Sporanox (Generic name: Itraconazole)

What is the most important information I should know about Sporanox?

• Do not take Sporanox if you are taking astemizole (Hismanal), cisapride (Propulsid), pimozide (Orap), triazolam (Halcion), midazolam (Versed), lovastatin (Mevacor), simvastatin (Zocor), or quinidine (Cardioquin, Quinora, Quinidex, Quinaglute, Quin-Release, Quin-G). Combined with these drugs, Sporanox could cause serious, even fatal, problems.
• In rare cases, Sporanox has caused severe liver damage, sometimes resulting in death. Notify your doctor immediately if you develop nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes, itching, dark urine, or clay colored stools. These symptoms may be early signs of liver damage.
• In rare cases, Sporanox has been associated with the onset of congestive heart failure (CHF). Do not take Sporanox without first talking to your doctor if you have CHF or a history of CHF; other heart or heart valve disease; a lung disease such as chronic obstructive pulmonary disease; or significant swelling or water retention (edema). Contact your doctor if you develop symptoms that may indicate CHF including shortness of breath, chest pain, or swelling during treatment with Sporanox.
• Take all of the Sporanox that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.

What is Sporanox?

• Sporanox is an antifungal medication. It is like an antibiotic but is used to treat fungal infections.
• Sporanox is used to treat fungal infections in the lungs, in the central nervous system, in other parts of the body, as well as serious fungal infections of the skin and nails. The Sporanox oral solution is used to treat yeast infections of the mouth, throat, and esophagus.
• Sporanox may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Sporanox?

• Do not take Sporanox if you are taking any of the following drugs:
  • astemizole (Hismanal);
  • cisapride (Propulsid);
  • pimozide (Orap);
  • quinidine (Cardioquin, Quinora, Quinidex, Quinaglute, Quin-Release, Quin-G);
  • midazolam (Versed) or triazolam (Halcion); or
  • lovastatin (Mevacor) or simvastatin (Zocor).
• Dangerous or life-threatening events may occur if Sporanox is taken with any of the medicines listed above.
• In rare cases, Sporanox has been associated with the onset of congestive heart failure (CHF). Do not take Sporanox without first talking to your doctor if you have CHF or a history of CHF; other heart or heart valve disease; a lung disease such as chronic obstructive pulmonary disease; or significant swelling or water retention (edema). Contact your doctor if you develop symptoms that may indicate CHF including shortness of breath, chest pain, or swelling during treatment with Sporanox.
• Before taking Sporanox, tell your doctor if you have
  • liver disease; or
  • achlorhydria (decreased stomach acid production) or if you take antacids, stomach acid reducers, or stomach ulcer medicines.
• You may not be able to take Sporanox, or you may require a dosage adjustment, special monitoring, or special directions for use during your treatment.
• Sporanox is in the FDA pregnancy category C. This means that it is not known whether Sporanox will be harmful to an unborn baby. Effective contraception is recommended for any woman who could potentially become pregnant during treatment with Sporanox and for 2 months following the end of treatment. Do not take this medication without first talking to your doctor if you are pregnant.
• Sporanox passes into breast milk and may affect a nursing infant. Do not take Sporanox without first talking to your doctor if you are breast-feeding a baby.

How should I take Sporanox?

• Take Sporanox exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each capsule with a full glass of water.
• Take Sporanox capsules after a full meal to increase absorption in your stomach.
• To treat yeast infections of the mouth, throat, or esophagus, the oral solution should be swished vigorously in the mouth for several seconds, then swallowed. Take the oral solution without food if possible.
• Sporanox capsules and oral solution are different preparations and cannot be used interchangeably.
• Take all of the Sporanox that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.
• Grapefruit and grapefruit juice may interact with Sporanox. The interaction could lead to potentially dangerous effects. Discuss the use of grapefruit and grapefruit juice with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.
• Store Sporanox at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose as directed. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

• Seek emergency medical attention if an overdose is suspected.
• Symptoms of an Sporanox overdose are not well known but might include dizziness, ringing in the ears, headache, nausea, vomiting, diarrhea, and abdominal pain.

What should I avoid while taking Sporanox?

• Use alcohol with moderation while taking Sporanox. Alcohol and Sporanox can both affect the liver.
• Use caution when driving or performing other hazardous activities. Sporanox may cause dizziness. If you experience dizziness, avoid these activities.
• Grapefruit and grapefruit juice may interact with Sporanox. The interaction could lead to potentially dangerous effects. Discuss the use of grapefruit and grapefruit juice with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

What are the possible side effects of Sporanox?

• If you experience any of the following serious side effects, stop taking Sporanox and seek emergency medical attention or notify your doctor immediately:
  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • liver damage (pale stools, yellowish skin or eyes, abdominal pain, unusual fatigue, or dark urine);
  • symptoms of congestive heart failure including shortness of breath, chest pain, or swelling; or
  • nerve pain, numbness or tingling.
• Other, less serious side effects may be more likely to occur. If you experience any of the following side effects, continue taking Sporanox and talk to your doctor:
  • nausea, vomiting, or diarrhea;
  • headache;
  • dizziness;
  • fatigue; or
  • itching or a rash.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Sporanox?

• Do not take Sporanox if you are taking any of the following drugs:
  • astemizole (Hismanal);
  • cisapride (Propulsid);
  • pimozide (Orap);
  • quinidine (Cardioquin, Quinora, Quinidex, Quinaglute, Quin-Release, Quin-G);
  • midazolam (Versed) or triazolam (Halcion); or
  • lovastatin (Mevacor) or simvastatin (Zocor).
• Dangerous or life-threatening events may occur if Sporanox is taken with any of the medicines listed above.
• Before taking Sporanox, tell your doctor if you are taking any other medicines, especially any of the following:
  • digoxin (Lanoxin, Lanoxicaps);
  • carbamazepine (Tegretol, others) or phenytoin (Dilantin, others);
  • rifabutin (Mycobutin) or rifampin (Rifadin, Rimactane);
  • busulfan (Myleran), docetaxel (Taxotere), vinblastine sulfate (Velban), vincristine sulfate (Oncovin), or vinorelbine (Navelbine);
  • trimetrexate (Neutrexin);
  • alprazolam (Xanax) or diazepam (Valium);
  • verapamil (Isoptin, Verelan, Calan, Covera-HS), amlodipine (Norvasc), felodipine (Plendil), isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat, Procardia), nimodipine (Nimotop), or nisoldipine (Sular);
  • atorvastatin (Lipitor) or cerivastatin (Baycol);
  • tacrolimus (Prograf);
  • sirolimus (Rapamune);
  • cyclosporine (Sandimmune, Neoral);
  • glipizide (Glucotrol), glyburide (Diabeta, Micronase, Glynase), tolbutamide (Orinase), tolazamide (Tolinase), chlorpropamide (Diabinese), and others;
  • indinavir (Crixivan), ritonavir (Norvir), or saquinavir (Fortovase, Invirase);
  • buspirone (Buspar);
  • antacids;
  • cimetidine (Tagamet, Tagamet HB), nizatidine (Axid, Axid AR), famotidine (Pepcid, Pepcid AC), or ranitidine (Zantac, Zantac 75);
  • omeprazole (Prilosec), lansoprazole (Prevacid), or rabeprazole (Aciphex);
  • isoniazid (Nydrazid);
  • nevirapine (Viramune);
  • methylprednisolone (Medrol, others);
  • clarithromycin (Biaxin); or
  • warfarin (Coumadin).
• You may not be able to take Sporanox, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.
• Drugs other than those listed here may also interact with Sporanox or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.