Brand Name(s):

• Onmel®
• Sporanox®

IMPORTANT WARNING

Itraconazole can cause congestive heart failure (condition in which the heart cannot pump enough blood through the body). Tell your doctor if you have or have ever had heart failure. Your doctor may tell you not to take itraconazole. Also tell your doctor if you have or have ever had a heart attack; an irregular heartbeat; any other type of heart disease; lung, liver, or kidney disease; or any other serious health problem. If you experience any of the following symptoms, stop taking itraconazole and call your doctor immediately: shortness of breath; coughing up white or pink phlegm; weakness; excessive tiredness; fast heartbeat; swelling of the feet, ankles, or legs; waking up at night; and sudden weight gain.

Do not take cisapride (Propulsid), dofetilide (Tikosyn), levomethadyl acetate (Orlaam) (not available in the U.S.), methadone (Dolophine, Methadose), pimozide (Orap), or quinidine while taking itraconazole. Taking these medications with itraconazole can cause a serious irregular heartbeat, which can lead to death.

You also should not take certain calcium channel blockers such as felodipine (Plendil) and nisoldipine (Sular); certain cholesterol-lowering medications (statins) such as lovastatin (Altoprev, Mevacor, in Advicor) and simvastatin (Zocor); ergot-type medications such as bromocriptine (Cycloset, Parlodel), cabergoline, dihydroergotamine (D.H.E. 45, Migranal), ergoloid mesylates (Hydergine), ergotamine (Cafergot, Ergomar, Migergot), and methylergonovine (Methergine); midazolam; or triazolam (Halcion) while taking itraconazole.

Talk to your doctor about the risks of taking itraconazole.

WHY is this medicine prescribed?

Itraconazole capsules are used to treat fungal infections in the lungs that can spread throughout the body. Itraconazole capsules are also used to treat fungal infections of the fingernails. Itraconazole tablets and capsules are used to treat fungal infections of the toenails. Itraconazole oral solution (liquid) is used to treat yeast infections of the mouth and throat or of the esophagus (tube that connects the throat to the stomach) . Itraconazole is in a class of antifungals called triazoles. It works by slowing the growth of fungi that cause infection.

HOW should this medicine be used?

Itraconazole comes as a capsule a tablet, and a solution (liquid) to take by mouth. If you are taking itraconazole to treat fungal infections in the lungs, the capsules are usually taken with 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 to treat fungal infections of the toenails (including or without fingernail infections), the capsules or tablets are usually taken once a day with a full meal for 3 months. If you are taking itraconazole to treat fungal infections of the fingernails only, the capsules are usually taken twice a day with a full meal for one week, skipped for three weeks, and then taken twice a day with a meal for a week. Itraconazole solution is usually taken on an empty stomach once or twice a day for 1–4 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.

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 (Tagamet); famotidine (Pepcid); nizatidine (Axid); proton-pump inhibitors such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), and rabeprazole (AcipHex); or ranitidine (Zantac). 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. Repeat if necessary to take your entire dose.

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 nails will probably not look healthier until new nails grow. It can take up to 6 months to grow a new fingernail and up to 12 months to grow a new toenail, so you should not expect to see improvement during your treatment or for several months afterward. 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.

Are there OTHER USES for this medicine?

Itraconazole is also sometimes used to treat other types of fungal infections and to prevent fungal infections in people who have human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). Talk to your doctor about the possible risks of using this drug for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking itraconazole,

• tell your doctor and pharmacist if you are allergic to itraconazole; other antifungal medications such as fluconazole (Diflucan), ketoconazole (Nizoral), or voriconazole (Vfend); or any other medications. If you are taking itraconazole oral solution, tell your doctor if you are allergic to saccharin or sulfa medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking, especially alfentanil (Alfenta); alprazolam (Xanax); anticoagulants ('blood thinners') such as warfarin (Coumadin); atorvastatin (Lipitor); buspirone (BuSpar); busulfan (Myleran); calcium channel blockers such as amlodipine (Norvasc), isradipine (Dynacirc), nifedipine (Adalat, Procardia), nicardipine (Cardene), nimodipine (Nimotop), and verapamil (Calan, Isoptin, Verelan); carbamazepine (Tegretol); cilostazol (Pletal); clarithromycin (Biaxin); cyclosporine (Neoral, Sandimmune); diazepam (Valium); digoxin (Lanoxin); disopyramide (Norpace); docetaxel (Taxotere); eletriptan (Relpax); erythromycin (E.E.S., Erythrocin, E-Mycin); fentanyl (Actiq, Duragesic); halofantrine (Halfan); HIV protease inhibitors such as indinavir (Crixivan), ritonavir (Norvir), and saquinavir (Fortovase, Invirase); isoniazid (INH, Nydrazid); medications for erectile dysfunction such as sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra); midazolam (Versed); nevirapine (Viramune); oral medicine for diabetes; phenobarbital (Luminal); phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifamate, Rifater); sirolimus (Rapamune); steroids such as dexamethasone (Decadron), budesonide (Entocort EC), fluticasone (Flonase, Flovent, in Advair), and methylprednisolone (Medrol); tacrolimus (Prograf); trimetrexate (Neutrexin) (not available in the U.S.); vinblastine; vincristine; and vinorelbine (Navelbine). Many other medications may also interact with itraconazole, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• if you are taking an antacid, take it 1 hour before or 2 hours after you take itraconazole.
• tell your doctor if you have or have ever had the conditions mentioned in the IMPORTANT WARNING section, cystic fibrosis (an inborn disease that causes problems with breathing, digestion, and reproduction), or any condition that decreases the amount of acid in your stomach.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not take itraconazole to treat nail fungus if you are pregnant or could become pregnant. You may start to take itraconazole to treat nail fungus only on the second or third day of your menstrual period when you are sure you are not pregnant. You must use effective birth control during your treatment and for 2 months afterward. If you become pregnant while taking itraconazole to treat any condition, call your doctor.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

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.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: September 15, 2012.