South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

janssen pharmaceutica (pty) ltd - capsules - see ingredients - each capsule contains itraconazole 100 mg

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

janssen pharmaceutica (pty) ltd - capsules - see ingredients - each capsule contains itraconazole 100,0 mg

Israel - English - Ministry of Health

j-c health care ltd - itraconazole - solution - itraconazole 10 mg/ml - itraconazole - itraconazole - sporanox oral solution is indicated for the treatment of oropharyngeal and esophageal candidiasis. prevention of fungal infection during neutropenia of immunodeficient patients.

Malta - English - Medicines Authority

janssen-cilag international nv turnhoutsewes 30, b-2340 beerse, belgium - itraconazole - hard capsule - itraconazole 100 mg - antimycotics for systemic use

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - itraconazole (unii: 304nug5gf4) (itraconazole - unii:304nug5gf4) - itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: 1. blastomycosis, pulmonary and extrapulmonary 2. histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and 3. 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: 1. onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and 2. onychomycosis of the fingernail due to dermatophytes (tinea unguium). prior to initiating treatment, appropriate nail specimens for laboratory testing (koh preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis.(see clinical pharmacology: special populations, contraindications, warnings,and adverse reactions: post-marketing experience for more information.)                                 description of clinical studies: blastomycosis:      analyses were conducted on data from two open-label, non-concurrently controlled studies (n=73 combined) in patients with normal or abnormal immune status. the median dose was 200 mg/day. a response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 6 months. results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of blastomycosis compared with the natural history of untreated cases. histoplasmosis: analyses were conducted on data from two open-label, non-concurrently controlled studies (n=34 combined) in patients with normal or abnormal immune status (not including hiv-infected patients). the median dose was 200 mg/day. a response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 12 months. results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of histoplasmosis, compared with the natural history of untreated cases. histoplasmosis in hiv-infected patients:  data from a small number of hiv-infected patients suggested that the response rate of histoplasmosis in hiv-infected patients is similar to that of non-hiv-infected patients. the clinical course of histoplasmosis in hiv-infected patients is more severe and usually requires maintenance therapy to prevent relapse. aspergillosis: analyses were conducted on data from an open-label, "single-patient-use" protocol designed to make itraconazole available in the u.s. for patients who either failed or were intolerant of amphotericin b therapy (n=190). the findings were corroborated by two smaller open-label studies (n=31 combined) in the same patient population. most adult patients were treated with a daily dose of 200 to 400 mg, with a median duration of 3 months. results of these studies demonstrated substantial evidence of  effectiveness of itraconazole as a second-line therapy for the treatment of aspergillosis compared with the natural history of the disease in patients who either failed or were intolerant of amphotericin b therapy. onychomycosis of the toenail: analyses were conducted on data from three double-blind, placebo-controlled studies (n=214 total;110 given itraconazole capsules) in which patients with onychomycosis of the toenails received 200 mg of itraconazole capsules once daily for 12 consecutive weeks. results of these studies demonstrated mycologic cure, defined as simultaneous occurrence of negative koh plus negative culture, in 54% of patients. thirty-five percent (35%) of patients were considered an overall success(mycologic cure plus clear or minimal nail involvement with significantly decreased signs) and 14% of patients demonstrated mycologic cure plus clinical cure (clearance of all signs, with or without residual nail deformity). the mean time to overall success was approximately 10 months. twenty-one percent (21%) of the overall success group had a relapse (worsening of the global score or conversion of koh or culture from negative to positive). onychomycosis of the fingernail: analyses were conducted on data from a double-blind, placebo-controlled study (n=73 total; 37 given itraconazole capsules) in which patients with onychomycosis of the fingernails received a 1-week course of 200 mg of itraconazole capsules b.i.d., followed by a 3-week period without itraconazole, which was followed by a second 1-week course of 200 mg of itraconazole capsules b.i.d. results demonstrated mycologic cure in 61% of patients. fifty-six percent (56%) of patients were considered an overall success and 47% of patients demonstrated mycologic cure plus clinical cure. the mean time to overall success was approximately 5 months. none of the patients who achieved overall success relapsed. congestive heart failure: 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. (see boxed warning,  warnings,precautions: drug interactions-calcium channel blockers, adverse reactions: post-marketing experience, and clinical pharmacology: special populations.) drug interactions: coadministration of a number of cyp3a4 substrates are contraindicated with itraconazole capsules. plasma concentrations increase for the following drugs: 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.(see precautions: drug interactions section for specific examples.) this increase in drug concentrations caused by coadministration with itraconazole 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 torsade de pointes, a potentially fatal arrhythmia. specific examples are listed in precautions: drug interactions. coadministration with venetoclax is contraindicated in patients with cll/sll during the dose initiation and ramp-up phase of venetoclax due to the potential for an increased risk of tumor lysis syndrome. itraconazole capsules should not be administered for the treatment of onychomycosis to pregnant patients or to women contemplating pregnancy. itraconazole capsules are contraindicated for patients who have shown hypersensitivity to itraconazole. there is limited information regarding cross-hypersensitivity between itraconazole and other azole antifungal agents. caution should be used when prescribing itraconazole capsules to patients with hypersensitivity to other azoles.

