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SPORANOX
Generic Name: itraconazole (ih tra CAW nah zole)
Brand Names: Sporanox
What is the most important information I should know about itraconazole?
• Do not take itraconazole 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, itraconazole could cause
serious, even fatal, problems.
• In rare cases, itraconazole 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, itraconazole has been associated with the onset of congestive
heart failure (CHF). Do not take itraconazole 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 itraconazole.
• Take all of the itraconazole 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 itraconazole?
• Itraconazole is an antifungal medication. It is like an antibiotic but is used
to treat fungal infections.
• Itraconazole 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 itraconazole oral solution is used to treat yeast
infections of the mouth, throat, and esophagus.
• Itraconazole may also be used for purposes other than those listed in this
medication guide.
What should I discuss with my healthcare provider before taking itraconazole?
• Do not take itraconazole 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 itraconazole is taken with
any of the medicines listed above.
• In rare cases, itraconazole has been associated with the onset of congestive
heart failure (CHF). Do not take itraconazole 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 itraconazole.
• Before taking itraconazole, 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 itraconazole, or you may require a dosage
adjustment, special monitoring, or special directions for use during your
treatment.
• Itraconazole is in the FDA pregnancy category C. This means that it is not
known whether itraconazole will be harmful to an unborn baby. Effective
contraception is recommended for any woman who could potentially become pregnant
during treatment with itraconazole and for 2 months following the end of
treatment. Do not take this medication without first talking to your doctor if
you are pregnant.
• Itraconazole passes into breast milk and may affect a nursing infant. Do not
take itraconazole without first talking to your doctor if you are breast-feeding
a baby.
How should I take itraconazole?
• Take itraconazole 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 itraconazole 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.
• Itraconazole capsules and oral solution are different preparations and cannot
be used interchangeably.
• Take all of the itraconazole 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 itraconazole. 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 itraconazole 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 itraconazole 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 itraconazole?
• Use alcohol with moderation while taking itraconazole. Alcohol and
itraconazole can both affect the liver.
• Use caution when driving or performing other hazardous activities.
Itraconazole may cause dizziness. If you experience dizziness, avoid these
activities.
• Grapefruit and grapefruit juice may interact with itraconazole. 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 itraconazole?
• If you experience any of the following serious side effects, stop taking
itraconazole 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 itraconazole 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 itraconazole?
• Do not take itraconazole 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 itraconazole is taken with
any of the medicines listed above.
• Before taking itraconazole, 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 itraconazole, 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 itraconazole or
affect your condition. Talk to your doctor and pharmacist before taking any
prescription or over-the-counter medicines, including herbal products.
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