Ireland - English - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - voriconazole - film-coated tablet - 200 milligram(s) - triazole derivatives; voriconazole

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

arrotex pharmaceuticals pty ltd - voriconazole, quantity: 200 mg - tablet, film coated - excipient ingredients: lactose monohydrate; pregelatinised maize starch; maize starch; croscarmellose sodium; povidone; silicon dioxide; magnesium stearate; titanium dioxide; hypromellose; triacetin - voriconazole is indicated for treatment of the following fungal infections:invasive aspergillosis. serious candida infections (including c. krusei), including oesophageal and systemic candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia). serious fungal infections caused by scedosporium spp and fusarium spp. other serious fungal infections, in patients intolerant of, or refractory to, other therapy. prophylaxis in patients who are at high risk of developing invasive fungal infections. the indication is based on studies including patients undergoing haematopoietic stem cell transplantation.

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

vetoquinol usa, inc. - miconazole nitrate (unii: vw4h1cyw1k) (miconazole - unii:7nno0d7s5m), salicylic acid (unii: o414pz4lpz) (salicylic acid - unii:o414pz4lpz), chloroxylenol (unii: 0f32u78v2q) (chloroxylenol - unii:0f32u78v2q) - miconazole nitrate 20 mg in 1 ml - vetoquinol sebozole™ shampoo is uniquely formulated to provide antimicrobial, antifungal and antiseborrheic agents for optimal therapeutic effectiveness. indications for use: for dermatological conditions associated with infections responsive to miconazole nitrate, salicylic acid and chloroxylenol.

