itraconazole

it-ra-KON-a-zole

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, pimozide, quinidine, dofetilide, or levacetylmethadol (levomethadyl) 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, 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, continued itraconazole use should be reassessed. Coadministration of cisapride, pimozide, quinidine, dofetilide, or levacetylmethadol (levomethadyl) 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, levacetylmethadol (levomethadyl), or quinidine concomitantly with itraconazole and/or other CYP3A4 inhibitors .

Commonly used brand name(s)

In the U.S.

• Sporanox

Available Dosage Forms:

• Solution


• Capsule

Therapeutic Class: Antifungal

Chemical Class: Triazole

Uses For itraconazole

Itraconazole is used to treat serious fungal or yeast infections, such as oropharyngeal candidiasis (thrush, oral thrush), esophageal candidiasis (candida esophagitis), blastomycosis (Gilchrist’s disease), aspergillosis (fungal infection in the lungs), histoplasmosis (Darling’s disease), or onychomycosis (fungal infection in the fingernails or toenails). itraconazole works by killing the fungus or yeast and preventing its growth.

itraconazole is available only with your doctor's prescription.

Before Using itraconazole

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 itraconazole, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to itraconazole 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. However, pediatric-specific problems that would limit the usefulness of itraconazole in children are not expected.

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, which may require caution in patients receiving itraconazole.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal 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.

Interactions with 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 itraconazole, 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 itraconazole 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


• Cisapride


• Colchicine


• Conivaptan


• Dihydroergotamine


• Dofetilide


• Dronedarone


• Eplerenone


• Ergoloid Mesylates


• Ergonovine


• Ergotamine


• Levomethadyl


• Lovastatin


• Methylergonovine


• Methysergide


• Midazolam


• Nisoldipine


• Pimozide


• Quinidine


• Ranolazine


• Silodosin


• Simvastatin


• Terfenadine


• Tolvaptan


• Triazolam

Using itraconazole 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.

• Abiraterone


• Aliskiren


• Amiodarone


• Aprepitant


• Atorvastatin


• Boceprevir


• Brentuximab Vedotin


• Bretylium


• Cabazitaxel


• Cerivastatin


• Clozapine


• Crizotinib


• Cyclosporine


• Dasatinib


• Diazepam


• Digoxin


• Disopyramide


• Docetaxel


• Efavirenz


• Erythromycin


• Etravirine


• Everolimus


• Fentanyl


• Fluticasone


• Halofantrine


• Ibutilide


• Iloperidone


• Isoniazid


• Ixabepilone


• Lapatinib


• Nevirapine


• Nilotinib


• Oxycodone


• Pazopanib


• Repaglinide


• Rifabutin


• Rifampin


• Rivaroxaban


• Romidepsin


• Ruxolitinib


• Salmeterol


• Sirolimus


• Sotalol


• Sunitinib


• Tacrolimus


• Tadalafil


• Tamsulosin


• Temsirolimus


• Ticagrelor


• Toremifene


• Vemurafenib


• Venlafaxine


• Vinblastine


• Vincamine


• Vincristine


• Vincristine Liposome


• Vindesine


• Vinorelbine

Using itraconazole 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


• Aluminum Carbonate, Basic


• Aluminum Hydroxide


• Aluminum Phosphate


• Amlodipine


• Anisindione


• Betamethasone


• Bexarotene


• Bortezomib


• Budesonide


• Buspirone


• Busulfan


• Calcium


• Cinacalcet


• Ciprofloxacin


• Clarithromycin


• Conjugated Estrogens


• Corticotropin


• Cosyntropin


• Dexamethasone


• Dicumarol


• Didanosine


• Dihydroxyaluminum Aminoacetate


• Dihydroxyaluminum Sodium Carbonate


• Esterified Estrogens


• Estradiol


• Estriol


• Estrone


• Estropipate


• Famotidine


• Felodipine


• Fesoterodine


• Fludrocortisone


• Fosphenytoin


• Gefitinib


• Hydrocortisone


• Indinavir


• Isradipine


• Loperamide


• Magaldrate


• Magnesium Carbonate


• Magnesium Hydroxide


• Magnesium Oxide


• Magnesium Trisilicate


• Meloxicam


• Methadone


• Methylprednisolone


• Micafungin


• Nicardipine


• Nifedipine


• Nimodipine


• Pantoprazole


• Phenobarbital


• Phenprocoumon


• Phenytoin


• Prednisolone


• Prednisone


• Rabeprazole


• Ranitidine


• Ranitidine Bismuth Citrate


• Rifapentine


• Risperidone


• Ritonavir


• Rosuvastatin


• Saquinavir


• Sildenafil


• Sodium Bicarbonate


• Telithromycin


• Tolterodine


• Trazodone


• Triamcinolone


• Trimetrexate


• Vardenafil


• Verapamil


• Warfarin

Interactions with Food/Tobacco/Alcohol

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 itraconazole 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 itraconazole, 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 itraconazole. Make sure you tell your doctor if you have any other medical problems, especially:

