Ketoconazole

CAUTION:
Ketoconazole may cause liver damage. Inform your doctor if you drink or have ever drunk large amounts of alcohol and if you have or have ever had liver disease. Inform your doctor and pharmacist if you are taking acetaminophen (Tylenol, others); cholesterol-lowering medications (statins) such as atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), or simvastatin (Zocor); isoniazid (INH, Nydrazid); methotrexate (Rheumatrex); niacin (nicotinic acid); or rifampin. If you have any of the following symptoms, call your doctor without delay: extreme tiredness, loss of appetite (anorexia), upset stomach, vomiting, yellowing of the skin or eyes, jaundice, dark yellow urine, pale stools, pain in the upper right part of the stomach, or flu-like symptoms.

General Information and Indications:

Ketoconazole is used to treat fungal infections. Ketoconazole is most often used to treat fungal infections that can spread to different parts of the body through the bloodstream such as yeast infections of the mouth, skin, urinary tract, and blood, and certain fungal infections that begin on the skin or in the lungs and can spread through the body. Ketoconazole is also used to treat fungal infections of the skin or nails that cannot be treated with other medications. Ketoconazole is in a class of antifungals called imidazoles. It works by slowing the growth of fungi that cause infection.

Information For Users:

Ketoconazole comes as a tablet to take by mouth. It is usually taken once a day. To help you remember to take ketoconazole, take it at around the same time every day. Follow the directions on your prescription label, ask your doctor or pharmacist If you have any questions. Take ketoconazole exactly as directed. Do not take more or less of it or take it more often than prescribed by your health care provider.

If you have certain medical conditions, your doctor will tell you to take ketoconazole tablets dissolved in an acid solution. Your doctor will tell you exactly how to do this. Follow these directions carefully.

Your doctor will probably start you on an average dose of ketoconazole. Your doctor may increase your dose if your infection is very serious or your condition does not improve.

You may need to take ketoconazole for several weeks or months to cure your infection completely. Your doctor will probably order laboratory tests to be sure your infection has been treated. Continue taking ketoconazole until your doctor tells you that you should stop, even if you feel better. Do not discontinue taking ketoconazole without informing your doctor. If you stop taking ketoconazole too soon, your infection may come back after a short time.
Other uses for this medicine

Ketoconazole is also sometimes used to treat vaginal yeast infections, tinea versicolor (spots on skin caused by yeast), eumycetoma (a severe fungal skin infection that often affects the foot), leishmaniasis (a disease caused by the bite of an infected sand fly), prostate cancer (cancer that begins in a male reproductive organ), high blood levels of calcium in patients with certain conditions, Cushing's syndrome (high blood levels of a natural substance called cortisol), and excessive hair growth in women. Talk to your doctor about the possible risks of using this medication.

special precautions:

o Inform your doctor or pharmacist if you have allergy to ketoconazole, other antifungal medications such as fluconazole (Diflucan), itraconazole (Sporonox), or voriconazole (Vfend); any other medications; or corn.
o do not take ketoconazole if you are taking any of the medications listed in the CAUTION section or triazolam (Halcion).
o Inform your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention the medications listed in the CAUTION section and any of the following: alprazolam (Xanax); anticoagulants ('blood thinners') such as warfarin (Coumadin); buspirone (Buspar); calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac), felodipine (Plendil), nifedipine (Adalat, Procardia), nisoldipine (Sular),and verapamil (Calan, Covera, Isoptin, Verelan);clarithromycin (Biaxin); cyclosporine (Neoral, Sandimmune); diazepam (Valium); digoxin (Lanoxin); erythromycin (E.E.S., E-Mycin, Erythrocin); HIV protease inhibitors such as indinavir (Crixivan), ritonavir (Norvir), and saquinavir (Invirase, Fortovase); loratadine (Claritin); medications for diabetes; medications for erectile dysfunction such as sildenafil (Viagra), tadalafil (Cialis) and vardenafil (Levitra); methadone (Dolophine); methylprednisolone (Medrol); midazolam (Versed); phenytoin (Dilantin); pimozide (Orap); quinidine (Quinidex, Quinaglute); quinine; tacrolimus (Prograf); tamoxifen (Nolvadex); telithromycin (Ketek); trazodone (Desyrel); and vincristine (Vincasar). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
o if you are taking antacids; antihistamines; medications for heartburn or ulcers such as cimetidine (Tagamet), famotidine (Pepcid), nizatadine (Axid), or ranitidine (Zantac); or medications for irritable bowel disease, motion sickness, Parkinson's disease, ulcers, or urinary problems, take them 2 hours after you take ketoconazole.
o inform your doctor if you are breast-feeding the conditions mentioned in the CAUTION section or any condition that decreases the amount of acid in your stomach.
o Inform your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking ketoconazole, call your doctor. Do not breastfeed while you are taking ketoconazole.
o ask your doctor about the safe use of alcoholic beverages while you are taking ketoconazole. You may experience unpleasant symptoms such as flushing, rash, upset stomach, headache, and swelling of the hands, feet, ankles, or lower legs if you drink alcohol while you are taking ketoconazole.

Possible Adverse Effects:

Ketoconazole may cause adverse effects. Inform your doctor if either of these symptoms is severe or does not go away:

o stomach pain
o depression

Some adverse effects could be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the CAUTION section, call your doctor without delay:

o rash
o hives (Urticaria)
o itching
o difficulty swallowing or breathing
o thinking about harming or killing yourself or planning or trying to do so

A small number of patients who were taking high doses of ketoconazole for prostate cancer died soon after they began taking the medication. It is not known whether they died because of their disease or their treatment with ketoconazole or for other reasons. Talk to your doctor about the risks of taking ketoconazole.

Ketoconazole may cause a decrease in the number of sperm (male reproductive cells) produced, especially if it is taken at high doses. Talk to your doctor about the risks of taking this medication if you are a man and would like to have children.

Brand Name(s):

o Nizoral®