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

lupin pharmaceuticals,inc. - voriconazole (unii: jfu09i87tr) (voriconazole - unii:jfu09i87tr) - voriconazole 50 mg - voriconazole is indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (ia). in clinical trials, the majority of isolates recovered were aspergillus fumigatus . there was a small number of cases of culture-proven disease due to species of aspergillus other than a. fumigatus  [see clinical studies (14.1, 14.5) and microbiology (12.4)]. voriconazole is indicated in adults and pediatric patients (2 years of age and older) for the treatment of candidemia in non-neutropenic patients and the following candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds [see clinical studies (14.2, 14.5) and microbiology (12.4)]. voriconazole is indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (ec) in adults and pediatric patients (2 years of age and older) [see clinical studies (14.3, 14.5) and microbiology (12.4)]. voriconazole is indicated for the treatment of serious fungal infections caused by scedosporium apiospermum (asexual form of pseudallescheria boydii ) and fusarium spp . including fusarium solani , in adults and pediatric patients (2 years of age and older) intolerant of, or refractory to, other therapy [see clinical studies (14.4) and microbiology (12.4)] specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). therapy may be instituted before the results of the cultures and other laboratory studies are known. however, once these results become available, antifungal therapy should be adjusted accordingly. - voriconazole is contraindicated in patients with known hypersensitivity to voriconazole or its excipients. there is no information regarding cross-sensitivity between voriconazole and other azole antifungal agents. caution should be used when prescribing voriconazole to patients with hypersensitivity to other azoles. - coadministration of pimozide, quinidine or ivabradine with voriconazole is contraindicated because increased plasma concentrations of these drugs can lead to qt prolongation and rare occurrences of torsade de pointes [see drug interactions (7)] . - coadministration of voriconazole with sirolimus is contraindicated because voriconazole significantly increases sirolimus concentrations [see drug interactions (7) and clinical pharmacology (12.3)] . - coadministration of voriconazole with rifampin, carbamazepine, long-acting barbiturates, and st john's wort is contraindicated because these drugs are likely to decrease plasma voriconazole concentrations significantly [see drug interactions (7) and clinical pharmacology (12.3)] . coadministration of standard doses of voriconazole with efavirenz doses of 400 mg every 24 hours or higher is contraindicated, because efavirenz significantly decreases plasma voriconazole concentrations in healthy subjects at these doses. voriconazole also significantly increases efavirenz plasma concentrations [see drug interactions (7) and clinical pharmacology (12.3)] . - coadministration of standard doses of voriconazole with efavirenz doses of 400 mg every 24 hours or higher is contraindicated, because efavirenz significantly decreases plasma voriconazole concentrations in healthy subjects at these doses. voriconazole also significantly increases efavirenz plasma concentrations [see drug interactions (7) and clinical pharmacology (12.3)]. - coadministration of voriconazole with high dose ritonavir (400 mg every 12 hours) is contraindicated because ritonavir (400 mg every 12 hours) significantly decreases plasma voriconazole concentrations. coadministration of voriconazole and low-dose ritonavir (100 mg every 12 hours) should be avoided, unless an assessment of the benefit/risk to the patient justifies the use of voriconazole [see drug interactions (7) and clinical pharmacology (12.3)] . - coadministration of voriconazole with rifabutin is contraindicated since voriconazole significantly increases rifabutin plasma concentrations and rifabutin also significantly decreases voriconazole plasma concentrations [see drug interactions (7) and clinical pharmacology (12.3)]. - coadministration of voriconazole with ergot alkaloids (ergotamine and dihydroergotamine) is contraindicated because voriconazole may increase the plasma concentration of ergot alkaloids, which may lead to ergotism [see drug interactions (7)] . - coadministration of voriconazole with naloxegol is contraindicated because voriconazole may increase plasma concentrations of naloxegol which may precipitate opioid withdrawal symptoms [see drug interactions (7) and clinical pharmacology (12.3)] . - coadministration of voriconazole with tolvaptan is contraindicated because voriconazole may increase tolvaptan plasma concentrations and increase risk of adverse reactions [see drug interactions (7). - coadministration of voriconazole with venetoclax at initiation and during the ramp-up phase is contraindicated in patients with chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll) due to the potential for increased risk of tumor lysis syndrome [see drug interactions (7) ]. - coadministration of voriconazole with lurasidone is contraindicated since it may result in significant increases in lurasidone exposure and the potential for serious adverse reactions [see drug interactions (7)]. risk summary voriconazole can cause fetal harm when administered to a pregnant woman. there are no available data on the use of voriconazole in pregnant women. in animal reproduction studies, oral voriconazole was associated with fetal malformations in rats and fetal toxicity in rabbits. cleft palates and hydronephrosis/hydroureter were observed in rat pups exposed to voriconazole during organogenesis at and above 10 mg/kg (0.3 times the rmd of 200 mg