• Chronic obstructive pulmonary disease (COPD), history of or


• Congestive heart failure, history of or


• Heart problems (e.g., heart attack history, valve problem), history of or


• Kidney disease, history of—Use with caution. May increase the risk for side effects.

• Cystic fibrosis or


• Hypochlorhydria (low level of acid in the stomach)—Absorption from the stomach may change.

• Liver disease—Use with caution. The effects of itraconazole may be increased because of slower removal from the body.

• Liver disease, severe—Use with caution. May make this condition worse.

Proper Use of itraconazole

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 itraconazole 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 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 should be taken with a full meal. The oral solution is best taken on an empty stomach.

Measure the oral solution 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 do not have oral thrush, the liquid should be swallowed without swishing as a single dose.

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 itraconazole 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 itraconazole. 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—At first, 100 milligrams (mg) or 10 milliliters (mL) once a day. Your doctor may increase your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For serious fungal infections:
    
    • Adults—200 milligrams (mg) or 20 milliliters (mL) two times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oropharyngeal candidiasis:
    
    • Adults—200 milligrams (mg) or 20 milliliters (mL) once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of itraconazole, take it as soon as possible. However, if it is almost time for your next dose, 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 itraconazole

It is very important that your doctor check your progress at regular visits to make sure that itraconazole 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 itraconazole for several weeks or months before your infection gets better.

Stop using itraconazole and 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.

Itraconazole should not be taken with cisapride (Propulsid®), dofetilide (Tikosyn™), oral midazolam (Versed®), nisoldipine (Sular®), pimozide (Orap®), quinidine (Quinaglute®), triazolam (Halcion®), or levomethadyl (Orlaam®). You should not use itraconazole if you are also using lovastatin (Mevacor®), simvastatin (Zocor®), or an ergot medicine such as dihydroergotamine (Migranal®), ergometrine or ergonovine (Ergotrate Maleate®), ergotamine (Ergomar®), or methylergometrine or methylergonovine (Methergine®). Doing so may increase the risk of serious side effects.

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.

Make sure your doctor knows if you are pregnant or planning to get pregnant before you start using itraconazole for a fingernail or toenail infection. The oral capsule 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 itraconazole 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.

Liver problems may occur while you are taking itraconazole. 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.

Stop using itraconazole 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 itraconazole. Stop using itraconazole and check with your doctor right away if you have any changes in your hearing.

itraconazole 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

• 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


• abdominal or stomach 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


• large amount of triglyceride in the blood


• 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


• seizures


• 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 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


• increased sweating


• 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 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 in 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 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.

See also: itraconazole side effects (in more detail)

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More itraconazole resources

• Itraconazole Side Effects (in more detail)
• Itraconazole Use in Pregnancy & Breastfeeding
• Drug Images
• Itraconazole Drug Interactions
• Itraconazole Support Group
• 11 Reviews for Itraconazole - Add your own review/rating

• Itraconazole Prescribing Information (FDA)


• Itraconazole Professional Patient Advice (Wolters Kluwer)


• Itraconazole Monograph (AHFS DI)


• Itraconazole MedFacts Consumer Leaflet (Wolters Kluwer)


• Sporanox Consumer Overview


• Sporanox Prescribing Information (FDA)


• Sporanox PulsePak MedFacts Consumer Leaflet (Wolters Kluwer)

Compare itraconazole with other medications

• Aspergillosis, Aspergilloma
• Blastomycosis
• Candida Infections, Systemic
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• Coccidioidomycosis
• Cryptococcosis
• Dermatophytosis
• Esophageal Candidiasis
• Febrile Neutropenia
• Histoplasmosis
• Onychomycosis, Fingernail
• Onychomycosis, Toenail
• Oral Thrush
• Paracoccidioidomycosis
• Sporotrichosis
• Tinea Capitis
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• Vaginal Yeast Infection