Соединенные Штаты - английский - NLM (National Library of Medicine)

accord healthcare inc. - rosuvastatin calcium (unii: 83mvu38m7q) (rosuvastatin - unii:413kh5zj73) - rosuvastatin 5 mg - pediatric use information for patients 7 to 17 years of age is approved for astrazeneca’s crestor (rosuvastatin calcium) tablets. however, due to astrazeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. rosuvastatin tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. rosuvastatin tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (type iii hyperlipoproteinemia). rosuvastatin tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., ldl apheresis) or alone if such treatments are unavailable to reduce ldl-c, total-c, and apob in adult patients with homozygous familial hypercholesterolemia. rosuvastatin tablets have not been studied in fredrickson type i and v dyslipidemias. rosuvastatin tablets are contraindicated in the following conditions: - patients with a known hypersensitivity to any component of this product. hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin [ see adverse reactions (6.1) ]. - patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels [ see warnings and precautions (5.3) ]. - pregnancy [ see use in specific populations (8.1, 8.3)]. - lactation. limited data indicate that rosuvastatin is present in human milk. because statins have the potential for serious adverse reactions in nursing infants, women who require rosuvastatin treatment should not breastfeed their infants [ see use in specific populations (8.2) ]. risk summary rosuvastatin is contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit to therapy with rosuvastatin during pregnancy. because hmg-coa reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, rosuvastatin may cause fetal harm when administered to pregnant women. rosuvastatin should be discontinued as soon as pregnancy is recognized [see contraindications (4)] . limited published data on the use of rosuvastatin are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. in animal reproduction studies, there were no adverse developmental effects with oral administration of rosuvastatin during organogenesis at systemic exposures equivalent to a maximum recommended human dose (mrhd) of 40 mg/day in rats or rabbits (based on auc and body surface area, respectively). in rats and rabbits, decreased pup/fetal survival occurred at 12 times and equivalent, respectively, to the mrhd of 40 mg/day [see data] . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.  data  human data  limited published data on rosuvastatin have not shown an increased risk of major congenital malformations or miscarriage. rare reports of congenital anomalies have been received following intrauterine exposure to other statins. in a review of approximately 100 prospectively followed pregnancies in women exposed to simvastatin or lovastatin, the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed what would be expected in the general population. the number of cases is adequate to exclude a ≥3 to 4-fold increase in congenital anomalies over the background incidence. in 89% of the prospectively followed pregnancies, drug treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. animal data  rosuvastatin crosses the placenta in rats and rabbits and is found in fetal tissue and amniotic fluid at 3% and 20%, respectively, of the maternal plasma concentration following a single 25 mg/kg oral gavage dose on gestation day 16 in rats. a higher fetal tissue distribution (25% maternal plasma concentration) was observed in rabbits after a single oral gavage dose of 1 mg/kg on gestation day 18.   rosuvastatin administration did not indicate a teratogenic effect in rats at ≤25 mg/kg/day or in rabbits ≤3 mg/kg/day (doses equivalent to the mrhd of 40 mg/day based on auc and body surface area, respectively).   in female rats given 5, 15 and 50 mg/kg/day before mating and continuing through to gestation day 7 resulted in decreased fetal body weight (female pups) and delayed ossification at 50 mg/kg/day (10 times the human exposure at the mrhd dose of 40 mg/day based on auc).   in pregnant rats given 2, 10 and 50 mg/kg/day of rosuvastatin from gestation day 7 through lactation day 21 (weaning), decreased pup survival occurred at 50 mg/kg/day (dose equivalent to 12 times the mrhd of 40 mg/day based body surface area).  in pregnant rabbits given 0.3, 1, and 3 mg/kg/day of rosuvastatin from gestation day 6 to day 18, decreased fetal viability and maternal mortality was observed at 3 mg/kg/day (dose equivalent to the mrhd of 40 mg/day based on body surface area). risk summary  rosuvastatin use is contraindicated during breastfeeding [see contraindications (4)] . limited data indicate that rosuvastatin is present in human milk. there is no available information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. because of the potential for serious adverse reactions in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with rosuvastatin. contraception rosuvastatin may cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. advise females of reproductive potential to use effective contraception during treatment with rosuvastatin. pediatric use information for patients 7 to 17 years of age is approved for astrazeneca’s crestor (rosuvastatin calcium) tablets. however, due to astrazeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. of the 10,275 patients in clinical studies with rosuvastatin, 3159 (31%) were 65 years and older, and 698 (6.8%) were 75 years and older. 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 patients, but greater sensitivity of some older individuals cannot be ruled out. elderly patients are at higher risk of myopathy and rosuvastatin should be prescribed with caution in the elderly [ see warnings and precautions (5.1) and clinical pharmacology (12.3) ]. rosuvastatin exposure is not influenced by mild to moderate renal impairment (cl cr ≥ 30 ml/min/1.73 m2). exposure to rosuvastatin is increased to a clinically significant extent in patients with severe renal impairment (cl cr < 30 ml/min/1.73 m 2 ) who are not receiving hemodialysis and dose adjustment is required [ see dosage and administration (2.5) , warnings and precautions (5.1) and clinical pharmacology (12.3) ]. rosuvastatin is contraindicated in patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels. chronic alcohol liver disease is known to increase rosuvastatin exposure; rosuvastatin tablets should be used with caution in these patients [ see contraindications (4) , warning and precautions (5.3) and clinical pharmacology (12.3) ]. pharmacokinetic studies have demonstrated an approximate 2‑fold increase in median exposure to rosuvastatin in asian subjects when compared with caucasian controls. rosuvastatin dosage should be adjusted in asian patients [ see dosage and administration (2.3) and clinical pharmacology (12.3) ].