United States - English - NLM (National Library of Medicine)

mayne pharma commercial llc - itraconazole (unii: 304nug5gf4) (itraconazole - unii:304nug5gf4) - tolsura is indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised adult patients: - 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, anti-fungal therapy should be adjusted accordingly limitations of use: tolsura is not indicated for the treatment of onychomycosis. tolsura is not interchangeable or substitutable with other itraconazole products due to the differences in the dosing between tolsura and other itraconazole products. therefore, follow the specific dosage recommendations for tolsura [see dosage and administration (2)]. - co-administration of certain drugs that are metabolized by human cyp3a4 substrates are contraindicated with tolsura because plasma concentrations of such drugs are increased, which may also increase or prolong both the pharmacologic effects and/or adverse reactions to these drugs [see warnings and precaution (5.4)and drug interactions (7.1)] . - co-administration with colchicine, fesoterodine and solifenacin is contraindicated in subjects with varying degrees of renal or hepatic impairment. - co-administration with eliglustat is contraindicated in subjects that are poor or intermediate metabolizers of cyp2d6 and in subjects taking strong or moderate cyp2d6 inhibitors [see drug interactions (7.1)] . - increased plasma concentrations of some of these drugs due to co-administration of tolsura can lead to qt prolongation and ventricular tachyarrhythmias including occurrences of torsade de pointes , a potentially fatal arrhythmia [ see drug interactions (7.1)] . tolsura is contraindicated in patients with known hypersensitivity to itraconazole. there is limited information regarding cross-hypersensitivity between itraconazole and other azole antifungal agents [see warnings and precautions (5.7)] . risk summary there are no data on exposure to itraconazole during pregnancy for the approved indications. published epidemiologic studies of women exposed to short courses of treatment with itraconazole in the first trimester of pregnancy have reported no risk of major birth defects overall and inconclusive findings on the risk of miscarriage (see data) . in animal reproduction studies, itraconazole was found to cause a dose-related increase in maternal toxicity, embryotoxicity, and teratogenicity in rats at dosage levels of approximately (6-25 times the maximum recommended human dose [mrhd] of 390 mg/day based on mg/kg comparisons), and in mice at dosage levels of approximately 80 mg/kg/day (12 times the mrhd). all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data human data published prospective and retrospective cohort studies of women exposed to short courses of treatment with itraconazole in the first trimester of pregnancy (sample size 198-687) have reported no increase in the rate of major birth defects. the most important methodological limitation of these studies is the short duration of exposure in pregnancy (mean duration 6.9 to 8.5 days), or the lack of information on treatment duration. the risk of prolonged exposure in pregnancy is not known. published prospective and retrospective cohort studies of pregnant women exposed to itraconazole (sample size 131-198) have reported inconsistent findings on the risk of miscarriage. available data are inconclusive and limited by possible bias due to earlier enrollment and possible residual confounding in the exposed group compared to the unexposed group. animal data itraconazole has been shown to cross the placenta in a rat model. in animal reproduction studies, itraconazole administration to rats and mice during organogenesis resulted in maternal toxicity, embryotoxicity and teratogenicity at and above 40 and 80 mg/kg respectively (doses equivalent to 6- and 12-times the mrhd of 390 mg/day, based on mg/kg comparisons). in rats, the teratogenicity consisted of major skeletal defects; in mice, it consisted of encephaloceles and/or macroglossia. risk summary itraconazole is excreted in human milk; however, there are no data on the amount of itraconazole in human milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tolsura and any potential adverse effects on the breastfed child from tolsura or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. the long-term effects of itraconazole on bone growth in children are unknown. bone lesions were observed in the young adult rats dosed with oral itraconazole for 3 to 12 months [see nonclinical toxicology (13.2)] . clinical studies of itraconazole did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. it is advised to use tolsura capsules in these patients only if it is determined that the potential benefit outweighs the potential risks. in general, it is recommended that the dose selection for an elderly patient should be taken into consideration, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. reversible or permanent hearing loss has been reported in elderly patients receiving treatment with itraconazole. several of these reports included concurrent administration of quinidine which is contraindicated [see boxed warning, contraindications (4.1) and drug interactions (7.1)] . limited data are available on the use of oral itraconazole in patients with renal impairment. it is recommended that patients with renal impairment be carefully monitored when taking tolsura [see clinical pharmacology (12)and warnings and precautions (5.1)] . limited data are available on the use of oral itraconazole in patients with hepatic impairment. it is recommended that patients with impaired hepatic function be carefully monitored when taking tolsura. it is recommended that the prolonged elimination half-life of itraconazole observed in the single oral dose clinical trial with itraconazole capsules in cirrhotic patients be considered when deciding to initiate therapy with other medications metabolized by cyp3a4 [see clinical pharmacology (12.3)] . in patients with elevated or abnormal liver enzymes or active liver disease, or who have experienced liver toxicity with other drugs, treatment with tolsura is strongly discouraged unless there is a serious or life-threatening situation where the expected benefit exceeds the risk. it is recommended that liver function monitoring be done in patients with pre-existing hepatic function abnormalities or those who have experienced liver toxicity with other medications [see clinical pharmacology (12)and warnings and precautions (5.2)].

