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

pharmacor pty ltd - atorvastatin calcium trihydrate, quantity: 86.76 mg (equivalent: atorvastatin, qty 80 mg) - tablet, film coated - excipient ingredients: magnesium stearate; calcium carbonate; hyprolose; croscarmellose sodium; microcrystalline cellulose; lactose monohydrate; polysorbate 80; titanium dioxide; macrogol 8000; hypromellose; purified talc - 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 section 5.1, pharmacodynamic properties, 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)

mylan pharmaceuticals inc. - atorvastatin calcium trihydrate (unii: 48a5m73z4q) (atorvastatin - unii:a0jwa85v8f) - atorvastatin 10 mg - atorvastatin calcium tablets are indicated: discontinue atorvastatin calcium tablets when pregnancy is recognized. alternatively, consider the ongoing therapeutic needs of the individual patient. atorvastatin calcium tablets decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, atorvastatin calcium tablets 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 malformation

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

nucare pharmaceuticals,inc. - atorvastatin calcium trihydrate (unii: 48a5m73z4q) (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)

remedyrepack 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: - 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

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

arrotex pharmaceuticals pty ltd - atorvastatin calcium trihydrate, quantity: 86.76 mg (equivalent: atorvastatin, qty 80 mg) - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; calcium carbonate; hyprolose; microcrystalline cellulose; polysorbate 80; croscarmellose sodium; titanium dioxide; macrogol 8000; hypromellose; purified talc; purified water; sodium chloride; dimeticone 100; benzoic acid; sorbic acid; methylcellulose; polysorbate 65; glyceryl distearate; silicon dioxide; dimeticonol; peg-4 stearate - 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.,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)

arrotex pharmaceuticals pty ltd - atorvastatin calcium trihydrate, quantity: 43.38 mg (equivalent: atorvastatin, qty 40 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; polysorbate 80; croscarmellose sodium; magnesium stearate; hyprolose; candelilla wax; calcium carbonate; purified water; sodium chloride; dimeticone 100; benzoic acid; sorbic acid; methylcellulose; polysorbate 65; glyceryl distearate; silicon dioxide; dimeticonol; peg-4 stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc - 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.,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)

arrotex pharmaceuticals pty ltd - atorvastatin calcium trihydrate, quantity: 21.69 mg (equivalent: atorvastatin, qty 20 mg) - tablet, film coated - excipient ingredients: candelilla wax; lactose monohydrate; croscarmellose sodium; polysorbate 80; hyprolose; magnesium stearate; calcium carbonate; microcrystalline cellulose; purified water; sodium chloride; dimeticone 100; benzoic acid; sorbic acid; methylcellulose; polysorbate 65; glyceryl distearate; silicon dioxide; dimeticonol; peg-4 stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc - 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.,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)

arrotex pharmaceuticals pty ltd - atorvastatin calcium trihydrate, quantity: 10.845 mg (equivalent: atorvastatin, qty 10 mg) - tablet, film coated - excipient ingredients: candelilla wax; croscarmellose sodium; magnesium stearate; hyprolose; lactose monohydrate; microcrystalline cellulose; calcium carbonate; polysorbate 80; purified water; sodium chloride; dimeticone 100; benzoic acid; sorbic acid; methylcellulose; polysorbate 65; glyceryl distearate; silicon dioxide; dimeticonol; peg-4 stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc - 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.,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)

arrotex pharmaceuticals pty ltd - atorvastatin calcium trihydrate, quantity: 86.76 mg (equivalent: atorvastatin, qty 80 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; magnesium stearate; calcium carbonate; hyprolose; lactose monohydrate; polysorbate 80; croscarmellose sodium; purified water; sodium chloride; dimeticone 100; benzoic acid; sorbic acid; methylcellulose; polysorbate 65; glyceryl distearate; dimeticonol; peg-4 stearate; silicon dioxide; titanium dioxide; macrogol 8000; hypromellose; purified talc - 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.,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)

arrotex pharmaceuticals pty ltd - atorvastatin calcium trihydrate, quantity: 86.76 mg (equivalent: atorvastatin, qty 80 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; lactose monohydrate; calcium carbonate; polysorbate 80; microcrystalline cellulose; magnesium stearate; hyprolose; purified water; sodium chloride; dimeticone 100; benzoic acid; sorbic acid; methylcellulose; polysorbate 65; glyceryl distearate; dimeticonol; peg-4 stearate; silicon dioxide; titanium dioxide; macrogol 8000; hypromellose; purified talc - 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.,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.