Соединенные Штаты - английский - NLM (National Library of Medicine)

avpak - rosuvastatin calcium (unii: 83mvu38m7q) (rosuvastatin - unii:413kh5zj73) - pediatric use information for patients 7 to 17 years of age is approved for astrazeneca’s crestor (rosuvastatin calcium) tablets. however, due to astrazeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. rosuvastatin calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. rosuvastatin calcium tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (type iii hyperlipoproteinemia). rosuvastatin calcium tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., ldl apheresis) or alone if such treatments are unavailable to reduce ldl-c, total-c, and apob in adult patients with homozygous familial hypercholesterolemia. rosuvastatin calcium tablets have not been studied in fredrickson type i and v dyslipidemias. rosuvastatin calcium tablets are contraindicated in the following conditions: •patients with a known hypersensitivity to any component of this product. hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin calcium tablets [see adverse reactions (6.1)]. •patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels [see warnings and precautions (5.2)]. •pregnancy [see use in specific populations (8.1, 8.3)]. •lactation. limited data indicate that rosuvastatin calcium is present in human milk. because statins have the potential for serious adverse reactions in nursing infants, women who require rosuvastatin calcium tablets treatment should not breastfeed their infants [see use in specific populations (8.2)]. risk summary rosuvastatin calcium tablets are contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit to therapy with rosuvastatin calcium tablets during pregnancy. because hmg-coa reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, rosuvastatin calcium tablets may cause fetal harm when administered to pregnant women. rosuvastatin calcium tablets should be discontinued as soon as pregnancy is recognized [ see contraindications (4)]. limited published data on the use of rosuvastatin are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. in animal reproduction studies, there were no adverse developmental effects with oral administration of rosuvastatin during organogenesis at systemic exposures equivalent to a maximum recommended human dose (mrhd) of 40 mg/day in rats or rabbits (based on auc and body surface area, respectively). in rats and rabbits, decreased pup/fetal survival occurred at 12 times and equivalent, respectively, to the mrhd of 40 mg/day [see data]. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data human data limited published data on rosuvastatin have not shown an increased risk of major congenital malformations or miscarriage. rare reports of congenital anomalies have been received following intrauterine exposure to other statins. in a review of approximately 100 prospectively followed pregnancies in women exposed to simvastatin or lovastatin, the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed what would be expected in the general population. the number of cases is adequate to exclude a ≥3 to 4-fold increase in congenital anomalies over the background incidence. in 89% of the prospectively followed pregnancies, drug treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. animal data rosuvastatin crosses the placenta in rats and rabbits and is found in fetal tissue and amniotic fluid at 3% and 20%, respectively, of the maternal plasma concentration following a single 25 mg/kg oral gavage dose on gestation day 16 in rats. a higher fetal tissue distribution (25% maternal plasma concentration) was observed in rabbits after a single oral gavage dose of 1 mg/kg on gestation day 18. rosuvastatin administration did not indicate a teratogenic effect in rats at ≤25 mg/kg/day or in rabbits ≤3 mg/kg/day (doses equivalent to the mrhd of 40 mg/day based on auc and body surface area, respectively). in female rats given 5, 15 and 50 mg/kg/day before mating and continuing through to gestation day 7 resulted in decreased fetal body weight (female pups) and delayed ossification at 50 mg/kg/day (10 times the human exposure at the mrhd dose of  40 mg/day based on auc). in pregnant rats given 2, 10 and 50 mg/kg/day of rosuvastatin from gestation day 7 through lactation day 21 (weaning), decreased pup survival occurred at 50 mg/kg/day (dose equivalent to 12 times the mrhd of 40 mg/day based body surface area). in pregnant rabbits given 0.3, 1, and 3 mg/kg/day of rosuvastatin from gestation day 6 to day 18, decreased fetal viability and maternal mortality was observed at 3 mg/kg/day (dose equivalent to the mrhd of 40 mg/day based on body surface area). risk summary   rosuvastatin use is contraindicated during breastfeeding [see contraindications (4)] . limited data indicate that rosuvastatin calcium is present in human milk. there is no available information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. because of the potential for serious adverse reactions in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with rosuvastatin calcium. contraception rosuvastatin calcium may cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. advise females of reproductive potential to use effective contraception during treatment with rosuvastatin calcium. pediatric use information for patients 7 to 17 years of age is approved for astrazeneca's crestor (rosuvastatin calcium) tablets. however, due to astrazeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. of the 10,275 patients in clinical studies with rosuvastatin calcium tablets, 3159 (31%) were 65 years and older, and 698 (6.8%) were 75 years and older. 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 patients, but greater sensitivity of some older individuals cannot be ruled out. elderly patients are at higher risk of myopathy and rosuvastatin calcium tablets should be prescribed with caution in the elderly [see warnings and precautions (5.1) and clinical pharmacology (12.3)]. rosuvastatin exposure is not influenced by mild to moderate renal impairment (clcr ≥30 ml/min/1.73 m2). exposure to rosuvastatin is increased to a clinically significant extent in patients with severe renal impairment (clcr <30 ml/min/1.73 m2) who are not receiving hemodialysis and dose adjustment is required [see dosage and administration (2.5),warnings and precautions (5.1) and clinical pharmacology (12.3)]. rosuvastatin calcium tablets are contraindicated in patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels. chronic alcohol liver disease is known to increase rosuvastatin exposure; rosuvastatin calcium tablets should be used with caution in these patients [see contraindications (4), warning and precautions (5.2) and clinical pharmacology (12.3)]. pharmacokinetic studies have demonstrated an approximate 2-fold increase in median exposure to rosuvastatin in asian subjects when compared with caucasian controls. rosuvastatin calcium tablets dosage should be adjusted in asian patients [see dosage and administration (2.3) and clinical pharmacology (12.3)].