every 12 hours based on body surface area comparisons). in rabbits, embryomortality, reduced fetal weight and increased incidence of skeletal variations, cervical ribs and extrasternal ossification sites were observed in pups when pregnant rabbits were orally dosed at 100 mg/kg (6 times the rmd based on body surface area comparisons) during organogenesis. rats exposed to voriconazole from implantation to weaning experienced increased gestational length and dystocia, which were associated with increased perinatal pup mortality at the 10 mg/kg dose [see data] . if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, inform the patient of the potential hazard to the fetus [see warnings and precautions (5.9)] . the 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 2-4% and 15-20% respectively. data animal data voriconazole was administered orally to pregnant rats during organogenesis (gestation days 6-17) at 10, 30, and 60 mg/kg/day. voriconazole was associated with increased incidences of the malformations hydroureter and hydronephrosis at 10 mg/kg/day or greater, approximately 0.3 times the recommended human dose (rmd) based on body surface area comparisions, and cleft palate at 60 mg/kg, approximately 2 times the rmd based on body surface area comparisions. reduced ossification of sacral and caudal vertebrae, skull, pubic, and hyoid bone, supernumerary ribs, anomalies of the sternebrae, and dilatation of the ureter/renal pelvis were also observed at doses of 10 mg/kg or greater. there was no evidence of maternal toxicity at any dose. voriconazole was administered orally to pregnant rabbits during the period of organogenesis (gestation days 7-19) at 10, 40, and 100 mg/kg/day. voriconazole was associated with increased post-implantation loss and decreased fetal body weight, in association with maternal toxicity (decreased body weight gain and food consumption) at 100 mg/kg/day (6 times the rmd based on body surface area comparisons). fetal skeletal variations (increases in the incidence of cervical rib and extra sternebral ossification sites) were observed at 100 mg/kg/day. in a peri- and postnatal toxicity study in rats, voriconazole was administered orally to female rats from implantation through the end of lactation at 1, 3, and 10 mg/kg/day. voriconazole prolonged the duration of gestation and labor and produced dystocia with related increases in maternal mortality and decreases in perinatal survival of f1 pups at 10 mg/kg/day, approximately 0.3 times the rmd. risk summary no data are available regarding the presence of voriconazole in human milk, the effects of voriconazole on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for voriconazole and any potential adverse effects on the breastfed child from voriconazole or from the underlying maternal condition. contraception advise females of reproductive potential to use effective contraception during treatment with voriconazole. the coadministration of voriconazole with the oral contraceptive, ortho-novum® (35 mcg ethinyl estradiol and 1 mg norethindrone), results in an interaction between these two drugs, but is unlikely to reduce the contraceptive effect. monitoring for adverse reactions associated with oral contraceptives and voriconazole is recommended [see drug interactions (7) and clinical pharmacology (12.3)] . the safety and effectiveness of voriconazole have been established in pediatric patients 2 years of age and older based on evidence from adequate and well-controlled studies in adult and pediatric patients and additional pediatric pharmacokinetic and safety data. a total of 105 pediatric patients aged 2 to less than 12 [n=26] and aged 12 to less than 18 [n=79] from two, non-comparative phase 3 pediatric studies and eight adult therapeutic trials provided safety information for voriconazole use in the pediatric population [see adverse reactions (6.1), clinical pharmacology(12.3), and clinical studies (14)]. safety and effectiveness in pediatric patients below the age of 2 years has not been established. therefore, voriconazole is not recommended for pediatric patients less than 2 years of age. a higher frequency of liver enzyme elevations was observed in the pediatric patients [see dosage and administration (2.5), warnings and precautions (5.1), and adverse reactions (6.1) ]. the frequency of phototoxicity reactions is higher in the pediatric population. squamous cell carcinoma has been reported in patients who experience photosensitivity reactions. stringent measures for photoprotection are warranted. sun avoidance and dermatologic follow-up are recommended in pediatric patients experiencing photoaging injuries, such as lentigines or ephelides, even after treatment discontinuation [see  warnings and precautions (5.6)] . voriconazole has not been studied in pediatric patients with hepatic or renal impairment [see  dosage and administration (2.5, 2.6) ]. hepatic function and serum creatinine levels should be closely monitored in pediatric patients [see dosage and administration (2.6) and warnings and precautions (5.1, 5.10) ]. in multiple dose therapeutic trials of voriconazole, 9.2% of patients were ≥65 years of age and 1.8% of patients were ≥75 years of age. in a study in healthy subjects, the systemic exposure (auc) and peak plasma concentrations (cmax) were increased in elderly males compared to young males. pharmacokinetic data obtained from 552 patients from 10 voriconazole therapeutic trials showed that voriconazole plasma concentrations in the elderly patients were approximately 80% to 90% higher than those in younger patients after either iv or oral administration. however, the overall safety profile of the elderly patients was similar to that of the young so no dosage adjustment is recommended [see clinical pharmacology (12.3) ].

