Sporanox (Itraconazole)

(℞) Prescription Required

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Sporanox 100mg

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Manufactured by: Janssen-Cilag
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Sporanox 100mg
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Sporanox Oral Solution 10mg/mL

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Sporanox Oral Solution 10mg/mL
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Itraconazole 100mg

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Itraconazole 100mg
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Sporanox 100mg

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Sporanox 100mg
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Sporanox Oral Solution 10mg/mL

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Manufactured by: Janssen-Ortho
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Sporanox Oral Solution 10mg/mL
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Sporanox (Itraconazole) Dosage and Side Effects

SPORANOX is a prescription medication used to treat fungal infections of the skin, mouth, eyes, nails or internal organs.

Warnings and Precautions

Serious Warnings and Precautions

  • Liver toxicity
  • Heart problems
  • Drug Interactions

SPORANOX treatment is not for everyone. Your doctor will decide if SPORANOX is the right treatment for you. Some patients should not take SPORANOX capsules because they may have certain health problems or may be taking certain medications that could lead to serious or life-threatening medical problems if taken together with SPORANOX.

Tell your doctor about any other medical conditions you have, or have had, especially heart, lung, liver or kidney conditions.

  • If you have a liver problem, your dose of SPORANOX capsules may have to be adjusted;
  • If you have a kidney disorder, your dose of SPORANOX capsules may have to be adjusted.

Also tell your doctor and pharmacist the name of all the prescription and non-prescription medications you are taking, including dietary supplements and herbal remedies.

BEFORE you use SPORANOX capsules let your doctor or pharmacist know if:

  • you have or have had heart disease, including congestive heart failure;
  • you have elevated or abnormal liver enzymes or active liver disease, or have experienced liver toxicity with other drugs;
  • you are a neutropenic (low white blood cell count), AIDS, or organ transplant patient. The dose of SPORANOX capsules may have to be adapted;
  • you have cystic fibrosis;
  • you have ever had an allergic reaction to itraconazole or any of the other ingredients in SPORANOX capsules.

SPORANOX capsules can sometimes cause dizziness, blurred/double vision or hearing loss. If you have these symptoms, do not drive or use machines.

Since scientific information on the use of SPORANOX capsules in children is limited, it is not recommended for use in children under 18 years of age.

Pregnancy:

Do not take SPORANOX capsules if you are pregnant (unless your doctor knows you are pregnant and decides you need SPORANOX) or planning to become pregnant within 2 months after you have finished your treatment.

If you are able to become pregnant, do not use SPORANOX capsules for the treatment of fungal skin or nail infections unless you use effective birth control during SPORANOX treatment and for 2 months after finishing treatment. Ask your doctor about effective types of birth control.

Breast-feeding:

Do not take SPORANOX capsules if you are breast-feeding or discontinue nursing if you are taking SPORANOX. SPORANOX is found in human breast milk.

Side Effects

The most common side effects that cause people to stop treatment either for a short time or completely include: skin rash, high triglyceride test results (fats in your blood), high liver test results, and digestive system problems (such as nausea, bloating, and diarrhea).

Other side effects that may occur with SPORANOX treatment include upset stomach, vomiting, abdominal pain, constipation or excess gas in stomach, cough, fluid in the lungs, altered voice, inflammation of the sinuses, inflammation of the nose, upper respiratory tract infection, headache, dizziness, menstrual disorders, erectile dysfunction, confusion, tremor, sleepiness, fatigue, chills, muscle weakness or pain, painful joints, pain, chest pain, swelling, generalized swelling, unpleasant taste, hair loss, inflammation of the pancreas, fever or excessive sweating may also occur.

Report any side effects to your doctor or pharmacist.

Interactions with this medication

A wide variety of drugs may interact with SPORANOX capsules.

