कनाडा - अंग्रेज़ी - Health Canada

accord healthcare inc - oseltamivir (oseltamivir phosphate) - capsule - 45mg - oseltamivir (oseltamivir phosphate) 45mg

कनाडा - अंग्रेज़ी - Health Canada

accord healthcare inc - oseltamivir (oseltamivir phosphate) - capsule - 75mg - oseltamivir (oseltamivir phosphate) 75mg

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

cadila healthcare limited - oseltamivir phosphate (unii: 4a3o49ngez) (oseltamivir acid - unii:k6106lv5q8) -

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

ax pharmaceutical corp - oseltamivir phosphate (unii: 4a3o49ngez) (oseltamivir phosphate - unii:4a3o49ngez) - oseltamivir phosphate 24.75 g in 25 g

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

proficient rx lp - oseltamivir phosphate (unii: 4a3o49ngez) (oseltamivir acid - unii:k6106lv5q8) - oseltamivir phosphate capsules are indicated for the treatment of acute, uncomplicated illness due to influenza a and b infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. oseltamivir phosphate capsules are indicated for the prophylaxis of influenza a and b in patients 1 year and older. • oseltamivir phosphate capsules are not a substitute for early influenza vaccination on an annual basis as recommended by the centers for disease control and prevention advisory committee on immunization practices. • influenza viruses change over time. emergence of resistance substitutions could decrease drug effectiveness. other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use oseltamivir phosphate capsules [see microbiology ( error! hyperlink reference not valid. • oseltamivir phosphate capsules are not recommended for patients with end-stage renal disease not undergoing dialysis [see dosage and administration (2.4) and use in specific populations (8.6)]. oseltamivir phosphate capsules are contraindicated in patients with known serious hypersensitivity to oseltamivir or any component of the product. severe allergic reactions have included anaphylaxis and serious skin reactions including toxic epidermal necrolysis, stevens-johnson syndrome, and erythema multiforme [see warnings and precautions (5.1)]. pregnancy category c risk summary there are no adequate and well-controlled studies with oseltamivir phosphate in pregnant women. available published epidemiological data suggest that oseltamivir phosphate, taken in any trimester, is not associated with an increased risk of birth defects. however, these studies individually are limited by small sample sizes, use of different comparison groups, and some lacked information on dose, which preclude a definitive assessment of the risk. in animal studies, there was a dose-dependent increase in the incidence rates of a variety of minor skeletal abnormalities and variants in offspring of rats and rabbits exposed at maternally toxic doses 100 and 50 times human exposures, respectively. oseltamivir phosphate capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus [see clinical pharmacology (12.3)]. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnant women are at higher risk of severe complications from influenza, which may lead to adverse pregnancy and/or fetal outcomes including maternal death, still births, birth defects, preterm delivery, low birth weight and small for gestational age. data human data published prospective and retrospective observational studies of approximately 1,500 women exposed to oseltamivir phosphate during pregnancy, including approximately 400 women exposed in the first trimester, suggest that the observed rate of congenital malformations was not increased above the rate in the general comparison population, regardless of when therapy was administered during the gestational period. however, individually, none of these studies had adequate sample sizes and some lacked information on dose, which preclude a definitive assessment of the risk. animal data studies for effects on embryo-fetal development were conducted in rats (50, 250, and 1500 mg/kg/day) and rabbits (50, 150, and 500 mg/kg/day) by the oral route. relative exposures at these doses were, respectively, 2, 13, and 100 times human exposure in the rat and 4, 8, and 50 times human exposure in the rabbit, based on auc. pharmacokinetic studies indicated that there was fetal exposure in both species. in the rat study, minimal maternal toxicity was reported in the 1500 mg/kg/day group. in the rabbit study, slight and marked maternal toxicities were observed, respectively, in the 150 and 500 mg/kg/day groups. at the maternally toxic doses, statistically significant increases in the incidence rates of a variety of minor skeletal abnormalities and variants were observed in the exposed offspring. however, the individual incidence rate of each skeletal abnormality or variant remained within the background rates of occurrence in the species studied. risk summary based on limited published data, oseltamivir and oseltamivir carboxylate are present in human milk at low levels considered unlikely to lead to toxicity in the breastfed infant. exercise caution when oseltamivir phosphate is administered to a nursing woman. treatment of influenza the safety and efficacy of oseltamivir phosphate for the treatment of influenza in pediatric patients 2 weeks old to 17 years of age has been established [see dosage and administration (2.2),clinical pharmacology ( 12.3),and  (clinical studies (14.1)] and is based on: • 13 to 17 years of age: safety and efficacy in adolescent patients 13 to 17 years of age was supported by adequate and well-controlled trials in adults and adolescents and younger pediatric patients and safety data in adolescents treated with oseltamivir phosphate in a study of treatment and prophylaxis. • 1 year to 12 years of age: safety and efficacy in pediatric patients 1 year to 12 years of age was supported by results of one double-blind, placebo-controlled trial in 452 pediatric patients with influenza in whom oseltamivir phosphate 2 mg per kg twice daily or placebo was administered within 48 hours of symptom onset [see clinical studies(14.1)]. additional safety information was provided in a double-blind, placebo-controlled trial in pediatric patients 6 to 12 years of age with known asthma. efficacy could not be established in pediatric patients with asthma. • 2 weeks to less than 1 year of age: safety and efficacy in pediatric patients 2 weeks to less than 1 year of age is supported by adequate and well-controlled trials in adults and older pediatric patients and two open-label trials of oseltamivir phosphate (2 to 3.5 mg per kg twice daily for 5 days) in 136 pediatric subjects 2 weeks to less than 1 year of age. in these two trials, the oseltamivir plasma concentrations in these subjects were similar to or higher than the oseltamivir plasma concentrations observed in older pediatric subjects and adults [see clinical pharmacology(12.3)and clinical studies (14.1)]. the safety and efficacy of oseltamivir phosphate for treatment of influenza in pediatric patients less than 2 weeks of age have not been established. prophylaxis of influenza the safety and efficacy of oseltamivir phosphate for the prophylaxis of influenza in pediatric patients 1 year to 17 years old has been established [see dosage and administration (2.3),clinical pharmacology(12.3),and clinical studies (14.2)] and is based on: • 13 to 17 years of age: prophylaxis in adolescent patients 13 to 17 years of age is supported by one randomized, placebo-controlled post-exposure household prophylaxis trial of oseltamivir phosphate 75 mg taken orally once daily for 7 days in household contacts including 207 adolescents [see clinical studies (14.2)]. the safety and efficacy of oseltamivir phosphate for prophylaxis of influenza have not been established for pediatric patients less than 1 year of age. treatment of influenza of the 4,765 adults in clinical trials of oseltamivir phosphate for the treatment of influenza, 948 (20%) were 65 years and older, while 329 (7%) were 75 years and older. in three double-blind, placebo-controlled trials in the treatment of influenza in patients at least 65 years old, that enrolled 741 subjects (374 received placebo and 362 received oseltamivir phosphate), no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects [see clinical studies (14.1)]. prophylaxis of influenza  of the 4,603 adults in clinical trials of oseltamivir phosphate for the prophylaxis of influenza, 1,046 (23%) were 65 years and older, while 719 (16%) were 75 years and older. in a randomized, placebo-controlled trial in elderly residents of nursing homes who took oseltamivir phosphate for up to 42 days for the prophylaxis of influenza (oseltamivir phosphate n=276, placebo n=272), no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects [see clinical studies (14.2)].   patients with renal impairment had higher blood levels of oseltamivir carboxylate compared to patients with normal renal function which may increase the risk of oseltamivir phosphate-associated adverse reactions. therefore, dosage adjustment is recommended for patients with a serum creatinine clearance between 10 and 60 ml/minute and for patients with end-stage renal disease (esrd) undergoing routine hemodialysis or continuous peritoneal dialysis treatment [see dosage and administration (2.4)]. oseltamivir phosphate is not recommended for patients with esrd not undergoing dialysis [see indications and usage (1.3)and clinical pharmacology (12.3)]. no dosage adjustment is required in patients with mild to moderate hepatic impairment. the safety and pharmacokinetics in patients with severe hepatic impairment have not been evaluated [see clinical pharmacology (12.3)]. efficacy of oseltamivir phosphate in the treatment of influenza in patients with chronic cardiac disease and/or respiratory disease was evaluated in one randomized, placebo-controlled clinical trial. efficacy in this population, as measured by time to alleviation of all symptoms, was not established but no new safety signals were identified [see clinical studies (14.1)]. no clinical trial data are available regarding treatment of influenza in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring hospitalization. efficacy of oseltamivir phosphate for the treatment or prophylaxis of influenza has not been established in immunocompromised patients [see clinical studies (14.2)]. safety of oseltamivir phosphate for prophylaxis of influenza has been demonstrated for up to 12 weeks in immunocompromised patients [see adverse reactions (6.1)].

