Sporanox

Generic name: Itraconazole

What is Sporanox?

Sporanox capsules are used to treat serious fungal infections: blastomycosis, histoplasmosis, and aspergillosis. Blastomycosis can affect the lungs, bones, and skin. Histoplasmosis can affect the lungs, heart, and blood. Aspergillosis can affect the lungs, kidneys, and other organs.

Sporanox capsules are also used to treat onychomycosis, which infects the toenails and fingernails.

Sporanox oral solution is used to treat candidiasis (fungal infection) of the mouth, throat, and esophagus, and for other fungal infections in people with weakened immunity and fever.

What is the most important information I should know about Sporanox?

Do not take Sporanox if you are taking cisapride, dofetilide, ergot alkaloids such as dihydroergotamine and ergometrine, levacetylmethadol, nisoldipine, pimozide, or quinidine. Combined with these drugs, Sporanox could cause serious—even fatal—problems.

In rare cases, Sporanox has caused severe liver damage, sometimes resulting in death. Tell your doctor immediately if you develop nausea, vomiting, abdominal pain, unusual tiredness, loss of appetite, yellow skin or eyes, itching, dark urine, or clay colored stools.

In rare cases, Sporanox has been associated with the onset of congestive heat failure (CHF). Contact your doctor if you develop symptoms that may indicate CHF, including shortness of breath, chest pain, or swelling during treatment with Sporanox.

Who should not take Sporanox?

If you are sensitive to or have ever had an allergic reaction to Sporanox or similar antifungal drugs such as ketoconazole, do not take Sporanox.

Sporanox can have a negative effect on the heart. It should not be used for fungal nail infections in people with heart problems such as congestive heart failure.

Serious heart problems, such as irregular heartbeats and even death, have occurred in people who have taken Sporanox at the same time as cisapride, dofetilide, midazolam, pimozide, quinidine, triazolam, or cholesterol-lowering drugs known as statins, such as lovastatin and simvastatin.

What should I tell my doctor before I take the first dose of Sporanox?

Tell your doctor about all prescription, over-the-counter, and herbal medication you are taking before beginning treatment with Sporanox. Also, talk to your doctor about your complete medical history, especially if you have kidney or liver disease, heart or heart valve disease, chronic obstructive pulmonary disease, or swelling or water retention.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

Adults: Aspergillosis. The usual dose is 200-400 milligrams (mg) a day. Treatment usually continues for a minimum of 3 months, until tests indicate that the fungal infection has subsided.

Blastomycosis and Histoplasmosis

The usual dose is 2 100-mg capsules, taken after a full meal once a day. If you feel no improvement, or if there is evidence that the fungal disease has spread, your doctor will increase the dose to 100 mg at a time to a maximum of 400 mg a day. Daily dosages above 200 mg a day should be divided into 2 smaller doses.

Candidiasis, esophagus

The usual dose is 10 mL of oral solution a day for at least 3 weeks. You should continue the treatment for 2 weeks after your symptoms clear up. If necessary, the doctor may increase the dose to 20 mL a day.

Candidiasis, mouth and throat

The usual dose is 20 milliliters (mL) of oral solution a day for 1-2 weeks. If the infection does not go away, your dose will be changed to 10 mL twice a day.

Fungal Infections in People with Weakened Immunity and Fever

Recommended treatment starts with 200 mg injections twice a day for 2 days followed by 200 mg injected once a day for up to 14 days. This may be followed by 20 mL of oral solution twice a day for up to a total of 28 days of treatment.

Onychomycosis

The usual dose for a toenail infection, whether or not fingernails are also involved, is 200 mg once a day for 12 weeks.

If only fingernails are infected, treatment is given in 2 7-day-long sessions during which you take 200 mg twice a day with a 3-week rest period between sessions.

Children: The safety and effectiveness of Sporanox in children have not been established.

How should I take Sporanox?

Take Sporanox exactly as prescribed. Be sure to take Sporanox for as long as your doctor prescribes. It will take 3 months or more to cure some infections completely. If you stop taking Sporanox too soon, the infection may return.

To make sure the capsules are properly absorbed, you should take them after a full meal. The oral solution should be taken without food. Do not take antacids within 1 hour before or 2 hours after taking Sporanox. The oral solution and capsules cannot be used interchangeably.

Swish the oral solution, 10 mL at a time, in your mouth for a few seconds before swallowing it.

What should I avoid while taking Sporanox?

Use alcohol with caution. Alcohol and Sporanox can both affect the liver.

Grapefruit and grapefruit juice may interact with Sporanox. The interaction could lead to potentially dangerous effects. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

What are possible food and drug interactions associated with Sporanox?

If Sporanox is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Sporanox with the following:

Acid-blocking drugs such as famotidine and ranitidine,Alprazolam,Amphotericin B,Antacids such as cimetidine, ranitidine, esomeprazole, and pantoprazole,Antiarrhythmics such as digoxin, dofetilide, and quinidine,Antibiotics such as clarithromycin and erythromycin,Antiseizure drugs such as carbamazepine, phenobarbital, and phenytoin,Alfentanil,Blood-thinners such as warfarin,Buspirone,Calcium-blocking drugs such as amlodipine and verapamil,Cholesterol-lowering drugs such as atorvastatin, lovastatin, and simvastatin,Cilostazol,Cisapride,Corticosteroids such as budesonide, dexamethasone, and methylprednisolone,Cyclosporine,Diabetes drugs such as glipizide and glyburide,Diazepam,Digoxin,Dofetilide,Drugs to treat cancer such as busulfan, docetaxel, and vinca alkaloids,Eletriptan,Fentanyl,Halofantrine,HIV drugs such as indinavir, nevirapine, ritonavir, and saquinavir,Isoniazid,Midazolam,Pimozide,Rifabutin,Rifampin,Sirolimus,Tacrolimus,Triazolam,Trimetrexate

What are the possible side effects of Sporanox?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

Side effects may include: Abdominal pain, anxiety, bursitis, constipation, depression, diarrhea, dizziness, fatigue, fever, gas, headache, high blood pressure, indigestion, injury, itchiness, liver disorders, muscle pain, nasal and sinus inflammation, nausea, pain, rash, respiratory infection, swelling due to water retention, upper respiratory tract infection, upset stomach, urinary infection, vomiting

Additional side effects that may be seen with the oral solution are: Back pain, blood in the urine, chest pain, cough, dehydration, difficulty breathing, difficulty swallowing, hemorrhoids, hot flashes, impaired speech, inflamed mouth, insomnia, pneumonia, shivering, sweating, vision problems, weight loss

Can I receive Sporanox if I am pregnant or breastfeeding?

The effects of Sporanox during pregnancy and breastfeeding are unknown. Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding. You should not take Sporanox to treat fungal nail infections if you are or may become pregnant. Do not breastfeed while you are taking Sporanox.

What should I do if I miss a dose of Sporanox?

Take the forgotten dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and go back to your regular schedule. Never take 2 doses at once.

How should I store Sporanox?

Store at room temperature. Protect the capsules from light and moisture. Do not freeze the oral solution.