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

ncs healthcare of ky, llc dba vangard labs - pravastatin sodium (unii: 3m8608uq61) (pravastatin - unii:kxo2kt9n0g) - pravastatin sodium 20 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 indicated 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 hypercholesterolemic patients without clinically evident coronary heart disease (chd), pravastatin sodium tablets are indicated to: - reduce the risk of myocardial infarction (mi). - reduce the risk of undergoing myocardial revascularization procedures. - reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes. in patients with clinically evident chd, pravastatin sodium tablets are indicated to: - reduce the risk of total mortality by reducing coronary death. - reduce the risk of mi. - reduce the risk of undergoing myocardial revascularization procedures. - reduce the risk

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

ncs healthcare of ky, inc dba vangard labs - pravastatin sodium (unii: 3m8608uq61) (pravastatin - unii:kxo2kt9n0g) - pravastatin sodium 20 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 indicated 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 hypercholesterolemic patients without clinically evident coronary heart disease (chd), pravastatin sodium tablets are indicated to: - reduce the risk of myocardial infarction (mi). - reduce the risk of undergoing myocardial revascularization procedures. - reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes. pravastatin sodium tablets are indicated: - as an adjunct to diet to reduce elevated total cholesterol (total-c), low-density lipoprotein cholesterol (ldl-c), apolipoprotein b (apob), and triglyceride (tg) levels and to increase high-density lipoprotein cholesterol

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

sandoz pty ltd - pravastatin sodium, quantity: 40 mg - tablet - excipient ingredients: lactose monohydrate; microcrystalline cellulose; iron oxide red; povidone; sodium lauryl sulfate; croscarmellose sodium; colloidal anhydrous silica; dibasic sodium phosphate; magnesium stearate - as an adjunct to diet for the treatment of hypercholesterolaemia. prior to initiating therapy with pravastatin, 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. patients with previous myocardial infarction including those who have normal (4.0 to 5.5 mmol/l) serum cholesterol levels. patients with unstable angina pectoris (see clinical trials). as an adjunct to diet and lifestyle modification for the treatment of heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older (see clinical trials).

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

lupin australia pty limited - pravastatin sodium, quantity: 40 mg - tablet, film coated - excipient ingredients: lactose monohydrate; crospovidone; sodium bicarbonate; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; macrogol 8000; purified talc; iron oxide yellow - 1. as an adjunct to diet for the treatment of hypercholesterolaemia. prior to initiating therapy with pravastatin-lupin, secondary causes of hypercholesterolaemia (eg, poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. 2. pravastatin-lupin is indicated in patients with previous myocardial infarction including those who have normal (4.0-5.5 mmol/l) serum cholesterol levels. 3. pravastatin-lupin is indicated in patients with unstable angina pectoris (see clinical trials). 4. pravastatin-lupin is indicated as an adjunct to diet and lifestyle modification for the treatment of heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older (see clinical trials).

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

dr reddys laboratories australia pty ltd - pravastatin sodium, quantity: 40 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; meglumine; crospovidone; magnesium stearate; croscarmellose sodium; titanium dioxide; hypromellose; macrogol 8000; purified talc - as an adjunct to diet for the treatment of hypercholesterolaemia. prior to initiating therapy with pravastatin, 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. pravastatin-drla is indicated in patients with previous myocardial infarction including those who have normal (4.0 to 5.5 mmol/l) serum cholesterol levels. pravastatin-drla is indicated in patients with unstable angina pectoris (see clinical trials). pravastatin-drla is indicated as an adjunct to diet and lifestyle modification for the treatment of heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older (see clinical trials).

Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - pravastatin sodium - tablet - pravastatin sodium 40 mg - lipid modifying agents

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

amneal pharma australia pty ltd - pravastatin sodium, quantity: 40 mg - tablet, uncoated - excipient ingredients: magnesium stearate; povidone; iron oxide yellow; microcrystalline cellulose; croscarmellose sodium; lactose monohydrate; heavy magnesium oxide - 1. as an adjunct to diet for the treatment of hypercholesterolaemia. prior to initiating therapy with pravastatin, secondary causes of hypercholesterolaemia (eg, poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.,2. pravastatin is indicated in patients with previous myocardial infarction including those who have normal (4.0 ? 5.5 mmol/l) serum cholesterol levels.,3. pravastatin is indicated in patients with unstable angina pectoris (see clinical trials).,4. pravastatin is indicated as an adjunct to diet and lifestyle modification for the treatment of heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older (see clinical trials).

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

arrotex pharmaceuticals pty ltd - pravastatin sodium, quantity: 40 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; iron oxide yellow; brilliant blue fcf - as an adjunct to diet for the treatment of hypercholesterolaemia. prior to initiating therapy with pravastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephritic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. patients with previous myocardial infarction including those who have normal (4.0 to 5.5 mmol / l) serum cholesterol levels. patients with unstable angina pectoris. as an adjunct to diet and lifestyle modification for the treatment of heterozygenous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older.

New Zealand - English - Medsafe (Medicines Safety Authority)

clinect nz pty limited - pravastatin sodium 40mg - tablet - 40 mg - active: pravastatin sodium 40mg excipient: brilliant blue fcf croscarmellose sodium iron oxide yellow lactose monohydrate magnesium stearate microcrystalline cellulose - in hypercholesterolemic patients without clinically evident coronary heart disease, pravastatin is indicated as an adjunct to diet to reduce the risk of fatal and non-fatal myocardial infarction, need for myocardial revascularisation procedures, and to improve survival by reducing cardiovascular deaths.

Israel - English - Ministry of Health

teva israel ltd - pravastatin sodium - tablets - pravastatin sodium 40 mg - hmg coa reductase inhibitors - pravastatin is indicated as a component of multiple risk factor intervention in those individuals at increased risk for atherosclerotic vascular disease due to hypercholesterolemia . pravastatin should be used in addition to a diet restricted in saturated fat and cholesterol when the response to diet and other nonpharmacological measures alone has been inadequate. *primary prevention of coronary events: in hypercholesterolemic patients whthout clinically evident coronary heart disease pravastatin is indicated to: - reduce the risk of myocardial infarcton. - reduce the risk for revascularization. - reduce the risk of deaths due to cardiovascular causes with no increase in deaths from non-cardiovascular causes. *secondary prevention of cardiovascular events: atherosclerosis: in hypercholesterolemic patients with clinically evident coronary artery disease including prior mi pravastatin is indicated to: - slow the progression of coronary atherosclerosis. - reduce the risk of acute coronary events. myocardial infarction: in patients with previous myocardial infarction and normal cholesterol levels pravastatin is indicated to: - reduce the risk of recurrent myocardial infarction. - reduce the risk of undergoing myocardial revascularization procedures. - reduce the risk of stroke and transient ischemic attack (tia). *hypercholesterolemia and mixed dyslipidemia: pravastatin is indicated as an adjunct to diet to reduce elevated total-c ldl-c and tg levels in patients with primary hypercholesterolemia and mixed dyslipidemia (fredrickson type iia and iib).