Description and Brand Names

US Brand Name

  1. Onmel
  2. Sporanox

Descriptions


Itraconazole is used to treat serious fungal or yeast infections. Itraconazole oral solution is only used to treat oropharyngeal or esophageal candidiasis (thrush, oral thrush). Itraconazole capsule is used to treat fungal infections, such as aspergillosis (fungal infection in the lungs), blastomycosis (Gilchrist’s disease), or histoplasmosis (Darling’s disease). Sporanox® capsule is also used to treat onychomycosis (fungal infection in the fingernails or toenails). Itraconazole tablet is only used to treat onychomycosis of the toenails. This medicine works by killing the fungus or yeast and preventing its growth.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Capsule
  • Solution
  • Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of itraconazole have not been performed in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of itraconazole in the elderly. However, elderly patients are more likely to have temporary or permanent hearing loss or age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving itraconazole.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Alfuzosin
  • Alprazolam
  • Amisulpride
  • Astemizole
  • Avanafil
  • Bepridil
  • Cisapride
  • Colchicine
  • Conivaptan
  • Dabigatran Etexilate
  • Dihydroergotamine
  • Disopyramide
  • Dofetilide
  • Dronedarone
  • Eletriptan
  • Eliglustat
  • Eplerenone
  • Ergonovine
  • Ergotamine
  • Felodipine
  • Flibanserin
  • Fluconazole
  • Irinotecan
  • Irinotecan Liposome
  • Isavuconazonium Sulfate
  • Ivabradine
  • Levomethadyl
  • Lomitapide
  • Lovastatin
  • Lurasidone
  • Maraviroc
  • Mesoridazine
  • Methadone
  • Methylergonovine
  • Methysergide
  • Midazolam
  • Naloxegol
  • Nelfinavir
  • Nisoldipine
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Quinidine
  • Ranolazine
  • Silodosin
  • Simvastatin
  • Solifenacin
  • Sparfloxacin
  • Telithromycin
  • Terfenadine
  • Thioridazine
  • Ticagrelor
  • Tolvaptan
  • Triazolam
  • Venetoclax
  • Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acalabrutinib
  • Ado-Trastuzumab Emtansine
  • Afatinib
  • Alfentanil
  • Aliskiren
  • Amiodarone
  • Anagrelide
  • Apalutamide
  • Apixaban
  • Aprepitant
  • Aripiprazole
  • Aripiprazole Lauroxil
  • Arsenic Trioxide
  • Atorvastatin
  • Axitinib
  • Bedaquiline
  • Benzhydrocodone
  • Betrixaban
  • Boceprevir
  • Bosutinib
  • Bretylium
  • Brexpiprazole
  • Brigatinib
  • Bromocriptine
  • Buprenorphine
  • Buserelin
  • Cabazitaxel
  • Cabozantinib
  • Calcifediol
  • Carbamazepine
  • Cariprazine
  • Ceritinib
  • Cilostazol
  • Citalopram
  • Clarithromycin
  • Clofazimine
  • Clozapine
  • Cobicistat
  • Cobimetinib
  • Codeine
  • Copanlisib
  • Crizotinib
  • Cyclosporine
  • Dabrafenib
  • Daclatasvir
  • Darifenacin
  • Dasatinib
  • Deflazacort
  • Degarelix
  • Delamanid
  • Deslorelin
  • Deutetrabenazine
  • Digoxin
  • Dihydrocodeine
  • Docetaxel
  • Domperidone
  • Donepezil
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Duvelisib
  • Edoxaban
  • Efavirenz
  • Elagolix
  • Elbasvir
  • Elvitegravir
  • Encorafenib
  • Entrectinib
  • Erlotinib
  • Escitalopram
