Itraconazole should not be used to treat nail fungal infections onychomycosis in pregnant patients. Women of child bearing age undergoing treatment for fungal infections of the nails must use adequate contraception measures while receiving itraconazole and for two months after treatment.
Itraconazole is excreted in human milk. Therefore, it should not be administered to nursing women or, alternatively, breastfeeding should be discontinued. What else should I know about itraconazole?
What preparations of itraconazole are available? CYP3A4 is a primary metabolic pathway for eszopiclone, and increased systemic exposure to eszopiclone increases the risk of next-day psychomotor or memory impairment, which may decrease the ability to perform tasks requiring full mental alertness such as driving. A pharmacokinetic study of ketoconazole coadministered with eszopiclone resulted in a 2. Although other azole antifungals e.
Ethinyl Estradiol; Ethynodiol Diacetate: Minor Coadministration of etonogestrel and strong CYP3A4 inhibitors such as itraconazole may increase the serum concentration of etonogestrel. Ethinyl Estradiol; Norethindrone Acetate: Ethinyl Estradiol; Norethindrone Acetate; Ferrous fumarate: Ethinyl Estradiol; Norethindrone; Ferrous fumarate: Major Monitor for an increased incidence of etoposide-related adverse effects if used concomitantly with itraconazole.
Coadministration may cause accumulation of etoposide and decreased metabolism, resulting in increased etoposide concentrations. Etravirine is a substrate and an inducer of CYP3A4. Coadministration with itraconazole may increase plasma concentrations of etravirine.
Simultaneously, plasma concentrations of itraconazole may be decreased by etravirine. Dose adjustments for itraconazole may be necessary when coadministered with etravirine. Monitor patients closely for etravirine-related adverse effects and for efficacy of itraconazole. Major Avoid coadministration of itraconazole with everolimus Afinitor; Afinitor Disperz due to increased plasma concentrations of everolimus. Coadministration of itraconazole with everolimus Zortress is not recommended without close monitoring of everolimus whole blood trough concentrations.
Once treatment is stopped, itraconazole plasma concentrations decrease to an almost undetectable concentration within 7 to 14 days, depending on the dose and duration of treatment. Severe Simvastatin is contraindicated for use during and for 2 weeks after itraconazole therapy. The risk of developing myopathy, rhabdomyolysis, and acute renal failure is increased if simvastatin is administered concomitantly with potent CYP3A4 inhibitors such as itraconazole.
If therapy with itraconazole is unavoidable, simvastatin therapy must be suspended during the course of itraconazole treatment. There are no known adverse effects with short-term discontinuation of simvastatin. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with itraconazole include ezogabine. Major Avoid use of fentanyl during and for 2 weeks after itraconazole therapy. Concomitant use may increase fentanyl plasma concentrations and prolong opioid adverse reactions, including hypotension, respiratory depression, profound sedation, coma, and death.
Monitor patients closely at frequent intervals and consider a dosage reduction of fentanyl until stable drug effects are achieved. Discontinuation of itraconazole could decrease fentanyl plasma concentrations, decrease opioid efficacy, and potentially lead to a withdrawal syndrome in those with physical dependence to fentanyl.
Major Avoid use of fesoterodine during and for 2 weeks after itraconazole in patients with normal renal and hepatic function. In patients with moderate to severe renal or hepatic impairment, use of fesoterodine is contraindicated during and for 2 weeks after itraconazole.
Fesoterodine is rapidly hydrolyzed to its active metabolite, 5-hydroxymethyltolterodine, which is metabolized via hepatic CYP3A4. The potent CYP3A4 inhibitory effects of itraconazole may result in elevated plasma concentrations of 5-hydroxymethyltolterodine and an increased risk for adverse reactions. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with itraconazole include fingolimod.
Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with itraconazole include flecainide. Severe The concomitant use of flibanserin and strong CYP3A4 inhibitors, such as itraconazole, is contraindicated.
Strong CYP3A4 inhibitors can increase flibanserin concentrations, which can cause severe hypotension and syncope. If initiating a strong CYP3A4 inhibitor following flibanserin use, start the strong CYP3A4 inhibitor at least 2 days after the last dose of flibanserin.
Major Typically voriconazole would not be used in combination with other systemic azole antifungal agents due to similar mechanisms of action and indications for use duplicate therapies.
