Description
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
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
- Astemizole
- Atazanavir
- Avanafil
- Bepridil
- Bromocriptine
- Cisapride
- Colchicine
- Conivaptan
- Dihydroergotamine
- Disopyramide
- Dofetilide
- Dronedarone
- Eletriptan
- Eliglustat
- Eplerenone
- Ergoloid Mesylates
- Ergonovine
- Ergotamine
- Felodipine
- Fesoterodine
- Finerenone
- Flibanserin
- Fluconazole
- Gepirone
- Irinotecan
- Irinotecan Liposome
- Isavuconazonium Sulfate
- Ivabradine
- Ketoconazole
- Levoketoconazole
- Lisuride
- Lomitapide
- Lonafarnib
- Lovastatin
- Lurasidone
- Mavacamten
- Mesoridazine
- Metergoline
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.
- Abametapir
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Acalabrutinib
- Adagrasib
- Ado-Trastuzumab Emtansine
- Afatinib
- Alfentanil
- Aliskiren
- Alitretinoin
- Amiodarone
- Amisulpride
- Amitriptyline
- Amlodipine
- Anagrelide
- Apalutamide
- Apixaban
- Apomorphine
- Aprepitant
- Aranidipine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asciminib
- Asenapine
- Atogepant
- Atorvastatin
- Avacopan
- Avapritinib
- Avatrombopag
- Axitinib
- Azithromycin
- Bedaquiline
- Belumosudil
- Benzhydrocodone
- Betrixaban
- Bictegravir
- Boceprevir
- Bortezomib
- Bosentan
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
- Aluminum Carbonate, Basic
- Aluminum Hydroxide
- Aluminum Phosphate
- Anisindione
- Calcium Carbonate
- Calcium Silicate
- Cimetidine
- Dexlansoprazole
- Dicumarol
- Didanosine
- Dihydroxyaluminum Aminoacetate
- Dihydroxyaluminum Sodium Carbonate
- Ebrotidine
- Esomeprazole
- Lansoprazole
- Magaldrate
- Magnesium Carbonate
- Magnesium Hydroxide
- Magnesium Oxide
- Magnesium Peroxide
- Magnesium Trisilicate
- Meloxicam
- Nirmatrelvir
- Nizatidine
- Pantoprazole
- Phenprocoumon
- Rabeprazole
- Ranitidine
- Ranitidine Bismuth Citrate
- Roxatidine
- Sodium Bicarbonate
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.
- Adults:
- 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.
- Adults:
- 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 aspergillosis:
- 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 esophageal candidiasis:
- 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.
- For onychomycosis of the toenails:
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 avanafil (Stendra™), cisapride (Propulsid®), disopyramide (Norpace®), dofetilide (Tikosyn®), dronedarone (Multaq®), eliglustat (Cerdelga™), eplerenone (Inspra®), felodipine (Plendil®), finerenone (Kerendia®), 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®), venetoclax (Venclexta®), voclosporin (Lupkynis®), an ergot medicine (eg, dihydroergotamine, ergometrine, ergotamine, methylergometrine, Cafergot®, Ergomar®, Wigraine®), or certain medicines to lower cholesterol (eg, lovastatin, simvastatin, Mevacor®, Zocor®) during and 2 weeks after treatment with itraconazole. Do not use colchicine (Colcrys®), fesoterodine (Toviaz®), solifenacin (Vesicare®), or telithromycin (Ketek®) during and 2 weeks after treatment with itraconazole, 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 patients 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 or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular breathing, an irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain. These could be symptoms of congestive heart failure.
Rarely, this medicine may cause severe liver problems. Check with your doctor right away if you have 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
- Decreased urine output
- dry mouth
- fever
- increased thirst
- irregular heartbeat
- loss of appetite
- mood changes
- muscle pain or cramps
- nausea
- numbness or tingling in the hands, feet, or lips
- seizures
- trouble breathing
- unusual tiredness or weakness
- vomiting
Less common
- Blurred vision
- chest pain
- chills
- clay-colored stools
- cloudy urine
- cold sweats
- confusion
- cough
- dark urine
- decrease in urine-concentrating ability
- diarrhea
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- feeling unusually cold
- headache
- itching, skin rash
- light-colored stools
- mental changes
- muscle cramps in the hands, arms, feet, legs, or face
- muscle spasms (tetany) or twitching
- nervousness
- noisy, rattling breathing
- numbness and tingling around the mouth or fingertips
- pounding in the ears
- shivering
- slow, fast, or pounding heartbeat or pulse
- sneezing
- sore throat
- stomach cramps or pain
- sweating
- swelling of the fingers, hands, feet, or lower legs
- tightness in the chest
- trembling
- trouble breathing at rest
- unpleasant breath odor
- vomiting of blood
- weight gain
- yellow eyes or skin
Rare
- Black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of the skin
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the urine or stools
- blue lips and fingernails
- burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings
- continuing ringing or buzzing or other unexplained noise in the ears
- coughing that sometimes produces a pink frothy sputum
- cracks in the skin
- decreased appetite
- difficulty with swallowing
- dilated neck veins
- disturbed color perception
- double vision
- extreme tiredness or weakness
- fast or irregular breathing
- feeling of discomfort
- general feeling of tiredness or weakness
- halos around lights
- hearing loss
- hives or welts
- inflammation of the joints
- joint pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- loss of heat from the body
- loss of vision
- lower back or side pain
- night blindness
- overbright appearance of lights
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- red skin lesions, often with a purple center
- red, irritated eyes
- red, swollen skin
- scaly skin
- sores, ulcers, or white spots on the lips or in the mouth
- stomach pain, continuing
- stomach tenderness
- swollen lymph glands
- tunnel vision
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual weight gain or loss
- upper right abdominal or stomach pain
- weakness in the arms, hands, legs, or feet
Incidence not known
- Bloating
- constipation
- difficult, fast, noisy breathing
- indigestion
- loss of bladder control
- 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
- Decreased interest in sexual intercourse
- difficulty having a bowel movement
- difficulty with moving
- discouragement
- feeling of constant movement of self or surroundings
- feeling sad or empty
- inability to have or keep an erection
- irritability
- loss in sexual ability, desire, drive, or performance
- loss of interest or pleasure
- muscle aching or stiffness
- pain or tenderness around the eyes and cheekbones
- passing of gas
- sensation of spinning
- sleepiness or unusual drowsiness
- soreness of the skin
- stomach fullness or discomfort
- stuffy or runny nose
- trouble concentrating
- trouble sleeping
Rare
- Belching
- change in taste
- hair loss or thinning of the hair
- heartburn
- increased need to urinate
- increased sensitivity of the eyes or skin to sunlight
- loss of taste
- menstrual changes
- passing urine more often
- redness or other discoloration of the skin
- 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.
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