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Itraconazole is an antifungal medication that is used in adults to treat infections caused by fungus. This includes infections in any part of the body including the lungs, mouth or throat, toenails, or fingernails.
Some brands of itraconazole are not for use in treating fungal infections of the fingernails or toenails. Avoid medication errors by using only the brand and strength your doctor prescribes.
Itraconazole may also be used for purposes not listed in this medication guide.
You should not take itraconazole if you have ever had heart failure.
If you have liver or kidney disease, you should not take itraconazole with colchicine, fesoterodine, or solifenacin.
Itraconazole may harm an unborn baby. Avoid getting pregnant while taking itraconazole and for 2 months after your last dose.
Stop using itraconazole and call your doctor at once if you have signs of congestive heart failure: feeling tired or short of breath, cough with mucus, fast heartbeats, swelling, rapid weight gain, or sleep problems.
Life-threatening side effects may occur if you take itraconazole with certain other drugs. Tell your doctor about all your current medicines and any you start or stop using.
You should not take this medicine if you are allergic to itraconazole or similar medicines such as fluconazole or ketoconazole, or if you have ever had congestive heart failure.
Life-threatening side effects may occur if you take itraconazole with certain other drugs. Your doctor may change your treatment plan if you have used other medicines in the past 2 weeks, especially:
avanafil;
cisapride;
eliglustat;
irinotecan;
isavuconazonium;
methadone;
naloxegol;
ranolazine;
ticagrelor;
lurasidone or pimozide (anti-psychotic medications);
lomitapide, lovastatin, simvastatin (cholesterol-lowering medicines);
dihydroergotamine, ergonovine, ergotamine, or methylergonovine (ergot medicines);
eplerenone, felodipine, ivabradine, or nisoldipine (heart or blood pressure medicines);
disopyramide, dofetilide, dronedarone, or quinidine (medicines for heart rhythm disorders); or
oral midazolam, or triazolam (Valium-like sedatives).
If you have liver or kidney disease, you should not take itraconazole with colchicine, fesoterodine, solifenacin, or telithromycin.
Itraconazole may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 2 months after your last dose. Tell your doctor if you become pregnant.
Tell your doctor if you have ever had:
heart problems;
cystic fibrosis or other lung problems;
liver or kidney disease; or
a weak immune system.
It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Do not share itraconazole with another person, even if they have the same symptoms you have.
The itraconazole capsule should be taken with food.
Swallow the capsule whole and do not crush, chew, break, or open it.
Take itraconazole oral solution (liquid) on an empty stomach, at least 1 hour before or 2 hours after a meal. Swish the liquid in your mouth for several seconds before swallowing it.
Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).
The Sporanox PulsePak has a special dosing schedule that includes not taking the medicine for several days in a row. Follow all dosing instructions carefully.
Itraconazole capsules should not be used in place of itraconazole oral solution (liquid) if that is what your doctor has prescribed. Avoid medication errors by using only the form and strength your doctor prescribes.
If you also take a stomach acid reducer (Tagamet, Pepcid, Axid, Zantac, and others), take itraconazole with an acidic drink such as non-diet cola.
Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Itraconazole will not treat a viral infection such as the flu or a common cold.
You may need frequent medical tests.
Store at room temperature away from moisture, heat, and light.
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Avoid driving or hazardous activity until you know how itraconazole will affect you. Your reactions could be impaired.
Avoid taking antacids within 1 hour before or 2 hours after you take itraconazole. Some antacids can make it harder for your body to absorb itraconazole.
Get emergency medical help if you have signs of an allergic reaction: hives, severe skin rash, tingling in your arms or legs; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using itraconazole and call your doctor at once if you have signs of congestive heart failure: feeling tired or short of breath, cough with mucus, fast heartbeats, swelling, rapid weight gain, or sleep problems.
Keep taking itraconazole but call your doctor at once if you have:
confusion, a light-headed feeling (like you might pass out);
blurred vision, double vision, ringing in your ears, problems with hearing;
fast heartbeats;
numbness or tingly feeling, loss of bladder control;
little or no urinating, pain or burning when you urinate;
low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, muscle weakness or limp feeling;
pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting; or
liver problems--nausea, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common side effects may include:
headache, dizziness, drowsiness, tiredness;
increased blood pressure;
rash, itching;
nausea, vomiting, stomach pain, diarrhea, constipation;
swelling;
abnormal liver function or blood tests;
fever, muscle or joint pain;
unusual or unpleasant taste in your mouth;
hair loss;
impotence, erection problems; or
changes in your menstrual periods.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Many drugs can affect itraconazole, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Itraconazole (www.drugs.com/mtm/itraconazole.html).