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

novel laboratories, inc. - voriconazole (unii: jfu09i87tr) (voriconazole - unii:jfu09i87tr) - voriconazole 40 mg in 1 ml - voriconazole is indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (ia). in clinical trials, the majority of isolates recovered were aspergillus fumigatus . there was a small number of cases of culture-proven disease due to species of aspergillus other than a. fumigatus [see clinical studies (14.1, 14.5) and microbiology (12.4)] . voriconazole is indicated in adults and pediatric patients (2 years of age and older) for the treatment of candidemia in non-neutropenic patients and the following candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds [see clinical studies (14.2, 14.5) and microbiology (12.4)] . voriconazole is indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (ec) in adults and pediatric patients 2 years of age and older [see clinical studies (14.3, 14.5) and microbiology (12.4)] . voriconazole is indicated for the treatment of serious fungal infections caused by scedosporium apiospermum (asexual form of pseudallescheria boydii ) and fusarium spp. including fusarium solani , in adults and pediatric patients (2 years of age and older) intolerant of, or refractory to, other therapy [see clinical studies (14.4) and microbiology (12.4)] . specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). therapy may be instituted before the results of the cultures and other laboratory studies are known. however, once these results become available, antifungal therapy should be adjusted accordingly. - voriconazole is contraindicated in patients with known hypersensitivity to voriconazole or its excipients. there is no information regarding cross-sensitivity between voriconazole and other azole antifungal agents. caution should be used when prescribing voriconazole to patients with hypersensitivity to other azoles. - coadministration of pimozide, quinidine or ivabradine with voriconazole is contraindicated because increased plasma concentrations of these drugs can lead to qt prolongation and rare occurrences of torsade de pointes [see drug interactions (7)]. - coadministration of voriconazole with sirolimus is contraindicated because voriconazole significantly increases sirolimus concentrations [see drug interactions (7) and  clinical pharmacology (12.3)] . - coadministration of voriconazole with rifampin, carbamazepine, long-acting barbiturates, and st john's wort is contraindicated because these drugs are likely to decrease plasma voriconazole concentrations significantly [see drug interactions (7) and clinical pharmacology (12.3)]. - coadministration of standard doses of voriconazole with efavirenz doses of 400 mg every 24 hours or higher is contraindicated, because efavirenz significantly decreases plasma voriconazole concentrations in healthy subjects at these doses. voriconazole also significantly increases efavirenz plasma concentrations [see drug interactions (7) and clinical pharmacology (12.3)] . - coadministration of voriconazole with high-dose ritonavir (400 mg every 12 hours) is contraindicated because ritonavir (400 mg every 12 hours) significantly decreases plasma voriconazole concentrations. coadministration of voriconazole and low-dose ritonavir (100 mg every 12 hours) should be avoided, unless an assessment of the benefit/risk to the patient justifies the use of voriconazole [see drug interactions (7) and clinical pharmacology (12.3)] . - coadministration of voriconazole with rifabutin is contraindicated since voriconazole significantly increases rifabutin plasma concentrations and rifabutin also significantly decreases voriconazole plasma concentrations [see drug interactions (7) and clinical pharmacology (12.3)]. - coadministration of voriconazole with ergot alkaloids (ergotamine and dihydroergotamine) is contraindicated because voriconazole may increase the plasma concentration of ergot alkaloids, which may lead to ergotism [see drug interactions (7)] . - coadministration of voriconazole with naloxegol is contraindicated because voriconazole may increase plasma concentrations of naloxegol which may precipitate opioid withdrawal symptoms [see drug interactions (7)] . - coadministration of voriconazole with tolvaptan is contraindicated because voriconazole may increase tolvaptan plasma concentrations and increase risk of adverse reactions [see drug interactions (7)] . - coadministration of voriconazole with venetoclax at initiation and during the ramp-up phase is contraindicated in patients with chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll) due to the potential for increased risk of tumor lysis syndrome [see drug interactions (7)] . - coadministration of voriconazole with lurasidone is contraindicated since it may result in significant increases in lurasidone exposure and the potential for serious adverse reactions [see drug interactions (7)]. risk summary voriconazole can cause fetal harm when administered to a pregnant woman. there are no available data on the use of voriconazole in pregnant women. in animal reproduction studies, oral voriconazole was associated with fetal malformations in rats and fetal toxicity in rabbits. cleft palates and hydronephrosis/hydroureter were observed in rat pups exposed to voriconazole during organogenesis at and above 10 mg/kg (0.3 times the rmd of 200 mg every 12 hours based on body surface area comparisons). in rabbits, embryomortality, reduced fetal weight and increased incidence of skeletal variations, cervical ribs and extrasternal ossification sites were observed in pups when pregnant rabbits were orally dosed at 100 mg/kg (6 times the rmd based on body surface area comparisons) during organogenesis. rats exposed to voriconazole from implantation to weaning experienced increased gestational length and dystocia, which were associated with increased perinatal pup mortality at the 10 mg/kg dose [see data] . if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, inform the patient of the potential hazard to the fetus [see warnings and precautions (5.9)] . the 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 2-4% and 15-20% respectively. data animal data voriconazole was administered orally to pregnant rats during organogenesis (gestation days 6-17) at 10, 30, and 60 mg/kg/day. voriconazole was associated with increased incidences of the malformations hydroureter and hydronephrosis at 10 mg/kg/day or greater, approximately 0.3 times the recommended human dose (rmd) based on body surface area comparisons, and cleft palate at 60 mg/kg, approximately 2 times the rmd based on body surface area comparisons. reduced ossification of sacral and caudal vertebrae, skull, pubic, and hyoid bone, supernumerary ribs, anomalies of the sternebrae, and dilatation of the ureter/renal pelvis were also observed at doses of 10 mg/kg or greater. there was no evidence of maternal toxicity at any dose. voriconazole was administered orally to pregnant rabbits during the period of organogenesis (gestation days 7-19) at 10, 40, and 100 mg/kg/day. voriconazole was associated with increased post-implantation loss and decreased fetal body weight, in association with maternal toxicity (decreased body weight gain and food consumption) at 100 mg/kg/day (6 times the rmd based on body surface area comparisons). fetal skeletal variations (increases in the incidence of cervical rib and extra sternebral ossification sites) were observed at 100 mg/kg/day. in a peri- and postnatal toxicity study in rats, voriconazole was administered orally to female rats from implantation through the end of lactation at 1, 3, and 10 mg/kg/day. voriconazole prolonged the duration of gestation and labor and produced dystocia with related increases in maternal mortality and decreases in perinatal survival of f1 pups at 10 mg/kg/day, approximately 0.3 times the rmd. risk summary no data are available regarding the presence of voriconazole in human milk, the effects of voriconazole on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for voriconazole and any potential adverse effects on the breastfed child from voriconazole or from the underlying maternal condition. contraception advise females of reproductive potential to use effective contraception during treatment with voriconazole. the coadministration of voriconazole with the oral contraceptive, ortho-novum® (35 mcg ethinyl estradiol and 1 mg norethindrone), results in an interaction between these two drugs, but is unlikely to reduce the contraceptive effect. monitoring for adverse reactions associated with oral contraceptives and voriconazole is recommended [see drug interactions (7) and clinical pharmacology (12.3)] . the safety and effectiveness of voriconazole have been established in pediatric patients 2 years of age and older based on evidence from adequate and well-controlled studies in adult and pediatric patients and additional pediatric pharmacokinetic and safety data. a total of 105 pediatric patients aged 2 to less than 12 [n=26] and aged 12 to less than 18 [n=79] from two, non-comparative phase 3 pediatric studies and eight adult therapeutic trials provided safety information for voriconazole use in the pediatric population [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)] . safety and effectiveness in pediatric patients below the age of 2 years has not been established. therefore, voriconazole is not recommended for pediatric patients less than 2 years of age. a higher frequency of liver enzyme elevations was observed in the pediatric patients [see dosage and administration (2.5), warnings and precautions (5.1), and adverse reactions (6.1)] . the frequency of phototoxicity reactions is higher in the pediatric population. squamous cell carcinoma has been reported in patients who experience photosensitivity reactions. stringent measures for photoprotection are warranted. sun avoidance and dermatologic follow-up are recommended in pediatric patients experiencing photoaging injuries, such as lentigines or ephelides, even after treatment discontinuation [see warnings and precautions (5.6)]. voriconazole has not been studied in pediatric patients with hepatic or renal impairment [see dosage and administration (2.5, 2.6)] . hepatic function and serum creatinine levels should be closely monitored in pediatric patients [see dosage and administration (2.6) and warnings and precautions (5.1, (5.10)] . in multiple dose therapeutic trials of voriconazole, 9.2% of patients were ≥65 years of age and 1.8% of patients were ≥75 years of age. in a study in healthy subjects, the systemic exposure (auc) and peak plasma concentrations (cmax) were increased in elderly males compared to young males. pharmacokinetic data obtained from 552 patients from 10 voriconazole therapeutic trials showed that voriconazole plasma concentrations in the elderly patients were approximately 80% to 90% higher than those in younger patients after either iv or oral administration. however, the overall safety profile of the elderly patients was similar to that of the young so no dosage adjustment is recommended [see clinical pharmacology (12.3)].