Itraconazole has the potential to exhibit multiple hepatic cytochrome P interactions with voriconazole. Serum concentrations of voriconazole or itraconazole may increase or decrease. Furthermore, all systemic azole antifungal agents fluconazole, itraconazole, ketoconazole, posaconazole, and voriconazole have been associated with prolongation of the QT interval.
Coadministration would increase the risk of QT prolongation. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with itraconazole include fluoxetine. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with itraconazole include olanzapine. Drugs with a possible risk for QT prolongation that should be used cautiously and with close monitoring with itraconazole include fluphenazine.
Moderate CYP3A4 inhibitors, such as itraconazole, may reduce the metabolism of flurazepam and increase the potential for benzodiazepine toxicity.
Reduced flurazepam dosages or avoidance of benzodiazepine use may be recommended in selected situations. Major Avoid use of salmeterol during and for 2 weeks after discontinuation of itraconazole treatment due to increased salmeterol exposure resulting in adverse cardiovascular effects e. Itraconazole has been associated with QT prolongation.
Beta-agonists may be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses, when associated with hypokalemia, or when used with other drugs known to prolong the QT interval.
This risk may be more clinically significant with long-acting beta-agonists such as salmeterol compared to short-acting beta-agonists. Although this did not produce a statistical effect on the mean QTc, there were more frequent increases in QTc duration compared with salmeterol and placebo administration. Major There may be an increased risk for QT prolongation and torsade de pointes TdP during concurrent use of fluvoxamine and itraconazole.
Cases of QT prolongation and TdP have been reported during postmarketing use of fluvoxamine. Moderate Oral bioavailability of itraconazole from the capsules is increased if administered with a meal or cola beverage. Administration with orange juice should be avoided. Moderate The incidence of marijuana associated adverse effects may change following coadministration with itraconazole. Itraconazole is an inhibitor of CYP3A4, an isoenzyme partially responsible for the metabolism of marijuana's most psychoactive compound, deltatetrahydrocannabinol DeltaTHC.
When given concurrently with itraconazole, the amount of DeltaTHC converted to the active metabolite hydroxy-deltatetrahydrocannabinol OH-THC may be reduced. Moderate Concomitant administration of itraconazole and mometasone may increase systemic exposure to mometasone, increasing the risk of corticosteroid-related adverse events.
Exercise caution when administering mometasone with itraconazole long-term and monitor closely for hypercorticism and adrenal suppression. Monitor for an increase in itraconazole adverse effects.
Coadministration of fosamprenavir with itraconazole results in clinically significant increases in itraconazole plasma concentrations. Major When possible, avoid concurrent use of foscarnet with other drugs known to prolong the QT interval, such as itraconazole. Foscarnet has been associated with postmarketing reports of both QT prolongation and torsade de pointes TdP.
If these drugs are administered together, obtain an electrocardiogram and electrolyte concentrations before and periodically during treatment. Major Phenytoin has been shown to reduce itraconazole AUC and half-life. The mechanism appears to be enhanced first-pass and CYP3A4 hepatic enzyme metabolism of itraconazole.
Additionally, itraconazole may increase phenytoin AUC. In general, this drug combination should be avoided, as the serum concentrations of the azole antifungal may be drastically subtherapeutic. Moderate Galantamine is a primary substrate of CYP3A4 and the bioavailability of galantamine may be increased when coadministered with strong CYP3A4 inhibitors, such as itraconazole. Monitor patients for galantamine-related adverse effects such as nausea, vomiting, diarrhea, headache, loss of appetite, excess sweating, and confusion.
Moderate Substances that are potent inhibitors of cytochrome P 3A4 activity, such as itraconazole, decrease the metabolism of gefitinib and increase gefitinib concentrations. This increase may be clinically relevant as adverse reactions to gefitinib are related to dose and exposure; therefore, caution should be used when administering CYP3A4 inhibitors with gefitinib. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with itraconazole include gemifloxacin.
Major Use gemtuzumab ozogamicin and itraconazole together with caution due to the potential for additive QT interval prolongation and risk of torsade de pointes TdP. If these agents are used together, obtain an ECG and serum electrolytes prior to the start of gemtuzumab and as needed during treatment. Although QT interval prolongation has not been reported with gemtuzumab, it has been reported with other drugs that contain calicheamicin. Moderate Caution is advised with the coadministration of glecaprevir and itraconazole as coadministration may increase serum concentrations of both drugs and increase the risk of adverse effects.