Never take SPORANOX capsules if you are taking any of the following medications:

  • terfenadine, astemizole, mizolastine for allergy;
  • bepridil, felodipine, nisoldipine, lercanidipine, ivabradine, ranolazine, eplerenone used to treat angina (crushing chest pain) or high blood pressure;
  • ticagrelor used to slow down blood clotting;
  • cisapride used to treat certain digestive problems;
  • lovastatin and simvastatin which lower cholesterol;
  • triazolam and midazolam (oral) sleeping pills;
  • lurasidone, pimozide, sertindole used for psychotic disorders;
  • levacetylmethadol (levomethadyl), methadone;
  • dihydroergotamine or ergotamine (called ergot alkaloids); used in the treatment of migraine headaches;
  • ergometrine (ergonovine) and methylergometrine (methylergonovine) (called ergot alkaloids) used to control bleeding and maintain uterine contraction after child birth;
  • eletriptan used to treat migraine headaches;
  • halofantrine used to treat malaria;
  • irinotecan, an anti-cancer drug;
  • disopyramide, dronedarone, quinidine, dofetilide used to treat irregular heart beat rhythms;
  • domperidone used to treat nausea and vomiting.

If you have kidney or liver impairment, never take SPORANOX capsules while taking any of the following medications:

  • colchicine, a medication to treat gout;
  • fesoterodine or solifenacin used to treat overactive bladder;
  • telithromycin, an antibiotic.

Wait at least 2 weeks after stopping SPORANOX capsules before taking any of these medications.

Medications that can decrease the action of SPORANOX capsules and are not recommended unless your doctor feels it is necessary:

  • carbamazepine, phenytoin, phenobarbital used to treat epilepsy;
  • rifampicin, rifabutin, isoniazid used to treat tuberculosis;
  • efavirenz, nevirapine used to treat HIV/AIDS.

You should therefore always tell your doctor if you are using any of these products so that the appropriate measures can be taken.

Wait at least 2 weeks after stopping these medications before taking SPORANOX capsules.

Medications not recommended unless your doctor feels it is necessary:

  • axitinib, dabrafenib, dasatinib, ibrutinib, nilotinib, sunitinib, trabectedin; certain medications used in the treatment of cancer;
  • aliskiren used to treat hypertension;
  • sildenafil, when used to treat pulmonary hypertension (increased blood pressure in the blood vessels in the lungs);
  • rifabutin used to treat tuberculosis;
  • carbamazepine used to treat epilepsy;
  • colchicine used to treat gout;
  • conivaptan, tolvaptan used to treat low blood sodium;
  • darifenacin used to treat urinary incontinence;
  • everolimus, given after an organ transplant;
  • fentanyl, a strong medication to treat pain;
  • apixaban, rivaroxaban used to slow down blood clotting;
  • salmeterol used to improve breathing;
  • simeprevir used to treat hepatitis C;
  • tamsulosin used to treat male urinary incontinence;
  • vardenafil used to treat erectile dysfunction.

Wait at least 2 weeks after stopping these medications before taking SPORANOX capsules.

Medications that may require a dose change (for either SPORANOX capsules or the other medication):