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

lupin pharmaceuticals,inc. - voriconazole (unii: jfu09i87tr) (voriconazole - unii:jfu09i87tr) - voriconazole 40 mg in 1 ml - voriconazole is indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (ia). in clinical trials, the majority of isolates recovered were aspergillus fumigatus . there was a small number of cases of culture-proven disease due to species of aspergillus other than a. fumigatus [see clinical studies (14.1, 14.5) and microbiology (12.4)] . voriconazole is indicated in adults and pediatric patients (2 years of age and older) for the treatment of candidemia in non-neutropenic patients and the following candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds [see clinical studies (14.2, 14.5) and microbiology (12.4)] . voriconazole is indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (ec) in adults and pediatric patients 2 years of age and older [see clinical studies (14.3, 14.5) and microbiology (12.4)] . voriconazole is indicated for the treatment of serious fungal infections caused by scedosporium apiospermum (asexual form of pseudallescheria boydii ) and fusarium spp. including fusarium solani , in adults and pediatric patients (2 years of age and older) intolerant of, or refractory to, other therapy [see clinical studies (14.4) and microbiology (12.4)] . specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). therapy may be instituted before the results of the cultures and other laboratory studies are known. however, once these results become available, antifungal therapy should be adjusted accordingly. - voriconazole is contraindicated in patients with known hypersensitivity to voriconazole or its excipients. there is no information regarding cross-sensitivity between voriconazole and other azole antifungal agents. caution should be used when prescribing voriconazole to patients with hypersensitivity to other azoles. - coadministration of pimozide, quinidine or ivabradine with voriconazole is contraindicated because increased plasma concentrations of these drugs can lead to qt prolongation and rare occurrences of torsade de pointes [see drug interactions (7)]. - coadministration of voriconazole with sirolimus is contraindicated because voriconazole significantly increases sirolimus concentrations [see drug interactions (7) and  clinical pharmacology (12.3)] . - coadministration of voriconazole with rifampin, carbamazepine, long-acting barbiturates, and st john's wort is contraindicated because these drugs are likely to decrease plasma voriconazole concentrations significantly [see drug interactions (7) and clinical pharmacology (12.3)]. - coadministration of standard doses of voriconazole with efavirenz doses of 400 mg every 24 hours or higher is contraindicated, because efavirenz significantly decreases plasma voriconazole concentrations in healthy subjects at these doses. voriconazole also significantly increases efavirenz plasma concentrations [see drug interactions (7) and clinical pharmacology (12.3)] . - coadministration of voriconazole with high-dose ritonavir (400 mg every 12 hours) is contraindicated because ritonavir (400 mg every 12 hours) significantly decreases plasma voriconazole concentrations. coadministration of voriconazole and low-dose ritonavir (100 mg every 12 hours) should be avoided, unless an assessment of the benefit/risk to the patient justifies the use of voriconazole [see drug interactions (7) and clinical pharmacology (12.3)] . - coadministration of voriconazole with rifabutin is contraindicated since voriconazole significantly increases rifabutin plasma concentrations and rifabutin also significantly decreases voriconazole plasma concentrations [see drug interactions (7) and clinical pharmacology (12.3)]. - coadministration of voriconazole with ergot alkaloids (ergotamine and dihydroergotamine) is contraindicated because voriconazole may increase the plasma concentration of ergot alkaloids, which may lead to ergotism [see drug interactions (7)] . - coadministration of voriconazole with naloxegol is contraindicated because voriconazole may increase plasma concentrations of naloxegol which may precipitate opioid withdrawal symptoms [see drug interactions (7)] . - coadministration of voriconazole with tolvaptan is contraindicated because voriconazole may increase tolvaptan plasma concentrations and increase risk of adverse reactions [see drug interactions (7)] . - coadministration of voriconazole with venetoclax at initiation and during the ramp-up phase is contraindicated in patients with chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll) due to the potential for increased risk of tumor lysis syndrome [see drug interactions (7)] . - coadministration of voriconazole with lurasidone is contraindicated since it may result in significant increases in lurasidone exposure and the potential for serious adverse reactions [see drug interactions (7)]. risk summary voriconazole can cause fetal harm when administered to a pregnant woman. there are no available data on the use of voriconazole in pregnant women. in animal reproduction studies, oral voriconazole was associated with fetal malformations in rats and fetal toxicity in rabbits. cleft palates and hydronephrosis/hydroureter were observed in rat pups exposed to voriconazole during organogenesis at and above 10 mg/kg (0.3 times the rmd of 200 mg every 12 hours based on body surface area comparisons). in rabbits, embryomortality, reduced fetal weight and increased incidence of skeletal variations, cervical ribs and extrasternal