Commonly reported side effects of itraconazole include: nausea. Other side effects include: vomiting. See below for a comprehensive list of adverse effects.
Applies to itraconazole: oral capsule, oral solution, oral tablet
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 congestive heart failure occur during administration of itraconazole capsules, discontinue administration. When itraconazole was administered intravenously to dogs and healthy human volunteers, negative inotropic effects were seen.Drug Interactions: Coadministration of the following drugs are contraindicated with itraconazole capsules: methadone, disopyramide, dofetilide, dronedarone, quinidine, isavuconazole, ergot alkaloids (such as dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor. In addition, coadministration with colchicine, fesoterodine, and solifenacin is contraindicated in subjects with varying degrees of renal or hepatic impairment, and coadministration with eliglustat is contraindicated in subjects that are poor or intermediate metabolizers of CYP2D6 and in subjects taking strong or moderate CYP2D6 inhibitors. Coadministration with itraconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both the pharmacologic effects and/or adverse reactions to these drugs. For example, increased plasma concentrations of some of these drugs can lead to QT prolongation and ventricular tachyarrhythmias including occurrences of torsades de pointes, a potentially fatal arrhythmia.
Oral route (Solution)
Congestive Heart Failure, Cardiac Effects and Drug Interactions: If signs or symptoms of congestive heart failure occur during administration of itraconazole oral solution, continued itraconazole use should be reassessed. When itraconazole was administered intravenously to dogs and healthy human volunteers, negative inotropic effects were seen.Drug Interactions: Coadministration of the following drugs are contraindicated with itraconazole oral solution: methadone, disopyramide, dofetilide, dronedarone, quinidine, isavuconazole, ergot alkaloids (such as dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor. In addition, coadministration with colchicine, fesoterodine, and solifenacin is contraindicated in subjects with varying degrees of renal or hepatic impairment, and coadministration with eliglustat is contraindicated in subjects that are poor or intermediate metabolizers of CYP2D6 and in subjects taking strong or moderate CYP2D6 inhibitors. Coadministration with itraconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both the pharmacologic effects and/or adverse reactions to these drugs. For example, increased plasma concentrations of some of these drugs can lead to QT prolongation and ventricular tachyarrhythmias including occurrences of torsades de pointes, a potentially fatal arrhythmia.
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.
Along with its needed effects, itraconazole 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 while taking itraconazole:
More common
Less common
Rare
Some side effects of itraconazole 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
Rare
Applies to itraconazole: compounding powder, intravenous kit, oral capsule, oral solution, oral tablet
In clinical trials, side effects were reported in about 7% to 9% of patients receiving short-term therapy and about 15% of patients receiving prolonged (about 1 month) continuous therapy.
Pancreatitis, abdominal pain, vomiting, dyspepsia, nausea, diarrhea, and constipation have also been reported during postmarketing experience.
Very common (10% or more): Nausea (up to 11%), diarrhea (up to 11%)
Common (1% to 10%): Vomiting, abdominal pain or discomfort, dyspepsia, flatulence, gingivitis, constipation, ulcerative stomatitis, gastritis, gastroenteritis
Rare (less than 0.1%): Pancreatitis
Frequency not reported: Dysphagia, hemorrhoids, gastrointestinal disorder
Very common (10% or more): Hypertriglyceridemia (up to 11%)
Common (1% to 10%): Hypokalemia, increased blood alkaline phosphatase, hypomagnesemia, increased blood lactate dehydrogenase, hypophosphatemia, increased appetite
Uncommon (0.1% to 1%): Fluid overload, hypocalcemia, anorexia, hyperglycemia
Frequency not reported: Dehydration, decreased weight, hyperkalemia
Hypertriglyceridemia and hypokalemia have also been reported during postmarketing experience.
Common (1% to 10%): Headache, dizziness, hypoacusis, tremor, dysgeusia
Uncommon (0.1% to 1%): Vertigo, somnolence, hypoesthesia, transient or permanent hearing loss, peripheral neuropathy
Rare (less than 0.1%): Paresthesia, tinnitus
Peripheral neuropathy, paresthesia, hypoesthesia, headache, dizziness, tinnitus, transient or permanent hearing loss, dysgeusia, and tremor have also been reported during postmarketing experience.
