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IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
KETOCONAZOLE - ORAL
COMMON BRAND NAME(S): Nizoral
WARNING: Rarely, ketoconazole has caused severe (sometimes fatal) liver problems. Seek immediate medical attention if you develop signs of liver problems such as persistent nausea, vomiting, stomach/abdominal pain, dark urine, yellowing eyes/skin, unusual tiredness. To reduce your risk for liver problems, your doctor will monitor liver function tests while you are taking this medication. Do not drink alcohol while taking ketoconazole because alcohol increases the risk of serious liver problems. Ketoconazole must not be used with certain other medications because a serious, possibly fatal, drug interaction may occur. Ketoconazole interacts with drugs such as amiodarone, cisapride, dofetilide, pimozide, quinidine, macrolide antibiotics including erythromycin, among others. These interactions may increase the risk of a certain condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. Tell your doctor and pharmacist about all the medications and products you may be taking before you start ketoconazole treatment.
USES: This drug is used to treat certain fungal infections in the body or serious fungal infections on the skin and nails. Ketoconazole belongs to the class of drugs called azole antifungals. It works by stopping the growth of the fungus.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This drug may also be used to treat certain protozoal infections, Cushing's syndrome, advanced prostate cancer, and high calcium levels in the blood from sarcoidosis or tuberculosis.
HOW TO USE: Take this medication by mouth usually once a day or as directed by your doctor. This medication may be taken with or without food, but taking it with food helps to reduce stomach upset. If you are taking an antacid, take ketoconazole at least 2 hours before taking the antacid, otherwise ketoconazole may not be absorbed into the body. See also Drug Interactions for more information. The dosage and length of treatment is based on your medical condition and response to treatment. In children, the dosage is also based on weight. It may take from several days to several months to complete treatment. This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time each day. Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow the fungus to continue to grow, which may result in a return of the infection. Tell your doctor if your condition persists or worsens.
SIDE EFFECTS: See also Warning section. Nausea and vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these rare but serious side effects occur: headache, vision changes, mental/mood changes (such as depression, thoughts of suicide). Although unlikely, when ketoconazole is used at high doses, it may cause an adrenal gland problem (adrenal insufficiency), a decrease in testosterone levels, and a decrease in sperm production. These effects usually go away after ketoconazole treatment is stopped. Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual tiredness, weakness, dizziness upon standing, persistent nausea/vomiting, diarrhea, stomach pain, loss of appetite, weight loss, decreased sexual interest or ability, enlarged/tender breasts in men. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking ketoconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungal drugs (such as fluconazole, itraconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, alcohol use, low testosterone levels, decreased adrenal gland function problems (such as low cortisol levels, Addison's disease, adrenal insufficiency), little or no stomach acid production (achlorhydria). Do not drink alcohol while taking this medication because alcohol increases the risk of serious liver problems. Avoiding alcohol will also decrease the risk of a rare reaction with ketoconazole that may result in flushing, headache, and nausea. During pregnancy, this medication should be used only when clearly needed. It may cause harm to an unborn baby if taken during the first 3 months of pregnancy. Discuss the risks and benefits with your doctor. This medication passes into breast milk. However, this drug is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also Warning and How to Use sections. The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring. To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval. Ketoconazole can interact with many other medications and products. Some products that may interact with this drug include: lanthanum, warfarin. Other medications can affect the removal of ketoconazole from your body, which may affect how ketoconazole works. Examples include efavirenz, isoniazid, nevirapine, rifamycins (such as rifabutin, rifampin), St. John's wort, among others. This medication can slow down the removal of many other medications from your body, which may affect how they work. Examples of affected drugs include some benzodiazepines (such as alprazolam, triazolam), cyclosporine, digoxin, domperidone, eletriptan, eplerenone, ergot drugs (such as ergotamine), drugs used to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil), HIV protease inhibitors (such as ritonavir), some drugs used to treat seizures (such as carbamazepine, phenytoin), some statin drugs (such as atorvastatin, lovastatin, simvastatin), tacrolimus, among others. Ketoconazole requires acid in the stomach to be well absorbed. Therefore, if you are taking drugs that decrease the amount of stomach acid including antacids, heartburn/ulcer drugs (H2 blockers such as cimetidine, famotidine, ranitidine), sucralfate, or if you are taking drugs that slow down gut movement (anticholinergics such as dicyclomine, propantheline), take ketoconazole at least 2 hours before any of these drugs. If you are taking proton pump inhibitors (PPIs such as lansoprazole, omeprazole), ask your doctor or pharmacist for advice on how to reduce or avoid this interaction. This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in that case. Laboratory and/or medical tests (such as liver function tests) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details. Keep all medical and laboratory appointments.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2012. Copyright(c) 2012 First Databank, Inc.