ossification sites were observed in pups when pregnant rabbits were orally dosed at 100 mg/kg (6 times the rmd based on body surface area comparisons) during organogenesis. rats exposed to voriconazole from implantation to weaning experienced increased gestational length and dystocia, which were associated with increased perinatal pup mortality at the 10 mg/kg dose [see data] . if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, inform the patient of the potential hazard to the fetus [see warnings and precautions (5.9)] . the 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 2-4% and 15-20% respectively. data animal data voriconazole was administered orally to pregnant rats during organogenesis (gestation days 6-17) at 10, 30, and 60 mg/kg/day. voriconazole was associated with increased incidences of the malformations hydroureter and hydronephrosis at 10 mg/kg/day or greater, approximately 0.3 times the recommended human dose (rmd) based on body surface area comparisons, and cleft palate at 60 mg/kg, approximately 2 times the rmd based on body surface area comparisons. reduced ossification of sacral and caudal vertebrae, skull, pubic, and hyoid bone, supernumerary ribs, anomalies of the sternebrae, and dilatation of the ureter/renal pelvis were also observed at doses of 10 mg/kg or greater. there was no evidence of maternal toxicity at any dose. voriconazole was administered orally to pregnant rabbits during the period of organogenesis (gestation days 7-19) at 10, 40, and 100 mg/kg/day. voriconazole was associated with increased post-implantation loss and decreased fetal body weight, in association with maternal toxicity (decreased body weight gain and food consumption) at 100 mg/kg/day (6 times the rmd based on body surface area comparisons). fetal skeletal variations (increases in the incidence of cervical rib and extra sternebral ossification sites) were observed at 100 mg/kg/day. in a peri- and postnatal toxicity study in rats, voriconazole was administered orally to female rats from implantation through the end of lactation at 1, 3, and 10 mg/kg/day. voriconazole prolonged the duration of gestation and labor and produced dystocia with related increases in maternal mortality and decreases in perinatal survival of f1 pups at 10 mg/kg/day, approximately 0.3 times the rmd. risk summary no data are available regarding the presence of voriconazole in human milk, the effects of voriconazole on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for voriconazole and any potential adverse effects on the breastfed child from voriconazole or from the underlying maternal condition. contraception advise females of reproductive potential to use effective contraception during treatment with voriconazole. the coadministration of voriconazole with the oral contraceptive, ortho-novum® (35 mcg ethinyl estradiol and 1 mg norethindrone), results in an interaction between these two drugs, but is unlikely to reduce the contraceptive effect. monitoring for adverse reactions associated with oral contraceptives and voriconazole is recommended [see drug interactions (7) and clinical pharmacology (12.3)] . the safety and effectiveness of voriconazole have been established in pediatric patients 2 years of age and older based on evidence from adequate and well-controlled studies in adult and pediatric patients and additional pediatric pharmacokinetic and safety data. a total of 105 pediatric patients aged 2 to less than 12 [n=26] and aged 12 to less than 18 [n=79] from two, non-comparative phase 3 pediatric studies and eight adult therapeutic trials provided safety information for voriconazole use in the pediatric population [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)] . safety and effectiveness in pediatric patients below the age of 2 years has not been established. therefore, voriconazole is not recommended for pediatric patients less than 2 years of age. a higher frequency of liver enzyme elevations was observed in the pediatric patients [see dosage and administration (2.5), warnings and precautions (5.1), and adverse reactions (6.1)] . the frequency of phototoxicity reactions is higher in the pediatric population. squamous cell carcinoma has been reported in patients who experience photosensitivity reactions. stringent measures for photoprotection are warranted. sun avoidance and dermatologic follow-up are recommended in pediatric patients experiencing photoaging injuries, such as lentigines or ephelides, even after treatment discontinuation [see warnings and precautions (5.6)]. voriconazole has not been studied in pediatric patients with hepatic or renal impairment [see dosage and administration (2.5, 2.6)] . hepatic function and serum creatinine levels should be closely monitored in pediatric patients [see dosage and administration (2.6) and warnings and precautions (5.1, (5.10)] . in multiple dose therapeutic trials of voriconazole, 9.2% of patients were ≥65 years of age and 1.8% of patients were ≥75 years of age. in a study in healthy subjects, the systemic exposure (auc) and peak plasma concentrations (cmax) were increased in elderly males compared to young males. pharmacokinetic data obtained from 552 patients from 10 voriconazole therapeutic trials showed that voriconazole plasma concentrations in the elderly patients were approximately 80% to 90% higher than those in younger patients after either iv or oral administration. however, the overall safety profile of the elderly patients was similar to that of the young so no dosage adjustment is recommended [see clinical pharmacology (12.3)].