Соединенные Штаты - английский - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - rosuvastatin (unii: 413kh5zj73) (rosuvastatin - unii:413kh5zj73) - rosuvastatin tablets are indicated: - to reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at increased risk of cardiovascular (cv) disease based on age, hscrp ≥2 mg/l, and at least one additional cv risk factor. - as an adjunct to diet to: reduce ldl-c in adults with primary hyperlipidemia. reduce low-density lipoprotein cholesterol (ldl-c) and slow the progression of atherosclerosis in adults. reduce ldl-c in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (hefh). - reduce ldl-c in adults with primary hyperlipidemia. - reduce low-density lipoprotein cholesterol (ldl-c) and slow the progression of atherosclerosis in adults. - reduce ldl-c in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (hefh). - as an adjunct to other ldl-c-lowering therapies, or alone if such treatments are unavailable, to reduce ldl-c in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (hofh). - as an adjunct to diet for the treatment of adults with: primary dysbetalipoproteinemia. hypertriglyceridemia. - primary dysbetalipoproteinemia. - hypertriglyceridemia. rosuvastatin tablets are contraindicated in the following conditions: - acute liver failure or decompensated cirrhosis [see warnings and precautions (5.3)] . - hypersensitivity to rosuvastatin or any excipients in rosuvastatin tablets. hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin tablets [see adverse reactions (6.1)] . risk summary discontinue rosuvastatin when pregnancy is recognized. alternatively, consider the ongoing therapeutic needs of the individual patient. rosuvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, rosuvastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see clinical pharmacology (12.1)] . in addition, treatment of hyperlipidemia is not generally necessary during pregnancy. atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations. published data from prospective and retrospective observational cohort studies with rosuvastatin use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see data) . in animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered rosuvastatin during the period of organogenesis at doses that resulted in systemic exposures equivalent to human exposures at the maximum recommended human dose (mrhd) of 40 mg/day, based on auc and body surface area (mg/m 2 ), respectively (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data a medicaid cohort linkage study of 1,152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity scorebased methods. the relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus. there were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders. in the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births. animal data in female rats given 5 mg/kg/day, 15 mg/kg/day and 50 mg/kg/day before mating and continuing through to gestation day 7 resulted in decreased fetal body weight (female pups) and delayed ossification at 50 mg/kg/day (10 times the human exposure at the mrhd dose of 40 mg/day based on auc). in pregnant rats given 2 mg/kg/day, 10 mg/kg/day and 50 mg/kg/day of rosuvastatin from gestation day 7 through lactation day 21 (weaning), decreased pup survival occurred at 50 mg/kg/day (dose equivalent to 12 times the mrhd of 40 mg/day based body surface area). in pregnant rabbits given 0.3 mg/kg/day, 1 mg/kg/day, and 3 mg/kg/day of rosuvastatin from gestation day 6 to day 18, decreased fetal viability and maternal mortality was observed at 3 mg/kg/day (dose equivalent to the mrhd of 40 mg/day based on body surface area). rosuvastatin crosses the placenta in rats and rabbits and is found in fetal tissue and amniotic fluid at 3% and 20%, respectively, of the maternal plasma concentration following a single 25 mg/kg oral gavage dose on gestation day 16 in rats. in rabbits, fetal tissue distribution was 