Ketoconazole

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|Ketoconazole

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Ketoconazole


Generic Name: Ketoconazole Tablets (kee-toe-KOE-na-zole)
Brand Name: Nizoral

Ketoconazole has been shown to cause serious and sometimes fatal liver problems. Contact your doctor immediately if you experience symptoms of liver toxicity, such as yellowing of the eyes or skin, dark urine, pale stools, loss of appetite, abdominal pain, vomiting, or severe or persistent nausea. Your doctor will perform liver function tests before you begin taking Ketoconazole and periodically during treatment.

Use of Ketoconazole along with certain other medicines may increase your risk of serious and sometimes fatal heart problems, including irregular heartbeat. Do not take Ketoconazole if you are also taking astemizole, cisapride, or terfenadine.


Ketoconazole is used for:

Treating fungal infections. It may also be used for other conditions as determined by your doctor.

Ketoconazole is an azole antifungal. It kills sensitive fungi by interfering with the formation of the fungal cell membrane.

Do NOT use Ketoconazole if:

  • you are allergic to any ingredient in Ketoconazole
  • you are taking aldosterone blockers (eg, eplerenone), cisapride, dofetilide, ergot alkaloids (eg, ergotamine), erythromycin, H1 antagonists (eg, astemizole, terfenadine), HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), midazolam, nevirapine, pimozide, quinazolines (eg, alfuzosin), quinidine, rifabutin, rifampin, triazolam, or 5-HT receptor agonists (eg, eletriptan)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ketoconazole :

Some medical conditions may interact with Ketoconazole . 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 history of liver disease or blood problems (eg, porphyria)
  • if you drink alcohol regularly or have a history of addiction to alcohol
  • if you are allergic to other azole antifungals (eg, itraconazole)

Some MEDICINES MAY INTERACT with Ketoconazole . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for infections, seizures, anxiety, sleep, heartburn, high cholesterol, heart problems, high blood pressure, allergies, irregular heartbeat, pain, blood thinning, asthma, migraines, cancer, prostate problems, insulin, immune system suppression, erectile dysfunction, urinary problems, or contraception [birth control]), multivitamin products, and herbal or dietary supplements may interact with Ketoconazole , increasing the risk of serious side effects.
  • Nevirapine, rifabutin, or rifampin because they may decrease Ketoconazole "s effectiveness
  • Cisapride, dofetilide, erythromycin, H1 antagonists (eg, astemizole, terfenadine), HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), pimozide, or quinidine because the risk of severe heart effects may be increased
  • Midazolam or triazolam because their actions and the risk of their side effects may be increased by Ketoconazole , resulting in increased risk of sedation and breathing difficulties
  • Aldosterone blockers (eg, eplerenone) or ergot alkaloids (eg, ergotamine) because their actions and the risk of their side effects may be increased by Ketoconazole
  • Quinazolines (eg, alfuzosin) or 5-HT receptor agonists (eg, eletriptan) because their actions and the risk of their side effects may be increased by Ketoconazole

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ketoconazole 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 :

Use Ketoconazole as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Ketoconazole by mouth with or without food.
  • Do not take an antacid within 1 hour before or 2 hours after you take Ketoconazole .
  • If you are also taking an H2 antagonist (eg, famotidine) or a proton pump inhibitor (eg, omeprazole), take Ketoconazole at least 2 hours before the H2 antagonist or proton pump inhibitor.
  • To clear up your infection completely, take Ketoconazole for the full course of treatment. Keep taking it even if you feel better in a few days.
  • Ketoconazole works best if it is taken at the same time each day.
  • If you miss a dose of Ketoconazole , take 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 take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ketoconazole .

Important safety information:

  • Ketoconazole may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Ketoconazole with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Use of alcohol with Ketoconazole has rarely caused symptoms, such as flushing, rash, swelling of the hands and feet, nausea, and headache. Talk with your doctor before drinking alcohol while taking Ketoconazole .
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Ketoconazole only works against fungi; it does not treat viral infections (eg, the common cold) or bacterial infections.
  • Be sure to use Ketoconazole for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The infection could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
  • Diabetes patients - Ketoconazole may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Ketoconazole may decrease the effectiveness of your birth control pill. To prevent pregnancy, use an additional form of birth control.
  • Lab tests, including liver function tests, may be performed while you use Ketoconazole . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Ketoconazole should not be used in CHILDREN; safety and effectiveness in 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 while you are pregnant. Ketoconazole is found in breast milk. Do not breast-feed while using Ketoconazole .

Possible side effects of Ketoconazole :

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:

Nausea; stomach pain or upset.

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); bloating; dark urine; decreased sexual ability; depression; irregular heartbeat; fever, chills, or persistent sore throat; loss of appetite; numbness or tingling of the hands or feet; pale stools; severe or persistent nausea or stomach pain; swollen or tender abdomen; thoughts of suicide; unusual bruising or bleeding; unusual tiredness or fatigue; vision changes; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include changes in behavior; hallucinations; seizures; slowed breathing.

Proper storage of Ketoconazole :

Store Ketoconazole between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ketoconazole out of the reach of children and away from pets.

General information:

  • If you have any questions about Ketoconazole , please talk with your doctor, pharmacist, or other health care provider.
  • Ketoconazole 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.

This information is a summary only. It does not contain all information about Ketoconazole . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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