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

amneal pharmaceuticals llc - voriconazole (unii: jfu09i87tr) (voriconazole - unii:jfu09i87tr) - voriconazole 40 mg in 1 ml - voriconazole for oral suspension is indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (ia). in clinical trials, the majority of isolates recovered were aspergillus fumigatus . there was a small number of cases of culture-proven disease due to species of aspergillus other than a. fumigatus [see clinical studies (14.1, 14.5) and microbiology (12.4)] . voriconazole for oral suspension is indicated in adults and pediatric patients (2 years of age and older) for the treatment of candidemia in non-neutropenic patients and the following candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds [see clinical studies (14.2, 14.5) and microbiology (12.4)]. voriconazole for oral suspension is indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (ec) in adults and pediatric patients 2 years of age and older [see clinical studies (14.3, 14.5) and microbiology (12.4)]. voriconazole for oral suspension is indicated for the treatment of serious fungal infections caused by scedosporium apiospermum (asexual form of pseudallescheria boydii ) and fusarium spp. including fusarium solani , in adults and pediatric patients (2 years of age and older) intolerant of, or refractory to, other therapy [see clinical studies (14.4) and microbiology (12.4)]. specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). therapy may be instituted before the results of the cultures and other laboratory studies are known. however, once these results become available, antifungal therapy should be adjusted accordingly. - voriconazole for oral suspension is contraindicated in patients with known hypersensitivity to voriconazole or its excipients. there is no information regarding cross-sensitivity between voriconazole and other azole antifungal agents. caution should be used when prescribing voriconazole to patients with hypersensitivity to other azoles. - co-administration of pimozide, quinidine or ivabradine with voriconazole is contraindicated because increased plasma concentrations of these drugs can lead to qt prolongation and rare occurrences of torsade de pointes [see drug interactions (7) ] . - co-administration of voriconazole with sirolimus is contraindicated because voriconazole significantly increases sirolimus concentrations [see drug interactions (7) and clinical pharmacology (12.3)] . - co-administration of voriconazole with rifampin, carbamazepine, long-acting barbiturates, and st john’s wort is contraindicated because these drugs are likely to decrease plasma voriconazole concentrations significantly [see drug interactions (7) and clinical pharmacology (12.3) ] . - co-administration of standard doses of voriconazole with efavirenz doses of 400 mg every 24 hours or higher is contraindicated, because efavirenz significantly decreases plasma voriconazole concentrations in healthy subjects at these doses. voriconazole also significantly increases efavirenz plasma concentrations [see drug interactions (7) and clinical pharmacology (12.3) ] . - co-administration of voriconazole with high-dose ritonavir (400 mg every 12 hours) is contraindicated because ritonavir (400 mg every 12 hours) significantly decreases plasma voriconazole concentrations. co-administration of voriconazole and low-dose ritonavir (100 mg every 12 hours) should be avoided, unless an assessment of the benefit/risk to the patient justifies the use of voriconazole [see drug interactions (7) and clinical pharmacology (12.3)] . - co-administration of voriconazole with rifabutin is contraindicated since voriconazole significantly increases rifabutin plasma concentrations and rifabutin also significantly decreases voriconazole plasma concentrations [see drug interactions (7) and clinical pharmacology (12.3)] . - co-administration of voriconazole with ergot alkaloids (ergotamine and dihydroergotamine) is contraindicated because voriconazole may increase the plasma concentration of ergot alkaloids, which may lead to ergotism [see drug interactions (7) ] . - co-administration of voriconazole with naloxegol is contraindicated because voriconazole may increase plasma concentrations of naloxegol which may precipitate opioid withdrawal symptoms [see drug interactions (7) ] . - co-administration of voriconazole with tolvaptan is contraindicated because voriconazole may increase tolvaptan plasma concentrations and increase risk of adverse reactions [see drug interactions (7) ] . - co-administration of voriconazole with venetoclax at initiation and during the ramp-up phase is contraindicated in patients with chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll) due to the potential for increased risk of tumor lysis syndrome [see drug interactions (7)] . - co-administration of voriconazole with lurasidone is contraindicated since it may result in significant increases in lurasidone exposure and the potential for serious adverse reactions [see drug interactions (7)] . risk summary voriconazole can cause fetal harm when administered to a pregnant woman. there are no available data on the use of voriconazole in pregnant women. in animal reproduction studies, oral voriconazole was associated with fetal malformations in rats and fetal toxicity in rabbits. cleft palates and hydronephrosis/hydroureter were observed in rat pups exposed to voriconazole during organogenesis at and above 10 mg/kg (0.3 times the rmd of 200 mg every 12 hours based on body surface area comparisons). in rabbits, embryomortality, reduced fetal weight and increased incidence of skeletal variations, cervical ribs and extrasternal ossification sites were observed in pups when pregnant rabbits were orally dosed at 100 mg/kg (6 times the rmd based on body surface area comparisons) during organogenesis. rats exposed to voriconazole from implantation to weaning experienced increased gestational length and dystocia, which were associated with increased perinatal pup mortality at the 10 mg/kg dose [see data] . if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, inform the patient of the potential hazard to the fetus [see warnings and precautions (5.9) ] . the 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 animal data voriconazole was administered orally to pregnant rats during organogenesis (gestation days 6 to 17) at 10, 30, and 60 mg/kg/day. voriconazole was associated with increased incidences of the malformations hydroureter and hydronephrosis at 10 mg/kg/day or greater, approximately 0.3 times the recommended human dose (rmd) based on body surface area comparisons, and cleft palate at 60 mg/kg, approximately 2 times the rmd based on body surface area comparisons. reduced ossification of sacral and caudal vertebrae, skull, pubic, and hyoid bone, supernumerary ribs, anomalies of the sternebrae, and dilatation of the ureter/renal pelvis were also observed at doses of 10 mg/kg or greater. there was no evidence of maternal toxicity at any dose. voriconazole was administered orally to pregnant rabbits during the period of organogenesis (gestation days 7 to 19) at 10, 40, and 100 mg/kg/day. voriconazole was associated with increased post-implantation loss and decreased fetal body weight, in association with maternal toxicity (decreased body weight gain and food consumption) at 100 mg/kg/day (6 times the rmd based on body surface area comparisons). fetal skeletal variations (increases in the incidence of cervical rib and extra sternebral ossification sites) were observed at 100 mg/kg/day. in a peri- and postnatal toxicity study in rats, voriconazole was administered orally to female rats from implantation through the end of lactation at 1, 3, and 10 mg/kg/day. voriconazole prolonged the duration of gestation and labor and produced dystocia with related increases in maternal mortality and