Israel - English - Ministry of Health

rafa laboratories ltd - itraconazole - capsules - itraconazole 100 mg - itraconazole - itraconazole - blastomycosis (pulmonary and extrapulmonary). histoplasmosis. onchomycosis caused by dermatophytes and/or yeast. dermatomycoses. vulvovaginal candidosis. oral candidosis.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - itraconazole, quantity: 100 mg - capsule - excipient ingredients: hypromellose; macrogol 20000; sucrose; hydrolysed maize starch; titanium dioxide; purified water; gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - apo-itraconazole indicated for use in adults for the treatment of: ? superficial dermatomycoses not responding to topical treatment. ? fungal keratitis which has failed to respond to topical treatment or where the disease is either progressing rapidly or is immediately sight threatening. ? pityriasis versicolor not responding to any other treatment. ? vulvovaginal candidiasis not responding to topical treatment. ? oral candidiasis in immunocompromised patients. ? onychomycosis caused by dermatophytes. ? systemic mycoses: - systemic aspergillosis, histoplasmosis, sporotrichosis. - treatment and maintenance therapy in aids patients with disseminated or chronic pulmonary histoplasmosis infection. - treatment of oropharyngeal and/or oesophageal candidiasis when first line systemic antifungal therapy is inappropriate or has proven ineffective. - treatment of non-invasive candidiasis in non-neutropenic patients when first-line systemic antifungal therapy is inappropriate or has proven ineffective. this may be due to underlying pathology, insensitivity of the pathogen or drug toxicity.

