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

remedyrepack inc. - atorvastatin calcium trihydrate (unii: 48a5m73z4q) (atorvastatin - unii:a0jwa85v8f) - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. in patients with chd or multiple risk factors for chd, atorvastatin calcium tablets can be started simultaneously with diet. in adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low hdl-c, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to: - reduce the risk of myocardial infarction - reduce the risk of stroke - reduce the risk for revascularization procedures and angina in adult patients with type 2 diabetes, and without clinically evident coronary heart disease

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

remedyrepack inc. - atorvastatin calcium trihydrate (unii: 48a5m73z4q) (atorvastatin - unii:a0jwa85v8f) - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. in patients with chd or multiple risk factors for chd, atorvastatin calcium tablets can be started simultaneously with diet. in adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low hdl-c, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to: - reduce the risk of myocardial infarction - reduce the risk of stroke - reduce the risk for revascularization procedures and angina in adult patients with type 2 diabetes, and without clinically evident coronary heart disease

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

remedyrepack inc. - atorvastatin calcium trihydrate (unii: 48a5m73z4q) (atorvastatin - unii:a0jwa85v8f) - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. in patients with chd or multiple risk factors for chd, atorvastatin calcium tablets can be started simultaneously with diet. in adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low hdl-c, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to: - reduce the risk of myocardial infarction - reduce the risk of stroke - reduce the risk for revascularization procedures and angina in adult patients with type 2 diabetes, and without clinically evident coronary heart disease

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

preferred pharmaceuticals inc. - atorvastatin calcium trihydrate (unii: 48a5m73z4q) (atorvastatin - unii:a0jwa85v8f) - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. in patients with chd or multiple risk factors for chd, atorvastatin calcium tablets can be started simultaneously with diet. in adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low hdl-c, or a family history of early coronary heart disease, atorvastatin calcium tablets is indicated to: in patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, atorvastatin calcium

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

remedyrepack inc. - atorvastatin calcium trihydrate (unii: 48a5m73z4q) (atorvastatin - unii:a0jwa85v8f) - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. in patients with chd or multiple risk factors for chd, atorvastatin calcium tablets can be started simultaneously with diet. in adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low hdl-c, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to: - reduce the risk of myocardial infarction - reduce the risk of stroke - reduce the risk for revascularization procedures and angina in adult patients with type 2 diabetes, and without clinically evident coronary heart disease

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

remedyrepack inc. - atorvastatin calcium trihydrate (unii: 48a5m73z4q) (atorvastatin - unii:a0jwa85v8f) - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. in patients with chd or multiple risk factors for chd, atorvastatin calcium tablets can be started simultaneously with diet. in adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low hdl-c, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to: - reduce the risk of myocardial infarction - reduce the risk of stroke - reduce the risk for revascularization procedures and angina in adult patients with type 2 diabetes, and without clinically evident coronary heart disease

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

international laboratories, llc - atorvastatin calcium propylene glycol solvate (unii: yrz789owmi) (atorvastatin - unii:a0jwa85v8f) - atorvastatin 40 mg - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. in patients with chd or multiple risk factors for chd, atorvastatin calcium tablets can be started simultaneously with diet. in adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low hdl-c, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to: - reduce the risk of myocardial infarction - reduce the risk of stroke - reduce the risk for revascularization procedures and angina  in patients with type 2 diabetes, and without clinically evident coronary heart disease, but

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

direct rx - atorvastatin calcium trihydrate (unii: 48a5m73z4q) (atorvastatin - unii:a0jwa85v8f) - atorvastatin 10 mg - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. in patients with chd or multiple risk factors for chd, atorvastatin calcium tablets can be started simultaneously with diet. 1.1 prevention of cardiovascular disease in adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low hdl-c, or a family history of early coronary heart disease, atorvastatin calcium tablets is indicated to: reduce the risk of myocardial infarction reduce the risk of stroke reduce the risk for revascularization procedures and angina in patients with type 2 diabetes, and without cli

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

preferred pharmaceuticals inc. - atorvastatin calcium trihydrate (unii: 48a5m73z4q) (atorvastatin - unii:a0jwa85v8f) - atorvastatin 10 mg - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. in patients with chd or multiple risk factors for chd, atorvastatin calcium tablets can be started simultaneously with diet. in adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low hdl-c, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to: in adult patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, atorvastatin