25% of maternal plasma concentration after a single oral gavage dose of 1 mg/kg on gestation day 18. risk summary limited data from case reports in published literature indicate that rosuvastatin is present in human milk. there is no available information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. statins, including rosuvastatin, decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol and may cause harm to the breastfed infant. because of the potential for serious adverse reactions in a breastfed infant, based on the mechanism of action, advise patients that breastfeeding is not recommended during treatment with rosuvastatin [see use in specific populations (8.1)and clinical pharmacology (12.1)] . the safety and effectiveness of rosuvastatin as an adjunct to diet to reduce ldl-c have been established in pediatric patients 8 years of age and older with hefh. use of rosuvastatin for this indication is based on one 12-week controlled trial with a 40-week open-label extension period in 176 pediatric patients 10 years of age and older with hefh and one 2-year open-label, uncontrolled trial in 175 pediatric patients 8 years of age and older with hefh [see clinical studies (14)] . in the 1-year trial with a 12-week controlled phase, there was no detectable effect of rosuvastatin on growth, weight, bmi (body mass index), or sexual maturation in patients aged 10 to 17 years. the safety and effectiveness of rosuvastatin as an adjunct to other ldl-c-lowering therapies to reduce ldl-c have been established pediatric patients 7 years of age and older with hofh. use of rosuvastatin for this indication is based on a randomized, placebo-controlled, cross-over study in 14 pediatric patients 7 years of age and older with hofh [see clinical studies (14)] . the safety and effectiveness of rosuvastatin have not been established in pediatric patients younger than 8 years of age with hefh, younger than 7 years of age with hofh, or in pediatric patients with other types of hyperlipidemia (other than hefh or hofh). of the total number of rosuvastatin-treated patients in clinical studies, 3,159 (31%) were 65 years and older, and 698 (6.8%) were 75 years and older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. advanced age (≥65 years) is a risk factor for rosuvastatin-associated myopathy and rhabdomyolysis. dose selection for an elderly patient should be cautious, recognizing the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of myopathy. monitor geriatric patients receiving rosuvastatin for the increased risk of myopathy [see warnings and precautions (5.1)] . rosuvastatin exposure is not influenced by mild to moderate renal impairment (cl cr ≥ 30 ml/min/1.73 m 2 ). exposure to rosuvastatin is increased to a clinically significant extent in patients with severe renal impairment (cl cr < 30 ml/min/1.73 m 2 ) who are not receiving hemodialysis [ see clinical pharmacology (12.3) ]. renal impairment is a risk factor for myopathy and rhabdomyolysis. monitor all patients with renal impairment for development of myopathy. in patients with severe renal impairment not on hemodialysis, the recommended starting dosage is 5 mg daily and should not exceed 10 mg daily [see dosage and administration (2.5)and warnings and precautions (5.1)] . rosuvastatin is contraindicated in patients with acute liver failure or decompensated cirrhosis. chronic alcohol liver disease is known to increase rosuvastatin exposure. patients who consume substantial quantities of alcohol and/or have a history of liver disease may be at increased risk for hepatic injury [ see contraindications (4), warning and precautions (5.3) and clinical pharmacology (12.3) ]. pharmacokinetic studies have demonstrated an approximate 2-fold increase in median exposure to rosuvastatin in asian subjects when compared with white controls. adjust the rosuvastatin dosage in asian patients [ see dosage and administration (2.4) and clinical pharmacology (12.3) ].

