Skip to main content

Itraconazole (Oral route)

Pronunciation:

it-ra-KON-a-zole

Brand Names:

  • Onmel
  • Sporanox

Dosage Forms:

  • Solution
  • Capsule
  • Tablet

Warnings:

Oral route(Tablet)

Do not administer itraconazole tablets for onychomycosis in patients with ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF. Negative inotropic effects have been observed following intravenous administration in dogs and healthy human volunteers. If signs or symptoms of congestive heart failure occur during administration of itraconazole tablets, discontinue use. Coadministration of cisapride, pimozide, quinidine, dofetilide, levacetylmethadol (levomethadyl), felodipine, oral midazolam, nisoldipine, triazolam, lovastatin, simvastatin, ergot alkaloids such as dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine) or methadone with itraconazole tablets is contraindicated. Itraconazole is a potent CYP3A4 inhibitor and may increase plasma concentrations of CYP3A4 substrates. Serious cardiovascular events, including QT prolongation, torsades de pointes, ventricular tachycardia, cardiac arrest, and/or sudden death have occurred in patients using cisapride, pimozide, levacetylmethadol (levomethadyl), methadone or quinidine concomitantly with itraconazole and/or other CYP3A4 inhibitors .

Oral route(Capsule)

Itraconazole capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF. If signs or symptoms of CHF occur during administration of itraconazole capsules, discontinue administration. Coadministration of cisapride, oral midazolam, nisoldipine, felodipine, pimozide, quinidine, dofetilide, triazolam, levacetylmethadol (levomethadyl), lovastatin, simvastatin, ergot alkaloids such as dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine) or methadone with itraconazole is contraindicated. Itraconazole, a potent CYP3A4 inhibitor, may increase plasma concentrations of drugs metabolized by this pathway. Serious cardiovascular events, including QT prolongation, torsades de pointes, ventricular tachycardia, cardiac arrest, and/or sudden death have occurred in patients using cisapride, pimozide, methadone, levacetylmethadol (levomethadyl), or quinidine concomitantly with itraconazole and/or other CYP3A4 inhibitors .

Oral route(Solution)

If signs or symptoms of congestive heart failure occur during administration of itraconazole oral solution, continued itraconazole use should be reassessed. Coadministration of cisapride, oral midazolam, nisoldipine, felodipine, pimozide, quinidine, dofetilide, triazolam, levacetylmethadol (levomethadyl), lovastatin, simvastatin, ergot alkaloids such as dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine) or methadone with itraconazole is contraindicated. Itraconazole, a potent CYP3A4 inhibitor, may increase plasma concentrations of drugs metabolized by this pathway. Serious cardiovascular events, including QT prolongation, torsades de pointes, ventricular tachycardia, cardiac arrest, and/or sudden death have occurred in patients using cisapride, pimozide, methadone, levacetylmethadol (levomethadyl), or quinidine concomitantly with itraconazole and/or other CYP3A4 inhibitors .

Classifications:

Therapeutic—

Antifungal

Chemical—

Triazole

Uses of This Medicine:

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), histoplasmosis (Darling’s disease), or 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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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, which may require caution in patients receiving itraconazole.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

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.

Other medicines—

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
  • Amifampridine
  • Astemizole
  • Cisapride
  • Colchicine
  • Conivaptan
  • Dihydroergotamine
  • Dofetilide
  • Dronedarone
  • Eletriptan
  • Eplerenone
  • Ergoloid Mesylates
  • Ergonovine
  • Ergotamine
  • Felodipine
  • Ivabradine
  • Levomethadyl
  • Lomitapide
  • Lovastatin
  • Lurasidone
  • Maraviroc
  • Methadone
  • Methylergonovine
  • Methysergide
  • Midazolam
  • Nimodipine
  • Nisoldipine
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Quinidine
  • Ranolazine
  • Silodosin
  • Simvastatin
  • Terfenadine
  • Tolvaptan
  • Triazolam

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.

