole topical is used to treat fungal infections of the skin such as athlete's foot, jock itch, ringworm, and seborrhea (dry, flaking skin).

Ketoconazole topical is available as a cream, gel, and as a shampoo. The shampoo is used for the treatment of dandruff.

Ketoconazole topical may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of ketoconazole 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 include:

  • mild skin itching or irritation;
  • dry skin; or
  • headache.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ketoconazole topical (Xolegel)?

Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

Do not use bandages or dressings over the treated skin areas, unless your doctor has told you to.

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

Wait at least 20 minutes after applying this medicine before you use cosmetics or sunscreen on the treated skin area. Do not wash the treated skin for at least 3 hours after applying ketoconazole topical.

Call your doctor if your condition does not improve within 2 weeks, or if your symptoms get worse.

Stop using ketoconazole topical and call your doctor if you have severe burning, irritation, redness, pain, or oozing where the medicine is applied.

Ketoconazole topical gel is flammable. Do not use it while you are smoking or near an open flame.

Do not use this medication on a child younger than 12 years old.

Related Drug Centers
  • Xolegel
  • Ketoconazole Cream
  • Extina


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