Xolegel

Generic name: ketoconazole topical
Drug class: Topical antifungals

Medically reviewed by A Ras MD.

What is Xolegel used for?

Xolegel is a prescription medicine that is used to control seborrheic dermatitis.

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-4-yl]methoxy]phenyl]piperazine, with the molecular formula C26H28Cl2N4O4 and a molecular weight of 531.43.

Figure 1

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.

Mechanism of Action

The mechanism of action of ketoconazole in the treatment of seborrheic dermatitis is unknown.

Before taking Xolegel, tell your doctor:

If you are allergic to Xolegel; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Xolegel with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Xolegel?

Tell all of your health care providers that you take Xolegel. This includes your doctors, nurses, pharmacists, and dentists.
Talk with your doctor before you use other drugs or products on your skin.
This medicine may cause harm if swallowed. If Xolegel is swallowed, call a doctor or poison control center right away.
This medicine may catch on fire. Do not use near an open flame or while smoking.
Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Xolegel best taken?

Do not take Xolegel by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
Use as you have been told, even if your signs get better.
Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
Clean affected part before use. Make sure to dry well.
Put a thin layer on the affected skin and rub in gently.
Do not use coverings (bandages, dressings) unless told to do so by the doctor.
If your skin is broken or swollen, talk with your doctor before using Xolegel. Some drugs are not for use on broken or swollen skin.
Do not bathe, shower, or swim for 3 hours after putting on.

What do I do if I miss a dose?

Use a missed dose as soon as you think about it.
If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
Do not use 2 doses at the same time or extra doses.

What are the side effects of Xolegel that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

What are some other side effects of Xolegel?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

Burning.
Irritation where Xolegel is used.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

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.

How do I store and/or throw out Xolegel?

Store at room temperature. Do not refrigerate or freeze.
Store in a dry place. Do not store in a bathroom.
Protect from heat or open flame.
Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – 45 g Carton

NDC 16110-080-45
Xolegel®
(ketoconazole) Gel, 2%
AQUA
PHARMACEUTICALS
45 grams
Rx only. For topical use only.

SRC: NLM .

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