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

remedyrepack inc. - atorvastatin calcium trihydrate (unii: 48a5m73z4q) (atorvastatin - unii:a0jwa85v8f) - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. in patients with chd or multiple risk factors for chd, atorvastatin calcium tablets can be started simultaneously with diet. in adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low hdl-c, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to: - reduce the risk of myocardial infarction - reduce the risk of stroke - reduce the risk for revascularization procedures and angina in adult patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, atorvastatin calcium tablets are indicated to: - reduce the risk of myocardial infarction - reduce the risk of stroke in adult patients with clinically evident coronary heart disease, atorvastatin calcium tablets are indicated to: - reduce the risk of non-fatal myocardial infarction - reduce the risk of fatal and non-fatal stroke - reduce the risk for revascularization procedures - reduce the risk of hospitalization for chf - reduce the risk of angina atorvastatin calcium tablets are indicated: - as an adjunct to diet to reduce elevated total-c, ldl-c, apo b, and tg levels and to increase hdl-c in adult patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia ( fredrickson types iia and iib); - as an adjunct to diet for the treatment of adult patients with elevated serum tg levels ( fredrickson type iv); - for the treatment of adult patients with primary dysbetalipoproteinemia ( fredrickson type iii) who do not respond adequately to diet; - to reduce total-c and ldl-c in patients with homozygous familial hypercholesterolemia (hofh) as an adjunct to other lipid-lowering treatments (e.g., ldl apheresis) or if such treatments are unavailable; - as an adjunct to diet to reduce total-c, ldl-c, and apo b levels in pediatric patients,10 years to 17 years of age, with heterozygous familial hypercholesterolemia (hefh) if after an adequate trial of diet therapy the following findings are present: ldl-c remains ≥ 190 mg/dl or ldl-c remains ≥ 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other cvd risk factors are present in the pediatric patient - ldl-c remains ≥ 190 mg/dl or - ldl-c remains ≥ 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other cvd risk factors are present in the pediatric patient - there is a positive family history of premature cardiovascular disease or - two or more other cvd risk factors are present in the pediatric patient atorvastatin calcium tablets have not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons ( fredrickson types i and v). - active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels - hypersensitivity to any component of this medication - pregnancy [see use in specific populations ( 8.1, 8.3)]. - lactation [see use in specific populations ( 8.2)] . risk summary atorvastatin is contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit of lipid lowering drugs during pregnancy. because hmg-coa reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, atorvastatin may cause fetal harm when administered to a pregnant woman. atorvastatin should be discontinued as soon as pregnancy is recognized [see   contraindications ( 4)] . limited published data on the use of atorvastatin are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. in animal reproduction studies in rats and rabbits there was no evidence of embryo-fetal toxicity or congenital malformations at doses 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/m 2 ). in rats administered atorvastatin during gestation and lactation, decreased postnatal growth and development was 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 limited published data on atorvastatin calcium from observational studies, meta-analyses and case reports 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 hmg-coa reductase inhibitors. 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 atorvastatin crosses the rat placenta and reaches a level in fetal liver equivalent to that of maternal plasma. 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/m 2 ). 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 (rotarod 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. risk summary atorvastatin use is contraindicated during breastfeeding [see   contraindications ( 4)]. there is no available information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. it is not known whether atorvastatin is present in human milk, but it has been shown that another drug in this class passes into human milk and atorvastatin is present in rat milk. because of the potential for serious adverse reactions in a breastfed infant, advise women that breastfeeding is not recommended during treatment with atorvastatin. contraception atorvastatin may cause fetal harm when administered to a pregnant woman. advise females of reproductive potential to use effective contraception during treatment with atorvastatin [see   use in specific populations ( 8.1)]. heterozygous familial hypercholesterolemia (hefh) the safety and effectiveness of atorvastatin have been established in pediatric patients,10 years to 17 years of age, with hefh as an adjunct to diet to reduce total cholesterol, ldl-c, and apo b levels when, after an adequate trial of diet therapy, the following are present: - ldl-c ≥ 190 mg/dl, or - ldl-c ≥ 160 mg/dl and a positive family history of fh, or premature cvd in a first, or second-degree relative, or two or more other cvd risk factors are present. - a positive family history of fh, or premature cvd in a first, or second-degree relative, or - two or more other cvd risk factors are present. use of atorvastatin for this indication is supported by evidence from [see dosage and administration ( 2.2), adverse reactions ( 6.1), clinical pharmacology ( 12.3), and clinical studies ( 14.6)] : - a placebo-controlled clinical trial of 6 months duration in 187 boys and postmenarchal girls,10 years to 17 years of age. patients treated with 10 mg or 20 mg daily atorvastatin had an adverse reaction profile generally similar to that of patients treated with placebo. in this limited controlled study, there was no significant effect on growth or sexual maturation in boys or on menstrual cycle length in girls. - a three year open-label uncontrolled trial that included 163 pediatric patients 10 to 15 years of age with hefh who were titrated to achieve a target ldl-c < 130 mg/dl. the safety and efficacy of atorvastatin in lowering ldl-c appeared generally consistent with that observed for adult patients, despite limitations of this uncontrolled stud design. advise postmenarchal girls of contraception recommendations, if appropriate for the patient [see use in specific populations ( 8.1), ( 8.3)] . the long-term efficacy of atorvastatin therapy initiated in childhood to reduce morbidity and mortality in adulthood has not been established. the safety and efficacy of atorvastatin have not been established in pediatric patients younger than 10 years of age with hefh. homozygous familial hypercholesterolemia (hofh) clinical efficacy of atorvastatin with dosages up to 80 mg/day for 1 year was evaluated in an uncontrolled study of patients with hofh including 8 pediatric patients [see clinical studies ( 14.5)].   of the 39,828 patients who received atorvastatin in clinical studies, 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 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 adults cannot be ruled out. since advanced age (≥65 years) is a predisposing factor for myopathy, atorvastatin should be prescribed with caution in the elderly. atorvastatin is contraindicated in patients with active liver disease which may include unexplained persistent elevations in hepatic transaminase levels [see contraindications ( 4) and clinical pharmacology ( 12.3)] .