Соединенные Штаты - английский - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - rosuvastatin (unii: 413kh5zj73) (rosuvastatin - unii:413kh5zj73) - rosuvastatin tablets are indicated: - to reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at increased risk of cardiovascular (cv) disease based on age, hscrp ≥2 mg/l, and at least one additional cv risk factor. - as an adjunct to diet to: reduce ldl-c in adults with primary hyperlipidemia. reduce low-density lipoprotein cholesterol (ldl-c) and slow the progression of atherosclerosis in adults. reduce ldl-c in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (hefh). - reduce ldl-c in adults with primary hyperlipidemia. - reduce low-density lipoprotein cholesterol (ldl-c) and slow the progression of atherosclerosis in adults. - reduce ldl-c in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (hefh). - as an adjunct to other ldl-c-lowering therapies, or alone if such treatments are unavailable, to reduce ldl-c in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (hofh). - as an adjunct to diet for the treatment of adults with: primary dysbetalipoproteinemia. hypertriglyceridemia. - primary dysbetalipoproteinemia. - hypertriglyceridemia. rosuvastatin tablets are contraindicated in the following conditions: - acute liver failure or decompensated cirrhosis [see warnings and precautions (5.3)] . - hypersensitivity to rosuvastatin or any excipients in rosuvastatin tablets. hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin tablets [see adverse reactions (6.1)] . risk summary discontinue rosuvastatin when pregnancy is recognized. alternatively, consider the ongoing therapeutic needs of the individual patient. rosuvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, rosuvastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see clinical pharmacology (12.1)] . in addition, treatment of hyperlipidemia is not generally necessary during pregnancy. atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations. published data from prospective and retrospective observational cohort studies with rosuvastatin use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see data) . in animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered rosuvastatin during the period of organogenesis at doses that resulted in systemic exposures equivalent to human exposures at the maximum recommended human dose (mrhd) of 40 mg/day, based on auc and body surface area (mg/m 2 ), respectively (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data a medicaid cohort linkage study of 1,152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity scorebased methods. the relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus. there were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders. in the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births. animal data in female rats given 5 mg/kg/day, 15 mg/kg/day and 50 mg/kg/day before mating and continuing through to gestation day 7 resulted in decreased fetal body weight (female pups) and delayed ossification at 50 mg/kg/day (10 times the human exposure at the mrhd dose of 40 mg/day based on auc). in pregnant rats given 2 mg/kg/day, 10 mg/kg/day and 50 mg/kg/day of rosuvastatin from gestation day 7 through lactation day 21 (weaning), decreased pup survival occurred at 50 mg/kg/day (dose equivalent to 12 times the mrhd of 40 mg/day based body surface area). in pregnant rabbits given 0.3 mg/kg/day, 1 mg/kg/day, and 3 mg/kg/day of rosuvastatin from gestation day 6 to day 18, decreased fetal viability and maternal mortality was observed at 3 mg/kg/day (dose equivalent to the mrhd of 40 mg/day based on body surface area). rosuvastatin crosses the placenta in rats and rabbits and is found in fetal tissue and amniotic fluid at 3% and 20%, respectively, of the maternal plasma concentration following a single 25 mg/kg oral gavage dose on gestation day 16 in rats. in rabbits, fetal tissue distribution was 