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

medis pharma pty ltd - atorvastatin calcium trihydrate, quantity: 86.8 mg - tablet, film coated - excipient ingredients: povidone; microcrystalline cellulose; sodium carbonate; crospovidone; glycerol dibehenate; magnesium stearate; titanium dioxide; hypromellose; macrogol 6000 - atorvastatin is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia. prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated. ,atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (chd) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see clinical trials, prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.,these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

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

medis pharma pty ltd - atorvastatin calcium trihydrate, quantity: 86.8 mg - tablet, film coated - excipient ingredients: magnesium stearate; glycerol dibehenate; crospovidone; microcrystalline cellulose; povidone; sodium carbonate; titanium dioxide; hypromellose; macrogol 6000 - atorvastatin is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia. prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated. ,atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (chd) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see clinical trials, prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.,these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

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

medis pharma pty ltd - atorvastatin calcium trihydrate, quantity: 86.8 mg - tablet, film coated - excipient ingredients: povidone; crospovidone; microcrystalline cellulose; glycerol dibehenate; magnesium stearate; sodium carbonate; titanium dioxide; hypromellose; macrogol 6000 - atorvastatin is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia. prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated. ,atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (chd) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see clinical trials, prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.,these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

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

medis pharma pty ltd - atorvastatin calcium trihydrate, quantity: 86.8 mg - tablet, film coated - excipient ingredients: magnesium stearate; povidone; microcrystalline cellulose; glycerol dibehenate; crospovidone; sodium carbonate; titanium dioxide; hypromellose; macrogol 6000 - atorvastatin is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia. prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated. ,atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (chd) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see clinical trials, prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.,these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

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

medis pharma pty ltd - atorvastatin calcium trihydrate, quantity: 86.8 mg - tablet, film coated - excipient ingredients: magnesium stearate; povidone; sodium carbonate; microcrystalline cellulose; crospovidone; glycerol dibehenate; titanium dioxide; hypromellose; macrogol 6000 - atorvastatin is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia. prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated. ,atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (chd) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see clinical trials, prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.,these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

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

greenstone llc - 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)

major pharmaceuticals - 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)].

United States - English - 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

Malta - English - Medicines Authority

accord healthcare limited - atorvastatin calcium trihydrate - film-coated tablet - atorvastatin calcium trihydrate 40 mg - lipid modifying agents

Malta - English - Medicines Authority

accord healthcare limited - atorvastatin calcium trihydrate - film-coated tablet - atorvastatin calcium trihydrate 80 mg - lipid modifying agents