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

arrotex pharmaceuticals pty ltd - fluconazole, quantity: 200 mg - capsule, hard - excipient ingredients: magnesium stearate; erythrosine; pregelatinised maize starch; colloidal anhydrous silica; lactose monohydrate; purified talc; sodium lauryl sulfate; purified water; gelatin; titanium dioxide; brilliant blue fcf - fluconazole, given orally, is indicated for treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin b. note. data suggest that the clinical efficacy of fluconazole is lower than that of amphotericin b in the treatment of the acute phase of cryptococcal meningitis. maintenance therapy to prevent relapse of cryptococcal meningitis in patients with aquired immune deficiency syndrome (aids). treatment of oropharyngeal and oesophageal candidiasis in aids and other immunosuppressed patients. secondary prophylaxis of oropharyngeal candidiasis in patients with human immunodeficiency virus (hiv) infection. serious and life-threatening candida infections in patients who are unable to tolerate amphotericin b. note. it remains to be shown that fluconazole is as effective as amphotericin b in the treatment of serious and life threatening candida infections. until such data are available, amphotericin b remains the drug of choice. vaginal candidiasis, when topical therapy has failed. treatment of extensive tinea corporis, extensive tinea cruris and extensive tinea pedis infections in immunocompetent patients in whom topical therapy is not a practical treatment option. usually, topical therapy should be attempted first because oral therapy has a less favourable ratio of benefits to risks

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

arrotex pharmaceuticals pty ltd - fluconazole, quantity: 150 mg - capsule, hard - excipient ingredients: brilliant blue fcf; pregelatinised maize starch; gelatin; colloidal anhydrous silica; magnesium stearate; sodium lauryl sulfate; purified talc; lactose monohydrate; purified water; titanium dioxide - fluconazole, given orally, is indicated for treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin b. note. data suggest that the clinical efficacy of fluconazole is lower than that of amphotericin b in the treatment of the acute phase of cryptococcal meningitis. maintenance therapy to prevent relapse of cryptococcal meningitis in patients with aquired immune deficiency syndrome (aids). treatment of oropharyngeal and oesophageal candidiasis in aids and other immunosuppressed patients. secondary prophylaxis of oropharyngeal candidiasis in patients with human immunodeficiency virus (hiv) infection. serious and life-threatening candida infections in patients who are unable to tolerate amphotericin b. note. it remains to be shown that fluconazole is as effective as amphotericin b in the treatment of serious and life threatening candida infections. until such data are available, amphotericin b remains the drug of choice. vaginal candidiasis, when topical therapy has failed. treatment of extensive tinea corporis, extensive tinea cruris and extensive tinea pedis infections in immunocompetent patients in whom topical therapy is not a practical treatment option. usually, topical therapy should be attempted first because oral therapy has a less favourable ratio of benefits to risks

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

arrotex pharmaceuticals pty ltd - fluconazole, quantity: 50 mg - capsule, hard - excipient ingredients: purified talc; magnesium stearate; pregelatinised maize starch; colloidal anhydrous silica; erythrosine; titanium dioxide; lactose monohydrate; brilliant blue fcf; purified water; sodium lauryl sulfate; gelatin - fluconazole, given orally, is indicated for treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin b. note. data suggest that the clinical efficacy of fluconazole is lower than that of amphotericin b in the treatment of the acute phase of cryptococcal meningitis. maintenance therapy to prevent relapse of cryptococcal meningitis in patients with aquired immune deficiency syndrome (aids). treatment of oropharyngeal and oesophageal candidiasis in aids and other immunosuppressed patients. secondary prophylaxis of oropharyngeal candidiasis in patients with human immunodeficiency virus (hiv) infection. serious and life-threatening candida infections in patients who are unable to tolerate amphotericin b. note. it remains to be shown that fluconazole is as effective as amphotericin b in the treatment of serious and life threatening candida infections. until such data are available, amphotericin b remains the drug of choice. vaginal candidiasis, when topical therapy has failed. treatment of extensive tinea corporis, extensive tinea cruris and extensive tinea pedis infections in immunocompetent patients in whom topical therapy is not a practical treatment option. usually, topical therapy should be attempted first because oral therapy has a less favourable ratio of benefits to risks.

USA - engelsk - NLM (National Library of Medicine)

stat rx usa llc - fluconazole (unii: 8vzv102jfy) (fluconazole - unii:8vzv102jfy) - fluconazole is indicated for the treatment of: - vaginal candidiasis (vaginal yeast infections due to candida ). - oropharyngeal and esophageal candidiasis. in open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of candida urinary tract infections, peritonitis, and systemic candida infections including candidemia, disseminated candidiasis, and pneumonia. - cryptococcal meningitis. before prescribing fluconazole for aids patients with cryptococcal meningitis, please see clinical studies section. studies comparing fluconazole to amphotericin b in non-hiv infected patients have not been conducted. prophylaxis. fluconazole is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify

USA - engelsk - NLM (National Library of Medicine)

blenheim pharmacal, inc. - fluconazole (unii: 8vzv102jfy) (fluconazole - unii:8vzv102jfy) - fluconazole tablets usp are indicated for the treatment of: - vaginal candidiasis (vaginal yeast infections due to candida ). - oropharyngeal and esophageal candidiasis. in open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of candida urinary tract infections, peritonitis, and systemic candida infections including candidemia, disseminated candidiasis, and pneumonia. - cryptococcal meningitis. before prescribing fluconazole tablets usp for aids patients with cryptococcal meningitis, please see clinical studies section. studies comparing fluconazole to amphotericin b in non-hiv infected patients have not been conducted. prophylaxis. fluconazole tablets usp are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. specimens for fungal culture and other relevant laborat

