Sporanox

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Itraconazole should not be used to treat fungal nail infections if you have a history of heart failure. Itraconazole may rarely cause or worsen heart failure. Tell your doctor right away if you develop symptoms of heart failure, such as shortness of breath, swelling ankles/feet, unusual tiredness, or unusual/sudden unexplained weight gain. Consult your doctor for more details.

This medication can slow down the removal of other medications from your body, which may cause very serious (possibly fatal) side effects to occur. Examples of affected drugs include certain "blood thinners" (such as ticagrelor), colchicine, certain drugs to treat irregular heartbeat (such disopyramide, dofetilide, dronedarone, quinidine), eplerenone, ergot alkaloids (such as dihydroergotamine, ergotamine, methylergonovine), felodipine, fesoterodine, irinotecan, ivabradine, lurasidone, methadone, midazolam, nisoldipine, pimozide, ranolazine, certain "statin" cholesterol drugs (such as lovastatin, simvastatin), solifenacin, telithromycin, triazolam, among others. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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 reduce the risk of certain fungal infections.

Read the Patient Information Leaflet if available from your pharmacist before you start taking itraconazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with a full meal as directed by your doctor, usually once or twice daily. Swallow the capsules whole.

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

The dosage and length of treatment are based on your medical condition and response to treatment. Take this medication exactly as prescribed by your doctor. Some conditions may require you to take this medication in cycles (twice daily for 1 week, then stopping the medication for 3 weeks).

For the best effect, take this antifungal at evenly spaced times. To help you remember, take this medication at the same time(s) each day. Mark your calendar with a reminder if you are taking this medication in cycles.

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

The capsule, tablet, and solution forms of this medication deliver different amounts of medication and may be used for different purposes. Do not switch between the different forms or brands of this drug without your doctor's direction.

Tell your doctor if your condition does not get better or if it gets worse.

See also Warning section.

Nausea/vomiting, diarrhea, headache, stomach upset, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: numbness/tingling of arms/legs, hearing loss, mental/mood changes (such as depression).

Itraconazole has rarely caused very serious (possibly fatal) liver disease. Tell your doctor right away if you develop symptoms of liver disease, such as: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.

Itraconazole can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before taking itraconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals (such as 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, kidney disease, heart disease (such as heart failure, coronary artery disease, heart valve disease), lung disease (such as chronic obstructive pulmonary disease-COPD), decreased or no stomach acid (achlorhydria).

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Alcohol may also increase the risk of serious liver problems.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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. This medication should not be used to treat fungal nail infections if you are pregnant or could become pregnant during treatment. Women of childbearing age should start this medication 2 to 3 days after the start of their periods to make sure that they are not pregnant. Discuss the use of reliable forms of birth control while taking this medication and for 2 months after stopping treatment.

Itraconazole passes into breast milk. Consult your doctor before breastfeeding.

See also Warning and How to Use sections.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Itraconazole interacts with many medications. See also Warning section.

Other medications can affect the removal of itraconazole from your body, which may affect how itraconazole works. Examples include efavirenz, isoniazid, nevirapine, rifamycins (such as rifabutin), certain drugs used to treat seizures (such as phenytoin), among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later to treat or prevent another infection unless your doctor tells you to.

Lab and/or medical tests (such as liver function, potassium level, blood pressure) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.