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Generic Name: itraconazole (i-tra-KOE-na-zole)
Brand Name: Examples included Sporanox and Sporanox PulsePak
Sporanox PulsePak should not be used to treat certain fungal infections (onychomycosis) in patients with heart problems (eg, history of congestive heart failure). Contact your doctor immediately if you experience symptoms of congestive heart failure such as swelling of the hands, ankles, feet, or abdomen; bloating; shortness of breath; fast or irregular heartbeat; severe or persistent nausea; or confusion.
Use of Sporanox PulsePak along with certain other medicines may increase your risk of serious and sometimes fatal heart problems, including irregular heartbeat. Do not take Sporanox PulsePak if you are also taking cisapride, pimozide, quinidine, dofetilide, or levacetylmethadol (levomethadyl).
Sporanox PulsePak is used for:
Treating fungal infections. It may also be used for other conditions as determined by your doctor.
Sporanox PulsePak is an azole antifungal. It kills sensitive fungi by interfering with the formation of the fungal cell membrane.
Do NOT use Sporanox PulsePak if:
- you are allergic to any ingredient in Sporanox PulsePak
- you are being treated for a certain type of fungal infection (onychomycosis) and you also have a history of heart problems (eg, congestive heart failure) or are pregnant or may become pregnant
- you are taking aldosterone blockers (eg, eplerenone), cisapride, dofetilide, ergot alkaloids (eg, ergotamine), erythromycin, H1 antagonists (eg, astemizole, terfenadine), HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), levacetylmethadol (levomethadyl), midazolam, nevirapine, pimozide, quinazolines (eg, alfuzosin), quinidine, rifabutin, rifampin, triazolam, or 5-HT receptor agonists (eg, eletriptan)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Sporanox PulsePak:
Some medical conditions may interact with Sporanox PulsePak. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of a weakened immune system, kidney or liver disease, heart problems (eg, congestive heart failure, irregular heartbeat), lung or breathing problems (eg, chronic obstructive pulmonary disease [COPD]), stomach problems (eg, low levels of stomach acid), nerve problems, HIV, or swelling
- if you are on dialysis
- if you are allergic to other azole antifungals (eg, itraconazole)
Some MEDICINES MAY INTERACT with Sporanox PulsePak. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Carbamazepine, H2 antagonists (eg, famotidine), nevirapine, phenobarbital, phenytoin, rifabutin, or rifampin because effectiveness of Sporanox PulsePak may be decreased
- Antiarrhythmics (eg, disopyramide, quinidine), cisapride, dofetilide, H1 antagonists (eg, astemizole, terfenadine), halofantrine, HIV protease inhibitors (eg, ritonavir), HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), levacetylmethadol (levomethadyl), macrolide antibiotics (eg, erythromycin), pimozide, or quinolones (eg, ciprofloxacin) because the risk of severe heart effects may be increased
- Benzodiazepines (eg, alprazolam, midazolam, triazolam), methadone, or narcotics (eg, codeine, morphine) because actions and side effects of these medicines may be increased, resulting in increased risk of sedation and breathing difficulties
- Aldosterone blockers (eg, eplerenone), anticoagulants (eg, warfarin), aripiprazole, buspirone, calcium channel blockers (eg, nifedipine, verapamil), cilostazol, corticosteroids (eg, prednisone), cyclophosphamide, digoxin, ergot alkaloids (eg, ergotamine), erlotinib, gefitinib, imatinib, or immunosuppressants (eg, cyclosporine, sirolimus) because the actions and side effects of these medicines may be increased
- Muscarinic receptor antagonists (eg, darifenacin), phosphodiesterase type 5 inhibitors (eg, sildenafil), quinazolines (eg, alfuzosin), sulfonylureas (eg, glipizide), trimetrexate, vinca alkaloids (eg, vincristine), or 5-HT receptor agonists (eg, eletriptan) because the actions and side effects of these medicines may be increased
- Hormonal contraceptives (eg, birth control pills) because effectiveness may be decreased by Sporanox PulsePak and pregnancy may occur
This may not be a complete list of all interactions that may occur. Ask your health care provider if Sporanox PulsePak may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Sporanox PulsePak:
Use Sporanox PulsePak as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Sporanox PulsePak after a full meal.
