Ketoconazole

What is ketoconazole?

Ketoconazole is an antifungal antibiotic.

Ketoconazole is used to treat infections caused by fungus, which can invade any part of the body including the mouth, throat, esophagus, lungs, bladder, or skin.

Ketoconazole may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about ketoconazole?

You should not use this medication if you are allergic to ketoconazole, or if you are also taking triazolam (Halcion).

Before taking ketoconazole, tell your doctor if you have liver disease, kidney disease, a heart rhythm disorder, decreased stomach acid (achlorhydria), or a history of "Long QT syndrome."

Avoid taking antacids or stomach acid reducers (Tagamet, Pepcid, Axid, Zantac, and others) for at least 2 hours after you have taken your dose of ketoconazole. These medications can make it harder for the ketoconazole tablet to dissolve in your stomach.

What should I discuss with my healthcare provider before taking ketoconazole?

You should not use this medication if you are allergic to ketoconazole, or if you are also taking triazolam (Halcion).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take ketoconazole:

• decreased stomach acid (achlorhydria);

• liver disease;

• kidney disease;

• a heart rhythm disorder; or

• a personal or family history of "Long QT syndrome."

How should I take ketoconazole?

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

To be sure this medication is not causing harmful effects, your liver function may need to be checked with blood tests on a regular basis. Do not miss any scheduled appointments.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take 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. Symptoms of a ketoconazole overdose are not known.

What should I avoid while taking ketoconazole?

Avoid taking antacids or stomach acid reducers (Tagamet, Pepcid, Axid, Zantac, and others) for at least 2 hours after you have taken your dose of ketoconazole. These medications can make it harder for the ketoconazole tablet to dissolve in your stomach.

Ketoconazole side effects

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. Call your doctor at once if you have any of these serious side effects:

• dizziness, fainting, fast or pounding heartbeat;

• easy bruising or bleeding, unusual weakness;

• numbness or tingly feeling;

• severe depression, confusion, or thoughts of hurting yourself; or

• nausea, stomach pain, low fever, loss of appetite, weakness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• mild nausea, vomiting, or stomach pain;

• mild itching or skin rash;

• headache;

• dizziness;

• breast swelling; or

• impotence or loss of interest in sex.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ketoconazole Dosing Information

Usual Adult Dose for Oral Thrush:

Initial dose: 200 mg orally once a day.
May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for 1-2 weeks.

Usual Adult Dose for Dermatophytosis:

Initial dose: 200 mg orally once a day.
May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for 4 weeks.

Usual Adult Dose for Blastomycosis:

Initial dose: 200 mg orally once a day.
May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for at least 6 months.

Usual Adult Dose for Coccidioidomycosis:

Initial dose: 200 mg orally once a day.
May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for at least 6 months.

Usual Adult Dose for Histoplasmosis:

Initial dose: 200 mg orally once a day.
May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for at least 6 months.

Usual Adult Dose for Paracoccidioidomycosis:

Initial dose: 200 mg orally once a day.
May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for at least 6 months.

Usual Adult Dose for Chronic Mucocutaneous Candidiasis:

Initial dose: 200 mg orally once a day.
May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for 3-12 months. Patients usually require maintenance therapy.

Usual Adult Dose for Esophageal Candidiasis:

Initial dose: 200 mg orally once a day.
May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for 2-3 weeks.

Usual Adult Dose for Onychomycosis -- Fingernail:

Initial dose: 200 mg orally once a day.
May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for 6-12 months.

Usual Adult Dose for Onychomycosis -- Toenail:

Initial dose: 200 mg orally once a day.
May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for 6-12 months.

Usual Adult Dose for Vaginal Candidiasis:

Initial dose: 200 mg orally once a day.
May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for approximately 1 to 2 weeks and until tests indicate the resolution of the infection.

Usual Pediatric Dose for not applicable:

Infants and children: 3.3-6.6 mg/kg orally once a day for 2-4 weeks.
Prophylaxis for recurrence of mucocutaneous candidiasis with HIV infections: 5-10 mg/kg/day divided every 12-24 hours to a maximum of 800 mg/day divided in two doses

What other drugs will affect ketoconazole?

Many drugs can interact with ketoconazole. Below is just a partial list. Tell your doctor if you are using:

• acetaminophen (Tylenol);

• cyclosporine (Gengraf, Sandimmune, Neoral);

• digoxin (digitalis, Lanoxin);

• tacrolimus ((Prograf);

• loratadine (Alavert, Claritin, Tavist ND);

• methylprednisolone (Medrol);

• phenytoin (Dilantin);

• rifampin (Rifadin, Rifater, Rifamate, Rimactane);

• diabetes medication you take by mouth;

• a sedative such as midazolam (Versed);

• a blood thinner such as warfarin (Coumadin);

• cancer medications;

• birth control pills or hormone replacement therapy;

• methotrexate (Rheumatrex, Trexall);

• cholesterol medications such as niacin (Advicor), atorvastatin (Lipitor), lovastatin (Altocor, Mevacor), simvastatin (Zocor), and others; or

• medications to treat HIV or AIDS.

This list is not complete and there are many other drugs that can interact with ketoconazole. 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.