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

exelan pharmaceuticals, inc. - oseltamivir phosphate (unii: 4a3o49ngez) (oseltamivir acid - unii:k6106lv5q8) - oseltamivir phosphate capsules are indicated for the treatment of acute, uncomplicated illness due to influenza a and b infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. oseltamivir phosphate capsules are indicated for the prophylaxis of influenza a and b in patients 1 year and older. - oseltamivir phosphate capsules are not a substitute for early influenza vaccination on an annual basis as recommended by the centers for disease control and prevention advisory committee on immunization practices. - influenza viruses change over time. emergence of resistance substitutions could decrease drug effectiveness. other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use oseltamivir phosphate capsules[see microbiology (12.4)] . - oseltamivir phosphate capsules are not recommended for patients with end-stage renal disease not undergoing dialysis [see dosage and administration (2.4) and use in specific populations (8.6)]. oseltamivir phosphate is contraindicated in patients with known serious hypersensitivity to oseltamivir or any component of the product. severe allergic reactions have included anaphylaxis and serious skin reactions including toxic epidermal necrolysis, stevens-johnson syndrome, and erythema multiforme [see warnings and precautions (5.1)]. risk summary there are no adequate and well-controlled studies with oseltamivir phosphate in pregnant women to inform a drug-associated risk of adverse developmental outcomes. available published epidemiological data suggest that oseltamivir phosphate, taken in any trimester, is not associated with an increased risk of birth defects. however, these studies individually are limited by small sample sizes, use of different comparison groups, and some lacked information on dose, which preclude a definitive assessment of the risk [see data and clinical pharmacology (12.3) ]. in animal reproduction studies with oseltamivir, no adverse developmental effects were observed at clinically relevant exposures (see data). the background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnant women are at higher risk of severe complications from influenza, which may lead to adverse pregnancy and/or fetal outcomes including maternal death, still births, birth defects, preterm delivery, low birth weight and small for gestational age. data human data published prospective and retrospective observational studies of more than 5,000 women exposed to oseltamivir phosphate during pregnancy, including more than 1,000 women exposed in the first trimester, suggest that the observed rate of congenital malformations was not increased above the rate in the general comparison population, regardless of when therapy was administered during the gestational period. however, individually, none of these studies had adequate sample sizes and some lacked information on dose, which preclude a definitive assessment of the risk. animal data oseltamivir was administered orally during organogenesis to pregnant rats (at 50, 250, or 1500 mg/kg/day on gestation days 6 to 17) and rabbits (at 50, 150, or 500 mg/kg/day on gestation days 6 to 18). in rats, embryo-fetal effects consisting of an increased incidence of minor skeletal malformations were observed at a maternally toxic dose (1500 mg/kg/day), resulting in systemic drug exposures (based on auc for oseltamivir carboxylate) 190 times human exposures at the maximum recommended human dose (mrhd) of oseltamivir (75 mg twice a day). in the rabbit study, embryo-fetal effects consisting of an increased incidence of minor skeletal abnormalities and variants were observed at maternally toxic doses (≥150 mg/kg/day) resulting in systemic exposures (based on auc for oseltamivir carboxylate) ≥8 times human exposures at the mrhd of oseltamivir. in prenatal and postnatal development studies in rats, oseltamivir was administered orally (at 50, 250, 500, or 1500 mg/kg/day) from organogenesis through late gestation, delivery, and lactation (gestation day 6 to postpartum/lactation day 20). prolonged parturition duration and reduced offspring viability were observed at a maternally toxic dose (1500 mg/kg/day). no adverse maternal or offspring effects were observed at doses ≤500 mg/kg/day, resulting in systemic drug exposures (based on auc for oseltamivir carboxylate) 44 times human exposures at the mrhd of oseltamivir. risk summary based on limited published data, oseltamivir and oseltamivir carboxylate have been shown to be present in human milk at low levels considered unlikely to lead to toxicity in the breastfed infant. postmarketing experience has not reported any information to suggest serious adverse effects of oseltamivir exposure via breast milk in infants. it is not known if oseltamivir affects human milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for oseltamivir phosphate and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. treatment of influenza the safety and efficacy of oseltamivir phosphate for the treatment of influenza in pediatric patients 2 weeks old to 17 years of age has been established [see dosage and administration (2.2), clinical pharmacology (12.3), and clinical studies (14.1)] and is based on: - 13 to 17 years of age: safety and efficacy in adolescent patients 13 to 17 years of age was supported by adequate and well-controlled trials in adults and adolescents and younger pediatric patients and safety data in adolescents treated with oseltamivir phosphate in a study of treatment and prophylaxis.    - 1 year to 12 years of age: safety and efficacy in pediatric patients 1 year to 12 years of age was supported by results of one double-blind, placebo-controlled trial in 452 pediatric patients with influenza in whom oseltamivir phosphate 2 mg  per kg  twice daily or placebo was administered   within 48 hours of symptom onset [see clinical studies (14.1)] . additional safety information was provided in a double-blind, placebo-controlled trial in pediatric patients 6 to 12 years of age with known asthma. efficacy could not be established in pediatric patients with asthma. - 2 weeks to less than 1 year of age: safety and efficacy in pediatric patients 2 weeks to less than 1 year of age is supported by adequate and well-controlled trials in adults and older pediatric patients and two open-label trials of oseltamivir phosphate (2 to 3.5 mg per kg twice daily for 5 days) in 136 pediatric subjects 2 weeks to less than 1 year of age. in these two trials, the oseltamivir plasma concentrations in these subjects were similar to or higher than the oseltamivir plasma concentrations observed in older pediatric subjects and adults [see clinical pharmacology (12.3) and clinical studies (14.1)] . the safety and efficacy of oseltamivir phosphate for treatment of influenza in pediatric patients less than   2 weeks of age have not been established. prophylaxis of influenza the safety and efficacy of oseltamivir phosphate for the prophylaxis of influenza in pediatric patients 1 year to 17 years old has been established [see dosage and administration (2.3), clinical pharmacology (12.3), and clinical studies (14.2)] and is based on: - 13 to 17 years of age: prophylaxis in adolescent patients 13 to 17 years of age is supported by one randomized, placebo-controlled post-exposure household prophylaxis trial of oseltamivir phosphate 75 mg taken orally once daily for 7 days in household contacts including 207 adolescents [see clinical studies (14.2)] . - 1 year to 12 years of age: oseltamivir phosphate for prophylaxis in pediatric patients 1 year to 12 years of age is supported by one  randomized, open-label, post-exposure household prophylaxis trial including pediatric subjects 1 year to 12 years of age who received 30 to 60 mg of oseltamivir phosphate for oral suspension (supplied as powder) taken orally once daily for 10 days [see clinical studies (14.2)] . additional safety information was provided in a 6-week seasonal prophylaxis (community outbreak) safety study in 49 patients 1 year to 12 years of age. the safety and efficacy of oseltamivir phosphate for prophylaxis of influenza have not been established for pediatric patients less than 1 year of age. treatment of influenza of the 4,765 adults in clinical trials of oseltamivir phosphate for the treatment of influenza, 948 (20%) were 65 years and older, while 329 (7%) were 75 years and older. in three double-blind, placebo- controlled trials in the treatment of influenza in patients at least 65 years old, that enrolled 741 subjects (374 received placebo and 362 received oseltamivir phosphate), no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects [see clinical studies (14.1)] . prophylaxis of influenza of the 4,603 adults in clinical trials of oseltamivir phosphate for the prophylaxis of influenza, 1,046 (23%) were 65 years and older, while 719 (16%) were 75 years and older. in a randomized, placebo- controlled trial in elderly residents of nursing homes who took oseltamivir phosphate for up to 42 days for the prophylaxis of influenza (oseltamivir phosphate n=276, placebo n=272), no  overall differences    in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and  younger subjects [see clinical studies (14.2)] . patients with renal impairment had higher blood levels of oseltamivir carboxylate compared to patients with normal renal function which may increase the risk of oseltamivir phosphate-associated adverse reactions. therefore, dosage adjustment is recommended for patients with a serum creatinine clearance between 10 and 60 ml/minute and for patients with end-stage renal disease (esrd) undergoing routine hemodialysis or continuous peritoneal dialysis treatment [see dosage and administration (2.4)] . oseltamivir phosphate is not recommended for patients with esrd not undergoing dialysis [see indications and usage (1.3) and clinical pharmacology (12.3)] . no dosage adjustment is required in patients with mild to moderate hepatic impairment. the safety and pharmacokinetics in patients with severe hepatic impairment have not been evaluated [see clinical pharmacology (12.3)] . efficacy of oseltamivir phosphate in the treatment of influenza in patients with chronic cardiac disease and/or respiratory disease was evaluated in one randomized, placebo-controlled clinical trial. efficacy in this population, as measured by time to alleviation of all symptoms, was not established, but no new safety signals were identified [see clinical studies (14.1)] . no clinical trial data are available regarding treatment of influenza in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring hospitalization. efficacy of oseltamivir phosphate for the treatment or prophylaxis of influenza has not been established in immunocompromised patients [see clinical studies (14.2)] . safety of oseltamivir phosphate for prophylaxis of influenza has been demonstrated for up to 12 weeks in immunocompromised patients [see adverse reactions (6.1)] .

