Itraconazole (By mouth)

Introduction

Itraconazole (it-ra-KON-a-zole)

Treats fungal infections. This medicine is an antifungal antibiotic.

Brand Name(s)

Sporanox

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to itraconazole, or if you are also using cisapride (Propulsid®), dofetilide (Tikosyn?), nisoldipine (Sular®), oral midazolam (Versed®), pimozide (Orap®), quinidine (Cardioquin®, Quinaglute®, Quinidex®), triazolam (Halcion®), or levomethadyl (Orlaam®). Do not use this medicine if you are using medicine to lower cholesterol (such as lovastatin, simvastatin, Advicor®, Altocor?, Mevacor®, Zocor®) or an ergot medicine (such as dihydroergotamine, ergometrine, ergonovine, ergotamine, Cafergot®, Ergomar®, Methergine®, Migranal®). You should not use this medicine if you are pregnant, if you are planning on becoming pregnant within two months after you have finished your treatment, or if you have a history of certain heart problems such as heart failure.

How to Use This Medicine

Capsule, Liquid

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• Sporanox® oral liquid works differently than Sporanox® capsules, even at the same dose (number of milligrams). Do not switch from the capsules to the oral liquid unless your doctor tells you to.
• Take the capsule with or just after eating a full meal.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup. If you have thrush, swish the liquid in your mouth for several seconds and then swallow it.
• Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon. It may take several weeks or months for your infection to clear up completely. If you are taking this medicine for a nail infection, it may take even longer for you to see the nail get better because it usually takes several months to grow new nails.
• If you are using antacids (such as Maalox®, Mylanta®, Pepcid® Complete, Rolaids®, or Tums®), take the antacid at least 1 hour before or 2 hours after the itraconazole.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using cyclosporine, (Gengraf®, Neoral®, Sandimmune®), sirolimus (Rapamune®), tacrolimus (Prograf®), busulfan (Myleran®), docetaxel (Taxotere®), vincristine (Oncovin®, Vincasar®), halofantrine (Halfan®), alfentanil (Alfenta®), buspirone (Buspar®), trimetrexate (Neutrexin®), cilostazol (Pletal®), eletriptan (Relpax®), or fentanyl (Sublimaze®). Tell your doctor if you are using a steroid medicine (such as budesonide, dexamethasone, fluticasone, methylprednisolone, Flonase®, Pulmicort®) or a blood thinner (such as warfarin, Coumadin®).
• Tell your doctor if you also use medicine to treat HIV/AIDS (such as indinavir, nevirapine, ritonavir, saquinavir, Crixivan®, Fortovase®, Invirase®, Norvir®, Viramune®), medicine to treat an infection (such as clarithromycin, erythromycin, isoniazid, rifabutin, rifampin, Biaxin®, Ery-tab®, Mycobutin®, Rimactane®, Rifadin®), medicine to lower cholesterol (such as atorvastatin, Lipitor®), medicine for heart problems (such as digoxin, disopyramide, Lanoxin®, Norpace®), medicine to treat seizures (such as carbamazepine, phenobarbital, phenytoin, Dilantin®, Luminal®, Tegretol®), medicine for nerves or sleeping (such as alprazolam, diazepam, Valium®, Xanax®), certain blood pressure medicines (such as amlodipine, felodipine, nicardipine, nifedipine, verapamil, Calan®, Cardene®, Isoptin®, Norvasc®, Plendil®, Procardia®, Verelan®), or diabetes medicines that you take by mouth (such as glyburide, metformin, Actos®, Avandia®, Glucotrol®, Glucovance®).
• Make sure your doctor knows if you are using antacids (such as Maalox®, Mylanta®, Pepcid® Complete, Rolaids®, or Tums®), or other stomach medicine (such as cimetidine, omeprazole, ranitidine, Nexium®, Prevacid®, Protonix®, Tagamet®, Zantac®).
• There are many other drugs that can interact with itraconazole. Make sure your doctor knows about all other medicines you are using.

Warnings While Using This Medicine

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant while using this medicine, and for two months after finishing treatment. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you are breastfeeding, or if you have a history of heart disease, liver disease, kidney disease, asthma or other lung problems, HIV infection or AIDS, or if you have a condition called cystic fibrosis. Tell your doctor if you have had an allergic reaction to any other antifungal medicines such as fluconazole or ketoconazole. Make sure your doctor knows if you have ever had problems with swelling anywhere in your body, or if you have any serious health condition.
• Stop using this medicine and check with your doctor right away if you are having chest pain; decreased urine output; dilated neck veins; extreme fatigue; irregular breathing; an irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; tightness in the chest; troubled breathing; weight gain; or wheezing. These could be symptoms of a side effect called congestive heart failure.
• Rarely, this medicine may cause severe liver problems. Stop taking this medicine and call your doctor right away if you have yellow skin or eyes, dark-colored urine, pale stools, nausea, vomiting, loss of appetite, or pain in the upper stomach. Tell your doctor if you have ever had liver problems caused by other medicines.
• Stop using this medicine and call your doctor right away if your skin feels like it is burning, crawling, itching, or if you have numbness, prickling, "pins and needles", or a tingling feeling after taking this medicine.
• Temporary or permanent hearing loss may occur while you are taking this medicine. Stop using this medicine and check with your doctor right away if you have any changes in your hearing.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• If your symptoms do not improve or if they get worse, call your doctor.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain or coughing up blood.
• Dark-colored urine or pale stools.
• Dry mouth, increased thirst, or muscle cramps.
• Fast, pounding, or uneven heartbeat.
• Hearing loss.
• Lightheadedness, dizziness, or fainting.
• Nausea, vomiting, stomach pain, bloating, or loss of appetite.
• Numbness or tingling anywhere in your body.
• Rapid weight gain.
• Shortness of breath, cold sweats, and bluish-colored skin.
• Swelling in your face, hands, ankles, or feet.
• Trouble urinating, discomfort when urinating, or a change in how much or how often you urinate.
• Unusual tiredness or weakness.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Cough, runny or stuffy nose.
• Headache or drowsiness.
• Muscle pain.
• Problems with sex.
• Skin rash or itching.
• Stomach upset, gas, diarrhea, or constipation.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088