Itraconazole is an antifungal medication that is used in adults to treat infections caused by fungus. This includes infections in any part of the body including the lungs, mouth or throat, toenails, or fingernails.

The Tolsura brand of itraconazole is not for use in treating fungal infections of the fingernails or toenails. Avoid medication errors by using only the brand and strength your doctor prescribes.

Itraconazole may also be used for purposes not listed in this medication guide.

You should not take itraconazole if you have ever had heart failure.

If you have liver or kidney disease, you should not take itraconazole with colchicine, fesoterodine, or solifenacin.

Itraconazole may harm an unborn baby. Avoid getting pregnant while taking itraconazole and for 2 months after your last dose.

Stop using itraconazole and call your doctor at once if you have signs of congestive heart failure: feeling tired or short of breath, cough with mucus, fast heartbeats, swelling, rapid weight gain, or sleep problems.

Life-threatening side effects may occur if you take itraconazole with certain other drugs. Tell your doctor about all your current medicines and any you start or stop using.

Itraconazole comes as a capsule and a solution (liquid) to take by mouth. If you are taking itraconazole capsules (Sporanox, Tolsura) to treat fungal infections in the lungs, the capsules are usually taken during or right after a full meal one or two times a day for at least 3 months. However, if you are taking itraconazole to treat a serious fungal infection in the lungs, the capsules may be taken with a meal three times a day for the first 3 days of treatment and then taken once or twice a day with a meal for at least 3 months. If you are taking itraconazole capsules (Sporanox) to treat fungal infections of the toenails (including or without fingernail infections), the capsules are usually taken once a day with a full meal for 12 weeks. If you are taking itraconazole capsules (Sporanox) to treat fungal infections of the fingernails only, the capsules are usually taken twice a day with a full meal for 1 week, skipped for 3 weeks, and then taken twice a day with a meal for a week. Itraconazole oral solution is usually taken on an empty stomach once or twice a day for 1 to 4 weeks or sometimes longer. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take itraconazole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow itraconazole capsules whole; do not open, chew, or crush them.

Your doctor may tell you to take itraconazole capsules with a cola soft drink if you have certain medical conditions or are taking any of the following medications: cimetidine; dexlansoprazole (Dexilant), esomeprazole (Nexium, in Vimovo), famotidine (Pepcid, in Duexis); lansoprazole (Prevacid), nizatidine (Axid AR); omeprazole (Prilosec, Zegerid), pantoprazole (Protonix), rabeprazole (AcipHex), or ranitidine. Follow these directions carefully.

To take itraconazole oral solution for fungal infections of the mouth or throat, swish 10 milliliters (about 2 teaspoons) of the solution in your mouth for several seconds and swallow.

Itraconazole capsules and oral solution are absorbed into the body in different ways and work to treat different conditions. Do not substitute the capsules for the liquid or the liquid for the capsules. Be sure that your pharmacist gives you the itraconazole product that your doctor prescribed.

If you are taking itraconazole to treat a nail infection, your fungus may not be completely cured until several months after you finish taking itraconazole. This is because it takes time for a healthy nail to grow in. Continue to take itraconazole even if you do not see any improvement.

Continue to take itraconazole until your doctor tells you to stop even if you feel well. Do not stop taking itraconazole without talking to your doctor. If you stop taking itraconazole too soon, your infection may come back after a short time.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not share itraconazole with another person, even if they have the same symptoms you have.

The itraconazole capsule should be taken with food.

Swallow the capsule whole and do not crush, chew, break, or open it.

Take itraconazole oral solution (liquid) on an empty stomach, at least 1 hour before or 2 hours after a meal. Swish the liquid in your mouth for several seconds before swallowing it.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

The Sporanox PulsePak has a special dosing schedule that includes not taking the medicine for several days in a row. Follow all dosing instructions carefully.

Itraconazole capsules should not be used in place of itraconazole oral solution (liquid) if that is what your doctor has prescribed. Avoid medication errors by using only the form and strength your doctor prescribes.

If you also take a stomach acid reducer (Tagamet, Pepcid, Axid, Zantac, and others), take itraconazole with an acidic drink such as non-diet cola.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Itraconazole will not treat a viral infection such as the flu or a common cold.

You may need frequent medical tests.

Store at room temperature away from moisture, heat, and light.

You should not take this medicine if you are allergic to itraconazole or similar medicines such as fluconazole or ketoconazole, or if you have ever had congestive heart failure.

Life-threatening side effects may occur if you take itraconazole with certain other drugs. Your doctor may change your treatment plan if you have used other medicines in the past 2 weeks, especially:

• avanafil;

• cisapride;

• eliglustat;

• irinotecan;

• isavuconazonium;

• methadone;

• naloxegol;

• ranolazine;

• ticagrelor;

• lurasidone or pimozide (anti-psychotic medications);

• lomitapide, lovastatin, simvastatin (cholesterol-lowering medicines);

• dihydroergotamine, ergonovine, ergotamine, or methylergonovine (ergot medicines);

• eplerenone, felodipine, ivabradine, or nisoldipine (heart or blood pressure medicines);

• disopyramide, dofetilide, dronedarone, or quinidine (medicines for heart rhythm disorders); or

• oral midazolam, or triazolam (Valium-like sedatives).

If you have liver or kidney disease, you should not take itraconazole with colchicine, fesoterodine, solifenacin, or telithromycin.

Itraconazole may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 2 months after your last dose. Tell your doctor if you become pregnant.

Tell your doctor if you have ever had:

• heart problems;

• cystic fibrosis or other lung problems;

• liver or kidney disease; or

• a weak immune system.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat, light, and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Talk to your doctor about drinking grapefruit juice while taking this medication.

Avoid driving or hazardous activity until you know how itraconazole will affect you. Your reactions could be impaired.

Avoid taking antacids within 1 hour before or 2 hours after you take itraconazole. Some antacids can make it harder for your body to absorb itraconazole.

Get emergency medical help if you have signs of an allergic reaction: hives, severe skin rash, tingling in your arms or legs; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using itraconazole and call your doctor at once if you have signs of congestive heart failure: feeling tired or short of breath, cough with mucus, fast heartbeats, swelling, rapid weight gain, or sleep problems.

Keep taking itraconazole but call your doctor at once if you have:

• confusion, a light-headed feeling (like you might pass out);

• blurred vision, double vision, ringing in your ears, problems with hearing;

• fast heartbeats;

• numbness or tingly feeling, loss of bladder control;

• little or no urinating, pain or burning when you urinate;

• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, muscle weakness or limp feeling;

• pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting; or

• liver problems--nausea, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of itraconazole may include:

• headache, dizziness, drowsiness, tiredness;

• increased blood pressure;

• rash, itching;

• nausea, vomiting, stomach pain, diarrhea, constipation;

• swelling;

• abnormal liver function or blood tests;

• fever, muscle or joint pain;

• unusual or unpleasant taste in your mouth;

• hair loss;

• impotence, erection problems; or

• changes in your menstrual periods.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect itraconazole, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to itraconazole.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. If you still have symptoms of infection after you finish the itraconazole, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.