Yhdysvallat - englanti - NLM (National Library of Medicine)

american health packaging - simvastatin (unii: agg2fn16ev) (simvastatin - unii:agg2fn16ev) - simvastatin 10 mg - simvastatin tablets usp are indicated: - to reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. - as an adjunct to diet to reduce low-density lipoprotein cholesterol (ldl-c): in adults with primary hyperlipidemia. in adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (hefh). - in adults with primary hyperlipidemia. - in adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (hefh). - as an adjunct to other ldl-c-lowering therapies to reduce ldl-c in adults with homozygous familial hypercholesterolemia (hofh). - as an adjunct to diet for the treatment of adults with: primary dysbeta

Yhdysvallat - englanti - NLM (National Library of Medicine)

cardinal health 107, llc - atorvastatin calcium propylene glycol solvate (unii: yrz789owmi) (atorvastatin - unii:a0jwa85v8f) - atorvastatin 10 mg - atorvastatin calcium tablets are indicated: risk summary discontinue atorvastatin calcium when pregnancy is recognized. alternatively, consider the ongoing therapeutic needs of the individual patient. atorvastatin calcium decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, atorvastatin calcium 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 atorvastatin calcium tablets 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 atorvastatin at doses that resulted in up to 30 and 20 times, respectively, the human exposure at the maximum recommended human dose (mrhd) of 80 mg, based on body surface area (mg/m2 ). in rats administered atorvastatin during gestation and lactation, decreased postnatal growth and development delay were observed at doses ≥ 6 times the mrhd (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 1152 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 score-based 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 atorvastatin was administered to pregnant rats and rabbits during organogenesis at oral doses up to 300 mg/kg/day and 100 mg/kg/day, respectively. atorvastatin was not teratogenic in rats at doses up to 300 mg/kg/day or in rabbits at doses up to 100 mg/kg/day. these doses resulted in multiples of about 30 times (rat) or 20 times (rabbit) the human exposure at the mrhd based on surface area (mg/m2 ). in rats, the maternally toxic dose of 300 mg/kg resulted in increased post-implantation loss and decreased fetal body weight. at the maternally toxic doses of 50 and 100 mg/kg/day in rabbits, there was increased post-implantation loss, and at 100 mg/kg/day fetal body weights were decreased. in a study in pregnant rats administered 20, 100, or 225 mg/kg/day from gestation day 7 through to lactation day 20 (weaning), there was decreased survival at birth, postnatal day 4, weaning, and post-weaning in pups of mothers dosed with 225 mg/kg/day, a dose at which maternal toxicity was observed. pup body weight was decreased through postnatal day 21 at 100 mg/kg/day, and through postnatal day 91 at 225 mg/kg/day. pup development was delayed (rotorod performance at 100 mg/kg/day and acoustic startle at 225 mg/kg/day; pinnae detachment and eye-opening at 225 mg/kg/day). these doses correspond to 6 times (100 mg/kg) and 22 times (225 mg/kg) the human exposure at the mrhd, based on auc. atorvastatin crosses the rat placenta and reaches a level in fetal liver equivalent to that of maternal plasma. risk summary there is no information about the presence of atorvastatin in human milk,  the effects of the drug on the breastfed infant or the effects of the drug on milk production. however, it has been shown that another drug in this class passes into human milk. studies in rats have shown that atorvastatin and/or its metabolites are present in the breast milk of lactating rats. when a drug is present in animal milk, it is likely that the drug will be present in human milk (see data). statins, including atorvastatin calcium, 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 atorvastatin calcium [see use in specific populations (8.1), clinical pharmacology (12.1)]. data following a single oral administration of 10 mg/kg of radioactive atorvastatin to lactating rats, the concentration of total radioactivity was determined. atorvastatin and/or its metabolites were measured in the breast milk and pup plasma at a 2:1 ratio (milk: plasma). the safety and effectiveness of atorvastatin calcium as an adjunct to diet to reduce ldl-c have been established pediatric patients 10 years of age and older with hefh. use of atorvastatin calcium for this indication is based on a double-blind, placebo-controlled clinical trial in 187 pediatric patients 10 years of age and older with hefh. in this limited controlled trial, there was no significant effect on growth or sexual maturation in the boys or girls, or on menstrual cycle length in girls.   the safety and effectiveness of atorvastatin calcium as an adjunct to other ldl-c-lowering therapies to reduce ldl-c have been established pediatric patients 10 years of age and older with hofh. use of atorvastatin calcium for this indication is based on a trial without a concurrent control group in 8 pediatric patients 10 years of age and older with hofh [see clinical studies (14)].   the safety and effectiveness of atorvastatin calcium have not been established in pediatric patients younger than 10 years of age with hefh or hofh, or in pediatric patients with other types of hyperlipidemia (other than hefh or hofh). of the total number of atorvastatin calcium tablets-treated patients in clinical trials, 15,813 (40%) were ≥65 years old and 2,800 (7%) were ≥75 years old. no overall differences in safety or effectiveness were observed between these patients and younger patients.   advanced age (≥65 years) is a risk factor for atorvastatin calcium tablets-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 atorvastatin calcium tablets for the increased risk of myopathy [see warnings and precautions (5.1) and clinical pharmacology (12.3)]. renal impairment is a risk factor for myopathy and rhabdomyolysis. monitor all patients with renal impairment for development of myopathy. renal impairment does not affect the plasma concentrations of atorvastatin, therefore there is no dosage adjustment in patients with renal impairment [see warnings and precautions (5.1) and clinical pharmacology (12.3)]. in patients with chronic alcoholic liver disease, plasma concentrations of atorvastatin are markedly increased. cmax and auc are each 4-fold greater in patients with childs-pugh a disease. cmax and auc are approximately 16-fold and 11-fold increased, respectively, in patients with childs-pugh b disease. atorvastatin calcium tablets are contraindicated in patients with acute liver failure or decompensated cirrhosis [see contraindications (4)].