United States - English - NLM (National Library of Medicine)

janssen pharmaceuticals, inc. - itraconazole (unii: 304nug5gf4) (itraconazole - unii:304nug5gf4) - itraconazole 100 mg - sporanox ® (itraconazole) capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: - 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. sporanox ® 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). prior to initiating treatment, appropriate nail specimens for laboratory testing (koh preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. (see clinical pharmacology: special populations, contraindications, warnings, and adverse reactions: post-marketing experiencefor more information.) analyses were conducted on data from two open-label, non-concurrently controlled studies (n=73 combined) in patients with normal or abnormal immune status. the median dose was 200 mg/day. a response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 6 months. results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of blastomycosis compared with the natural history of untreated cases. analyses were conducted on data from two open-label, non-concurrently controlled studies (n=34 combined) in patients with normal or abnormal immune status (not including hiv-infected patients). the median dose was 200 mg/day. a response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 12 months. results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of histoplasmosis, compared with the natural history of untreated cases. data from a small number of hiv-infected patients suggested that the response rate of histoplasmosis in hiv-infected patients is similar to that of non-hiv-infected patients. the clinical course of histoplasmosis in hiv-infected patients is more severe and usually requires maintenance therapy to prevent relapse. analyses were conducted on data from an open-label, "single-patient-use" protocol designed to make itraconazole available in the u.s. for patients who either failed or were intolerant of amphotericin b therapy (n=190). the findings were corroborated by two smaller open-label studies (n=31 combined) in the same patient population. most adult patients were treated with a daily dose of 200 to 400 mg, with a median duration of 3 months. results of these studies demonstrated substantial evidence of effectiveness of itraconazole as a second-line therapy for the treatment of aspergillosis compared with the natural history of the disease in patients who either failed or were intolerant of amphotericin b therapy. analyses were conducted on data from three double-blind, placebo-controlled studies (n=214 total; 110 given sporanox ® capsules) in which patients with onychomycosis of the toenails received 200 mg of sporanox ® capsules once daily for 12 consecutive weeks. results of these studies demonstrated mycologic cure, defined as simultaneous occurrence of negative koh plus negative culture, in 54% of patients. thirty-five percent (35%) of patients were considered an overall success (mycologic cure plus clear or minimal nail involvement with significantly decreased signs) and 14% of patients demonstrated mycologic cure plus clinical cure (clearance of all signs, with or without residual nail deformity). the mean time to overall success was approximately 10 months. twenty-one percent (21%) of the overall success group had a relapse (worsening of the global score or conversion of koh or culture from negative to positive). analyses were conducted on data from a double-blind, placebo-controlled study (n=73 total; 37 given sporanox ® capsules) in which patients with onychomycosis of the fingernails received a 1-week course (pulse) of 200 mg of sporanox ® capsules b.i.d., followed by a 3-week period without sporanox ® , which was followed by a second 1-week pulse of 200 mg of sporanox ® capsules b.i.d. results demonstrated mycologic cure in 61% of patients. fifty-six percent (56%) of patients were considered an overall success and 47% of patients demonstrated mycologic cure plus clinical cure. the mean time to overall success was approximately 5 months. none of the patients who achieved overall success relapsed. sporanox ® (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. (see boxed warning, warnings, precautions: drug interactions-calcium channel blockers, adverse reactions: post-marketing experience, and clinical pharmacology: special populations.) coadministration of a number of cyp3a4 substrates are contraindicated with sporanox ® . some examples of drugs for which plasma concentrations increase are: 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, finerenone, voclosporin. 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. (see precautions: drug interactionssection for specific examples.) this increase in drug concentrations caused by coadministration with itraconazole 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 torsade de pointes , a potentially fatal arrhythmia. some specific examples are listed in precautions: drug interactions. coadministration with venetoclax is contraindicated in patients with cll/sll during the dose initiation and ramp-up phase of venetoclax due to the potential for an increased risk of tumor lysis syndrome. sporanox ® should not be administered for the treatment of onychomycosis to pregnant patients or to women contemplating pregnancy. sporanox ® is contraindicated for patients who have shown hypersensitivity to itraconazole. there is limited information regarding cross-hypersensitivity between itraconazole and other azole antifungal agents. caution should be used when prescribing sporanox ® to patients with hypersensitivity to other azoles.