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

exelan pharmaceuticals, inc. - oseltamivir phosphate (unii: 4a3o49ngez) (oseltamivir acid - unii:k6106lv5q8) - oseltamivir phosphate for oral suspension is indicated for the treatment of acute, uncomplicated illness due to influenza a and b infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. oseltamivir phosphate for oral suspension is indicated for the prophylaxis of influenza a and b in patients 1 year and older. - oseltamivir phosphate for oral suspension is not a substitute for early influenza vaccination on an annual basis as recommended by the centers for disease control and prevention advisory committee on immunization practices. - influenza viruses change over time. emergence of resistance substitutions could decrease drug effectiveness. other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use oseltamivir phosphate for oral suspension [see microbiology (12.4)]. - oseltamivir phosphate for oral suspension is not recommended for patients with end-stage renal disease not undergoing dialysis [see dosage and administration (2.4) and use in specific populations (8.6)]. oseltamivir phosphate for oral suspension is contraindicated in patients with known serious hypersensitivity to oseltamivir or any component of the product. severe allergic reactions have included anaphylaxis and serious skin reactions including toxic epidermal necrolysis, stevens - johnson syndrome, and erythema multiforme [see warnings and precautions (5.1)]. risk summary there are no adequate and well-controlled studies with oseltamivir phosphate for oral suapension in pregnant women to inform a drug-associated risk of adverse developmental outcomes. available published epidemiological data suggest that oseltamivir phosphate for oral suapension, taken in any trimester, is not associated with an increased risk of birth defects. however, these studies individually are limited by small sample sizes, use of different comparison groups, and some lacked information on dose, which preclude a definitive assessment of the risk [see data and clinical pharmacology (12.3)] . in animal reproduction studies with oseltamivir, no adverse developmental effects were observed at clinically relevant exposures (see data) . the background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnant women are at higher risk of severe complications from influenza, which may lead to adverse pregnancy and/or fetal outcomes including maternal death, still births, birth defects, preterm delivery, low birth weight and small for gestational age. data human data published prospective and retrospective observational studies of more than 5,000 women exposed to oseltamivir phosphate during pregnancy, including more than 1,000 women exposed in the first trimester, suggest that the observed rate of congenital malformations was not increased above the rate in the general comparison population, regardless of when therapy was administered during the gestational period. however, individually, none of these studies had adequate sample sizes and some lacked information on dose, which preclude a definitive assessment of the risk. animal data oseltamivir was administered orally during organogenesis to pregnant rats (at 50, 250, or 1500 mg/kg/day on gestation days 6 to 17) and rabbits (at 50, 150, or 500 mg/kg/day on gestation days 6 to 18). in rats, embryo-fetal effects consisting of an increased incidence of minor skeletal malformations were observed at a maternally toxic dose (1500 mg/kg/day), resulting in systemic drug exposures (based on auc for oseltamivir carboxylate) 190 times human exposures at the maximum recommended human dose (mrhd) of oseltamivir phosphate (75 mg twice a day). in the rabbit study, embryo-fetal effects consisting of an increased incidence of minor skeletal abnormalities and variants were observed at maternally toxic doses (≤150 mg/kg/day) resulting in systemic exposures (based on auc for oseltamivir carboxylate) greater than or equal to 8 times human exposures at the mrhd of oseltamivir. in prenatal and postnatal development studies in rats, oseltamivir was administered orally (at 50 mg/kg/day, 250 mg/kg/day, 500 mg/kg/day, or 1500 mg/kg/day) from organogenesis through late gestation, delivery, and lactation (gestation day 6 to postpartum/lactation day 20). prolonged parturition duration and reduced offspring viability were observed at a maternally toxic dose (1500 mg/kg/day). no adverse maternal or offspring effects were observed at doses less than or equal to 500 mg/kg/day, resulting in systemic drug exposures (based on auc for oseltamivir carboxylate) 44 times human exposures at the mrhd of oseltamivir. risk summary based on limited published data, oseltamivir and oseltamivir carboxylate have been shown to be present in human milk at low levels considered unlikely to lead to toxicity in the breastfed infant. postmarketing experience has not reported any information to suggest serious adverse effects of oseltamivir exposure via breast milk in infants. it is not known if oseltamivir affects human milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for oseltamivir phosphate and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. treatment of influenza the safety and efficacy of oseltamivir phosphate for the treatment of influenza in pediatric patients 2 weeks old to 17 years of age has been established [see dosage and administration (2.2), clinical pharmacology (12.3), and clinical studies (14.1)] and is based on: - 13 to 17 years of age: safety and efficacy in adolescent patients 13 to 17 years of age was supported by adequate and well-controlled trials in adults and adolescents and younger pediatric patients and safety data in adolescents treated with