Glecaprevir and itraconazole are both substrates and inhibitors of P-glycoprotein P-gp. Moderate Caution is advised with the coadministration of pibrentasvir and itraconazole as coadministration may increase serum concentrations of both drugs and increase the risk of adverse effects.
Both pibrentasvir and itraconazole are substrates and inhibitors of P-glycoprotein P-gp. Major Itraconazole should be used cautiously and with close monitoring with goserelin. Androgen deprivation therapy e. Major Caution is advised when administering itraconazole with drugs that are known to prolong that QT interval and are metabolized by CYP3A4, such as granisetron.
Both granisetron and itraconazole are associated with QT prolongation; coadministration may increase this risk. In addition, coadministration of itraconazole a potent CYP3A4 inhibitor with granisetron a CYP3A4 substrate may result in elevated granisetron plasma concentrations and an increased risk for adverse events, including QT prolongation.
Minor Grapefruit juice reduced the mean peak itraconazole concentration by 35 percent when itraconazole capsules were administered with grapefruit juice in healthy volunteers; the AUC was reduced by an average of 43 percent compared to administration with water.
Conversely, another study reported that grapefruit juice did not significantly affect the bioavailability of itraconazole capsules. Major Itraconazole may significantly increase guanfacine plasma concentrations. FDA-approved labeling for extended-release ER guanfacine recommends that, if these agents are taken together, the guanfacine dosage should be decreased to half of the recommended dose.
Specific recommendations for immediate-release IR guanfacine are not available. Monitor patients closely for alpha-adrenergic effects including hypotension, drowsiness, lethargy, and bradycardia. Upon itraconazole discontinuation, the guanfacine ER dosage should be increased back to the recommended dose.
Major Due to itraconazole-induced inhibition of cytochrome P CYP 3A4, interactions are possible with agents that are substrates of this enzyme, such as halofantrine. Major Caution is advised when administering itraconazole with drugs that are known to prolong that QT interval and are metabolized by CYP3A4, such as haloperidol.
Haloperidol is primarily metabolized by CYP2D6. However, in patients that are lacking in CYP2D6 enzyme activity slow metabolizers , the CYP3A4 enzyme may play a larger role in haloperidol metabolism. Concurrent use of itraconazole a potent inhibitor of CYP3A4 with haloperidol has resulted in increased serum haloperidol concentrations.
Neurologic side effects and arrhythmias have been noted clinically in some patients because of impaired haloperidol elimination; however, QT prolongation has not been observed in single-dose studies. QT prolongation and torsade de pointes TdP have been observed during haloperidol treatment.
Itraconazole has also been associated with QT prolongation; coadministration with haloperidol may increase this risk. If these drugs must be used together, the haloperidol dose may need to be reduced and the patients should be monitored closely for adverse events.
Of note, once itraconazole is discontinued, plasma concentrations decrease to almost undetectable concentrations within 7 to 14 days. Hydrocodone; Potassium Guaiacolsulfonate; Pseudoephedrine: Major Avoid coadministration of hydroxychloroquine and itraconazole.
Hydroxychloroquine increases the QT interval and should not be administered with other drugs known to prolong the QT interval. Ventricular arrhythmias and torsade de pointes have been reported with the use of hydroxychloroquine. The metabolism of progesterone is inhibited by ketoconazole, a known inhibitor of cytochrome P 3A4 hepatic enzymes.
Theoretically, the metabolism of hydroxyprogesterone may also be inhibited by ketoconazole. It has not been determined whether other drugs which inhibit CYP3A4 hepatic enzymes, like itraconazole, would have a similar effect. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with hydroxyzine include itraconazole.
Major Avoid ibrutinib use during and for 2 weeks after discontinuation of itraconazole treatment. If short-term use of itraconazole is necessary e. Taking these drugs together may result in increased ibrutinib plasma concentrations, resulting in severe ibrutinib toxicity e. When ibrutinib was administered with multiple doses of other strong CYP3A4 inhibitors, the Cmax and AUC values of ibrutinib were increased significantly.
Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with itraconazole include ibutilide. Moderate Monitor for increased idelalisib and itraconazole adverse reactions if coadministration is necessary. A dose reduction of either agent may be necessary.
Both itraconazole and idelalisib are strong CYP3A4 inhibitors and substrates. Major The concomitant use of ifosfamide, a CYP3A4 substrate, and itraconazole, a strong CYP3A4 inhibitor and substrate, may decrease the metabolism of ifosfamide to its active metabolite, 4-hydroxy-ifosfamide.
As a result of this interaction, ifosfamide treatment effectiveness may be reduced. Major Avoid concurrent administration of itraconazole and iloperidone.
If concurrent use is necessary, the iloperidone dose should be reduced by one-half. Coadministration of itraconazole a potent CYP3A4 inhibitor with iloperidone a CYP3A4 substrate may result in elevated iloperidone plasma concentrations and could increase the risk for adverse events, including QT prolongation.
If itraconazole is subsequently withdrawn, the iloperidone dose should be returned to the previous amount. In addition, both iloperidone and itraconazole are associated with QT prolongation; coadministration may increase this risk. Moderate Agents that inhibit cytochrome P 3A4, such as itraconazole, may decrease imatinib, STI metabolism and increase concentrations leading to toxicity. There was a significant increase in imatinib Cmax and AUC when given with another systemic azole antifungal i.
This may result in indacaterol side effects like tremor, nervousness, or a fast, irregular heart rate. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with itraconazole include the beta-agonists.
Major Monitor for increased indinavir and itraconazole adverse reactions if coadministration is necessary. Dose reduction of indinavir to mg every 8 hours is recommended when administering itraconazole mg twice daily concurrently. An itraconazole dose reduction may also be necessary. Both itraconazole and indinavir are strong CYP3A4 inhibitors and substrates.
Major Avoid coadministration of inotuzumab ozogamicin with itraconazole due to the potential for additive QT prolongation and risk of torsade de pointes TdP. If coadministration is unavoidable, obtain an ECG and serum electrolytes prior to the start of treatment, after treatment initiation, and periodically during treatment. Both inotuzumab and itraconazole have been associated with QT prolongation. Severe Irinotecan liposomal is contraindicated for use during and for 2 weeks after discontinuation of itraconazole therapy.
Exposure to irinotecan and to the active metabolite, SN, is increased when the drugs are used together. Severe Irinotecan is contraindicated for use during and for 2 weeks after discontinuation of itraconazole therapy. Severe Isavuconazonium is contraindicated for use with and for 2 weeks after itraconazole therapy, due to the risk for increased isavuconazole serum concentrations and serious adverse reactions, such as hepatic toxicity.
Isavuconazole, the active moiety of isavuconazonium, is a sensitive substrate of hepatic isoenzyme CYP3A4; itraconazole is a strong inhibitor of this enzyme. Isavuconazole serum concentrations were increased 5-fold when coadministered with another strong CYP3A4 inhibitor. Elevated itraconazole concentrations would also be expected with coadministration, as itraconazole is a substrate and isavuconazole is an inhibitor of CYP3A4 and the drug transporter P-glycoprotein P-gp.
Major Use of isoniazid is not recommended for 2 weeks before or during itraconazole therapy. Isoniazid may reduce itraconazole serum concentrations resulting in antifungal treatment failure.
Major Avoid the concomitant use of rifamycins i. Rifamycins may decrease the bioavailability of itraconazole resulting in antifungal treatment failure. Consider an alternative antifungal or antimycobacterial agent. If coadministration is necessary, monitor the antifungal activity of itraconazole and increase the dose as necessary.
In addition, itraconazole may increase isradipine serum concentrations via inhibition of CYP3A4 with the potential for isradipine toxicity. Severe Ivabradine is contraindicated for use during and for 2 weeks after itraconazole therapy.
Coadministration will increase the plasma concentrations of ivabradine. Increased ivabradine concentrations may result in bradycardia exacerbation and conduction disturbances. Major If itraconazole and ivacaftor are taken together, administer ivacaftor at the usual recommended dose but reduce the frequency to twice weekly e. Coadministration of another strong CYP3A inhibitor, increased ivacaftor exposure by 8. Always seek the advice of a physician or other qualified healthcare provider with any questions you may have regarding a medical condition.
