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ITRACONAZOLE is an antifungal medicine. It is used to treat certain kinds of fungal or yeast infections. Compare azole antifungals.
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What is Onmel?

Commonly Used Brand Name(s)Onmel, Sporanox

Therapeutic ClassificationsAntifungal

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Blackbox WarningTOP

Oral route (Capsule)

Itraconazole should not be used to treat onychomycosis in patients with ventricular dysfunction (eg, congestive heart failure). If signs or symptoms of congestive heart failure occur, discontinue. Itraconazole is contraindicated in patients concomitantly taking methadone, disopyramide, dofetilide, dronedarone, quinidine, ergot alkaloids (eg, dihydroergotamine, ergometrine [ergonovine], ergotamine, methylergometrine [methylergonovine]), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ranolazine, eplerenone, cisapride, lovastatin, simvastatin, ticagrelor and, in subjects with varying degrees of renal or hepatic impairment, colchicine, fesoterodine, telithromycin or solifenacin. Concomitant administration can cause the plasma levels of the concomitant drug to increase, thereby increasing or prolonging the pharmacologic or adverse effects .

Oral route (Solution)

Itraconazole should not be used to treat onychomycosis in patients with ventricular dysfunction (eg, congestive heart failure). If signs or symptoms of congestive heart failure occur, continued use should be reassessed. Itraconazole is contraindicated in patients concomitantly taking methadone, disopyramide, dofetilide, dronedarone, quinidine, ergot alkaloids (eg, dihydroergotamine, ergometrine [ergonovine], ergotamine, methylergometrine [methylergonovine]), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ranolazine, eplerenone, cisapride, lovastatin, simvastatin, ticagrelor and, in subjects with varying degrees of renal or hepatic impairment, colchicine, fesoterodine, telithromycin or solifenacin. Concomitant administration can cause the plasma levels of the concomitant drug to increase, thereby increasing or prolonging the pharmacologic or adverse effects .

Oral route (Tablet)

Do not use itraconazole to treat onychomycosis in patients with ventricular dysfunction (eg, congestive heart failure). If signs or symptoms of congestive heart failure occur, continued use should be reassessed. Itraconazole is contraindicated in patients concomitantly taking 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. Concomitant administration can cause the plasma levels of the concomitant drug to increase. Serious cardiovascular events have been reported in patients taking cisapride, pimozide, levacetylmethadol (levomethadyl), methadone, or quinidine concomitantly with itraconazole or other CYP3A4 inhibitors .

OverviewTOP

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.

Proper UseTOP

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.

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.

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 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 (eg, Maalox®, Mylanta®, Pepcid® Complete, Rolaids®, or Tums®), take the antacid at least 1 hour before or 2 hours after taking itraconazole. You may also take itraconazole with an acidic beverage (eg, non-diet cola) if you are taking it with an antacid.

DosingTOP

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 DoseTOP

Call your doctor or pharmacist for instructions.

Use & StorageTOP

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.

Before UsingTOP

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:

AllergiesTOP

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.

PediatricTOP

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.

GeriatricTOP

Although appropriate studies on the relationship of age to the effects of itraconazole have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have temporary or permanent hearing loss or have kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving itraconazole.

PregnancyTOP

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 FeedingTOP

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 InteractionsTOP

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.

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.

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.

Other InteractionsTOP

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 ProblemsTOP

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:

  • Cystic fibrosis or
  • Hypochlorhydria (low level of acid in the stomach) in HIV-infected patients—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.

PrecautionsTOP

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: cisapride (Propulsid®), disopyramide (Norpace®). dofetilide (Tikosyn®), dronedarone (Multaq®), eplerenone (Inspra®), felodipine (Plendil®), irinotecan (Camptosar®), lurasidone (Latuda®), methadone (Dolophine®), nisoldipine (Sular®), oral midazolam (Versed®), pimozide (Orap®), quinidine (Cardioquin®, Quinaglute®), ranolazine (Ranexa®), ticagrelor (Brilinta®), triazolam (Halcion®), certain medicines to lower cholesterol (such as lovastatin, simvastatin, Mevacor®, Zocor®), or an ergot medicine (such as dihydroergotamine, ergometrine, ergotamine, methylergometrine, Cafergot®, Ergomar®, Wigraine®). 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 of 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 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.

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, 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 and 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 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.

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.

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.

Chemical ClassificationsTOP

Triazole
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