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Sporanox

Pronunciation

Generic Name: itraconazole (Oral route)

it-ra-KON-a-zole

Oral route(Capsule;Solution;Tablet)

Itraconazole 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 or tablets, discontinue administration . If signs or symptoms of congestive heart failure occur during administration of itraconazole oral solution, continued itraconazole use should be reassessed . Coadministration of itraconazole with cisapride, colchicine (in patients with renal or hepatic impairment), disopyramide, dofetilide, dronedarone, eplerenone, ergot alkaloids (such as dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)), felodipine, irinotecan, lovastatin, lurasidone, methadone, oral midazolam, nisoldipine, pimozide, quinidine, ranolazine, simvastatin, or triazolam and in patients with renal or hepatic impairment 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 may occur

Commonly used brand name(s)

In the U.S.

  • Onmel
  • Sporanox

Available Dosage Forms:

  • Solution
  • Capsule
  • Tablet

Therapeutic Class: Antifungal

Chemical Class: Triazole

Uses For Sporanox

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.

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

Before Using Sporanox

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

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.

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 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
  • Dabigatran Etexilate
  • Dabrafenib
  • Dihydroergotamine
  • Disopyramide
  • Dofetilide
  • Dronedarone
  • Eletriptan
  • Eplerenone
  • Ergonovine
  • Ergotamine
  • Eszopiclone
  • Felodipine
  • Fluconazole
  • Irinotecan
  • Ivabradine
  • Levomethadyl
  • Lomitapide
  • Lovastatin
  • Lurasidone
  • Maraviroc
  • Methadone
  • Methylergonovine
  • Methysergide
  • Midazolam
  • Nelfinavir
  • Nimodipine
  • Nisoldipine
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Quinidine
  • Ranolazine
  • Silodosin
  • Simvastatin
  • Terfenadine
  • Tolvaptan
  • Triazolam
  • Vorapaxar

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
  • Betamethasone
  • Boceprevir
  • Bosutinib
  • Brentuximab Vedotin
  • Bretylium
  • Bromocriptine
  • Cabazitaxel
  • Cabozantinib
  • Carbamazepine
  • Ceritinib
  • Cerivastatin
  • Ciclesonide
  • Citalopram
  • Clarithromycin
  • Clozapine
  • Cobicistat
  • Corticotropin
  • Cosyntropin
  • Crizotinib
  • Cyclosporine
  • Dasatinib
  • Delamanid
  • Dexamethasone
  • Diazepam
  • Digoxin
  • Docetaxel
  • Domperidone
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Efavirenz
  • Elvitegravir
  • Enzalutamide
  • Erythromycin
  • Escitalopram
  • Eslicarbazepine Acetate
  • Etravirine
  • Everolimus
  • Fentanyl
  • Fludrocortisone
  • Fluoxetine
  • Fluticasone
  • Fosphenytoin
  • Halofantrine
  • Hydrocodone
  • Hydrocortisone
  • Ibrutinib
  • Ibutilide
  • Ifosfamide
  • Iloperidone
  • Isoniazid
  • Ivacaftor
  • Ixabepilone
  • Lapatinib
  • Lenalidomide
  • Levomilnacipran
  • Macitentan
  • Methylprednisolone
  • Mifepristone
  • Mitotane
  • Morphine
  • Morphine Sulfate Liposome
  • Nevirapine
  • Nilotinib
  • Ondansetron
  • Oxycodone
  • Pazopanib
  • Phenobarbital
  • Phenytoin
  • Pixantrone
  • Pomalidomide
  • Ponatinib
  • Prednisolone
  • Prednisone
  • Primidone
  • Quetiapine
  • Ramelteon
  • Regorafenib
  • Repaglinide
  • Retapamulin
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Rivaroxaban
  • Romidepsin
  • Ruxolitinib
  • Salmeterol
  • Sevoflurane
  • Siltuximab
  • Simeprevir
  • Sirolimus
  • Sotalol
  • St John's Wort
  • Sunitinib
  • Tacrolimus
  • Tadalafil
  • Tamsulosin
  • Temsirolimus
  • Ticagrelor
  • Topotecan
  • Toremifene
  • Trabectedin
  • Triamcinolone
  • Vandetanib
  • 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
  • Bexarotene
  • Bortezomib
  • Budesonide
  • Buspirone
  • Busulfan
  • Cinacalcet
  • Ciprofloxacin
  • Conjugated Estrogens
  • Dicumarol
  • Didanosine
  • Esterified Estrogens
  • Estradiol
  • Estriol
  • Estrone
  • Estropipate
  • Gefitinib
  • Indinavir
  • Isradipine
  • Loperamide
  • Meloxicam
  • Micafungin
  • Nicardipine
  • Nifedipine
  • Phenprocoumon
  • Risperidone
  • Ritonavir
  • Rosuvastatin
  • Saquinavir
  • Sildenafil
  • Telithromycin
  • Tolterodine
  • Trazodone
  • Trimetrexate
  • Verapamil

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 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, 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—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 of itraconazole

This section provides information on the proper use of a number of products that contain itraconazole. It may not be specific to Sporanox. Please read with care.

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.

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

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 While Using Sporanox

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®), 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®) 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, weight gain, or wheezing. 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.

Sporanox 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 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
  • 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.

See also: Side effects (in more detail)

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