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Ketoconazole Gel and Pyrithione Zinc Shampoo

Generic Name: Ketoconazole Gel and Pyrithione Zinc Shampoo (KEE toe KON a zole & PIR i THYE one zink)
Brand Name: Xolegel Duo/Head & Shoulders, Xolegel Duo/Xolex

Uses of Ketoconazole Gel and Pyrithione Zinc Shampoo:

  • It is used to control seborrheic dermatitis.
  • It is used to treat dandruff.

What do I need to tell my doctor BEFORE I take Ketoconazole Gel and Pyrithione Zinc Shampoo?

  • If you have an allergy to ketoconazole, pyrithione zinc, or any other part of ketoconazole gel and pyrithione zinc shampoo.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

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 this medicine 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 Ketoconazole Gel and Pyrithione Zinc Shampoo?

All products:

  • Tell all of your health care providers that you take ketoconazole gel and pyrithione zinc shampoo. This includes your doctors, nurses, pharmacists, and dentists.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Shampoo:

  • This medicine may cause harm if swallowed. If ketoconazole gel and pyrithione zinc shampoo is swallowed, call a doctor or poison control center right away.

How is this medicine (Ketoconazole Gel and Pyrithione Zinc Shampoo) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

All products:

  • Use as you have been told, even if your signs get better.
  • To gain the most benefit, do not miss doses.
  • Do not take ketoconazole gel and pyrithione zinc shampoo by mouth. Use on your scalp and hair only. Keep out of your mouth, nose, ears, and eyes (may burn).
  • This medicine may catch on fire. Do not use near an open flame or while smoking.

Gel:

  • Wash your hands before and after use.
  • Put a thin layer of gel on the affected part and rub in gently.

Shampoo:

  • Shake well before use.
  • Wet hair and scalp.
  • Put on enough shampoo to make a lather.
  • Lather well and leave on as you have been told.
  • Rinse well.

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 take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad scalp irritation.
  • Very bad skin irritation.

What are some other side effects of Ketoconazole Gel and Pyrithione Zinc Shampoo?

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:

  • Scalp irritation.
  • Skin irritation.
  • Burning.

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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Side Effects (complete list)

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 Ketoconazole Gel and Pyrithione Zinc Shampoo?

  • Store at room temperature. Do not refrigerate or freeze.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • 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.

This information should not be used to decide whether or not to take ketoconazole gel and pyrithione zinc shampoo or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 ketoconazole gel and pyrithione zinc shampoo. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: December 6, 2017

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