Ketoconazole

What it is used for

• Ketoconazole tablets are prescription medicine used to treat serious fungal infections including: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis.
• Ketoconazole tablets are not for people with fungal nail infections.
• Ketoconazole tablets have not been approved for the treatment of advanced prostate cancer or Cushing's syndrome. The safety and efficacy have not been established.
• Ketoconazole tablets should only be used in children if prescribed by the healthcare provider who has determined that the benefits outweigh the risks.

The most important thing to know

Ketoconazole tablets is not the only medicine available to treat fungal infections and should only be used when other medicines are not right for you. Talk to your healthcare provider to find out if ketoconazole tablets are right for you.

How to take it

• Take ketoconazole tablets 1 time each day.
• Do not stop taking ketoconazole tablets without first talking to your healthcare provider.

Side effects, and when to stop

• liver problems (hepatotoxicity). Some people who were treated with ketoconazole the active ingredient in ketoconazole tablets, had serious liver problems that led to death or the need for a liver transplant. Call your healthcare provider right away if you have any of the following symptoms:
  • loss of appetite or start losing weight (anorexia)
  • nausea or vomiting
  • feel tired
  • stomach pain or tenderness
  • dark urine or light colored stools
  • yellowing of your skin or the whites of your eyes
  • fever or rash
• changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heart beats that can be life threatening. This can happen when ketoconazole tablets are taken with certain medicines, such as dofetilide, quinidine, pimozide, cisapride, methadone, disopyramide, dronedarone, and ranolazine. Talk to your healthcare provider about other medicines you are taking before you start taking ketoconazole tablets. Tell your healthcare provider right away if you feel faint, lightheaded, dizzy, or feel your heart beating irregularly or fast. These may be symptoms related to QT prolongation.

Ketoconazole tablets may cause serious side effects, including:

• adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Ketoconazole tablets may cause adrenal insufficiency if you take a high dose. Your healthcare provider will follow you closely if you have adrenal insufficiency or if you are taking prednisone or other similar medicines for long periods of time. Call your healthcare provider right away if you have symptoms of adrenal insufficiency such as tiredness, weakness, dizziness, nausea, and vomiting.
• serious allergic reactions. Some people can have a serious allergic reaction to ketoconazole tablets. Stop taking ketoconazole tablets and go to the nearest hospital emergency room right away if you get a rash, itching, hives, fever, swelling of the lips or tongue, chest pain, or have trouble breathing. These could be signs of a serious allergic reaction.
• muscle problems. Taking certain medicines with ketoconazole tablets may cause muscle problems. See " WHO SHOULD NOT TAKE KETOCONAZOLE TABLETS USP"

The most common side effects of ketoconazole tablets include nausea, headache, diarrhea, stomach pain, and abnormal liver function tests.

These are not all the possible side effects of ketoconazole tablets. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For more information about Ketoconazole Tablets USP, 200 mg, please contact Burel Pharmaceuticals, LLC at 1-844-436-7010.

Who should not take it

• Do not take ketoconazole tablets if you:
  • have liver problems
  • take simvastatin, and lovastatin. Ketoconazole tablets when taken with these medicines may cause muscle problems.
  • take eplerenone, dihydroergotamine, ergotamine, ergometrine (ergonovine), methylergometrine (methylergonovine) or nisoldipine.
  • take triazolam, midazolam, or alprazolam. Taking ketoconazole tablets with these medicines may make you very drowsy and make your drowsiness last longer.
  • are allergic to ketoconazole or any of the ingredients in ketoconazole tablets. See the end of this Medication Guide for a complete list of ingredients in ketoconazole tablets.

What to say before you start

• have had an abnormal heart rhythm tracing (ECG) or anyone in your family have or have had a heart problem called "congenital long QT syndrome".
• have adrenal insufficiency.
• are pregnant or plan to become pregnant. It is not known if ketoconazole tablets will harm your unborn baby.
• are breastfeeding or plan to breastfeed. Ketoconazole tablets can pass into your breast milk. You and your healthcare provider should decide if you will take ketoconazole tablets or breastfeed. You should NOT do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Using ketoconazole tablets with certain other medicines may affect each other. Using ketoconazole tablets with other medicines can cause serious side effects.

What to avoid

• Do not drink alcohol while taking ketoconazole tablets.