- Sporanox PulsePak may come with an additional patient leaflet. Read it carefully and reread it each time you get Sporanox PulsePak refilled.
- If you are using the Pulse Pak, Sporanox PulsePak should be taken in "pulses." Take Sporanox PulsePak for 1 week, and then do not take Sporanox PulsePak for 3 weeks, and then repeat the same cycle, unless directed otherwise by your doctor. This pack contains enough medicine for 1 week. Be sure to refill Sporanox PulsePak before your next "pulse" begins.
- Do not take antacids within 1 hour before or 2 hours after taking Sporanox PulsePak.
- Take Sporanox PulsePak at least 2 hours before proton pump inhibitors (eg, omeprazole).
- To clear up your infection completely, continue taking Sporanox PulsePak for the full course of treatment even if you feel better in a few days. Do not miss any doses.
- Sporanox PulsePak works best if it is taken at the same time each day.
- If you miss a dose of Sporanox PulsePak, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Sporanox PulsePak.
Important safety information:
- Sporanox PulsePak may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Sporanox PulsePak. Using Sporanox PulsePak alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
- Sporanox PulsePak has been known to cause rare cases of serious liver damage, including death, mainly in patients with serious medical conditions. Liver damage caused by Sporanox PulsePak has not been attributed to total daily dose, length of therapy, or sex or age of the patient. This type of liver damage may or may not be reversible when Sporanox PulsePak is stopped. If you notice any of the following, contact your doctor immediately: swollen or tender abdomen, yellowing of the skin or eyes.
- Sporanox PulsePak is effective only against fungi. It is not effective for treating viral infections (eg, the common cold).
- It is important to use Sporanox PulsePak for the full course of treatment. Failure to do so may decrease the effectiveness of Sporanox PulsePak and may increase the risk that the fungus will no longer be sensitive to Sporanox PulsePak and will not be able to be treated by this or certain other antibiotics in the future.
- Long-term or repeated use of Sporanox PulsePak may cause a second infection. Your doctor may want to change your medicine to treat the second infection. Contact your doctor if signs of a second infection occur.
- Diabetes patients - Sporanox PulsePak may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
- Do not switch between the capsule and oral solution forms of Sporanox PulsePak without checking with your doctor. Effectiveness and side effects of these forms of Sporanox PulsePak may be different even at the same dose.
- Sporanox PulsePak may decrease the effectiveness of your birth control pill. To prevent pregnancy, use an additional form of birth control.
- If you are using Sporanox PulsePak to treat a certain type of fungal infection (onychomycosis), you should use an effective form of contraception while you are on Sporanox PulsePak and for 2 months after you have stopped treatment. Talk with your doctor about effective forms of contraception.
- LAB TESTS, including liver function tests, may be required to monitor therapy. Be sure to keep all doctor and lab appointments.
- Use Sporanox PulsePak with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Sporanox PulsePak during pregnancy. Sporanox PulsePak is excreted in breast milk. Do not breast-feed while using Sporanox PulsePak.
Possible side effects of Sporanox PulsePak:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Diarrhea; dizziness; gas; headache; nausea; stomach pain or upset; stuffy nose.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloating; chest pain; confusion; dark urine; diarrhea; depression; fast or irregular heartbeat; fever; loss of appetite; numbness or tingling of the hands or feet; pale stools; red, swollen, blistered, or peeling skin; severe or persistent nausea; shortness of breath; sudden weight gain; swelling of the hands, ankles, or feet; swollen or tender abdomen; unusual tiredness or fatigue; vomiting; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/), or emergency room immediately. Symptoms may include changes in behavior; hallucinations; seizures; slowed breathing.Proper storage of Sporanox PulsePak:
Store Sporanox PulsePak at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sporanox PulsePak out of the reach of children and away from pets.
- If you have any questions about Sporanox PulsePak, please talk with your doctor, pharmacist, or other health care provider.
- Sporanox PulsePak is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Sporanox PulsePak. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.