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Drug Information For:

KETOCONAZOLE 200MG TABLETS

Ingredient Name:

KETOCONAZOLE (kee-toe-KON-a-zole)

Drug Manufacturer:

MUTUAL PHARMACEUTICAL

Common Uses:

This medicine is an imidazole antifungal agent used to treat certain fungal infections.

Before Using This Medicine:

WARNING: This medicine should only be used when other treatments cannot be used or have not worked. Talk with your doctor to be sure that the benefits of using this medicine outweigh the risks. SERIOUS AND SOMETIMES FATAL LIVER PROBLEMS, including the need for liver transplant, have occurred with the use of this medicine. Some patients this happened to were not at risk for liver problems. Contact your doctor immediately if you have symptoms of liver problems (eg, unusual fatigue, yellowing of the eyes or skin, dark urine, pale stools, loss of appetite, stomach pain, vomiting, severe or persistent nausea). Most of the time, but not always, liver problems have gone back to normal after this medicine was stopped. Your doctor will perform liver function tests before you begin taking this medicine and at times during treatment. Use of this medicine along with certain other medicines may increase your risk of serious and sometimes fatal heart problems, including irregular heartbeat. DO NOT TAKE THIS MEDICINE IF YOU are also taking cisapride, disopyramide, dofetilide, dronedarone, methadone, pimozide, quinidine, or ranolazine. DO NOT TAKE THIS MEDICINE if you are taking colchicine and also have kidney or liver problems. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking alprazolam, eplerenone, an ergot alkaloid (eg, dihydroergotamine, ergotamine), felodipine, irinotecan, lovastatin, lurasidone, nisoldipine, oral midazolam, ranolazine, simvastatin, tolvaptan, or triazolam. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you take other prescription and nonprescription medicines (eg, used for infections, HIV, seizures, anxiety, sleep, heartburn, diabetes, high cholesterol, heart problems, high blood pressure, allergies, irregular heartbeat, pain, blood thinning, asthma, migraines, mood or mental problems, cancer, prostate problems, immune system suppression, erectile dysfunction, urinary problems, contraception / birth control), multivitamin products, or herbal or dietary supplements. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with this medicine. Inform your doctor of any other medical conditions, including low stomach acid (such hypochlorhydria), allergies (including other azole antifungals, such as itraconazole), pregnancy, or breast-feeding. Tell your doctor if you have a history of regular alcohol use, abuse, or dependence; liver problems; adrenal gland problems; or blood problems (eg, porphyria). Tell your doctor if you have a history of irregular heartbeat (eg, QT prolongation) or if a member of your family has a certain type of irregular heartbeat called congenital long QT syndrome. USEOF THIS MEDICINE IS NOT RECOMMENDED IF you have liver problems. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.

How to Use This Medicine:

Follow the directions for using this medicine provided by your doctor. This medicine has a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully. Read it again each time you get this medicine refilled. Ask your doctor, nurse, or pharmacist any questions that your may have about this medicine. This medicine may be taken on an empty stomach or with food. TALK WITH YOUR DOCTOR if you are also taking antacids, an H2 blocker (eg, famotidine), or a proton pump inhibitor (PPI) (eg, omeprazole). You may need to take this drug with an acidic drink (eg, non-diet cola). DO NOT TAKE ALUMINUM hydroxide within 1 hour before or 2 hours after you take this medicine. STORE THIS MEDICINE at room temperature, between 59 and 77 degrees F (15 and 25 degrees C) away from heat, moisture, and light. KEEP THIS MEDICINE out of the reach of children and away from pets. TO CLEAR UP YOUR INFECTION COMPLETELY, take this medicine for the full course of treatment. Keep taking it even if you feel better in a few days. This medicine works best if it is taken at the same time each day. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, 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.

Cautions:

DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or are allergic to any ingredient in this product. IF YOU EXPERIENCE difficulty breathing; tightness of chest; swelling of eyelids, face, or lips; or if you develop a rash or hives, tell your doctor immediately. Do not take any more of this medicine unless your doctor tells you to do so. DO NOT TAKE more than the recommended dose, stop taking this medicine, or use this medicine for longer than prescribed without checking with your doctor. Laboratory and/or medical tests, including liver function may be performed to monitor your progress or to check for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are taking this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine. USE OF ALCOHOL WITH THIS MEDICINE has rarely caused symptoms such as flushing, rash, swelling of the hands and feet, nausea, and headache. Do not drink alcohol while taking this medicine. THIS MEDICINE MAY CAUSE dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. THIS MEDICINE MAY LOWER blood testosterone levels. This may lead to decreased sexual ability, enlarged breasts, or low sperm counts. Testosterone levels return to normal after this medicine is stopped. Discuss any questions or concerns with your doctor. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN CHILDREN because they may be more sensitive to the effects of the medicine. FOR WOMEN TAKING BIRTH CONTROL PILLS: this medicine may decrease the effectiveness of your birth control pills. To prevent pregnancy, use an additional form of birth control while you are taking this medicine. IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. THIS MEDICINE IS EXCRETED IN BREAST MILK. DO NOT BREAST-FEED while taking this medicine. IF YOU HAVE DIABETES, this medicine may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.

Possible Side Effects:

SIDE EFFECTS that may occur while using this medicine include diarrhea; headache; mild stomach pain or upset; or nausea. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience bloating; burning, numbness, or tingling; or fever, chills, or persistent sore throat. CONTACT YOUR DOCTOR IMMEDIATELY if you experience chest pain; depression or thoughts of suicide; dizziness or lightheadedness; fainting; fast or irregular heartbeat; swelling of the hands, ankles, or feet; swollen or tender abdomen; symptoms of liver problems (eg, unusual fatigue, yellowing of the eyes or skin, dark urine, pale stools, loss of appetite, stomach pain, vomiting, severe or persistent nausea); unusual bruising or bleeding; unusual tiredness or weakness; or vision changes. An allergic reaction to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Overdose:

If overdose is suspected, contact your local poison control center or emergency room immediately.

Additional Information:

DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children and pets. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.

Copyright 2014 Wolters Kluwer Health, Inc.

Disclaimer

- This information is not intended to substitute for professional medical advice. Be sure to contact your physician, pharmacist or other health care provider for more information about this medication. By searching these web site pages, you agree to our terms and conditions of use.