  • Ado-Trastuzumab Emtansine
  • Afatinib
  • Aliskiren
  • Amiodarone
  • Apixaban
  • Aprepitant
  • Atorvastatin
  • Avanafil
  • Axitinib
  • Bedaquiline
  • Boceprevir
  • Bosutinib
  • Brentuximab Vedotin
  • Bretylium
  • Bromocriptine
  • Cabazitaxel
  • Cabozantinib
  • Carbamazepine
  • Cerivastatin
  • Citalopram
  • Clozapine
  • Cobicistat
  • Crizotinib
  • Cyclosporine
  • Dabrafenib
  • Dasatinib
  • Diazepam
  • Digoxin
  • Disopyramide
  • Docetaxel
  • Domperidone
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Efavirenz
  • Elvitegravir
  • Enzalutamide
  • Erythromycin
  • Eslicarbazepine Acetate
  • Etravirine
  • Everolimus
  • Fentanyl
  • Fluoxetine
  • Fluticasone
  • Halofantrine
  • Hydrocodone
  • Ibrutinib
  • Ibutilide
  • Ifosfamide
  • Iloperidone
  • Isoniazid
  • Ivacaftor
  • Ixabepilone
  • Lapatinib
  • Lenalidomide
  • Levomilnacipran
  • Macitentan
  • Mifepristone
  • Mitotane
  • Nevirapine
  • Nilotinib
  • Ondansetron
  • Oxycodone
  • Pazopanib
  • Pixantrone
  • Pomalidomide
  • Ponatinib
  • Quetiapine
  • Regorafenib
  • Repaglinide
  • Retapamulin
  • Rifabutin
  • Rifampin
  • Rivaroxaban
  • Romidepsin
  • Ruxolitinib
  • Salmeterol
  • Simeprevir
  • Sirolimus
  • Sotalol
  • Sunitinib
  • Tacrolimus
  • Tadalafil
  • Tamsulosin
  • Temsirolimus
  • Ticagrelor
  • Toremifene
  • Trabectedin
  • Vemurafenib
  • Venlafaxine
  • Vilanterol
  • Vilazodone
  • Vinblastine
  • Vincristine
  • Vincristine Sulfate Liposome
  • Vinflunine
  • Vinorelbine
  • Warfarin

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
  • Alfentanil
  • Amlodipine
  • Anisindione
  • Betamethasone
  • Bexarotene
  • Bortezomib
  • Budesonide
  • Buspirone
  • Busulfan
  • Cinacalcet
  • Ciprofloxacin
  • Clarithromycin
  • Conjugated Estrogens
  • Corticotropin
  • Cosyntropin
  • Dexamethasone
  • Dicumarol
  • Didanosine
  • Esterified Estrogens
  • Estradiol
  • Estriol
  • Estrone
  • Estropipate
  • Fludrocortisone
  • Fosphenytoin
  • Gefitinib
  • Hydrocortisone
  • Indinavir
  • Isradipine
  • Loperamide
  • Meloxicam
  • Methylprednisolone
  • Micafungin
  • Nicardipine
  • Nifedipine
  • Phenobarbital
  • Phenprocoumon
  • Phenytoin
  • Prednisolone
  • Prednisone
  • Rifapentine
  • Risperidone
  • Ritonavir
  • Rosuvastatin
  • Saquinavir
  • Sildenafil
  • Telithromycin
  • Tolterodine
  • Trazodone
  • Triamcinolone
  • Trimetrexate
  • Verapamil

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 (e.g., ischemic disease, valve problems) or
  • Heart rhythm problems or
  • Kidney disease—Use with caution. May increase the risk for more serious side effects.
  • Congestive heart failure—Should not be used in patients with this condition or a history of this condition except for the treatment of serious infections determined by you doctor.
  • Cystic fibrosis or
  • Hypochlorhydria (low level of acid in the stomach)—Absorption from the stomach may change.
  • Elevated liver enzymes or
  • Liver disease, active or history of—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

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

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.