Common (1% to 10%): Rhinitis, upper respiratory tract infection, sinusitis, cough, pneumonia, increased sputum, dyspnea, pharyngitis, pulmonary infiltration
Uncommon (0.1% to 1%): Pulmonary edema, pharyngolaryngeal pain
Frequency not reported: Dysphonia
Pulmonary edema and dyspnea have also been reported during postmarketing experience.
Edema and pyrexia have also been reported during postmarketing experience.
Common (1% to 10%): Pyrexia, injury, edema, chest pain, fatigue, malaise, pain, asthenia, Pneumocystis carinii infection, herpes zoster
Frequency not reported: Unspecified infection, rigors, back pain, hot flushes, implantation complication, face edema, chills, generalized edema
Postmarketing reports: Peripheral edema
Toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, alopecia, photosensitivity, rash, pruritus, and urticaria have also been reported during postmarketing experience.
Common (1% to 10%): Rash, pruritus, hyperhidrosis, unspecified skin disorder, erythematous rash
Uncommon (0.1% to 1%): Urticaria
Rare (less than 0.1%): Toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, leukocytoclastic vasculitis, erythema multiforme, photosensitivity, alopecia
Common (1% to 10%): Increased hepatic enzymes (including reversible increases), bilirubinemia, abnormal liver function, increased ALT, jaundice, increased AST, increased GGT, hepatitis, hyperbilirubinemia
Rare (less than 0.1%): Serious hepatotoxicity (including some cases of fatal acute liver failure)
Frequency not reported: Cholestasis, cholestatic jaundice, hepatic failure
Mild, transient elevations in liver function tests have occurred in 1% to 7% of patients receiving continuous therapy.
Serious hepatotoxicity (including some cases of fatal acute liver failure), hepatitis, and reversible increases in hepatic enzymes have also been reported during postmarketing experience.
Congestive heart failure has also been reported during postmarketing experience.
Common (1% to 10%): Hypertension, vein disorder, abnormal electrocardiogram
Uncommon (0.1% to 1%): Hypotension, orthostatic hypotension, vasculitis, sinus bradycardia, tachycardia
Rare (less than 0.1%): Congestive heart failure
Frequency not reported: Premature ventricular contractions, cardiac failure, left ventricular failure
Common (1% to 10%): Increased serum creatinine
Uncommon (0.1% to 1%): Abnormal renal function, increased blood urea
Frequency not reported: Renal impairment
Common (1% to 10%): Depression, anxiety, abnormal dreaming
Frequency not reported: Insomnia, decreased libido, visual hallucinations, confusional state
An elderly patient experienced visual hallucinations, confusion, and weakness after receiving itraconazole. The symptoms reappeared following accidental itraconazole doses 7 and 10 days later.
Pollakiuria, menstrual disorders, and erectile dysfunction have also been reported during postmarketing experience.
Common (1% to 10%): Cystitis, urinary tract infection
Uncommon (0.1% to 1%): Impotence, menstrual disorders, abnormal urine analysis
Rare (less than 0.1%): Pollakiuria, erectile dysfunction
Frequency not reported: Albuminuria, hematuria, gynecomastia, male breast pain, bacteriuria
Postmarketing reports: Urinary incontinence
Common (1% to 10%): Myalgia, bursitis, back pain
Rare (less than 0.1%): Increased blood creatine phosphokinase
Postmarketing reports: Arthralgia
Increased blood creatine phosphokinase and myalgia have also been reported during postmarketing experience.
IV:
Common (1% to 10%): Application site reaction
Frequency not reported: Injection site inflammation
Uncommon (0.1% to 1%): Hypersensitivity
Rare (less than 0.1%): Allergic reactions (e.g., pruritus, rash, urticaria, angioedema), serum sickness, angioneurotic edema, anaphylactic reaction
Frequency not reported: Anaphylactic shock
Postmarketing reports: Anaphylaxis, anaphylactoid reaction
At least 1 case of anaphylactic shock after long-term IV therapy has been reported.
Anaphylactic reactions, allergic reactions, serum sickness, and angioneurotic edema have also been reported during postmarketing experience.
Visual disturbances (including blurred vision, diplopia) have also been reported during postmarketing experience.
Uncommon (0.1% to 1%): Visual disturbances (including blurred vision, diplopia)
Frequency not reported: Abnormal vision
Rare (less than 0.1%): Leukopenia
Frequency not reported: Granulocytopenia
Postmarketing reports: Neutropenia, thrombocytopenia
Leukopenia has also been reported during postmarketing experience.
Frequency not reported: Adrenal insufficiency
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Itraconazole (www.drugs.com/mtm/itraconazole.html).
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