decreases in perinatal survival of f1 pups at 10 mg/kg/day, approximately 0.3 times the rmd. risk summary no data are available regarding the presence of voriconazole in human milk, the effects of voriconazole on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for voriconazole and any potential adverse effects on the breastfed child from voriconazole or from the underlying maternal condition. contraception advise females of reproductive potential to use effective contraception during treatment with voriconazole. the co-administration of voriconazole with the oral contraceptive, ortho-novum® (35 mcg ethinyl estradiol and 1 mg norethindrone), results in an interaction between these two drugs, but is unlikely to reduce the contraceptive effect. monitoring for adverse reactions associated with oral contraceptives and voriconazole is recommended [see drug interactions (7) and clinical pharmacology (12.3)] . the safety and effectiveness of voriconazole have been established in pediatric patients 2 years of age and older based on evidence from adequate and well-controlled studies in adult and pediatric patients and additional pediatric pharmacokinetic and safety data. a total of 105 pediatric patients aged 2 to less than 12 [n=26] and aged 12 to less than 18 [n=79] from two, non-comparative phase 3 pediatric studies and eight adult therapeutic trials provided safety information for voriconazole use in the pediatric population [see adverse reactions (6.1) , clinical pharmacology (12.3), and clinical studies (14)] . safety and effectiveness in pediatric patients below the age of 2 years has not been established. therefore, voriconazole is not recommended for pediatric patients less than 2 years of age. a higher frequency of liver enzyme elevations was observed in the pediatric patients [see dosage and administration (2.5), warnings and precautions (5.1), and adverse reactions (6.1)] . the frequency of phototoxicity reactions is higher in the pediatric population. squamous cell carcinoma has been reported in patients who experience photosensitivity reactions. stringent measures for photoprotection are warranted. sun avoidance and dermatologic follow-up are recommended in pediatric patients experiencing photoaging injuries, such as lentigines or ephelides, even after treatment discontinuation [see warnings and precautions (5.6)]. voriconazole has not been studied in pediatric patients with hepatic or renal impairment [see dosage and administration (2.5, 2.6)] . hepatic function and serum creatinine levels should be closely monitored in pediatric patients [see dosage and administration (2.6) and warnings and precautions (5.1, 5.10)] . in multiple dose therapeutic trials of voriconazole, 9.2% of patients were ≥ 65 years of age and 1.8% of patients were ≥ 75 years of age. in a study in healthy subjects, the systemic exposure (auc) and peak plasma concentrations (cmax ) were increased in elderly males compared to young males. pharmacokinetic data obtained from 552 patients from 10 voriconazole therapeutic trials showed that voriconazole plasma concentrations in the elderly patients were approximately 80% to 90% higher than those in younger patients after either iv or oral administration. however, the overall safety profile of the elderly patients was similar to that of the young so no dosage adjustment is recommended [see clinical pharmacology (12.3)] . voriconazole (vor” i kon’ a zole) for oral suspension, 40 mg/ml read this instructions for use before you start taking voriconazole for oral suspension and each time you get a refill. there may be new information. this information does not take the place of talking with your healthcare provider about your medical condition or treatment. important information: - follow your healthcare provider’s instructions for the dose of voriconazole for oral suspension to take. - ask your healthcare provider or pharmacist if you are not sure how to take voriconazole for oral suspension. - voriconazole for oral suspension is a liquid form of voriconazole. your pharmacist will mix (reconstitute) the medicine before it is dispensed to you. if voriconazole for oral suspension is still in powder form, do not use it. return it to your pharmacist. - always use the oral dispenser provided with voriconazole for oral suspension to make sure you measure the right amount of voriconazole oral suspension. - shake the closed bottle of mixed (reconstituted) oral suspension well for about 10 seconds before each use. each pack contains: how to prepare the bottle and take voriconazole for oral suspension: 1 remove the child-resistant bottle cap by pushing down while twisting the cap to the left (counter-clockwise). 2 push the bottle adapter firmly into the bottle (if your pharmacist has not already inserted the bottle adapter). if the bottle adapter is missing, contact your pharmacist. do not remove the bottle adapter after it is inserted. 3 important: bottle adapter must be fully inserted before use. 4 pull back on the oral dispenser plunger to your prescribed dose. 5 insert the tip of the oral dispenser into the bottle adapter. 6 while holding the bottle with 1 hand, push down on the oral dispenser plunger with your other hand to push air into the bottle. 7 turn the bottle upside down and slowly pull back on the oral dispenser plunger to withdraw your prescribed dose of medicine. 8 turn the bottle back upright with the oral dispenser still in place. remove the tip of the oral dispenser from the bottle adapter. place the tip of the oral dispenser in your mouth and point the tip of the oral dispenser towards the inside of the cheek. slowly push the plunger until all the medicine is given. do not squirt the medicine out quickly. this may cause you to choke. if the medicine is to be given to a child, keep your child in an upright position while giving the medicine. 9 screw the bottle cap back on the bottle tightly by turning the cap to the right (clockwise). do not remove the bottle adapter. the bottle cap will fit over it. rinse the oral dispenser after each use. - pull the plunger out of the oral dispenser and wash both parts with warm soapy water. - rinse both parts with water and allow to air dry after each use. - after air drying, push the plunger back into the oral dispenser. - store the oral dispenser with voriconazole for oral suspension in a clean safe place. how should i store voriconazole for oral suspension? - store voriconazole for oral suspension at room temperature between 20° to 25°c (68° to 77°f); excursions permitted between 15° to 30°c (59° to 86°f). - do not refrigerate or freeze. - keep the bottle cap tightly closed. - use voriconazole for oral suspension within 14 days after it has been mixed (reconstituted) by the pharmacist. the pharmacist will write the expiration date on the bottle label (the expiration date of the oral suspension is 14 days from the date it was mixed (reconstituted) by the pharmacist). throw away (discard) any unused voriconazole for oral suspension after the expiration date. - keep voriconazole for oral suspension and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. this product’s labeling may have been updated. for the most recent prescribing information, please visit www.amneal.com or call 1-877-835-5472. distributed by: amneal pharmaceuticals llc bridgewater, nj 08807 rev. 02-2021-05

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - voriconazole - powder for solution for infusion - 200 milligram(s) - triazole derivatives; voriconazole

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - voriconazole - powder for solution for infusion - 200 milligram(s) - triazole derivatives; voriconazole

Ireland - English - HPRA (Health Products Regulatory Authority)

instituto biochimico italiano g. lorenzini s.p.a. - voriconazole - powder for solution for infusion - 200 milligram(s) - triazole derivatives; voriconazole