Yhdysvallat - englanti - NLM (National Library of Medicine)

qpharma inc - atorvastatin calcium propylene glycol solvate (unii: yrz789owmi) (atorvastatin - unii:a0jwa85v8f) - atorvastatin 10 mg - atorvastatin calcium tablets are indicated: - to reduce the risk of: myocardial infarction (mi), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (chd) but without clinically evident chd mi and stroke in adults with type 2 diabetes mellitus with multiple risk factors for chd but without clinically evident chd non-fatal mi, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident chd - myocardial infarction (mi), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (chd) but without clinically evident chd - mi and stroke in adults with type 2 diabetes mellitus with multiple risk factors for chd but without clinically evident chd - non-fatal mi, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident

Yhdysvallat - englanti - NLM (National Library of Medicine)

legacy pharmaceutical packaging, llc - simvastatin (unii: agg2fn16ev) (simvastatin - unii:agg2fn16ev) - simvastatin 20 mg - simvastatin tablets usp are indicated: - to reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. - as an adjunct to diet to reduce low-density lipoprotein cholesterol (ldl-c): - in adults with primary hyperlipidemia. - in adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (hefh). - as an adjunct to other ldl-c-lowering therapies to reduce ldl-c in adults with homozygous familial hypercholesterolemia (hofh). - as an adjunct to diet for the treatment of adults with: - primary dysbetalipoproteinemia. - hypertriglyceridemia. simvastatin is contraindicated in the following conditions: - concomitant use of strong cyp3a4 inhibitors (select azole a

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

sun pharma anz pty ltd - rosuvastatin calcium, quantity: 41.581 mg - tablet, film coated - excipient ingredients: lactose monohydrate; sodium citrate dihydrate; magnesium stearate; microcrystalline cellulose; crospovidone; titanium dioxide; hypromellose; iron oxide red; macrogol 400 - rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate.,prevention of cardiovascular events,rosuvastatin is indicated for prevention of major cardiovascular events in men greater than or equal to 50 years old and women greater than or equal to 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low hdl-c, smoking, or a family history of premature coronary heart disease). rosuvastatin is indicated to:,? reduce the risk of nonfatal myocardial infarction,? reduce the risk of nonfatal stroke,? reduce the risk of coronary artery revascularisation procedures.,in patients with hypercholesterolaemia,rosuvastatin is indicated for the treatment of hypercholesterolaemia (excluding heterozygous familial hypercholesterolaemia).,prior to initiating therapy with rosuvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