25% of maternal plasma concentration after a single oral gavage dose of 1 mg/kg on gestation day 18. risk summary limited data from case reports in published literature indicate that rosuvastatin is present in human milk. there is no available information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. statins, including rosuvastatin, decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol and may cause harm to the breastfed infant. because of the potential for serious adverse reactions in a breastfed infant, based on the mechanism of action, advise patients that breastfeeding is not recommended during treatment with rosuvastatin [see use in specific populations (8.1)and clinical pharmacology (12.1)] . the safety and effectiveness of rosuvastatin as an adjunct to diet to reduce ldl-c have been established in pediatric patients 8 years of age and older with hefh. use of rosuvastatin for this indication is based on one 12-week controlled trial with a 40-week open-label extension period in 176 pediatric patients 10 years of age and older with hefh and one 2-year open-label, uncontrolled trial in 175 pediatric patients 8 years of age and older with hefh [see clinical studies (14)] . in the 1-year trial with a 12-week controlled phase, there was no detectable effect of rosuvastatin on growth, weight, bmi (body mass index), or sexual maturation in patients aged 10 to 17 years. the safety and effectiveness of rosuvastatin as an adjunct to other ldl-c-lowering therapies to reduce ldl-c have been established pediatric patients 7 years of age and older with hofh. use of rosuvastatin for this indication is based on a randomized, placebo-controlled, cross-over study in 14 pediatric patients 7 years of age and older with hofh [see clinical studies (14)] . the safety and effectiveness of rosuvastatin have not been established in pediatric patients younger than 8 years of age with hefh, younger than 7 years of age with hofh, or in pediatric patients with other types of hyperlipidemia (other than hefh or hofh). of the total number of rosuvastatin-treated patients in clinical studies, 3,159 (31%) were 65 years and older, and 698 (6.8%) were 75 years and older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. advanced age (≥65 years) is a risk factor for rosuvastatin-associated myopathy and rhabdomyolysis. dose selection for an elderly patient should be cautious, recognizing the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of myopathy. monitor geriatric patients receiving rosuvastatin for the increased risk of myopathy [see warnings and precautions (5.1)] . rosuvastatin exposure is not influenced by mild to moderate renal impairment (cl cr ≥ 30 ml/min/1.73 m 2 ). exposure to rosuvastatin is increased to a clinically significant extent in patients with severe renal impairment (cl cr < 30 ml/min/1.73 m 2 ) who are not receiving hemodialysis [ see clinical pharmacology (12.3) ]. renal impairment is a risk factor for myopathy and rhabdomyolysis. monitor all patients with renal impairment for development of myopathy. in patients with severe renal impairment not on hemodialysis, the recommended starting dosage is 5 mg daily and should not exceed 10 mg daily [see dosage and administration (2.5)and warnings and precautions (5.1)] . rosuvastatin is contraindicated in patients with acute liver failure or decompensated cirrhosis. chronic alcohol liver disease is known to increase rosuvastatin exposure. patients who consume substantial quantities of alcohol and/or have a history of liver disease may be at increased risk for hepatic injury [ see contraindications (4), warning and precautions (5.3) and clinical pharmacology (12.3) ]. pharmacokinetic studies have demonstrated an approximate 2-fold increase in median exposure to rosuvastatin in asian subjects when compared with white controls. adjust the rosuvastatin dosage in asian patients [ see dosage and administration (2.4) and clinical pharmacology (12.3) ].

