Itraconazole (Injection)

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 breast feeding, or if you have a history of heart disease, liver disease, kidney disease, asthma or other lung problems, or HIV infection or AIDS. 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.
• Rarely, this medicine may cause severe liver problems. You should stop receiving 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.
• 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.

Brand Name(s)

There may be other brand names for this medicine.

Introduction

Treats fungal infections. This medicine is an antifungal antibiotic. The manufacturer stopped making this medicine in late 2007. This decision was not due to safety problems.

When This Medicine Should Not Be Used

You should not receive this medicine if you have had an allergic reaction to itraconazole. You should not receive itraconazole while you are also using cisapride (Propulsid®), dofetilide (Tikosyn?), midazolam (Versed®), pimozide (Orap®), quinidine (Quinaglute®, Quinidex®), triazolam (Halcion®), or levacetylmethadol (levomethadyl, Orlaam®). You should not receive itraconazole if you are using medicine to lower cholesterol, such as Baycol®, Lipitor®, lovastatin (Mevacor®), or simvastatin (Zocor®). You should not receive itraconazole if you are taking an ergot medicine such as dihydroergotamine, ergometrine (ergonovine), ergotamine (Ergomar®), Migranal®, Methergine®, or Cafergot®. You should not receive 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

Injectable, Solution

• Your doctor will prescribe your exact dose and how often it should be given. A nurse or other trained health professional will give you this medicine. This medicine is given through a needle or catheter (flexible tube) into one of your veins.
• Sometimes you or a family member can be taught to give your medicine at home. Make sure you understand all instructions before giving yourself an injection.

If a dose is missed:

• This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, pharmacist, or home health caregiver for instructions.

How to Store and Dispose of This Medicine

• The medicine is mixed in an IV bag with another liquid before your treatment. Store the bag at room temperature away from light, or in the refrigerator for up to 48 hours. Do not freeze. Let the medicine come to room temperature before your treatment.
• Keep all medicine away from children and never share your medicine with anyone.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine, containers, and other supplies. You will also need to throw away old medicine after the expiration date has passed.

Drugs and Foods to Avoid

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

• Certain drugs should not be used while you are receiving itraconazole. Using these drugs can cause very serious medical problems, heart problems, or even death.
• Make sure your doctor knows about all other medicines you are taking.

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 a heartbeat that is fast, pounding, or uneven.
• Cold sweat, new coughing, coughing up blood, or skin turning a bluish color.
• Dark-colored urine or pale stools.
• Nausea, vomiting, stomach pain, bloating, or loss of appetite.
• New or worsening numbness (loss of feeling) or tingling anywhere in your body.
• Redness, pain, or swelling at the injection site.
• Skin rash.
• Sudden weight gain.
• Swelling in the face, hands, ankles, or feet, with or without trouble breathing.
• Trouble urinating, discomfort when urinating, or a change in how much or how often you urinate.
• Unusual tiredness.
• 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 dizziness.
• 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