Tolsura 65 mg oral solid dispersion capsule

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Medication name

Generic name:
Itraconazole 65 milligram capsule - oral

Pronunciation
(IT-ra-KON-a-zole)

Brand name(s)
Tolsura

Warning

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. 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).

Uses

Itraconazole is used to treat a variety of fungal infections. It belongs to a class of drugs known as azole antifungals. It works by stopping the growth of fungi.

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 reduce the risk of certain fungal infections.

How to use

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 food as directed by your doctor, usually once or twice daily. Swallow the capsules whole. Do not chew, crush, or break the capsules.

The dosage and length of treatment are based on your medical condition, response to treatment, and other medications you may be taking. Take this medication exactly as prescribed by your doctor.

For the best effect, take this antifungal at evenly spaced times. To help you remember, take this medication at the same time(s) every day.

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.

Side effects

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.

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 www.fda.gov/medwatch.

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

Precautions

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 problems
  • kidney problems
  • heart problems (such as heart failure, coronary artery disease, heart valve disease)
  • lung disease (such as chronic obstructive pulmonary disease-COPD)

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. Ask about 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.

Drug interactions

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.

Overdose

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.

Notes

Do not share this medication with others.

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

Lab and/or medical tests (such as liver function) 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.

Missed dose

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.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Important note

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.

Information last revised May 2024.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.