Never disregard professional medical advice or delay in seeking it because of something you have read on the Healthline Site. If you think you may have a medical emergency, call your doctor or immediately. Please read the Terms of Service for more information regarding use of the Healthline Site. The bioactive metabolite, hydroxyitraconazole, has not been evaluated against Histoplasma capsulatum and Blastomyces dermatitidis. Correlation between minimum inhibitory concentration MIC results in vitro and clinical outcome has yet to be established for azole antifungal agents.
Itraconazole administered orally was active in a variety of animal models of fungal infection using standard laboratory strains of fungi. Fungistatic activity has been demonstrated against disseminated fungal infections caused by Blastomyces dermatitidis, Histoplasma duboisii, Aspergillus fumigatus, Coccidioides immitis, Cryptococcus neoformans, Paracoccidioides brasiliensis, Sporothrix schenckii, Trichophyton rubrum and Trichophyton mentagrophytes.
Itraconazole administered at 2. Itraconazole has demonstrated antifungal activity in a variety of animal models infected with Candida albicans and other Candida species.
Resistance Isolates from several fungal species with decreased susceptibility to itraconazole have been isolated in vitro and from patients receiving prolonged therapy. Several in vitro studies have reported that some fungal clinical isolates, including Candida species, with reduced susceptibility to one azole antifungal agent may also be less susceptible to other azole derivatives.
The finding of cross-resistance is dependent on a number of factors, including the species evaluated, its clinical history, the particular azole compounds compared and the type of susceptibility test that is performed.
The relevance of these in vitro susceptibility data to clinical outcome remains to be elucidated. Studies both in vitro and in vivo suggest that the activity of amphotericin B may be suppressed by prior azole antifungal therapy. As with other azoles, itraconazole inhibits the 14C-demethylation step in the synthesis of ergosterol, a cell wall component of fungi.
Ergosterol is the active site for amphotericin B. In one study the antifungal activity of amphotericin B against Aspergillus fumigatus infections in mice was inhibited by ketoconazole therapy. The clinical significance of test results obtained in this study is unknown. Blastomycosis, pulmonary and extrapulmonary; Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis and Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy.
Specimens for fungal cultures and other relevant laboratory studies wet mount, histopathology, serology should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly. Itraconazole capsules are also indicated for the treatment of the following fungal infections in non-immunocompromised patients: Onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes tinea unguium and Onychomycosis of the fingernail due to dermatophytes tinea unguium.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop using Sporanox and tell your doctor straight away if you notice or suspect any of the following. You may need urgent medical treatment. Sudden signs of allergy such as rash, hives also known as nettle rash or urticaria , severe irritation of your skin, swelling of the face, lips, tongue or other parts of the body. These may be signs of a severe allergic reaction. This occurs rarely A tingling sensation, numbness or weakness in your limbs This occurs rarely Severe lack of appetite, feeling sick nausea , being sick vomiting , unusual tiredness, stomach pain, muscle weakness, yellowing of your skin or whites of your eyes jaundice , unusually dark urine, pale stools or hair loss.
These may be signs of a liver problem. This only happens in a small number of people Shortness of breath, unexpected weight gain, swelling of your legs or abdomen, feeling unusually tired or waking up short of breath at night.
These may be signs of heart failure. Shortness of breath can also be a sign of fluid on the lungs This occurs rarely Tell your doctor or pharmacist if you notice any of the following side effects: Common affects less than 1 in 10 people Stomach ache, feeling sick nausea Headache Uncommon affects less than 1 in people Problems with periods Sinusitis, runny nose, coughs and colds Constipation, diarrhoea, wind, being sick vomiting , indigestion Rare affects less than 1 in people Increases in liver function tests shown by blood tests Unexpected passing of urine or need to urinate pass water more often Problems with sight including blurred vision and double vision Change in taste Certain blood disorders which may increase the risk of infections Ringing in your ears Hearing loss may be permanent Severe upper stomach pain, often with nausea and vomiting inflammation of the pancreas Swelling due to fluid under the skin Unusual hair loss or thinning alopecia High levels of triglycerides in the blood shown by blood tests Red, itchy, flaking or peeling skin Sensitivity of the skin to light Erection difficulties If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
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