Consumer Drug Information

Sporanox Capsules


Generic Name: Itraconazole Capsules (IT-ra-KON-a-zole)
Brand Name: Sporanox

Sporanox Capsules should not be used to treat a fungal infection of the toenail or fingernail (onychomycosis) in patients with heart problems (eg, history of congestive heart failure). 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 Capsules along with certain other medicines may increase your risk of serious and sometimes fatal heart problems, including irregular heartbeat. Do not take Sporanox Capsules if you are also taking cisapride, pimozide, quinidine, dofetilide, or levacetylmethadol (levomethadyl).


Sporanox Capsules are used for:

Advertisement

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

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

Do NOT use Sporanox Capsules if:

  • you are allergic to any ingredient in Sporanox Capsules
  • you are being treated for a fungal infection of the toenail or fingernail (onychomycosis) and you also have a history of heart problems (eg, congestive heart failure) or are pregnant or may become pregnant
  • you are taking an aldosterone blocker (eg, eplerenone), alprazolam, astemizole, cisapride, conivaptan, dofetilide, an ergot alkaloid (eg, ergotamine), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), levacetylmethadol (levomethadyl), midazolam, nevirapine, nisoldipine, pimozide, a quinazoline (eg, alfuzosin), quinidine, rifabutin, rifampin, terfenadine, triazolam, or certain 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 Capsules:

Some medical conditions may interact with Sporanox Capsules. 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 are allergic to other azole antifungals (eg, itraconazole)
  • if you have HIV infection, a weakened immune system, kidney or liver problems, heart problems (eg, congestive heart failure, irregular heartbeat, heat valve problems), lung or breathing problems (eg, chronic obstructive pulmonary disease [COPD]), low stomach acid (eg, hypochlorhydria), nerve problems, or problems with swelling
  • if you have had serious liver problems cause by medicine

Some MEDICINES MAY INTERACT with Sporanox Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for infections, HIV, seizures, anxiety, sleep, heartburn, diabetes, high cholesterol, heart problems, high blood pressure, allergies, irregular heartbeat, pain, blood thinning, asthma, migraines, mood or mental problems, cancer, prostate problems, immune system suppression, erectile dysfunction, urinary problems, or contraception [birth control]), multivitamin products, and herbal or dietary supplements may interact with Sporanox Capsules, increasing the risk of serious side effects
  • Nevirapine, rifabutin, or rifampin because they may decrease Sporanox Capsules's effectiveness
  • Astemizole, cisapride, dofetilide, levacetymethadol (levomethadyl), nisoldipine, pimozide, quinidine, or terfenadine because the risk of severe heart effects may be increased
  • Alprazolam, midazolam, or triazolam because their actions and the risk of their side effects may be increased by Sporanox Capsules, resulting in increased risk of sedation and breathing difficulties
  • Aldosterone blockers (eg, eplerenone), conivaptan, ergot alkaloids (eg, ergotamine), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), quinazolines (eg, alfuzosin) or 5-HT receptor agonists (eg, eletriptan) because the risk of their side effects may be increased by Sporanox Capsules

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

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

  • Take Sporanox Capsules after a full meal. If you have low stomach acid or you take medicine to reduce stomach acid, take Sporanox Capsules with a cola beverage.
  • Do not take antacids within 1 hour before or 2 hours after taking Sporanox Capsules.
  • Take Sporanox Capsules at least 2 hours before proton pump inhibitors (eg, omeprazole).
  • To clear up your infection completely, take Sporanox Capsules for the full course of treatment. Keep taking it even if you feel better in a few days. Do not miss any doses.
  • Sporanox Capsules works best if it is taken at the same time each day.
  • If you miss a dose of Sporanox Capsules, 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 Capsules.

Important safety information:

  • Sporanox Capsules may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Sporanox Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Rarely, Sporanox Capsules has been associated with serious, sometimes fatal liver damage. Contact your doctor right away if you notice dark urine, pale stools, a swollen or tender stomach, or yellowing of the skin or eyes.
  • Sporanox Capsules only works against fungi; it does not treat viral infections (eg, the common cold).
  • Be sure to use Sporanox Capsules for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
  • Do not switch between the capsule and oral solution forms of Sporanox Capsules without checking with your doctor. Effectiveness and side effects of these forms of Sporanox Capsules may be different even at the same dose.
  • Diabetes patients - Sporanox Capsules may increase the risk of low blood sugar from your diabetes medicine. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using Sporanox Capsules. To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • If you are using Sporanox Capsules to treat a certain type of fungal infection (onychomycosis), you should use an effective form of contraception while you are on Sporanox Capsules and for 2 months after you have stopped treatment. Talk with your doctor about effective forms of contraception.
  • Lab tests, including liver function, may be may be performed while you use Sporanox Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Sporanox Capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: It is not known if Sporanox Capsules can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sporanox Capsules while you are pregnant. Sporanox Capsules are found in breast milk. Do not breast-feed while using Sporanox Capsules.

Possible side effects of Sporanox Capsules:

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; gas; headache; nausea; runny nose; stomach pain or upset; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloating; chest pain; confusion; dark urine; 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; severe or persistent vomiting; shortness of breath; sudden weight gain; swelling of the hands, ankles, or feet; swollen or tender stomach; unusual bruising or bleeding; unusual tiredness or fatigue; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), or emergency room immediately.

Proper storage of Sporanox Capsules:

Store Sporanox Capsules at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sporanox Capsules out of the reach of children and away from pets.

General information:

  • If you have any questions about Sporanox Capsules, please talk with your doctor, pharmacist, or other health care provider.
  • Sporanox Capsules are 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 Capsules. 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 4, 2009
Database Edition 09.4.1.002
Copyright © 2009 Wolters Kluwer Health, Inc.




MedNotes

Subscribe to our popular newsletter containing a regular roundup of medication news, alerts and new drug approvals.


(web4)