oseltamivir phosphate in a study of treatment and prophylaxis. - 1 year to 12 years of age: safety and efficacy in pediatric patients 1 year to 12 years of age was supported by results of one double-blind, placebo-controlled trial in 452 pediatric patients with influenza in whom oseltamivir phosphate 2 mg per kg twice daily or placebo was administered within 48 hours of symptom onset [see clinical studies (14.1)] . additional safety information was provided in a double-blind, placebo-controlled trial in pediatric patients 6 to 12 years of age with known asthma. efficacy could not be established in pediatric patients with asthma. - 2 weeks to less than 1 year of age: safety and efficacy in pediatric patients 2 weeks to less than 1 year of age is supported by adequate and well-controlled trials in adults and older pediatric patients and two open-label trials of oseltamivir phosphate (2 mg per kg to 3.5 mg per kg twice daily for 5 days) in 136 pediatric subjects 2 weeks to less than 1 year of age. in these two trials, the oseltamivir plasma concentrations in these subjects were similar to or higher than the oseltamivir plasma concentrations observed in older pediatric subjects and adults [see clinical pharmacology (12.3) and clinical studies (14.1)]. the safety and efficacy of oseltamivir phosphate for treatment of influenza in pediatric patients less than 2 weeks of age have not been established. prophylaxis of influenza the safety and efficacy of oseltamivir phosphate for the prophylaxis of influenza in pediatric patients 1 year to 17 years old has been established [see dosage and administration (2.3), clinical pharmacology (12.3), and clinical studies (14.2)] and is based on: - 13 to 17 years of age: prophylaxis in adolescent patients 13 to 17 years of age is supported by one randomized, placebo-controlled post-exposure household prophylaxis trial of oseltamivir phosphate 75 mg taken orally once daily for 7 days in household contacts including 207 adolescents [see clinical studies (14.2)]. - 1 year to 12 years of age: oseltamivir phosphate for prophylaxis in pediatric patients 1 year to 12 years of age is supported by one randomized, open-label, post-exposure household prophylaxis trial including pediatric subjects 1 year to 12 years of age who received 30 to 60 mg of oseltamivir phosphate for oral suspension (supplied as powder) taken orally once daily for 10 days [see clinical studies (14.2)]. additional safety information was provided in a 6-week seasonal prophylaxis (community outbreak) safety study in 49 patients 1 year to 12 years of age. the safety and efficacy of oseltamivir phosphate for prophylaxis of influenza have not been established for pediatric patients less than 1 year of age. treatment of influenza of the 4,765 adults in clinical trials of oseltamivir phosphate for the treatment of influenza, 948 (20%) were 65 years and older, while 329 (7%) were 75 years and older. in three double-blind, placebo-controlled trials in the treatment of influenza in patients at least 65 years old, that enrolled 741 subjects (374 received placebo and 362 received oseltamivir phosphate), no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects [see clinical studies (14.1)]. prophylaxis of influenza of the 4,603 adults in clinical trials of oseltamivir phosphate for the prophylaxis of influenza, 1,046 (23%) were 65 years and older, while 719 (16%) were 75 years and older. in a randomized, placebo-controlled trial in elderly residents of nursing homes who took oseltamivir phosphate for up to 42 days for the prophylaxis of influenza (oseltamivir phosphate n=276, placebo n=272), no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects [see clinical studies (14.2)]. patients with renal impairment had higher blood levels of oseltamivir carboxylate compared to patients with normal renal function which may increase the risk of oseltamivir phosphate-associated adverse reactions. therefore, dosage adjustment is recommended for patients with a serum creatinine clearance between 10 ml/minute and 60 ml/minute and for patients with end-stage renal disease (esrd) undergoing routine hemodialysis or continuous peritoneal dialysis treatment [see dosage and administration (2.4)]. oseltamivir phosphate is not recommended for patients with esrd not undergoing dialysis [see indications and usage (1.3) and clinical pharmacology (12.3)]. no dosage adjustment is required in patients with mild to moderate hepatic impairment. the safety and pharmacokinetics in patients with severe hepatic impairment have not been evaluated [see clinical pharmacology (12.3)]. efficacy of oseltamivir phosphate in the treatment of influenza in patients with chronic cardiac disease and/or respiratory disease was evaluated in one randomized, placebo-controlled clinical trial. efficacy in this population, as measured by time to alleviation of all symptoms, was not established, but no new safety signals were identified [see clinical studies (14.1)]. no clinical trial data are available regarding treatment of influenza in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring hospitalization. efficacy of oseltamivir phosphate for the treatment or prophylaxis of influenza has not been established in immunocompromised patients [see clinical studies (14.2)].  safety of oseltamivir phosphate for prophylaxis of influenza has been demonstrated for up to 12 weeks for prophylaxis of influenza in immunocompromised patients [see adverse reactions (6.1)]. instructions for use oseltamivir phosphate for oral suspension  (oh'' sel tam' i vir fos' fate) how do i give a dose of oseltamivir phosphate for oral suspension? step 1.      this instructions for use has been approved by the u.s. food and drug administration. revised: 11/2023

