Pronunciation: IT ra KON a zole

Brand: Onmel, Sporanox, Sporanox PulsePak

Sporanox 100 mg

slide 1 of 1, Sporanox 100 mg,

capsule, blue/pink, imprinted with JANSSEN, SPORANOX 100

Image of Sporanox 100 mg
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What is the most important information I should know about itraconazole?

You should not take this medicine if you have ever had congestive heart failure.

You should not take itraconazole to treat a toenail or fingernail infection if you are pregnant or may become pregnant during treatment.

Some medicines can cause unwanted or dangerous effects when used with itraconazole. Your doctor may need to change your treatment plan if you use any of the following drugs: cisapride, colchicine (if you have liver or kidney disease), dihydroergotamine, disopyramide, dofetilide, dronedarone, eplerenone, ergonovine, ergotamine, felodipine, irinotecan, lurasidone, lovastatin, methylergonovine, methadone, oral midazolam, nisoldipine, pimozide, quinidine, ranolazine, simvastatin, or triazolam.

Many drugs can interact with itraconazole. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with itraconazole.

What is itraconazole?

Itraconazole is an antifungal medication that fights infections caused by fungus.

Itraconazole is used to treat infections caused by fungus, which can invade any part of the body including the lungs, mouth or throat, toenails, or fingernails.

Itraconazole may also be used for purposes not listed in this medication guide.

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

You should not take this medicine if you are allergic to itraconazole or similar medicines such as fluconazole or ketoconazole, or if you have ever had congestive heart failure.

You should not take itraconazole to treat a toenail or fingernail infection if you are pregnant or may become pregnant during treatment.

Some medicines can cause unwanted or dangerous effects when used with itraconazole. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • cisapride;
  • colchicine (if you have liver or kidney disease);
  • eplerenone;
  • irinotecan;
  • methadone;
  • ranolazine;
  • disopyramide, dofetilide, dronedarone, quinidine;
  • felodipine or nisoldipine;
  • lovastatin or simvastatin;
  • oral midazolam, triazolam;
  • lurasidone, pimozide; or
  • ergot medicines such as dihydroergotamine, ergonovine, ergotamine, or methylergonovine.

To make sure itraconazole is safe for you, tell your doctor if you have:

  • heart disease, a heart rhythm disorder, circulation problems, or a history of stroke;
  • chronic obstructive pulmonary disease (COPD) or other breathing disorder;
  • kidney disease;
  • cirrhosis or other liver disease;
  • cystic fibrosis; or
  • a personal or family history of Long QT syndrome.

FDA pregnancy category C. It is not known whether itraconazole will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Itraconazole passes into breast milk and can harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take itraconazole?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

The itraconazole capsule should be taken after a full meal.

Take itraconazole oral solution (liquid) on an empty stomach, at least 1 hour before or 2 hours after a meal. Swish the liquid in your mouth for several seconds before swallowing it.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

The Sporanox PulsePak has a special dosing schedule that includes not taking the medicine for several days in a row. Follow all dosing instructions carefully.

Do not crush, chew, break, or open an itraconazole capsule. Swallow it whole.

Itraconazole capsules should not be used in place of itraconazole oral solution (liquid) if that is what your doctor has prescribed. Make sure you have received the correct type of this medicine at the pharmacy and ask the pharmacist if you have any questions.

If you also take a stomach acid reducer (Tagamet, Pepcid, Axid, Zantac, and others), take itraconazole with an acidic drink such as non-diet cola.

Take this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Itraconazole will not treat a viral infection such as the common cold or flu.

While using itraconazole, you may need frequent blood tests.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking itraconazole?

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid taking antacids within 1 hour before or 2 hours after you take itraconazole. Some antacids can make it harder for your body to absorb itraconazole.

What are the possible side effects of itraconazole?

Get emergency medical help if you have any of these signs of an allergic reaction: hives, severe skin rash, tingling in your arms or legs; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking itraconazole and call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • confusion, ringing in your ears, problems with hearing;
  • fast heartbeats;
  • numbness or tingly feeling, blurred vision, double vision, loss of bladder control;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting;
  • little or no urinating, pain or burning when you urinate;
  • signs of congestive heart failure --shortness of breath (even with mild exertion), cough with mucus, fast heartbeats, swelling, rapid weight gain, sleep problems; or
  • liver problems --nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • headache, dizziness;
  • nausea, vomiting, upset stomach, constipation;
  • hair loss;
  • fever, muscle aches, joint pain;
  • changes in your menstrual periods;
  • impotence, erection problems; or
  • unusual or unpleasant taste in the mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect itraconazole?

Many drugs can interact with itraconazole, and some drugs should not be used together. Tell your doctor about all your medicines and any you start or stop using during treatment with itraconazole, especially:

  • antipsychotic medicine or a sedative (such Valium or Xanax);
  • HIV/AIDS medicine;
  • medicine to treat high cholesterol;
  • an antibiotic --ciprofloxacin, clarithromycin, erythromycin;
  • a blood thinner --rivaroxaban, warfarin, Coumadin, Jantoven;
  • cancer medicine --dasatinib, nilotinib, and others;
  • drugs to treat urinary problems --Detrol, Flomax, Vesicare;
  • heart or blood pressure medication --aliskiren, digoxin, diltiazem, verapamil, and others;
  • immunosuppressants- -dexamethasone, everolimus, and others;
  • medicine to prevent organ transplant rejection --cyclosporine, sirolimus, and others;
  • migraine headache medicine --eletriptan and others;
  • narcotic pain medicine -- fentanyl, oxycodone, and others; or
  • seizure medicine --carbamazepine and others.

This list is not complete and many other drugs can interact with itraconazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about itraconazole.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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