Sporanox Solution


|Sporanox Solution

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Sporanox Solution

Generic Name: Itraconazole Oral Solution (i-tra-KOE-na-zole)
Brand Name: Sporanox

Sporanox Solution has been shown to cause decreased heart function. 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 Solution along with certain other medicines may increase your risk of serious and sometimes fatal heart problems, including irregular heartbeat. Do not take Sporanox Solution if you are also taking cisapride, pimozide, quinidine, dofetilide, or levacetylmethadol (levomethadyl).

Sporanox Solution is used for:

Treating fungal infections. It may also be used for other conditions as determined by your doctor.

Sporanox Solution is an azole antifungal. It kills sensitive fungi by interfering with the formation of the fungal cell membrane.

Do NOT use Sporanox Solution if:

  • you are allergic to any ingredient in Sporanox Solution
  • 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 Solution:

Some medical conditions may interact with Sporanox Solution. 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 weakened immune system, low white blood cell levels, cystic fibrosis, 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 Solution. 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 Solution 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 Solution and pregnancy may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sporanox Solution 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 Solution:

Use Sporanox Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Sporanox Solution on an empty stomach at least 1 hour before or 2 hours after eating.
  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
  • If you are using Sporanox Solution to treat a mouth or throat infection, swish Sporanox Solution in your mouth for several seconds before swallowing, unless directed otherwise by your doctor.
  • Do not take antacids within 1 hour before or 2 hours after taking Sporanox Solution.
  • Take Sporanox Solution at least 2 hours before proton pump inhibitors (eg, omeprazole).
  • To clear up your infection completely, continue taking Sporanox Solution for the full course of treatment even if you feel better in a few days. Do not miss any doses.
  • Sporanox Solution works best if it is taken at the same time each day.
  • If you miss a dose of Sporanox Solution, 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 Solution.

Important safety information:

  • Sporanox Solution may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Sporanox Solution. Using Sporanox Solution alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
  • Sporanox Solution 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 Solution 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 Solution is stopped. If you notice any of the following, contact your doctor immediately: swollen or tender abdomen, yellowing of the skin or eyes.
  • Sporanox Solution is effective only against fungi. It is not effective for treating viral infections (eg, the common cold).
  • It is important to use Sporanox Solution for the full course of treatment. Failure to do so may decrease the effectiveness of Sporanox Solution and may increase the risk that the fungus will no longer be sensitive to Sporanox Solution and will not be able to be treated by this or certain other antibiotics in the future.
  • Long-term or repeated use of Sporanox Solution 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 Solution 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 Solution without checking with your doctor. Effectiveness and side effects of these forms of Sporanox Solution may be different even at the same dose.
  • Sporanox Solution may decrease the effectiveness of your birth control pill. To prevent pregnancy, use an additional form of birth control.
  • LAB TESTS, including liver function tests, may be required to monitor therapy. Be sure to keep all doctor and lab appointments.
  • Use Sporanox Solution 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 Solution during pregnancy. Sporanox Solution is excreted in breast milk. Do not breast-feed while using Sporanox Solution.

Possible side effects of Sporanox Solution:

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:

Diarrhea; dizziness; gas; headache; nausea; stomach pain or upset; stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur:

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/findyour.htm), or emergency room immediately. Symptoms may include changes in behavior; hallucinations; seizures; slowed breathing.

Proper storage of Sporanox Solution:

Store Sporanox Solution below 77 degrees F (25 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sporanox Solution out of the reach of children and away from pets.

General information:

  • If you have any questions about Sporanox Solution, please talk with your doctor, pharmacist, or other health care provider.
  • Sporanox Solution 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 Solution. 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.

Issue Date: November 1, 2006
Database Edition
Copyright © 2006 Wolters Kluwer Health, Inc.

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