Sporanox Solution

Sporanox Solution is used for:

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

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

Do NOT use Sporanox Solution if:

• you are allergic to any ingredient in Sporanox Solution
• 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 Solution:

Some medical conditions may interact with Sporanox Solution. 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 have HIV infection, a weakened immune system, low white blood cell levels, cystic fibrosis, 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 caused by Sporanox Solution

Some MEDICINES MAY INTERACT with Sporanox Solution. 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 Solution, increasing the risk of serious side effects
• Nevirapine, rifabutin, or rifampin because they may decrease Sporanox Solution'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 Solution, 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 Solution

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

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

• Take Sporanox Solution on an empty stomach at least 1 hour before or 2 hours after eating.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you are using Sporanox Solution to treat a mouth or throat infection, swish Sporanox Solution in your mouth for several seconds before swallowing, unless directed otherwise by your doctor.
• Do not take antacids within 1 hour before or 2 hours after taking Sporanox Solution.
• Take Sporanox Solution at least 2 hours before proton pump inhibitors (eg, omeprazole).
• To clear up your infection completely, take Sporanox Solution for the full course of treatment. Keep taking it even if you feel better in a few days. Do not miss any doses.
• Sporanox Solution works best if it is taken at the same time each day.
• If you miss a dose of Sporanox Solution, 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 Solution.

Important safety information:

• Sporanox Solution may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Sporanox Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Rarely, Sporanox Solution 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 Solution only works against fungi; it does not treat viral infections (eg, the common cold).
• Be sure to use Sporanox Solution 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 Solution without checking with your doctor. Effectiveness and side effects of these forms of Sporanox Solution may be different even at the same dose.
• Diabetes patients - Sporanox Solution 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 Solution. To prevent pregnancy, use an extra form of birth control (eg, condoms).
• If you are using Sporanox Solution to treat a certain type of fungal infection (onychomycosis), you should use an effective form of contraception while you are on Sporanox Solution 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 Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Sporanox Solution 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 Solution 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 Solution while you are pregnant. Sporanox Solution is found in breast milk. Do not breast-feed while using Sporanox Solution.

Possible side effects of Sporanox Solution:

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

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 abdomen; 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.

Store Sporanox Solution below 77 degrees F (25 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sporanox Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Sporanox Solution, please talk with your doctor, pharmacist, or other health care provider.
• Sporanox Solution is 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 Solution. 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.

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