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

sun pharma anz pty ltd - rosuvastatin calcium, quantity: 20.79 mg - tablet, film coated - excipient ingredients: lactose monohydrate; sodium citrate dihydrate; magnesium stearate; microcrystalline cellulose; crospovidone; titanium dioxide; hypromellose; iron oxide red; macrogol 400 - rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate.,prevention of cardiovascular events,rosuvastatin is indicated for prevention of major cardiovascular events in men greater than or equal to 50 years old and women greater than or equal to 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low hdl-c, smoking, or a family history of premature coronary heart disease). rosuvastatin is indicated to:,? reduce the risk of nonfatal myocardial infarction,? reduce the risk of nonfatal stroke,? reduce the risk of coronary artery revascularisation procedures.,in patients with hypercholesterolaemia,rosuvastatin is indicated for the treatment of hypercholesterolaemia (excluding heterozygous familial hypercholesterolaemia).,prior to initiating therapy with rosuvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

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

sun pharma anz pty ltd - rosuvastatin calcium, quantity: 5.198 mg - tablet, film coated - excipient ingredients: crospovidone; lactose monohydrate; microcrystalline cellulose; sodium citrate dihydrate; magnesium stearate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400 - rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate.,prevention of cardiovascular events,rosuvastatin is indicated for prevention of major cardiovascular events in men greater than or equal to 50 years old and women greater than or equal to 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low hdl-c, smoking, or a family history of premature coronary heart disease). rosuvastatin is indicated to:,? reduce the risk of nonfatal myocardial infarction,? reduce the risk of nonfatal stroke,? reduce the risk of coronary artery revascularisation procedures.,in patients with hypercholesterolaemia,rosuvastatin is indicated for the treatment of hypercholesterolaemia (excluding heterozygous familial hypercholesterolaemia).,prior to initiating therapy with rosuvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

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

sun pharma anz pty ltd - rosuvastatin calcium, quantity: 10.395 mg - tablet, film coated - excipient ingredients: sodium citrate dihydrate; magnesium stearate; lactose monohydrate; microcrystalline cellulose; crospovidone; titanium dioxide; hypromellose; iron oxide red; macrogol 400 - rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate.,prevention of cardiovascular events,rosuvastatin is indicated for prevention of major cardiovascular events in men greater than or equal to 50 years old and women greater than or equal to 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low hdl-c, smoking, or a family history of premature coronary heart disease). rosuvastatin is indicated to:,? reduce the risk of nonfatal myocardial infarction,? reduce the risk of nonfatal stroke,? reduce the risk of coronary artery revascularisation procedures.,in patients with hypercholesterolaemia,rosuvastatin is indicated for the treatment of hypercholesterolaemia (excluding heterozygous familial hypercholesterolaemia).,prior to initiating therapy with rosuvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

Yhdysvallat - englanti - NLM (National Library of Medicine)

international laboratories, llc - lovastatin (unii: 9lhu78oqfd) (lovastatin - unii:9lhu78oqfd) - lovastatin 10 mg - therapy with lovastatin tablets usp should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. lovastatin tablets usp should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-c and ldl-c to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. primary prevention of coronary heart disease in individuals without symptomatic cardiovascular disease, average to moderately elevated total-c and ldl-c, and below average hdl-c, lovastatin tablets usp are indicated to reduce the risk of: - myocardial infarction - unstable angina - coronary revascularization procedures (see clinical pharmacology , clinical studies in adults .) coronary heart disease lovastatin tablets usp are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment str

Yhdysvallat - englanti - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - lovastatin (unii: 9lhu78oqfd) (lovastatin - unii:9lhu78oqfd) - lovastatin 10 mg - therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. lovastatin should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-c and ldl-c to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. primary prevention of coronary heart disease in individuals without symptomatic cardiovascular disease, average to moderately elevated total-c and ldl-c, and below average hdl-c, lovastatin is indicated to reduce the risk of: -  myocardial infarction -  unstable angina -  coronary revascularization procedures (see clinical pharmacology, clinical studies.) coronary heart disease lovastatin is indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-c and ldl-c to target leve