Ketoconazole Tablets

What is this medication?

KETOCONAZOLE (kee toe KON na zole) treats fungal or yeast infections. It belongs to a group of medications called antifungals. It will not treat colds, the flu, or infections caused by bacteria or viruses.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Nizoral

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Adrenal problems
• An alcohol abuse problem
• History of irregular heartbeat
• Low stomach acid production
• Liver disease
• An unusual or allergic reaction to ketoconazole, itraconazole, miconazole, other medications, foods, dyes or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a full glass of water. Follow the directions on the prescription label. This medication works best if you take it with food. Take your medication at regular intervals. Do not take your medication more often than directed. Do not stop taking except on your care team's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Alfuzosin
• Certain medications for anxiety or sleep like alprazolam, midazolam, triazolam
• Certain medications for blood pressure like felodipine, nisoldipine, eplerenone
• Certain medications for cancer like irinotecan, ibrutinib
• Certain medications for cholesterol like cerivastatin, lovastatin, simvastatin, lomitapide
• Certain medications for irregular heart rate like disopyramide, dofetilide, dronedarone, quinidine
• Cisapride
• Colchicine
• Conivaptan
• Ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine
• Lurasidone
• Methadone
• Naloxegol
• Nevirapine
• Other medications that prolong the QT interval (cause an abnormal heart rhythm)
• Pimozide
• Ranolazine
• Red yeast rice
• Sirolimus
• Thioridazine
• Tolvaptan

This medication may also interact with the following:

• Alcohol or any product that contains alcohol
• Aliskiren
• Amlodipine
• Antacids
• Antiviral medications for HIV or AIDS
• Aprepitant
• Atorvastatin
• Bosentan
• Buprenorphine
• Certain medications for bladder problems like fesoterodine, solifenacin, tolterodine
• Certain medications for cancer like bortezomib, busulfan, dasatinib, docetaxel, erlotinib, imatinib, ixabepilone, lapatinib, nilotinib, paclitaxel, trimetrexate, vinca alkaloids
• Certain medications for depression, anxiety, or psychotic disturbances like aripiprazole, buspirone, haloperidol, quetiapine, risperidone
• Certain medications for erectile dysfunction like vardenafil, sildenafil, tadalafil
• Certain medications for pain like alfentanil, fentanyl, oxycodone, sufentanil
• Certain medications for seizures like carbamazepine, phenytoin
• Certain medications for stomach problems like cimetidine, famotidine, omeprazole, lansoprazole
• Certain medications for tuberculosis like isoniazid, INH, rifabutin, rifampin, rifapentine
• Certain medications that treat or prevent blood clots like dabigatran, rivaroxaban, warfarin
• Cilostazol
• Cinacalcet
• Cyclosporine
• Digoxin
• Eletriptan
• Isradipine
• Nadolol
• Nifedipine
• Other medications for fungal infections
• Praziquantel
• Ramelteon
• Repaglinide
• Salmeterol
• Saxagliptin
• Steroid medications like budesonide, ciclesonide, dexamethasone, methylprednisolone
• Tacrolimus
• Tamsulosin
• Telithromycin
• Verapamil
• Ziprasidone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for check-ups. Tell your care team if your symptoms do not improve. Some fungal infections can take many weeks or months of treatment to cure.

Avoid medications for your stomach like antacids and acid blockers for at least two hours after taking this medication.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

Avoid alcohol while you are taking this medication. Alcohol can increase the risk of liver damage.

If you are going to have surgery, let your care team know that you have been taking this medication.

This medication may cause a decrease in vitamin D. You should make sure that you get enough vitamin D while you are taking this medication. Discuss the foods you eat and the vitamins you take with your care team.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Change in sex drive or performance
• Diarrhea
• Headache
• Nausea
• Stomach pain
• Unexpected breast tissue growth

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 25 degrees C (59 and 77 degrees F). Keep container tightly closed. Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.