United States - English - NLM (National Library of Medicine)

accord healthcare inc. - itraconazole (unii: 304nug5gf4) (itraconazole - unii:304nug5gf4) - itraconazole 100 mg - itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: - 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). prior to initiating treatment, appropriate nail specimens for laboratory testing (koh preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. (see clinical pharmacology: special populations, contraindications, warnings, and adverse reactions: post-marketing experience for more information.) analyses were conducted on data from two open-label, non-concurrently controlled studies (n=73 combined) in patients with normal or abnormal immune status. the median dose was 200 mg/day. a response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 6 months. results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of blastomycosis compared with the natural history of untreated cases. analyses were conducted on data from two open-label, non-concurrently controlled studies (n=34 combined) in patients with normal or abnormal immune status (not including hiv-infected patients). the median dose was 200 mg/day. a response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 12 months. results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of histoplasmosis, compared with the natural history of untreated cases. data from a small number of hiv-infected patients suggested that the response rate of histoplasmosis in hiv-infected patients is similar to that of non-hiv-infected patients. the clinical course of histoplasmosis in hiv-infected patients is more severe and usually requires maintenance therapy to prevent relapse. analyses were conducted on data from an open-label, "single-patient-use" protocol designed to make itraconazole available in the u.s. for patients who either failed or were intolerant of amphotericin b therapy (n=190). the findings were corroborated by two smaller open-label studies (n=31 combined) in the same patient population. most adult patients were treated with a daily dose of 200 to 400 mg, with a median duration of 3 months. results of these studies demonstrated substantial evidence of effectiveness of itraconazole as a second-line therapy for the treatment of aspergillosis compared with the natural history of the disease in patients who either failed or were intolerant of amphotericin b therapy. analyses were conducted on data from three double-blind, placebo-controlled studies (n=214 total; 110 given itraconazole capsules) in which patients with onychomycosis of the toenails received 200 mg of itraconazole capsules once daily for 12 consecutive weeks. results of these studies demonstrated mycologic cure, defined as simultaneous occurrence of negative koh plus negative culture, in 54% of patients. thirty-five percent (35%) of patients were considered an overall success (mycologic cure plus clear or minimal nail involvement with significantly decreased signs) and 14% of patients demonstrated mycologic cure plus clinical cure (clearance of all signs, with or without residual nail deformity). the mean time to overall success was approximately 10 months. twenty-one percent (21%) of the overall success group had a relapse (worsening of the global score or conversion of koh or culture from negative to positive). analyses were conducted on data from a double-blind, placebo-controlled study (n=73 total; 37 given itraconazole capsules) in which patients with onychomycosis of the fingernails received a 1-week course of 200 mg of itraconazole capsules b.i.d., followed by a 3-week period without itraconazole, which was followed by a second 1-week course of 200 mg of itraconazole capsules b.i.d. results demonstrated mycologic cure in 61% of patients. fifty-six percent (56%) of patients were considered an overall success and 47% of patients demonstrated mycologic cure plus clinical cure. the mean time to overall success was approximately 5 months. none of the patients who achieved overall success relapsed. 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. (see boxed warning, warnings, precautions: drug interactions-calcium channel blockers, adverse reactions: post-marketing experience, and clinical pharmacology: special populations.) coadministration of a number of cyp3a4 substrates are contraindicated with itraconazole. plasma concentrations increase for the following drugs: levaceytlmethadol (levomethadyl), 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. (see precautions: drug interactions section for specific examples.) this increase in drug concentrations caused by coadministration with itraconazole 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 torsade de pointes, a potentially fatal arrhythmia. specific examples are listed in precautions: drug interactions. itraconazole should not be administered for the treatment of onychomycosis to pregnant patients or to women contemplating pregnancy. itraconazole is contraindicated for patients who have shown hypersensitivity to itraconazole. there is limited information regarding cross-hypersensitivity between itraconazole and other azole antifungal agents. caution should be used when prescribing itraconazole to patients with hypersensitivity to other azoles.