Uses of Itraconazole Oral Solution:

• It is used to treat fungal infections.

What do I need to tell my doctor BEFORE I take Itraconazole Oral Solution?

For all uses of itraconazole oral solution:

• If you have an allergy to itraconazole or any other part of itraconazole oral solution.
• If you are allergic to itraconazole oral solution; any part of itraconazole oral solution; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

Nail fungal infections:

• If you are pregnant or may be pregnant. Do not take itraconazole oral solution if you are pregnant.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take itraconazole oral solution with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Itraconazole Oral Solution?

For all uses of itraconazole oral solution:

• Tell all of your health care providers that you take itraconazole oral solution. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how itraconazole oral solution affects you.
• If you have dizziness or change in eyesight, do not drive or do other tasks or actions that could be unsafe.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Do not use longer than you have been told. A second infection may happen.
• Talk with your doctor before you drink alcohol.
• Hearing loss has happened with itraconazole oral solution. Many times this has happened when itraconazole oral solution was taken along with quinidine. This will most often go away after itraconazole oral solution is stopped but may last for a long time in some people. Talk with your doctor.
• If you are 65 or older, use itraconazole oral solution with care. You could have more side effects.
• Use birth control that you can trust to prevent pregnancy while taking itraconazole oral solution and for at least 2 months after your last dose.
• If you get pregnant while taking itraconazole oral solution or within 2 months after your last dose, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Nail fungal infections:

• It may take a few weeks to months to see the full effect.

How is this medicine (Itraconazole Oral Solution) best taken?

Use itraconazole oral solution as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep taking itraconazole oral solution as you have been told by your doctor or other health care provider, even if you feel well.
• Take itraconazole oral solution at the same time of day.
• Take itraconazole oral solution without food.
• Measure liquid doses carefully. Use the measuring device that comes with itraconazole oral solution. If there is none, ask the pharmacist for a device to measure itraconazole oral solution.
• For fungal infections in the mouth, throat, or swallowing tube (esophagus): Swish in your mouth for a few seconds and swallow.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• A burning, numbness, or tingling feeling that is not normal.
• Trouble passing urine.
• Chest pain or pressure.
• Fever or chills.
• Change in eyesight.
• Feeling confused.
• Ringing in the ears, hearing loss, or any other changes in hearing.
• Swelling.
• Lowered interest in sex.
• Not able to get or keep an erection.
• Very bad and sometimes deadly liver problems have rarely happened with itraconazole oral solution. Sometimes this happened within 7 days of starting this drug. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

What are some other side effects of Itraconazole Oral Solution?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Upset stomach or throwing up.
• Stomach pain or diarrhea.
• Runny nose.
• Feeling tired or weak.
• Dizziness.
• Not hungry.
• Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Itraconazole Oral Solution?

• Store at room temperature. Do not freeze.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about itraconazole oral solution, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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