  • Eszopiclone
  • Everolimus
  • Fedratinib
  • Fentanyl
  • Fingolimod
  • Fluoxetine
  • Fluticasone
  • Fosaprepitant
  • Foscarnet
  • Fosnetupitant
  • Fosphenytoin
  • Glasdegib
  • Gonadorelin
  • Goserelin
  • Grazoprevir
  • Halofantrine
  • Haloperidol
  • Histrelin
  • Hydrocodone
  • Hydroxychloroquine
  • Hydroxyzine
  • Ibrutinib
  • Ibutilide
  • Idelalisib
  • Iloperidone
  • Inotuzumab Ozogamicin
  • Ivacaftor
  • Ivosidenib
  • Ixabepilone
  • Lapatinib
  • Larotrectinib
  • Lenvatinib
  • Leuprolide
  • Levofloxacin
  • Levomilnacipran
  • Lofexidine
  • Lorlatinib
  • Lumacaftor
  • Macimorelin
  • Macitentan
  • Manidipine
  • Meperidine
  • Metronidazole
  • Midostaurin
  • Mifepristone
  • Morphine
  • Morphine Sulfate Liposome
  • Moxifloxacin
  • Nafarelin
  • Neratinib
  • Netupitant
  • Nevirapine
  • Nifedipine
  • Nilotinib
  • Olaparib
  • Ondansetron
  • Osimertinib
  • Oxycodone
  • Palbociclib
  • Panobinostat
  • Pasireotide
  • Pazopanib
  • Pentazocine
  • Pexidartinib
  • Phenytoin
  • Pimavanserin
  • Pitolisant
  • Pixantrone
  • Ponatinib
  • Quetiapine
  • Reboxetine
  • Regorafenib
  • Repaglinide
  • Retapamulin
  • Ribociclib
  • Rifabutin
  • Rifampin
  • Riociguat
  • Risperidone
  • Rivaroxaban
  • Romidepsin
  • Ruxolitinib
  • Salmeterol
  • Sertraline
  • Sevoflurane
  • Sildenafil
  • Simeprevir
  • Siponimod
  • Sirolimus
  • Sonidegib
  • Sotalol
  • St John's Wort
  • Sufentanil
  • Sulpiride
  • Sunitinib
  • Suvorexant
  • Tacrolimus
  • Tadalafil
  • Talazoparib
  • Tamsulosin
  • Temsirolimus
  • Tezacaftor
  • Thiotepa
  • Topotecan
  • Toremifene
  • Trabectedin
  • Tramadol
  • Trazodone
  • Triclabendazole
  • Triptorelin
  • Valbenazine
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Venlafaxine
  • Vilanterol
  • Vilazodone
  • Vinblastine
  • Vincristine
  • Vincristine Sulfate Liposome
  • Vinflunine
  • Vinorelbine
  • Vorapaxar
  • Warfarin
  • Zolpidem
  • Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acenocoumarol
  • Anisindione
  • Buspirone
  • Busulfan
  • Ciprofloxacin
  • Dicumarol
  • Didanosine
  • Indinavir
  • Meloxicam
  • Micafungin
  • Phenprocoumon
  • Ritonavir
  • Rosuvastatin
  • Saquinavir
  • Tolterodine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • food
  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Chronic obstructive pulmonary disease (COPD) or
  • Edema (body swelling or fluid retention) or
  • Heart attack, history of or
  • Heart disease (eg, ischemic disease, valve problems) or
  • Heart rhythm problems—Use with caution. May increase the risk for more serious side effects.
  • Congestive heart failure—Use with caution. Tolsura™ may make this condition worse.
  • Congestive heart failure or history of—Should not be used to treat fungal infection of the fingernails or toenails in patients with this condition.
  • Cystic fibrosis or
  • Hypochlorhydria (low level of acid in the stomach) in HIV-infected patients or
  • Patients who have had an organ transplant—Absorption from the stomach may change.
  • Elevated liver enzymes or
  • Kidney disease or
  • Liver disease, active or history of—Use with caution. May make these conditions worse.