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

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 it in the mouth for several seconds, and then swallow it. Repeat these steps if your total dose is more than 10 mL.

If you are using antacids (e.g., Maalox®, Mylanta®, Pepcid® Complete, Rolaids®, or Tums®), take the antacid at least 1 hour before or 2 hours after taking itraconazole.

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—200 to 400 milligrams (mg) per day, given as a single dose once a day or divided in two doses.
      • Children—Use and dose must be determined by your doctor.
    • For blastomycosis or histoplasmosis:
      • Adults—200 milligrams (mg) once a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 400 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • For onychomycosis of the fingernails:
      • Adults—200 milligrams (mg) two times a day.
      • Children—Use and dose must be determined by your doctor.
    • For onychomycosis of the toenails:
      • Adults—200 milligrams (mg) once a day.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (solution):
    • 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 if 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 consecutive weeks.
      • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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 While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and 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: cisapride (Propulsid®), dofetilide (Tikosyn®), felodipine (Plendil®), levomethadyl (Orlaam®), methadone (Dolophine®), nisoldipine (Sular®), oral midazolam (Versed®), pimozide (Orap®), quinidine (Cardioquin®, Quinaglute®), triazolam (Halcion®), certain medicines to lower cholesterol (such as lovastatin, simvastatin, Mevacor®, Zocor®), or an ergot medicine (such as dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, Ergomar®, Wigraine®). Using these medicines together may increase your risk of serious side effects.

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, shortness of breath, swelling of the face, fingers, feet, or lower legs, tightness in the chest, troubled breathing, weight gain, or wheezing. These could be symptoms of a side effect called congestive heart failure.

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 oral capsule or tablet should not be used to treat onychomycosis in pregnant women or those who are planning to get pregnant. Use an effective form of birth control while you are using this medicine and for 2 months after you stop using it. If you think you have become pregnant while using the medicine, tell your doctor right away.

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 and vomiting, skin rash, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.

This medication may cause neuropathy (nerve problems) Stop using this medicine and 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 taking itraconazole.

Temporary or permanent hearing loss may occur while you are taking this medicine. Check with your doctor right away if you have any changes in your hearing.

Make sure your doctor knows about all medicines you are taking and 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 of This Medicine:

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
Convulsions
decreased urine
dry mouth
fever
increased thirst
irregular heartbeat
loss of appetite
mood changes
muscle pain or cramps
nausea or vomiting
numbness or tingling in the hands, feet, or lips
shortness of breath
unusual tiredness or weakness
Less common
Abdominal or stomach cramps or pain
blurred vision
chest pain
chills
clay-colored stools
cloudy urine
cold sweats
confusion
cough
dark urine
decrease in urine output or decrease in urine-concentrating ability
diarrhea
difficult or labored breathing
dizziness
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
drowsiness
feeling unusually cold
headache
itching
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
rash
shivering
slow, fast, or pounding heartbeat or pulse
sneezing
sore throat
sweating
swelling of the fingers, hands, feet, or lower legs
tightness in the chest
trembling
troubled breathing at rest
unpleasant breath odor
vomiting of blood
weight gain
wheezing
yellow eyes or skin
Rare
Abdominal or stomach tenderness
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 fatigue
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 sex organs
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
swollen lymph glands
tingling of the hands or feet
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

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 (stool)
difficulty with moving
discouragement
feeling of constant movement of self or surroundings
feeling sad or empty
inability to have or keep an erection
indigestion
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
swollen joints
tiredness
trouble concentrating
trouble sleeping
Rare
Acid or sour stomach
belching
change in taste
hair loss or thinning of the hair
heartburn
increased need to urinate
increased sensitivity of the eyes to sunlight
increased sensitivity of the skin to sunlight
loss of bladder control
loss of taste
menstrual changes
passing urine more often
redness or other discoloration of the skin
severe sunburn
stomach fullness, discomfort, or upset

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.


Last Updated: 4/4/2014

Copyright © 1984- Thomson Micromedex. All rights reserved.

Thomson & A.D.A.M