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Ketoconazole/ hydrocortisone gel

Generic Name: ketoconazole/hydrocortisone (KEE-toe-KON-a-zole/HYE-droe-KOR-ti-sone)
Brand Name: Xolegel CorePak

Ketoconazole/ hydrocortisone gel is used for:

Treating a skin condition called seborrheic dermatitis. It may also help to reduce itching, redness, and swelling.

Ketoconazole/hydrocortisone gel kit contains an antifungal medicine and a topical corticosteroid. The antifungal works by killing the fungus causing the skin condition. The corticosteroid works by reducing skin inflammation, which helps relieve redness, swelling, itching, and irritation.

Do NOT use ketoconazole/ hydrocortisone gel if:

  • you are allergic to any ingredient in ketoconazole/hydrocortisone gel

Contact your doctor or health care provider right away if this applies to you.

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Before using ketoconazole/ hydrocortisone gel:

Some medical conditions may interact with ketoconazole/hydrocortisone gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a weakened immune system, liver problems, or the blood disease porphyria
  • if you have a skin infection, measles, thinning of the skin, tuberculosis (TB), chickenpox, shingles, a positive TB skin test, or have recently had a vaccination

Some MEDICINES MAY INTERACT with ketoconazole/hydrocortisone gel. Because little, if any, of ketoconazole/hydrocortisone gel is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if ketoconazole/hydrocortisone gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use ketoconazole/ hydrocortisone gel:

Use ketoconazole/hydrocortisone gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with ketoconazole/hydrocortisone gel. Talk to your pharmacist if you have questions about this information.
  • Wash your hands before and immediately after using ketoconazole/hydrocortisone gel.
  • To use the antifungal: Spread a thin layer of the medicine onto the affected area with the tips of your fingers. Gently rub it in. Be sure to cover the entire affected area and the healthy skin around it.
  • Do not touch your eyes or nose while you are applying ketoconazole/hydrocortisone gel.
  • Wait for at least 20 minutes after you apply ketoconazole/hydrocortisone gel before you apply makeup or sunscreen.
  • Do not wash the area where you applied ketoconazole/hydrocortisone gel for at least 3 hours after you apply it.
  • To use the topical corticosteroid: Apply a small amount of medicine to the affected area. Gently rub it in until it is evenly distributed.
  • Do not bandage or wrap the affected area unless directed otherwise by your doctor.
  • If you miss a dose of ketoconazole/hydrocortisone gel, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use ketoconazole/hydrocortisone gel.

Important safety information:

  • Ketoconazole/hydrocortisone gel is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in your eyes, rinse at once with cool tap water. Do not get ketoconazole/hydrocortisone gel in your vagina.
  • Do not use ketoconazole/hydrocortisone gel for other skin conditions at a later time.
  • Ketoconazole/hydrocortisone gel is flammable. Do not store or use near an open flame. Do not smoke during or right after use of ketoconazole/hydrocortisone gel.
  • Check with your doctor before receiving vaccinations while you are using ketoconazole/hydrocortisone gel.
  • Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use ketoconazole/hydrocortisone gel, especially if the child is using a large amount of it or using it for a long period of time.
  • Ketoconazole/hydrocortisone gel should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using ketoconazole/hydrocortisone gel while you are pregnant. It is not known if ketoconazole/hydrocortisone gel is found in breast milk after topical use. If you are or will be breast-feeding while you use ketoconazole/hydrocortisone gel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of ketoconazole/ hydrocortisone gel:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild skin irritation or dryness; mild, temporary burning or stinging at the application site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); infection; new or worsening irritation, pain, redness, blistering, or severe burning at the application site; skin thinning or discoloration.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of ketoconazole/hydrocortisone gel:

Store ketoconazole/hydrocortisone gel at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do NOT store near an open flame. Keep ketoconazole/hydrocortisone gel out of the reach of children and away from pets.

General information:

  • If you have any questions about ketoconazole/hydrocortisone gel, please talk with your doctor, pharmacist, or other health care provider.
  • Ketoconazole/hydrocortisone gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take ketoconazole/hydrocortisone gel or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about ketoconazole/hydrocortisone gel. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to ketoconazole/hydrocortisone gel. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using ketoconazole/hydrocortisone gel.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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