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Before taking itraconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals (e.g., ketoconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease (including history of liver disease with other drugs), kidney disease, heart disease (e.g., coronary artery disease, heart valve disease, congestive heart failure), severe lung disease (e.g., chronic obstructive pulmonary disease-COPD), high blood pressure, decreased or no stomach acid (e.g., achlorhydria), cystic fibrosis.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages since they can increase the effects of dizziness and also increase the risk of serious liver problems.

Older adults may be at greater risk for hearing loss while using this drug.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.

Itraconazole passes into breast milk. Consult your doctor before breast-feeding.

Itraconazole solution is an azole antifungal medication used to treat certain fungal infections, including infections of the mouth, throat, and esophagus (oropharyngeal/esophageal candidiasis).

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to prevent certain fungal infections in patients with HIV.

How to use Sporanox

Read the Patient Information Leaflet provided by your pharmacist before you start taking itraconazole and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth without food, usually once or twice daily or as directed by your doctor. When using this drug to treat fungal infections of the mouth, throat, or esophagus, swish the solution (2 teaspoons or 10 milliliters at a time) in your mouth for several seconds, and then swallow.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication works best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals.

Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear. Stopping the medication too early may result in a return of the infection.

Take itraconazole 2 hours before or 1 hour after antacids. Antacids may decrease the absorption of this medication. Also, take this medication with a cola drink if you have decreased or no stomach acid (e.g., achlorhydria) or if you take drugs that decrease stomach acid (e.g., H2 blockers such as ranitidine, proton pump inhibitors such as omeprazole). Consult your doctor or pharmacist for more details.

The capsule and solution forms of this medication deliver different amounts of medication and may be used for different purposes. Do not switch between the capsule and solution forms without your doctor's permission and directions.

Inform your doctor if your condition persists or worsens.

What is Sporanox?

Sporanox (itraconazole) is an antifungal medication.

Sporanox is used to treat infections caused by fungus, which can invade any part of the body including the lungs, mouth or throat, toenails, or fingernails.

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

Important information about Sporanox

You should not take Sporanox if you are allergic to itraconazole or similar medications such as fluconazole or ketoconazole, if you have ever had congestive heart failure, or if you are pregnant or may become pregnant during treatment.

Some medicines can cause unwanted or dangerous effects when used with Sporanox. Your doctor may need to change your treatment plan if you use any of the following drugs: cisapride, dihydroergotamine, dofetilide, ergonovine, ergotamine, felodipine, lovastatin, methylergonovine, methadone, midazolam, nisoldipine, pimozide, quinidine, simvastatin, or triazolam.

Many drugs can interact with itraconazole. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Sporanox.

Before taking Sporanox, tell your doctor if you have heart disease, a history of stroke, a heart rhythm disorder, kidney or liver disease, a breathing disorder, cystic fibrosis, or a history of Long QT syndrome.

Take this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Sporanox will not treat a viral infection such as the common cold or flu.

Before taking Sporanox

You should not take Sporanox if you are allergic to itraconazole or similar medications such as fluconazole or ketoconazole, if you have ever had congestive heart failure, or if you are pregnant or may become pregnant during treatment.

Some medicines can cause unwanted or dangerous effects when used with Sporanox. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • cisapride;

  • dofetilide;

  • lovastatin or simvastatin;

  • methadone;

  • midazolam or triazolam;

  • felodipine or nisoldipine;

  • pimozide;

  • quinidine; or

  • ergot medicines such as dihydroergotamine, ergonovine, ergotamine, or methylergonovine.

To make sure Sporanox is safe for you, tell your doctor if you have:

  • heart disease, a heart rhythm disorder, circulation problems, or a history of stroke;

  • chronic obstructive pulmonary disease (COPD) or other breathing disorder;

  • kidney disease;

  • cirrhosis or other liver disease;

  • cystic fibrosis; or

  • a personal or family history of Long QT syndrome.

FDA pregnancy category C. It is not known whether Sporanox will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Itraconazole passes into breast milk and can harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Sporanox?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Sporanox capsules should be taken after a full meal. Take the 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 with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Sporanox capsules should not be used in place of Sporanox oral solution (liquid) if that is what your doctor has prescribed. Make sure you have received the correct type of this medication at the pharmacy and ask the pharmacist if you have any questions.

Take this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Sporanox will not treat a viral infection such as the common cold or flu.

While using Sporanox, you may need frequent blood tests at your doctor's office.

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

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking Sporanox?

Avoid taking antacids or stomach acid reducers (Tagamet, Pepcid, Axid, Zantac, and others) within 1 hour before or 2 hours after you take Sporanox. These medications can make it harder for your body to absorb Sporanox.

Sporanox side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Sporanox: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • fever;

  • feeling short of breath, even with mild exertion;

  • swelling, rapid weight gain;

  • ringing in your ears, problems with hearing;

  • numbness or tingly feeling, blurred vision, double vision, loss of bladder control;

  • pain or burning when you urinate;

  • nausea, pain in your upper stomach, itching, loss of appetite, weakness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate.

Other common Sporanox side effects may include:

  • diarrhea, constipation, bloating, mild nausea;

  • unpleasant taste in your mouth;

  • mild itching or skin rash;

  • joint pain, muscle pain or weakness;

  • headache, dizziness; or

  • runny nose or other cold symptoms.

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.

What other drugs will affect Sporanox?

Many drugs can interact with Sporanox. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Sporanox, especially:

  • a blood thinner such as warfarin, Coumadin;

  • cancer medications;

  • cholesterol medications such as atorvastatin;

  • cyclosporine;

  • diabetes medication you take by mouth;

  • digoxin, digitalis;

  • disopyramide;

  • fentanyl;

  • isoniazid (for treating tuberculosis);

  • rifabutin, rifampin, or rifapentine;

  • sirolimus or tacrolimus;

  • an antibiotic such as clarithromycin, erythromycin, or telithromycin;

  • an antifungal medication such as clotrimazole, ketoconazole, or voriconazole;

  • an antidepressant such as nefazodone, paroxetine, or sertraline;

  • a barbiturate such as amobarbital, butabarbital, mephobarbital, secobarbital or phenobarbital;

  • heart or blood pressure medications such as amlodipine, diltiazem, nifedipine, verapamil, and others;

  • HIV/AIDS medicine such as atazanavir, delavirdine, efavirenz, etravirine, indinavir, nelfinavir, nevirapine, saquinavir, or ritonavir;

  • a sedative such as alprazolam or diazepam (Valium); or

  • seizure medication such as carbamazepine, felbamate, oxcarbazepine, phenytoin, or primidone.

This list is not complete and many other drugs can interact with Sporanox. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

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