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ITRACONAZOLE-INJECTABLE (cont.)

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 for severe fungal infections. Discuss the risks and benefits with your doctor. A reliable method of birth control should be used during therapy, and for 2 months after stopping itraconazole therapy. Consult your doctor for more details. 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: Itraconazole should not be used with the following medications because very serious reactions may occur: certain non-drowsy antihistamines (astemizole, terfenadine), ergot alkaloids (e.g., ergotamine, dihydroergotamine), oral midazolam, certain statin drugs (lovastatin, simvastatin), triazolam. If you are currently taking these medications, tell your doctor or pharmacist before starting intraconazole. If you are currently using repaglinide and gemfibrozil, you should not start taking itraconazole before consulting your doctor. If you are currently using these three medications in combination, tell your doctor or pharmacist immediately. Serious reactions (very low blood sugar) could occur. (Also see Warning section) Before using itraconazole, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: alprazolam, aripiprazole, atorvastatin, budesoide, buspirone, calcium channel blockers (e.g., verapamil, dihydropyridine type such as nifedipine), certain chemotherapy drugs (e.g., busulfan, docetaxel, vinca alkaloids), cilostazol, oral anti-diabetic drugs (sulfonylureas such as glyburide), drugs for male erectile problems (e.g., sildenafil, tadalafil, vardenafil), drugs which decrease immune system function (e.g., cyclosporine, tacrolimus, sirolimus), eletriptan, eplerenone, halofantrine, certain heart medications (antiarrthymics such as disopyramide, digoxin), HIV protease inhibitors (e.g., indinavir, ritonavir, saquinavir), isoniazid, certain macrolide antibiotics (e.g., erythromycin, clarithromycin), injectable midazolam, nevirapine, other drugs removed by the liver (CYP3A4 substrates), rifamycins (e.g., rifabutin, rifampin), certain anti-seizure drugs (e.g., carbamazepine, phenobarbital, phenytoin), stomach acid reducers (e.g., antacids, cimetidine, omeprazole), tolterodine, trazodone, warfarin. Do not start or stop any medicine without doctor or pharmacist approval.




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