USA - engelsk - NLM (National Library of Medicine)

direct rx - fluconazole (unii: 8vzv102jfy) (fluconazole - unii:8vzv102jfy) - fluconazole tablets usp are indicated for the treatment of: 1. vaginal candidiasis (vaginal yeast infections due to candida). 2. oropharyngeal and esophageal candidiasis. in open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of candida urinary tract infections, peritonitis, and systemic candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. cryptococcal meningitis. before prescribing fluconazole tablets usp for aids patients with cryptococcal meningitis, please see clinical studies section. studies comparing fluconazole to amphotericin b in non-hiv infected patients have not been conducted. prophylaxis. fluconazole tablets usp are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. specimens for fungal culture and other relevant laboratory studies (serology, histopathology) s

USA - engelsk - NLM (National Library of Medicine)

drug ocean llc - fluconazole (unii: 8vzv102jfy) (fluconazole - unii:8vzv102jfy) - fluconazole tablets are indicated for the treatment of: - vaginal candidiasis (vaginal yeast infections due to candida ).  - oropharyngeal and esophageal candidiasis. in open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of candida urinary tract infections, peritonitis, and systemic candida infections including candidemia, disseminated candidiasis, and pneumonia.  - cryptococcal meningitis. before prescribing fluconazole tablets for aids patients with cryptococcal meningitis, please see clinical studies section. studies comparing fluconazole to amphotericin b in non-hiv infected patients have not been conducted. prophylaxis: fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to 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-infective therapy should be adjusted accordingly. fluconazole tablets usp are contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients. there is no information regarding cross-hypersensitivity between fluconazole and other azole antifungal agents. caution should be used in prescribing fluconazole tablets to patients with hypersensitivity to other azoles. coadministration of other drugs known to prolong the qt interval and which are metabolized via the enzyme cyp3a4 such as erythromycin, pimozide, and quinidine are contraindicated in patients receiving fluconazole (see clinical pharmacology: drug interaction studies and precautions .) an open-label, randomized, controlled trial has shown fluconazole to be effective in the treatment of oropharyngeal candidiasis in children 6 months to 13 years of age. (see clinical studies .) the use of fluconazole in children with cryptococcal meningitis, candida esophagitis, or systemic candida infections is supported by the efficacy shown for these indications in adults and by the results from several small noncomparative pediatric clinical studies. in addition, pharmacokinetic studies in children (see clinical pharmacology ) have established a dose proportionality between children and adults. (see dosage and administration .) in a noncomparative study of children with serious systemic fungal infections, most of which were candidemia, the effectiveness of fluconazole was similar to that reported for the treatment of candidemia in adults. of 17 subjects with culture-confirmed candidemia, 11 of 14 (79%) with baseline symptoms (3 were asymptomatic) had a clinical cure; 13/15 (87%) of evaluable patients had a mycologic cure at the end of treatment but two of these patients relapsed at 10 and 18 days, respectively, following cessation of therapy. the efficacy of fluconazole for the suppression of cryptococcal meningitis was successful in 4 of 5 children treated in a compassionate-use study of fluconazole for the treatment of life-threatening or serious mycosis. there is no information regarding the efficacy of fluconazole for primary treatment of cryptococcal meningitis in children. the safety profile of fluconazole in children has been studied in 577 children ages 1 day to 17 years who received doses ranging from 1 to 15 mg/kg/day for 1 to 1,616 days. (see adverse reactions .) efficacy of fluconazole has not been established in infants less than 6 months of age. (see clinical pharmacology .) a small number of patients (29) ranging in age from 1 day to 6 months have been treated safely with fluconazole. in non-aids patients, side effects possibly related to fluconazole treatment were reported in fewer patients aged 65 and older (9%, n=339) than for younger patients (14%, n=2240). however, there was no consistent difference between the older and younger patients with respect to individual side effects. of the most frequently reported (>1%) side effects, rash, vomiting, and diarrhea occurred in greater proportions of older patients. similar proportions of older patients (2.4%) and younger patients (1.5%) discontinued fluconazole therapy because of side effects. in post-marketing experience, spontaneous reports of anemia and acute renal failure were more frequent among patients 65 years of age or older than in those between 12 and 65 years of age. because of the voluntary nature of the reports and the natural increase in the incidence of anemia and renal failure in the elderly, it is however not possible to establish a causal relationship to drug exposure. controlled clinical trials of fluconazole did not include sufficient numbers of patients aged 65 and older to evaluate whether they respond differently from younger patients in each indication. other reported clinical experience has not identified differences in responses between the elderly and younger patients. fluconazole is primarily cleared by renal excretion as unchanged drug. because elderly patients are more likely to have decreased renal function, care should be taken to adjust dose based on creatinine clearance. it may be useful to monitor renal function. (see clinical pharmacology and dosage and administration .)

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

symbion pty ltd - clotrimazole,fluconazole -

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

bayer new zealand limited - fluconazole 150mg - capsule - 150 mg - active: fluconazole 150mg excipient: colloidal silicon dioxide gelatin lactose monohydrate magnesium stearate maize starch opacode black s-1-17823 sodium laurilsulfate titanium dioxide water - canesten fluconazole capsule, given orally, is indicated for vaginal candidiasis.

Canada - engelsk - Health Canada

taro pharmaceuticals inc - clotrimazole - cream - 1% - clotrimazole 1% - azoles