Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

ITRACONAZOLE - INJECTABLE

(eye-truh-CON-uh-zole)

COMMON BRAND NAME(S): Sporanox

WARNING: Itraconazole injection has caused serious heart problems in animal and human medical studies. Tell your doctor immediately if any of these serious side effects of heart failure occur while using itraconazole injection: swelling of the legs/feet, unusual weight gain, unusual weakness/fatigue, or trouble breathing. Also, this medication may cause serious, even fatal drug interactions when taken with certain other medications. Avoid taking/using cisapride, pimozide, quinidine, or dofetilide with itraconazole (See Drug Interactions section).

Uses

Itraconazole injection is used to treat serious fungal infections. It is used in people who cannot take the oral form of this drug.

How To Use

Follow all instructions for proper mixing and dilution with the correct IV fluids. If you have questions regarding the use of this medication, consult your pharmacist. Give this medication by vein (IV) over 1 hour in a saline (NS) solution usually once or twice daily; or as directed by your doctor. The dosage and length of treatment is based on your medical condition and response to therapy. Antifungals work best when the amount of medicine in your body is kept at a constant level. Therefore, give/use this drug at evenly spaced intervals. Continue to use this medication until the full-prescribed amount is finished even if symptoms disappear after a few days. Stopping the medication too early may allow fungus to continue to grow, which may result in a relapse of the infection. Do not mix this drug in a dextrose-containing (e.g., D5W) or a Lactated Ringer's solution. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard needles and medical supplies safely. Consult your pharmacist. When you are able to tolerate oral medication, your doctor may change your treatment to an oral form of this drug (e.g., capsules, oral solution). The capsules and oral solutions are not interchangeable. Consult your pharmacist.

Side Effects

Nausea, vomiting, diarrhea, or headache may occur. If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these serious side effects occur: pain, decrease in amount of urine, injection site problems (e.g., pain, redness, swelling), stomach pain, fever. Tell your doctor immediately if any of these unlikely but serious side effects occur: swelling of the hands/feet, trouble breathing, unusual weakness/fatigue, chest pain, unusually fast heartbeat, tingling or numbness of the hands/feet. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: dark urine, yellowing eyes or skin. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Tell your doctor your medical history, especially of: kidney problems, liver problems (including abnormal liver function tests, or disease caused by other medicines), heart disease (e.g., arrhythmias, heart failure), any allergies (especially to other azole antifungals such as ketoconazole). Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding. If you are HIV-positive, breast milk can transmit HIV; do not breast-feed.

Drug Interactions

Certain medications taken with this product could result in serious, even fatal, drug interactions. Avoid certain drugs that affect the heart rhythm (cisapride, dofetilide, pimozide, quinidine, sertindole), eletriptan, certain non-sedating antihistamines (astemizole, mizolastine, terfenadine), certain drugs for high cholesterol (lovastatin, simvastatin). Tell your doctor of all prescription and nonprescription medication you may use, especially: digoxin, anti-seizure drugs (e.g., carbamazepine, phenobarbital, phenytoin), macrolide antibiotics (e.g., clarithromycin, erythromycin), certain protease inhibitors (e.g., indinavir, ritonavir), rifamycins (e.g., rifampin), other statins for high cholesterol (e.g., atorvastatin), drugs which decrease immune system function (e.g., cyclosporine, sirolimus, tacrolimus), certain anti-anxiety drugs (alprazolam, oral midazolam, triazolam), certain calcium channel blockers (felodipine, nifedipine, nisoldipine), oral diabetes medication (e.g., glyburide), certain chemotherapy drugs (e.g., busulfan, docetaxel, vincristine), "blood thinners" (e.g., warfarin), methylprednisolone, isoniazid, nevirapine, tolterodine, cilostazol, sildenafil. Also, report other drugs that may affect the heart rhythm (QTc prolongation), such as: sotalol, procainamide, sparfloxacin, "water pills" (diuretics such as furosemide or hydrochlorothiazide). Ask your doctor or pharmacist for more details. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately.

Notes

Do not share this medication with others. Laboratory and/or medical tests (liver function tests, serum creatinine) may be performed to monitor your progress. This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in those cases.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Before mixing, store the unmixed drug (ampule/vial) below room temperature (less than 77 degrees F or 25 degrees C) away from light. Do not freeze. After dilution with IV fluids, this product is stable at or below room temperature for 48 hours. Protect from direct sunlight (room light is acceptable).