Itraconazole capsules and tablets

What is this medication?

ITRACONAZOLE (i tra KO na zole) is an antifungal medicine. It is used to treat certain kinds of fungal or yeast infections.

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

COMMON BRAND NAME(S): ONMEL, Sporanox, TOLSURA

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

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

• heart disease
• history of irregular heartbeat
• immune system problems
• kidney disease
• liver disease
• lung or breathing disease
• an unusual or allergic reaction to itraconazole, or other antifungal medicines, foods, dyes or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. Take this medicine with food. Avoid taking antacids, H2-blockers, or proton pump inhibitors within 2 hours of taking this medicine. It is best to separate these medicines by 2 hours. Take your medicine at regular intervals. Do not take your medicine more often than directed. Take all of your medicine as directed even if you think you are better. Do not skip doses or stop your medicine early.

Talk to your pediatrician regarding the use of this medicine 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 medicine with any of the following medications:

• alfuzosin
• alprazolam
• avanafil
• certain medicines for blood pressure like felodipine, nisoldipine
• certain medicines for cholesterol like cerivastatin, lovastatin, simvastatin, lomitapide
• certain medicines for the heart like disopyramide, dofetilide, dronedarone, eplerenone, ivabradine, quinidine, ranolazine
• cisapride
• colchicine (if you have liver or kidney problems)
• conivaptan
• ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine
• irinotecan
• isavuconazole
• lurasidone
• methadone
• midazolam
• naloxegol
• nevirapine
• other medicines that prolong the QT interval (cause an abnormal heart rhythm)
• pimozide
• red yeast rice
• sirolimus
• thioridazine
• ticagrelor
• triazolam

This medicine may also interact with the following medications:

• aliskiren
• amlodipine
• antacids
• antiviral medicines for HIV or AIDS
• aprepitant
• atorvastatin
• buprenorphine
• certain antibiotics like ciprofloxacin, clarithromycin, erythromycin
• certain medicines for bladder problems like fesoterodine, solifenacin, tolterodine
• certain medicines for cancer like axitinib, bortezomib, busulfan, dabrafenib, dasatinib, docetaxel, erlotinib, gefitinib, ibrutinib, imatinib, ixabepilone, lapatinib, nilotinib, ponatinib, sunitinib, trabectedin, trimetrexate, vinca alkaloids
• certain medicines for depression, anxiety, or psychotic disturbances like aripiprazole, buspirone, diazepam, haloperidol, perospirone, quetiapine, risperidone
• certain medicines for erectile dysfunction like vardenafil, sildenafil, tadalafil
• certain medicines for pain like alfentanil, fentanyl, oxycodone, sufentanil
• certain medicines for stomach problems like cimetidine, famotidine, omeprazole, lansoprazole
• certain medicines that treat or prevent blood clots like warfarin, dabigatran, rivaroxaban
• certain medicines for seizures like carbamazepine, phenytoin
• certain medicines for tuberculosis like isoniazid, INH, rifabutin, rifampin, rifapentine
• cilostazol
• cinacalcet
• cyclosporine
• digoxin
• eletriptan
• everolimus
• halofantrine
• isradipine
• meloxicam
• nadolol
• nifedipine
• other medicines for fungal infections
• praziquantel
• ramelteon
• repaglinide
• salmeterol
• saxagliptin
• steroid medicines like budesonide, ciclesonide, dexamethasone, fluticasone, methylprednisolone
• tacrolimus
• tamsulosin
• tolvaptan
• 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?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how the medicine 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.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• changes in hearing
• pain, tingling, numbness in the hands or feet
• signs and symptoms of heart failure like breathing problems; fast, irregular heartbeat; sudden weight gain; swelling of the ankles, feet; unusually weak or tired
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; right upper belly pain; yellowing of the eyes or skin

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

• blurred vision
• diarrhea
• dizziness
• headache
• nausea, vomiting

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). Protect from light and moisture. Throw away any unused medicine 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.