Ketoconazole Tablets

What is this medication?

KETOCONAZOLE (KEE toe KON a zole) treats fungal 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, Nizoral Tablet

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

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

• Alcohol use
• Heart disease
• Heart failure
• High or low levels of electrolytes, such as magnesium or potassium, in your blood
• Irregular heartbeat or rhythm
• Liver disease
• Low adrenal gland function
• Slow heartbeat
• An unusual or allergic reaction to ketoconazole, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. This medication works best when you take it with a meal. Take all of this medication unless your care team tells you to stop it early. Keep taking it even if you think you are better.

Take antacids, PPIs, and other medications that reduce stomach acid at a different time of day than this medication. Take them at least 1 hour before or 2 hours after this medication.

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:

• Adagrasib
• Alfuzosin
• Certain medications for anxiety or sleep, such as alprazolam, midazolam, triazolam
• Certain medications for blood pressure, such as felodipine, nisoldipine, eplerenone
• Certain medications for cancer, such as irinotecan, ibrutinib
• Certain medications for cholesterol, such as cerivastatin, lovastatin, simvastatin, lomitapide
• Certain medications for irregular heart rate, such as disopyramide, dofetilide, dronedarone, quinidine
• Cisapride
• Colchicine
• Conivaptan
• Ergot alkaloids, such as dihydroergotamine, ergonovine, ergotamine, methylergonovine
• Lurasidone
• Methadone
• Naloxegol
• Nevirapine
• Other medications that can cause heart rhythm changes
• 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, such as fesoterodine, solifenacin, tolterodine
• Certain medications for cancer, such as bortezomib, busulfan, dasatinib, docetaxel, erlotinib, imatinib, ixabepilone, lapatinib, nilotinib, paclitaxel, trimetrexate, vinca alkaloids
• Certain medications for depression, anxiety, or mental health conditions, such as aripiprazole, buspirone, haloperidol, quetiapine, risperidone
• Certain medications for erectile dysfunction, such as vardenafil, sildenafil, tadalafil
• Certain medications for pain, such as alfentanil, fentanyl, oxycodone, sufentanil
• Certain medications for seizures, such as carbamazepine or phenytoin
• Certain medications for stomach problems, such as cimetidine, famotidine, omeprazole, lansoprazole
• Certain medications for tuberculosis, such as isoniazid, INH, rifabutin, rifampin, rifapentine
• Certain medications that treat or prevent blood clots, such as dabigatran, rivaroxaban, warfarin
• Cilostazol
• Cinacalcet
• Cyclosporine
• Digoxin
• Eletriptan
• Isradipine
• Nadolol
• Nifedipine
• Other medications for fungal infections
• Praziquantel
• Ramelteon
• Repaglinide
• Salmeterol
• Saxagliptin
• Steroid medications, such as 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 regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Tell your care team right away if severe injury, infection, or other illness occurs while you are taking this medication. Tell them if you plan to have surgery. This medication can make it hard for your body to respond to stress. Your care team may reduce your dose or have you stop taking this medication until you recover.

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 these to your care team if they continue or are bothersome):

• Diarrhea
• Headache
• Nausea
• Stomach pain

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 and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from moisture. Keep the container tightly closed. Get rid of any unused mediation after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix it with cat litter, dirt, coffee grounds, or another unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.