  • ciprofloxacin, clarithromycin, erythromycin, telithromycin, antibiotics;
  • bosentan, digoxin, nadolol, riociguat, and certain calcium-channel blockers including verapamil that act on the heart or blood vessels;
  • coumarins, cilostazol, dabigatran; that slow down blood clotting;
  • methylprednisolone, budesonide, ciclesonide, fluticasone or dexamethasone (medications given by mouth, injection or inhalation for conditions such as inflammations, asthma, and allergies);
  • cyclosporine, tacrolimus, temsirolimus or rapamycin (also known as sirolimus), which are usually given after an organ transplant;
  • maraviroc, and protease inhibitors: indinavir, ritonavir, ritonavir-boosted darunavir, ritonavir-boosted fosamprenavir, saquinavir; used in the treatment of HIV/AIDS;
  • telaprevir, used in the treatment of Hepatitis C Virus;
  • bortezomib, busulphan, docetaxel, erlotinib, gefitinib, imatinib, ixabepilone, lapatinib, ponatinib, trimetrexate, vinca alkaloids; used in the treatment of cancer;
  • buspirone, perospirone, ramelteon, midazolam IV, alprazolam, brotizolam; for anxiety or to help you sleep (tranquillizer);
  • alfentanil, buprenorphine, oxycodone, sufentanil; certain strong medications to treat pain;
  • repaglinide, saxagliptin used to treat diabetes;
  • aripiprazole, haloperidol, quetiapine, risperidone used to treat psychosis;
  • aprepitant, certain medications used to treat nausea and vomiting;
  • fesoterodine, imidafenacin, oxybutynin, solifenacin, tolterodine; to control irritated urinary bladder;
  • sildenafil, tadalafil used to treat erectile dysfunction;
  • praziquantel used to treat fluke and tapeworms;
  • bilastine, ebastine; for allergy;
  • reboxetine used to treat depression;
  • atorvastatin used to lower cholesterol;
  • meloxicam used to treat joint inflammation and pain;
  • cinacalcet used to treat an over active parathyroid;
  • mozavaptan used to treat low blood sodium;
  • alitretinoin (oral formulation) used to treat eczema;
  • telithromycin used to treat pneumonia.

Always tell your doctor, nurse or pharmacist if you are taking any other medications, either prescription or over-the-counter, herbal medications or natural health products.

Proper Use of this medication

Always take SPORANOX capsules right after a full meal because it is better taken up by the body this way. Swallow the capsules whole with some water.

If you are taking acid-neutralizing medications (i.e., antacids), you should take these at least 1 hour before, or 2 hours after your SPORANOX capsules. For the same reason, if you take medications that stop the production of stomach acid, you should take your SPORANOX capsules with a non-diet cola beverage.

Do not use SPORANOX capsules for a condition for which it was not prescribed. Do not give SPORANOX capsules to other people, even if they have the same symptoms you have. It may harm them.

Do not switch to SPORANOX oral solution without talking to your doctor.

The SPORANOX PULSEPAK:

If you use the PULSEPAK, you will take SPORANOX capsules for 1 week and then take no SPORANOX treatment for the next 3 weeks before repeating the 1-week treatment. This is called "pulse dosing." The SPORANOX PULSEPAK contains enough medication for one "pulse" (1 week of treatment). The SPORANOX PULSEPAK is used only for fungal nail infections.

The SPORANOX PULSEPAK comes with special instructions. It contains 7 blister cards—one for each day of treatment. Each card contains 4 capsules. Looking at the back of the card, fold it back along the dashed line and peel away the backing so that you can remove 2 capsules.

Dosing for Fungal Nail Infection:

  • Take 2 capsules in the morning and 2 capsules in the evening. This means you will take 4 capsules a day for 7 days. At the end of 7 days, you will have taken all of the capsules in the PULSEPAK box.
  • After you finish the PULSEPAK, do not take any SPORANOX capsules for the next 3 weeks. Even though you are not taking any capsules during this time, SPORANOX treatment keeps working inside your nails to help fight the fungal infection.
  • You will need more than one “pulse” to treat your fungal nail infection. When your doctor prescribes another pulse treatment, be sure to get your refill before the end of week 4.
  • Nail lesions take up to 6 to 9 months to disappear after the end of treatment. Once the drug kills the fungus, the nail still needs to grow back, and regrowth takes many months. You should therefore stop treatment as prescribed by your doctor, even though you do not see any improvement.

Usual dose:

Your doctor will decide the right SPORANOX dose for you, and the length of SPORANOX treatment, depending on the type of fungus and the place of your infection. You will receive either a bottle of capsules or a PULSEPAK. Do not skip any doses. Be sure to finish all your SPORANOX capsules as prescribed by your doctor.

Overdose:

In case of drug overdose, contact a healthcare practitioner (e.g. doctor), hospital emergency department, or regional poison control centre, even if there are no symptoms.

Missed dose:

If you forget to take, or miss, doses of SPORANOX capsules, ask your doctor what you should do with the missed doses. Do not double dose.

Other related products

The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

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