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

slate run pharmaceuticals, llc - oseltamivir phosphate (unii: 4a3o49ngez) (oseltamivir acid - unii:k6106lv5q8) - oseltamivir phosphate is indicated for the treatment of acute, uncomplicated illness due to influenza a and b infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. oseltamivir phosphate is indicated for the prophylaxis of influenza a and b in patients 1 year and older. - oseltamivir phosphate is not a substitute for early influenza vaccination on an annual basis as recommended by the centers for disease control and prevention advisory committee on immunization practices. - influenza viruses change over time. emergence of resistance substitutions could decrease drug effectiveness. other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use oseltamivir phosphate [see microbiology ( 12.4)] . - oseltamivir phosphate is not recommended for patients with end-stage renal disease not undergoing dialysis [see dosage and administration ( 2.4) and use in specific populations ( 8.6)] . oseltamivir phosphate capsules are contraindicated in patients with known serious hypersensitivity to oseltamivir or any component of the product. severe allergic reactions have included anaphylaxis and serious skin reactions including toxic epidermal necrolysis, stevens-johnson syndrome, and erythema multiforme [see warnings and precautions ( 5.1) ]. there are no adequate and well-controlled studies with oseltamivir phosphate in pregnant women to inform a drug-associated risk of adverse developmental outcomes. available published epidemiological data suggest that oseltamivir phosphate, taken in any trimester, is not associated with an increased risk of birth defects. however, these studies individually are limited by small sample sizes, use of different comparison groups, and some lacked information on dose, which preclude a definitive assessment of the risk [see data and clinical pharmacology ( 12.3)] . in animal reproduction studies with oseltamivir, no adverse developmental effects were observed at clinically relevant exposures (see data) . the background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage is 2-4% and 15-20%, respectively. disease-associated maternal and/or embryo/fetal risk pregnant women are at higher risk of severe complications from influenza, which may lead to adverse pregnancy and/or fetal outcomes including maternal death, still births, birth defects, preterm delivery, low birth weight and small for gestational age. human data published prospective and retrospective observational studies of more than 5,000 women exposed to oseltamivir phosphate during pregnancy, including more than 1,000 women exposed in the first trimester, suggest that the observed rate of congenital malformations was not increased above the rate in the general comparison population, regardless of when therapy was administered during the gestational period. however, individually, none of these studies had adequate sample sizes and some lacked information on dose, which preclude a definitive assessment of the risk. animal data oseltamivir was administered orally during organogenesis to pregnant rats (at 50, 250, or 1500 mg/kg/day on gestation days 6 to 17) and rabbits (at 50, 150, or 500 mg/kg/day on gestation days 6 to 18). in rats, embryo-fetal effects consisting of an increased incidence of minor skeletal malformations were observed at a maternally toxic dose (1500 mg/kg/day), resulting in systemic drug exposures (based on auc for oseltamivir carboxylate) 190 times human exposures at the maximum recommended human dose (mrhd) of oseltamivir phosphate (75 mg twice a day). in the rabbit study, embryo-fetal effects consisting of an increased incidence of minor skeletal abnormalities and variants were observed at maternally toxic doses (≥150 mg/kg/day) resulting in systemic exposures (based on auc for oseltamivir carboxylate) ≥8 times human exposures at the mrhd of oseltamivir phosphate. in prenatal and postnatal development studies in rats, oseltamivir was administered orally (at 50, 250, 500, or 1500 mg/kg/day) from organogenesis through late gestation, delivery, and lactation (gestation day 6 to postpartum/lactation day 20). prolonged parturition duration and reduced offspring viability were observed at a maternally toxic dose (1500 mg/kg/day). no adverse maternal or offspring effects were observed at doses ≤500 mg/kg/day, resulting in systemic drug exposures (based on auc for oseltamivir carboxylate) 44 times human exposures at the mrhd of oseltamivir phosphate. based on limited published data, oseltamivir and oseltamivir carboxylate have been shown to be present in human milk at low levels considered unlikely to lead to toxicity in the breastfed infant. postmarketing experience has not reported any information to suggest serious adverse effects of oseltamivir exposure via breast milk in infants. it is not known if oseltamivir affects human milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for oseltamivir phosphate and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. the safety and efficacy of oseltamivir phosphate for the treatment of influenza in pediatric patients 2 weeks old to 17 years of age has been established [see dosage and administration ( 2.2), clinical pharmacology ( 12.3), and clinical studies ( 14.1)] and is based on: - 13 to 17 years of age: safety and efficacy in adolescent patients 13 to 17 years of age was supported by adequate and well-controlled