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Itraconazole capsules and tablets should be taken with a full meal. The oral liquid is best taken on an empty stomach.

Take the tablets at the same time each day.

Measure the oral liquid with a marked measuring spoon or medicine cup. If you have thrush in the mouth or throat, place 10 milliliters (mL) of the liquid in your mouth, swish for several seconds, then swallow. Repeat these steps if your total dose is more than 10 mL.

If you are using antacids (eg, Maalox®, Mylanta®, Pepcid® Complete, Rolaids®, or Tums®) or other stomach medicine (eg, H2 blocker, proton pump inhibitor), take them at least 2 hours before or 2 hours after using itraconazole. You may also take itraconazole with an acidic beverage (eg, non-diet cola) if you are taking it with an antacid.

Use only the brand and the dosage form of this medicine that your doctor prescribed. Different brands and dosage forms may not work the same way.

Sporanox® oral liquid works differently than itraconazole Sporanox® capsules, even at the same dose (number of milligrams). Do not switch from the capsules to the oral liquid unless your doctor tells you to.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

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

Call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

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.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Decreased urine output
  2. dry mouth
  3. fever
  4. increased thirst
  5. irregular heartbeat
  6. loss of appetite
  7. mood changes
  8. muscle pain or cramps
  9. nausea
  10. numbness or tingling in the hands, feet, or lips
  11. seizures
  12. trouble breathing
  13. unusual tiredness or weakness
  14. vomiting

Less common

  1. Blurred vision
  2. chest pain
  3. chills
  4. clay-colored stools
  5. cloudy urine
  6. cold sweats
  7. confusion
  8. cough
  9. dark urine
  10. decrease in urine-concentrating ability
  11. diarrhea
  12. dizziness
  13. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  14. drowsiness
  15. feeling unusually cold
  16. headache
  17. itching, skin rash
  18. light-colored stools
  19. mental changes
  20. muscle cramps in the hands, arms, feet, legs, or face
  21. muscle spasms (tetany) or twitching
  22. nervousness
  23. noisy, rattling breathing
  24. numbness and tingling around the mouth or fingertips
  25. pounding in the ears
  26. shivering
  27. slow, fast, or pounding heartbeat or pulse
  28. sneezing
  29. sore throat
  30. stomach cramps or pain
  31. sweating
  32. swelling of the fingers, hands, feet, or lower legs
  33. tightness in the chest
  34. trembling
  35. troubled breathing at rest
  36. unpleasant breath odor
  37. vomiting of blood
  38. weight gain
  39. yellow eyes or skin

Rare

  1. Black, tarry stools
  2. bleeding gums
  3. blistering, peeling, or loosening of the skin
  4. bloating or swelling of the face, arms, hands, lower legs, or feet
  5. blood in the urine or stools
  6. blue lips and fingernails
  7. burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings
  8. continuing ringing or buzzing or other unexplained noise in the ears
  9. coughing that sometimes produces a pink frothy sputum
  10. cracks in the skin
  11. decreased appetite
  12. difficulty with swallowing
  13. dilated neck veins
  14. disturbed color perception
  15. double vision
  16. extreme tiredness or weakness
  17. fast or irregular breathing
  18. feeling of discomfort
  19. general feeling of tiredness or weakness
  20. halos around lights
  21. hearing loss
  22. hives or welts
  23. inflammation of the joints
  24. joint pain
  25. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  26. loss of heat from the body
  27. loss of vision
  28. lower back or side pain
  29. night blindness
  30. overbright appearance of lights
  31. painful or difficult urination
  32. pale skin
  33. pinpoint red spots on the skin
  34. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  35. rapid weight gain
  36. red skin lesions, often with a purple center
  37. red, irritated eyes
  38. red, swollen skin
  39. scaly skin
  40. sores, ulcers, or white spots on the lips or in the mouth
  41. stomach pain, continuing
  42. stomach tenderness
  43. swollen lymph glands
  44. tunnel vision
  45. unsteadiness or awkwardness
  46. unusual bleeding or bruising
  47. unusual weight gain or loss
  48. upper right abdominal or stomach pain
  49. weakness in the arms, hands, legs, or feet

Incidence not known

  1. Bloating
  2. constipation
  3. difficult, fast, noisy breathing
  4. indigestion
  5. loss of bladder control
  6. pains in the stomach, side, or abdomen, possibly radiating to the back

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  1. Decreased interest in sexual intercourse
  2. difficulty having a bowel movement
  3. difficulty with moving
  4. discouragement
  5. feeling of constant movement of self or surroundings
  6. feeling sad or empty
  7. inability to have or keep an erection
  8. irritability
  9. loss in sexual ability, desire, drive, or performance
  10. loss of interest or pleasure
  11. muscle aching or stiffness
  12. pain or tenderness around the eyes and cheekbones
  13. passing of gas
  14. sensation of spinning
  15. sleepiness or unusual drowsiness
  16. soreness of the skin
  17. stomach fullness or discomfort
  18. stuffy or runny nose
  19. trouble concentrating
  20. trouble sleeping

Rare

  1. Belching
  2. change in taste
  3. hair loss or thinning of the hair
  4. heartburn
  5. increased need to urinate
  6. increased sensitivity of the eyes or skin to sunlight
  7. loss of taste
  8. menstrual changes
  9. passing urine more often
  10. redness or other discoloration of the skin
  11. severe sunburn

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.