Sporanox PulsePak

Sporanox PulsePak is an antifungal medicine for adults that treats infections caused by fungus. This includes infections in any part of the body, such as the lungs, mouth or throat, toenails, or fingernails.

Some brands of itraconazole should not be used for treating fungal infections of the fingernails or toenails. To avoid mistakes, use only the brand and strength that your doctor prescribes.

Sporanox PulsePak may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not share Sporanox PulsePak with another person, even if they have the same symptoms you have.

The Sporanox PulsePak capsule should be taken with food.

Swallow the capsule whole and do not crush, chew, break, or open it.

Take Sporanox PulsePak 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 carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

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.

Sporanox PulsePak capsules should not be used in place of itraconazole oral solution (liquid) if that is what your doctor has prescribed. Avoid medication errors by using only the form and strength your doctor prescribes.

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

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Sporanox PulsePak will not treat a viral infection such as the flu or a common cold.

You may need frequent medical tests.

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

You should not take Sporanox PulsePak if you have ever had heart failure.

If you have liver or kidney disease, do not take Sporanox PulsePak with colchicine, fesoterodine, or solifenacin.

Sporanox PulsePak may harm an unborn baby. Avoid getting pregnant while taking this medicine and for 2 months after your last dose.

Stop using Sporanox PulsePak and call your doctor immediately if you have signs of congestive heart failure: feeling tired or short of breath, cough with mucus, fast heartbeats, swelling, rapid weight gain, or sleep problems.

Life-threatening side effects may happen if you take Sporanox PulsePak with certain other drugs. Tell your doctor about all your current medicines and any that you start or stop using.

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

Life-threatening side effects may occur if you take Sporanox PulsePak with certain other drugs. Your doctor may change your treatment plan if you have used other medicines in the past 2 weeks, especially:

• avanafil;
• cisapride;
• eliglustat;
• irinotecan;
• isavuconazonium;
• methadone;
• naloxegol;
• ranolazine;
• ticagrelor;
• lurasidone or pimozide (anti-psychotic medications);
• lomitapide, lovastatin, simvastatin (cholesterol-lowering medicines);
• dihydroergotamine, ergonovine, ergotamine, or methylergonovine (ergot medicines);
• eplerenone, felodipine, ivabradine, or nisoldipine (heart or blood pressure medicines);
• disopyramide, dofetilide, dronedarone, or quinidine (medicines for heart rhythm disorders); or
• oral midazolam, or triazolam (Valium-like sedatives).

If you have liver or kidney disease, you should not take Sporanox PulsePak with colchicine, fesoterodine, solifenacin, or telithromycin.

Sporanox PulsePak may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 2 months after your last dose. Tell your doctor if you become pregnant.

Tell your doctor if you have ever had:

• heart problems;
• cystic fibrosis or other lung problems;
• liver or kidney disease; or
• a weak immune system.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

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

Stop using Sporanox PulsePak and call your doctor immediately if you have signs of congestive heart failure: feeling tired or short of breath, cough with mucus, fast heartbeats, swelling, rapid weight gain, or sleep problems.

Keep taking Sporanox PulsePak but call your doctor right away if you have:

• confusion, a light-headed feeling (like you might pass out);
• blurred vision, double vision, ringing in your ears, problems with hearing;
• fast heartbeats;
• numbness or tingling, loss of bladder control;
• little or no urinating, pain or burning when you urinate;
• low potassium level—leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, muscle weakness or feeling limp;
• pancreatitis—severe pain in your upper stomach spreading to your back, nausea, and vomiting; or
• liver problems—nausea, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of Sporanox PulsePak may include:

• headache, dizziness, drowsiness, tiredness;
• increased blood pressure;
• rash, itching;
• nausea, vomiting, stomach pain, diarrhea, constipation;
• swelling;
• abnormal liver function or blood tests;
• fever, muscle or joint pain;
• unusual or unpleasant taste in your mouth;
• hair loss;
• impotence, erection problems; or
• changes in your menstrual periods.

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.

Take the medicine as soon as you remember, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at the same time.

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

Do not drive or do anything dangerous until you understand how Sporanox PulsePak will affect you. Your reactions might be affected.

Do not take antacids within 1 hour before or 2 hours after you take Sporanox PulsePak. Some antacids can make it harder for your body to absorb this medicine.

Sometimes it is not safe to use certain medications at the same time. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medications less effective.

Many drugs can affect Sporanox PulsePak, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.