trials in adults and adolescents and younger pediatric patients and safety data in adolescents treated with oseltamivir phosphate in a study of treatment and prophylaxis. - 1 year to 12 years of age: safety and efficacy in pediatric patients 1 year to 12 years of age was supported by results of one double-blind, placebo-controlled trial in 452 pediatric patients with influenza in whom oseltamivir phosphate 2 mg per kg twice daily or placebo was administered within 48 hours of symptom onset [see clinical studies ( 14.1)] . additional safety information was provided in a double-blind, placebo‐controlled trial in pediatric patients 6 to 12 years of age with known asthma. efficacy could not be established in pediatric patients with asthma. - 2 weeks to less than 1 year of age: safety and efficacy in pediatric patients 2 weeks to less than 1 year of age is supported by adequate and well‐controlled trials in adults and older pediatric patients and two open-label trials of oseltamivir phosphate (2 to 3.5 mg per kg twice daily for 5 days) in 136 pediatric subjects 2 weeks to less than 1 year of age. in these two trials, the oseltamivir plasma concentrations in these subjects were similar to or higher than the oseltamivir plasma concentrations observed in older pediatric subjects and adults [see clinical pharmacology ( 12.3) and clinical studies ( 14.1)] . the safety and efficacy of oseltamivir phosphate for treatment of influenza in pediatric patients less than 2 weeks of age have not been established. the safety and efficacy of oseltamivir phosphate for the prophylaxis of influenza in pediatric patients 1 year to 17 years old has been established [see dosage and administration ( 2.3), clinical pharmacology ( 12.3), and clinical studies ( 14.2)] and is based on: - 13 to 17 years of age: prophylaxis in adolescent patients 13 to 17 years of age is supported by one randomized, placebo-controlled post-exposure household prophylaxis trial of oseltamivir phosphate 75 mg taken orally once daily for 7 days in household contacts including 207 adolescents [see clinical studies ( 14.2)] . - 1 year to 12 years of age: oseltamivir phosphate for prophylaxis in pediatric patients 1 year to 12 years of age is supported by one randomized, open-label, post-exposure household prophylaxis trial including pediatric subjects 1 year to 12 years of age who received 30 to 60 mg of oseltamivir phosphate for oral suspension (supplied as powder) taken orally once daily for 10 days [see clinical studies ( 14.2)] . additional safety information was provided in a 6-week seasonal prophylaxis (community outbreak) safety study in 49 patients 1 year to 12 years of age. the safety and efficacy of oseltamivir phosphate for prophylaxis of influenza have not been established for pediatric patients less than 1 year of age. of the 4,765 adults in clinical trials of oseltamivir phosphate for the treatment of influenza, 948 (20%) were 65 years and older, while 329 (7%) were 75 years and older. in three double-blind, placebo-controlled trials in the treatment of influenza in patients at least 65 years old, that enrolled 741 subjects (374 received placebo and 362 received oseltamivir phosphate), no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects [see clinical studies ( 14.1)] . of the 4,603 adults in clinical trials of oseltamivir phosphate for the prophylaxis of influenza, 1,046 (23%) were 65 years and older, while 719 (16%) were 75 years and older. in a randomized, placebo-controlled trial in elderly residents of nursing homes who took oseltamivir phosphate for up to 42 days for the prophylaxis of influenza (oseltamivir phosphate n=276, placebo n=272), no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects [see clinical studies ( 14.2)] . patients with renal impairment had higher blood levels of oseltamivir carboxylate compared to patients with normal renal function which may increase the risk of oseltamivir phosphate-associated adverse reactions. therefore, dosage adjustment is recommended for patients with a serum creatinine clearance between 10 and 60 ml/minute and for patients with end-stage renal disease (esrd) undergoing routine hemodialysis or continuous peritoneal dialysis treatment [see dosage and administration ( 2.4)] . oseltamivir phosphate is not recommended for patients with esrd not undergoing dialysis [see indications and usage ( 1.3) and clinical pharmacology ( 12.3)]. no dosage adjustment is required in patients with mild to moderate hepatic impairment. the safety and pharmacokinetics in patients with severe hepatic impairment have not been evaluated [see clinical pharmacology ( 12.3)] . efficacy of oseltamivir phosphate in the treatment of influenza in patients with chronic cardiac disease and/or respiratory disease was evaluated in one randomized, placebo-controlled clinical trial. efficacy in this population, as measured by time to alleviation of all symptoms, was not established, but no new safety signals were identified [see clinical studies ( 14.1)] . no clinical trial data are available regarding treatment of influenza in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring hospitalization. efficacy of oseltamivir phosphate for the treatment or prophylaxis of influenza has not been established in immunocompromised patients [see clinical studies ( 14.2)] . safety of oseltamivir phosphate has been demonstrated for up to 12 weeks for prophylaxis of influenza in immunocompromised patients [see adverse reactions ( 6.1)] .

