Itraconazole (patient information)

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; 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; and sudden weight gain.

Do not take cisapride (Propulsid), dofetilide (Tikosyn), pimozide (Orap), or quinidine (Quinaglute, Quinidex, others), while taking itraconazole. Taking these medications with itraconazole can cause serious irregular hearbeats.

Talk to your doctor about the risks of taking itraconazole.

Why this medication is prescribed

Itraconazole capsules are used to treat fungal infections that begin in the lungsand can spread through the body. Itraconazole capsules are also used to treat fungal infections of the fingernails and/or toenails. Itraconazole oral solution is used to treat yeast infections of the mouth and throat and suspected fungal infections in patients with fever and certain other signs of infection.Itraconazole is in a class of antifungals called triazoles. It works by slowing the growth of fungi that cause infection.

How this medication should be used

Itraconazole comes as a capsule and a solution (liquid) to take by mouth. Itraconazole capsules are usually taken with a full meal one to three times a day for at least 3 months. When itraconazole capsules are used to treat fungal infections of the fingernails, they are usually taken twice a day for one week, not taken at all for three weeks, and then taken twice a day for an additional week. Itraconazole solution is usually taken on an empty stomach once or twice a day for 1 to 4 weeks or 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); nizatadine (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 mL (about 2 teaspoons) of the solution in your mouth for a few seconds and swallow. Repeat if necessary until you have taken 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 form of itraconazole that your doctor prescribed.

Your doctor may tell you to take higher doses of itraconazole or to take itraconazole more often at the beginning of your treatment. Follow these directions carefully.

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.

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.

Special precautions

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); orany other medications. If you are taking itraconazole oral solution, tell your doctor if you are allergic to saccharin or sulfa medications.
• do not take itraconazole if you are taking any of the medications listed in the IMPORTANT WARNING section or any of the following medications: ergot-type medications such as dihydroergotamine (D.H.E. 45, Migranal), ergoloid mesylates (Germinal, Hydergine), ergonovine (Ergotrate), ergotamine (Bellergal-S, Cafergot, Ergomar, Wigraine), methylergonovine (Methergine), and methysergide (Sansert); lovastatin (Mevacor); simvastatin (Zocor); or triazolam (Halcion).
• 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), felodipine (Plendil), isradipine (Dynacirc), nifedipine (Adalat, Procardia) nicardipine (Cardene) nimodipine (Nimotop), nisoldipine (Sular), and verapamil (Calan, Covera, Isoptin, Verelan); carbamazepine (Tegretol); cerivastatin (Baycol) (not available in the United States); cilostazol (Pletal); clarithromycin (Biaxin); cyclosporine (Neoral, Sandimmune); diazepam (Valium); digoxin (Lanoxin); disopyramide (Norpace); docetaxel (Taxotere); eletriptan (Relpax); erythromycin (E.E.S., Erythrocin, E-Mycin); 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 contraceptives (birth control pills); oral medicine for diabetes; phenobarbital (Luminal, Solfoton); phenytoin (Dilantin); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); sirolimus (Rapamune); steroids such as dexamethasone (Decadron), budesonide (Entocort EC), and methylprednisolone (Medrol); tacrolimus (Prograf); , trimetrexate (Neutrexin); vinblastine (Velban); vincristine (Oncovin); 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.
• you should know that itraconazole may remain in your body for several months after you stop taking it. Tell your doctor that you have recently stopped taking itraconazole before you start taking any other medications during the first few months after your treatment.
• 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, AIDS, 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.

Special dietary instructions

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

What to do if you forget 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.

Side effects

Minor side effects

Itraconazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea or loose stools
• constipation
• gas
• stomach pain
• heartburn
• sore or bleeding gums
• sores in or around the mouth
• headache
• dizziness
• sweating
• muscle pain
• decreased sexual desire or ability
• nervousness
• depression
• runny nose and other cold symptoms
• unusual dreams

Severe side effects

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• excessive tiredness
• loss of appetite
• upset stomach
• vomiting
• yellowing of the skin or eyes
• dark urine
• pale stools
• tingling or numbness of the hands or feet
• fever, chills, or other signs of infection
• frequent or painful urination
• shaking hands that you cannot control
• rash
• hives
• itching
• difficulty breathing or swallowing

One of the ingredients in itraconazole oral solution caused cancer in some types of laboratory animals. It is not known whether people who take itraconazole solution have an increased risk of developing cancer. Talk to your doctor about the risks of taking itraconazole solution.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for 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 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.

In case of emergency/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.

Other information

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.

Brand names

• Sporanox®