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

alphapharm pty ltd - amlodipine besilate, quantity: 13.88 mg (equivalent: amlodipine, qty 10 mg); atorvastatin calcium trihydrate, quantity: 86.751 mg (equivalent: atorvastatin, qty 80 mg) - tablet, film coated - excipient ingredients: hyprolose; magnesium stearate; arginine; croscarmellose sodium; pregelatinised maize starch; microcrystalline cellulose; colloidal anhydrous silica; sodium carbonate; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin; indigo carmine aluminium lake - amlodipine besilate and atorvastatin calcium trihydrate tablet is indicated for patients in whom treatment with amlodipine and atorvastatin is appropriate at the doses presented.,the indications for amlodipine are:,1. hypertension: amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin converting enzyme inhibitor. 2. angina: amlodipine is indicated for the first line treatment of chronic stable angina. amlodipine may be used alone, as monotherapy or in combination with other antianginal drugs. the indications for atorvastatin are:,1. 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.,2. 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, clinical trials, atorvastatin component, 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)

alphapharm pty ltd - atorvastatin calcium trihydrate, quantity: 86.751 mg (equivalent: atorvastatin, qty 80 mg); amlodipine besilate, quantity: 6.94 mg (equivalent: amlodipine, qty 5 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; colloidal anhydrous silica; pregelatinised maize starch; magnesium stearate; arginine; microcrystalline cellulose; hyprolose; sodium carbonate; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin - amlodipine besilate and atorvastatin calcium trihydrate tablet is indicated for patients in whom treatment with amlodipine and atorvastatin is appropriate at the doses presented.,the indications for amlodipine are:,1. hypertension: amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin converting enzyme inhibitor. 2. angina: amlodipine is indicated for the first line treatment of chronic stable angina. amlodipine may be used alone, as monotherapy or in combination with other antianginal drugs. the indications for atorvastatin are:,1. 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.,2. 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, clinical trials, atorvastatin component, 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)

alphapharm pty ltd - atorvastatin calcium trihydrate, quantity: 86.751 mg (equivalent: atorvastatin, qty 80 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; colloidal anhydrous silica; microcrystalline cellulose; magnesium stearate; lactose; sodium carbonate; arginine; hyprolose; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin - lorstat 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.,lorstat 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) 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)

alphapharm pty ltd - atorvastatin calcium trihydrate, quantity: 86.751 mg (equivalent: atorvastatin, qty 80 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; colloidal anhydrous silica; microcrystalline cellulose; magnesium stearate; lactose; sodium carbonate; arginine; hyprolose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - lorstat 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.,lorstat 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, clinical trials) 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)

alphapharm pty ltd - atorvastatin calcium trihydrate, quantity: 86.751 mg (equivalent: atorvastatin, qty 80 mg) - tablet, film coated - excipient ingredients: sodium carbonate; lactose; microcrystalline cellulose; colloidal anhydrous silica; hyprolose; magnesium stearate; arginine; croscarmellose sodium; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - lorstat 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.,lorstat 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, clinical trials) 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.

Israel - English - Ministry of Health

teva pharmaceutical industries ltd, israel - atorvastatin as calcium - tablets - atorvastatin as calcium 10 mg - atorvastatin - atorvastatin - atorvastatin teva is indicated as an adjunct to diet for reduction of elevated total cholesterol ldl- cholesterol apolipoprotein b and triglycerides and to increase hdl cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types iia and iib of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. atorvastatin teva is also indicated to reduce total-c and ldl -c in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. ldl apheresis) or if such treatments are unavailable. pediatric patients (10-17 years of age) : atorvastatin is indicated as an adjunct to diet to reduce total -c ldl-c and apo b levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are prese

Israel - English - Ministry of Health

teva pharmaceutical industries ltd, israel - atorvastatin as calcium - tablets - atorvastatin as calcium 20 mg - atorvastatin - atorvastatin - atorvastatin teva is indicated as an adjunct to diet for reduction of elevated total cholesterol ldl- cholesterol apolipoprotein b and triglycerides and to increase hdl cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types iia and iib of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. atorvastatin teva is also indicated to reduce total-c and ldl -c in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. ldl apheresis) or if such treatments are unavailable. pediatric patients (10-17 years of age) : atorvastatin is indicated as an adjunct to diet to reduce total -c ldl-c and apo b levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are prese

Israel - English - Ministry of Health

teva pharmaceutical industries ltd, israel - atorvastatin as calcium - tablets - atorvastatin as calcium 40 mg - atorvastatin - atorvastatin - atorvastatin teva is indicated as an adjunct to diet for reduction of elevated total cholesterol ldl- cholesterol apolipoprotein b and triglycerides and to increase hdl cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types iia and iib of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. atorvastatin teva is also indicated to reduce total-c and ldl -c in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. ldl apheresis) or if such treatments are unavailable. pediatric patients (10-17 years of age) : atorvastatin is indicated as an adjunct to diet to reduce total -c ldl-c and apo b levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are prese

Israel - English - Ministry of Health

teva pharmaceutical industries ltd, israel - atorvastatin as calcium - tablets - atorvastatin as calcium 80 mg - atorvastatin - atorvastatin - atorvastatin teva is indicated as an adjunct to diet for reduction of elevated total cholesterol ldl- cholesterol apolipoprotein b and triglycerides and to increase hdl cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types iia and iib of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. atorvastatin teva is also indicated to reduce total-c and ldl -c in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. ldl apheresis) or if such treatments are unavailable. pediatric patients (10-17 years of age) : atorvastatin is indicated as an adjunct to diet to reduce total -c ldl-c and apo b levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are prese

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

pharmacor pty ltd - atorvastatin calcium trihydrate, quantity: 10.845 mg (equivalent: atorvastatin, qty 10 mg) - tablet, film coated - excipient ingredients: polysorbate 80; hyprolose; lactose monohydrate; microcrystalline cellulose; magnesium stearate; croscarmellose sodium; calcium carbonate; 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, 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.