Xolegel



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

What is Xolegel?

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

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

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

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

What is the most important information I should know about 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 Xolegel.

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

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

Xolegel 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.

What should I discuss with my healthcare provider berfore using Xolegel?

Do not use this medication if you are allergic to ketoconazole.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether Xolegel 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.

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

How should I apply Xolegel?

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

Do not use this medication for any skin condition that has not been diagnosed by a doctor.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply a thin layer of the cream or gel to the affected skin area as directed. This medicine is usually used for only 2 to 4 weeks.

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 Xolegel.

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

Use the shampoo twice per week, unless your doctor has told you otherwise. Apply enough shampoo to create a lather and massage the scalp for 1 minute. Rinse thoroughly and repeat, leaving the lather on for an additional 3 minutes. Then rinse it off completely. Allow at least 3 days to pass between uses of ketoconazole shampoo.

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

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

Store Xolegel at room temperature away from moisture and heat.

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

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it.

An overdose of Xolegel applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using Xolegel?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water.

Avoid covering treated skin areas with tight-fitting, synthetic clothing (such as nylon or polyester) that doesn't allow air to circulate to your skin. If you are treating your feet, wear clean cotton socks and sandals or shoes that allow for air circulation. Keep your feet as dry as possible.

Avoid using other skin or hair products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

What are the possible side effects of 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 Xolegel 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 other drugs will affect Xolegel?

There may be other drugs that can affect Xolegel. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about ketoconazole.


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.