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

epic pharma, llc - oseltamivir phosphate (unii: 4a3o49ngez) (oseltamivir acid - unii:k6106lv5q8) - oseltamivir phosphate capsules are indicated for the treatment of acute, uncomplicated illness due to influenza a and b infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. oseltamivir phosphate capsules are indicated for the prophylaxis of influenza a and b in patients 1 year and older. oseltamivir phosphate capsules are contraindicated in patients with known serious hypersensitivity to oseltamivir or any component of the product. severe allergic reactions have included anaphylaxis and serious skin reactions including toxic epidermal necrolysis, stevens‐johnson syndrome, and erythema multiforme [see warnings and precautions (5.1)]. there are no adequate and well‐controlled studies with oseltamivir phosphate in pregnant women to inform a drug‐associated risk of adverse developmental outcomes. available published epidemiological data suggest that oseltamivir phosphate, taken in any trimester, is not associated with an increased risk of birth defects. however, thes

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

hainan poly pharm. co., ltd. - oseltamivir phosphate (unii: 4a3o49ngez) (oseltamivir acid - unii:k6106lv5q8) - oseltamivir phosphate is indicated for the treatment of acute, uncomplicated illness due to influenza a and b infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. oseltamivir phosphate is indicated for the prophylaxis of influenza a and b in patients 1 year and older. - oseltamivir phosphate is not a substitute for early influenza vaccination on an annual basis as recommended by the centers for disease control and prevention advisory committee on immunization practices. - influenza viruses change over time. emergence of resistance substitutions could decrease drug effectiveness. other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use oseltamivir phosphate  [see microbiology (12.4)] . - oseltamivir phosphate is not recommended for patients with en