Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

imtrade australia pty ltd - carfentrazone-ethyl; n-methyl-2-pyrrolidone; liquid hydrocarbon - emulsifiable concentrate - carfentrazone-ethyl ungrouped active 240.0 g/l; n-methyl-2-pyrrolidone solvent other 20.0 g/l; liquid hydrocarbon solvent other 685.0 g/l - herbicide

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

zentiva pharma uk ltd - itraconazole - oral capsule - 100mg

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

patriot pharmaceuticals, llc - itraconazole (unii: 304nug5gf4) (itraconazole - unii:304nug5gf4) - itraconazole oral solution is indicated for the treatment of oropharyngeal and esophageal candidiasis. (see clinical pharmacology: special populations, warnings, and adverse reactions: post-marketing experiencefor more information.) itraconazole oral solution should not be administered to patients with evidence of ventricular dysfunction such as congestive heart failure (chf) or a history of chf except for the treatment of life-threatening or other serious infections. (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 oral solution. plasma concentrations increase for the following drugs: levaceytlmethadol (levomethadyl), methadone, disopyramide, dofetilide, dronedarone, quinidine, isavuconazole, ergot alkaloids (such as dihydroergotamine, ergometrine (ergonovine), er

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

mawdsley-brooks & company ltd - itraconazole - oral capsule - 100mg

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

camber pharmaceuticals, inc. - itraconazole (unii: 304nug5gf4) (itraconazole - unii:304nug5gf4) - itraconazole oral solution is indicated for the treatment of oropharyngeal and esophageal candidiasis. (see clinical pharmacology: special populations, warnings, and adverse reactions: post-marketing experience for more information.) congestive heart failure: itraconazole oral solution should not be administered to patients with evidence of ventricular dysfunction such as congestive heart failure (chf) or a history of chf except for the treatment of life-threatening or other serious infections. (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. plasma concentrations increase for the following drugs: levaceytlmethadol (levomethadyl), met

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

oz crop pty ltd - carfentrazone-ethyl; n-methyl-2-pyrrolidone; liquid hydrocarbon - emulsifiable concentrate - carfentrazone-ethyl ungrouped active 240.0 g/l; n-methyl-2-pyrrolidone solvent other 20.0 g/l; liquid hydrocarbon solvent other 699.0 g/l - herbicide

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

eon labs, inc. - itraconazole (unii: 304nug5gf4) (itraconazole - unii:304nug5gf4) - itraconazole 100 mg

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

attix pharmaceuticals inc - itraconazole (unii: 304nug5gf4) (itraconazole - unii:304nug5gf4) - itraconazole 5 kg in 5 kg

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

avpak - itraconazole (unii: 304nug5gf4) (itraconazole - unii:304nug5gf4) - 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). 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 capsules, 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: co-administration of a number of cyp3a4 substrates are contraindicated with itraconazole. plasma concentrations increase for the following drugs: methadone, disopyramide, dofetilide, dronedarone, quinidine, ergot alkaloids (such as dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, lovastatin, simvastatin, ticagrelor, and, in subjects with varying degrees of renal or hepatic impairment, colchicine, fesoterodine, telithromycin and solifenacin (see precautions: drug interactions section for specific examples). this increase in drug concentrations caused by co-administration with itraconazole may increase or prolong both the pharmacologic effect 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 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)

vensun pharmaceuticals, 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: - 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