Соединенные Штаты - английский - NLM (National Library of Medicine)

avpak - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 300 mg - gabapentin capsules, usp are indicated for: - management of postherpetic neuralgia in adults - adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy category c :  there are no adequate and well-controlled studies in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic when administered to pregnant animals at doses similar to or lower than those used clinically. gabapentin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. when pregnant mice received oral doses of gabapentin (500, 1000, or 3000 mg/kg/day) during the period of organogenesis, embryo-fetal toxicity (increased incidences of skeletal variations) was observed at the two highest doses. the no-effect dose for emb

Соединенные Штаты - английский - NLM (National Library of Medicine)

dusa - aminolevulinic acid hydrochloride (unii: v35kbm8jgr) (aminolevulinic acid - unii:88755taz87) - kit - 354 mg - the levulan kerastick for topical solution plus blue light illumination using the blu-u blue light photodynamic therapy illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses (grade 1 or 2, see table 2 for definition) of the face or scalp. the levulan kerastick for topical solution plus blue light illumination using the blu-u blue light photodynamic therapy illuminator is contraindicated in patients with cutaneous photosensitivity at wavelengths of 400-450 nm, porphyria or known allergies to porphyrins, and in patients with known sensitivity to any of the components of the levulan kerastick for topical solution.

Соединенные Штаты - английский - NLM (National Library of Medicine)

dusa pharmaceuticals, inc. - aminolevulinic acid hydrochloride (unii: v35kbm8jgr) (aminolevulinic acid - unii:88755taz87) - aminolevulinic acid hydrochloride 354 mg in 1.5 ml - the levulan kerastick for topical solution plus blue light illumination using the blu-u blue light photodynamic therapy illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face, scalp, or upper extremities. the levulan kerastick for topical solution plus blue light illumination using the blu-u blue light photodynamic therapy illuminator is contraindicated in patients with: risk summary limited available data with levulan kerastick topical solution use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. animal developmental toxicology studies were not conducted with aminolevulinic acid.  levulan kerastick solution has low systemic absorption following topical administration, and the risk of maternal use resulting in fetal exposure to the drug is unknown [see clinical pharmacology (12.3)]. the estimated background risk of major birth defects and miscarriage for the indicated population are unknown. all pregnancie

Соединенные Штаты - английский - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - rosuvastatin calcium (unii: 83mvu38m7q) (rosuvastatin - unii:413kh5zj73) - rosuvastatin 10 mg - pediatric use information for patients 7 to 17 years of age is approved for astrazeneca’s crestor (rosuvastatin calcium) tablets. however, due to astrazeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. rosuvastatin calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. rosuvastatin calcium tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (type iii hyperlipoproteinemia). rosuvastatin calcium tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., ldl apheresis) or alone if such treatments are unavailable to reduce ldl-c, total-c, and apob in adult patients with homozygous familial hypercholesterolemia. rosuvastatin calcium tablets have not been studied in fredrickson type i and v dyslipidemias. rosuvastatin calcium tablets are contraindicated in the following conditions: - patients with a known

Соединенные Штаты - английский - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - rosuvastatin calcium (unii: 83mvu38m7q) (rosuvastatin - unii:413kh5zj73) - pediatric use information for patients 7 to 17 years of age is approved for astrazeneca’s crestor (rosuvastatin calcium) tablets. however, due to astrazeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. rosuvastatin calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. rosuvastatin calcium tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (type iii hyperlipoproteinemia). rosuvastatin calcium tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., ldl apheresis) or alone if such treatments are unavailable to reduce ldl-c, total-c, and apob in adult patients with homozygous familial hypercholesterolemia. rosuvastatin calcium tablets have not been studied in fredrickson type i and v dyslipidemias. rosuvastatin calcium tablets are contraindicated in the following conditions: - patients with a known

Соединенные Штаты - английский - NLM (National Library of Medicine)

eugia us llc - nafcillin sodium (unii: 49g3001bck) (nafcillin - unii:4cnz27m7rv) - nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see clinical pharmacology - susceptibility test methods ) . nafcillin should not be used in infections caused by organisms susceptible to penicillin g. if the susceptibility tests indicate that the infection is due to methicillin-resistant staphylococcus sp., therapy with nafcillin for injection, usp should be discontinued and alternative therapy provided. to reduce the development of drug-resistant bacteria and maintain the effectiveness of nafcillin for injection, usp and other antibacterial drugs, nafcillin for injection, usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. a history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication.