Itraconazole is available as an oral solution and compound. It is available under the brand name Sporanox, Sporanox Pulsepak, and Tolsura. Although there used to be an itraconazole tablet marketed under the brand name Omnel, this formulation has since been discontinued.
What Is Sporanox Used For?
Sporanox treats fungal infections. The capsules are most commonly used for onychomycosis (toenail and fingernail fungus) but can also treat the following fungal infections:
Brand Name(s): Sporanox, Sporanox Pulsepak, Tolsura
Drug Availability: Prescription
Administration Route: Oral
Therapeutic Classification: Antifungal
Available Generically: No
Controlled Substance: N/A
Active Ingredient: Itraconazole
Dosage Form(s): Solution
Aspergillosis Blastomycosis Histoplasmosis
Although rare, these types of fungal infections most severely affect people who are immunocompromised. This includes people with human immunodeficiency virus (HIV), those receiving chemotherapy, and those with an organ transplant. Therefore, antifungal agents like Sporanox are also commonly used to prevent fungal infections in these populations.
The oral solution is only used to treat candidiasis (thrush).
How to Take Sporanox
If you are taking the capsule form, administer your dose with a full meal. Swallow the capsule whole; do not crush, break, or chew it.
Take itraconazole solution on an empty stomach. If you are being treated for thrush, swish 10 milliliters (mL) vigorously in your mouth and then swallow. The oral solution is usually preferred because the body absorbs it better than the capsules.
The solution and capsules are not interchangeable.
Storage
Capsules
Store Sporanox capsules at room temperature, away from light and moisture. You may store the capsules during travels between cool and slightly hot temperatures (59 and 86 degrees Fahrenheit). Do not store your drug in the bathroom. Instead, keep it in a dry place with the lid tightly closed, away from children and pets.
Solution
You can store itraconazole solution at room temperature or in the refrigerator, but do not freeze it. The solution is available in 10 milligrams (mg) per milliliter strength.
Compound
Sometimes your pharmacist may need to make a compound solution for you. Shake the compound well and take it as directed by your healthcare provider. Refrigerate and do not freeze. Sporanox compound is only suitable for 56 days. After 56 days, discard any unused liquid.
Throw away any unused and expired drugs. Do not pour Sporanox down the drain or toilet. Ask your pharmacist about the best ways to dispose of your medicines. There may be take-back programs near you.
Off-Label Uses
Healthcare providers may prescribe Sporanox for off-label uses, meaning for conditions not specifically indicated by the Food and Drug Administration (FDA).
Sporanox is used off-label for:
Vaginal yeast infections Valley fever Paracoccidioidomycosis Prevention against invasive fungal infections Rose gardener’s disease Ringworm Talaromycosis (formerly penicilliosis)
What Are the Side Effects of Sporanox?
This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.
Common Side Effects
Some common side effects of Sporanox are:
Stomach pain Diarrhea Loss of appetite Headache Nausea Vomiting Dizziness Sleepiness Weakness
Severe Side Effects
Call your healthcare provider as soon as possible if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you have a medical emergency.
Some people may have severe reactions while on Sporanox. Serious side effects and their symptoms can include the following:
Confusion Seizures Swelling Flushing (sudden reddening of the face, neck, and chest) Fruity breath Passing out Fever or chills Mood changes Change in eyesight Sexual dysfunction Chest pain or pressure Passing urine more often Ringing in the ears or hearing loss Burning, numbness, or tingling Weight gain (more than 5 pounds in 24 hours) New or worsening heart failure
Sporanox can cause deadly and severe liver problems, which can happen within seven days of starting this drug. Call your healthcare provider right away if you notice any of these symptoms:
Dark urine Feeling tired Loss of appetite Upset stomach Stomach pain Light-colored stools Throwing up Yellow skin or eyes
Long-Term Side Effects
Using azole antifungals for a long time can cause liver toxicity and hormone-related issues, such as gynecomastia (enlarged breasts), alopecia, and decreased libido. Other long-term effects of itraconazole can include:
Temporary or permanent hearing lossPancreatitis
Dosage: How Much of Sporanox Should I Take?
Modifications
Itraconazole is available as a 10 milligrams per milliliter solution. But, if you need a 20 milligrams per milliliter strength, your pharmacist can make this compound for you. Shake well and refrigerate. Toss any unused drug after 56 days.
If you experience a serious side effect, you or your healthcare provider may send a report to the FDA’s MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For oral dosage form (capsules): For aspergillosis: Adults: Sporanox®—200 to 400 milligrams (mg) per day. Tolsura™—130 mg (two capsules) once or 2 times a day. Children—Use and dose must be determined by your doctor. For blastomycosis or histoplasmosis: Adults: Sporanox®—200 milligrams (mg) (two capsules) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 400 mg per day. Tolsura™—130 mg (two capsules) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 260 mg per day. Children—Use and dose must be determined by your doctor. For onychomycosis of the fingernails: Adults—200 milligrams (mg) 2 times a day for 1 week, followed by a no treatment period of 3 weeks, then 200 mg 2 times a day for 1 week. Children—Use and dose must be determined by your doctor. For onychomycosis of the toenails: Adults—200 milligrams (mg) once a day for 12 weeks in a row. Children—Use and dose must be determined by your doctor. For oral dosage form (liquid): For esophageal candidiasis: Adults—100 milligrams (mg) or 10 milliliters (mL) once a day for a minimum of 3 weeks. Your doctor may increase your dose as needed. Children—Use and dose must be determined by your doctor. For oropharyngeal candidiasis: Adults—200 milligrams (mg) or 20 milliliters (mL) once a day for 1 to 2 weeks. Children—Use and dose must be determined by your doctor. For oral dosage form (tablets): For onychomycosis of the toenails: Adults—200 milligrams (mg) once a day for 12 weeks in a row. Children—Use and dose must be determined by your doctor.
Missed Dose
If you miss your dose, take it as soon as you remember. If it is too close to the next dose, skip the missed dose. Go back to your regular time. Do not double up on your pills or take extra.
Overdose: What Happens If I Take Too Much Sporanox?
There is limited data on the effects of taking high doses of Sporanox. Immediately contact a healthcare provider or the Poison Control Center if you have taken too much.
In some cases, you might need treatment with supportive measures, such as gastric lavage with sodium bicarbonate.
Precautions
What Are Reasons I Shouldn’t Take Sporanox?
Do not take Sporanox:
If someone collapses or isn’t breathing after taking Sporanox, call 911 immediately.
If your symptoms do not improve, or if they become worse, check with your doctor. You may need to take this medicine for several weeks or months before your infection gets better.
Do not use itraconazole if you are also using the following medicines: avanafil (Stendra™), cisapride (Propulsid®), disopyramide (Norpace®), dofetilide (Tikosyn®), dronedarone (Multaq®), eliglustat (Cerdelga™), eplerenone (Inspra®), felodipine (Plendil®), irinotecan (Camptosar®), isavuconazole (Cresemba®), ivabradine (Corlanor®), lomitapide (Juxtapid™), lurasidone (Latuda®), methadone (Dolophine®), naloxegol (Movantik®), nisoldipine (Sular®), oral midazolam (Versed®), pimozide (Orap®), quinidine (Cardioquin®, Quinaglute®), ranolazine (Ranexa®), ticagrelor (Brilinta®), triazolam (Halcion®), an ergot medicine (eg, dihydroergotamine, ergometrine, ergotamine, methylergometrine, Cafergot®, Ergomar®, Wigraine®), or certain medicines to lower cholesterol (eg, lovastatin, simvastatin, Mevacor®, Zocor®). Do not use itraconazole together with colchicine (Colcrys®), fesoterodine (Toviaz®), solifenacin (Vesicare®), or telithromycin (Ketek®) if you have kidney or liver disease. Using these medicines together may increase your risk for serious side effects.
Make sure your doctor knows if you are pregnant or planning to get pregnant before you start using this medicine for a fingernail or toenail infection. The capsule or tablet should not be used to treat onychomycosis in pregnant women or those who are planning to get pregnant. Use a highly effective form of birth control while you are using this medicine and for 2 months after your last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
Check with your doctor right away if you are having chest pain, decreased urine output, dilated neck veins, extreme fatigue, irregular breathing, an irregular heartbeat, swelling of the face, fingers, feet, or lower legs, tightness in the chest, trouble breathing, or weight gain. These could be symptoms of a side effect called congestive heart failure.
Rarely, this medicine may cause severe liver problems. Check with your doctor right away if you are having more than one of these symptoms: stomach pain or tenderness, clay-colored stools, dark urine, decreased appetite, fever, headache, itching, loss of appetite, nausea, vomiting, skin rash, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.
This medicine may cause nerve problems. Call your doctor right away if your skin feels like it is burning, crawling, itching, or if you have numbness, prickling, “pins and needles”, or a tingling feeling after using itraconazole.
Temporary or permanent hearing loss may occur while you are using this medicine. Check with your doctor right away if you have any changes in your hearing.
This medicine may make you feel dizzy or have blurred or double vision. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
If you are allergic to it or any part of the formulationTo treat toenail or fingernail fungus if you have heart failureIf you are taking any drugs that are contraindicated (should not be used) with it (see Interactions section)To treat toenail or fingernail fungus in people planning to become pregnant.
This drug is very harmful to the fetus if taken during pregnancy. Your healthcare provider may start this drug the second or third day after your period. Use effective contraception while on Sporanox and for two months after taking it.
What Other Medications Interact With Sporanox?
Sporanox interacts with many drugs, including prescription and over-the-counter (OTC) products. Do not take Sporanox with:
Uroxatral (alfuzosin) Tekturna (aliskiren) Xanax (alprazolam) Stendra (avanafil) Uceris (budesonide) Prepulsid, Propulsid (cisapride) Norpace (disopyramide) Tikosyn (dofetilide) Adriamycin (doxorubicin) Multaq (dronedarone) Relpax (eletriptan) Inspra (eplerenone) Ergot alkaloids, such as Trudhesa or Migranal (dihydroergotamine), ergonovine (also known as ergometrine), or methylergonovine Plendil (felodipine) Flonase (fluticasone) Camptosar, Novaplus Irinotecan Hydrochloride (irinotecan) Isavuconazole Corlanor (ivabradine) Juxtapid (lomitapide) Altoprev (lovastatin) Latuda (lurasidone) Methadose (methadone) Nayzilam (midazolam) Sular (nisoldipine) Orap (pimozide) Ranexa (ranolazine) Red yeast rice Xarelto (rivaroxaban) Serevent Diskus (salmeterol) Rapaflo (silodosin) Zocor (simvastatin) Belsomra (suvorexant) Flomax (tamsulosin) Halcion (triazolam) Cardioquin, Qunaglute, Quinalan, Quinidex Extentabs (quinidine)
This is not a complete list of all the medications that may interact with Sporanox. Talk to your healthcare provider about what medications (prescription and OTC), vitamins, and herbal supplements you are taking.
What Medications Are Similar?
There are many drugs similar to Sporanox, including:
Diflucan (fluconazole): Sporanox kills many fungi and has a broader spectrum than fluconazole. Unlike Sporanox, fluconazole is ineffective against Aspergillus. Vfend (voriconazole): Voriconazole and itraconazole have the same uses. In one analysis of multiple studies, itraconazole appeared to have slightly fewer treatment-related side effects overall, although both drugs had similar discontinuation rates due to side effects. However, no study has directly compared the tolerability of itraconazole and voriconazole. Noxafil (posaconazole): Noxafil is structurally similar to itraconazole and has a broad spectrum of antifungal activity. It can be used to prevent and treat Aspergillus and Candida infections. Administration forms include an oral solution and delayed-released tablets.
How Can I Stay Healthy While Taking Sporanox?
Having toenail or fingernail fungus can be bothersome. Sadly, it does not go away overnight. Don’t worry if you don’t see the full effects of Sporanox for a few weeks or months; it is still working. Even if it seems like you do not see an immediate impact, keep taking your medicine as directed by your healthcare provider.
DizzinessTiredness or weaknessHeadacheStomach painDiarrheaNausea or vomitingLoss of appetite
Some drugs may interact with Sporanox and cause severe and sometimes deadly effects. Do not start new medications without talking to your healthcare provider, including herbs, supplements, and OTC drugs.
