ATORVASTATIN CALCIUM tablet, film coated

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F)

Fáanlegur frá:

DIRECT RX

INN (Alþjóðlegt nafn):

ATORVASTATIN CALCIUM TRIHYDRATE

Samsetning:

ATORVASTATIN 10 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

Atorvastatin Calcium Tablets are supplied as white, round, film-coated tablets of atorvastatin calcium containing 10, 20, 40, and 80 mg atorvastatin. 10 mg tablets: debossed with "1" on one side and plain on the other. NDC 62175-890-46 bottles of 90 NDC 62175-890-43 bottles of 1000 NDC 62175-890-45 bottles of 5000 20 mg tablets: debossed with "2" on one side and plain on the other. NDC 62175-891-46 bottles of 90 NDC 62175-891-43 bottles of 1000 NDC 62175-891-45 bottles of 5000 40 mg tablets: debossed with "40" on one side and plain on the other. NDC 62175-892-46 bottles of 90 NDC 62175-892-41 bottles of 500 NDC 62175-892-44 bottles of 2500 80 mg tablets: debossed with "80" on one side and plain on the other. NDC 62175-897-46 bottles of 90 NDC 62175-897-41 bottles of 500 NDC 62175-897-44 bottles of 2500 Storage Store at controlled room temperature 20 - 25°C (68 - 77°F) [see USP].

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET, FILM COATED
DIRECT RX
----------
ATORVASTATIN CALCIUM
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 clinically evident
coronary heart disease, but with multiple
risk factors for coronary heart disease such as retinopathy,
albuminuria, smoking, or hypertension,
Atorvastatin Calcium Tablets is indicated to:
Reduce the risk of myocardial infarction
Reduce the risk of stroke
In patients with clinically evident coronary heart disease,
Atorvastatin Calcium Tablets is 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
1.2 Hyperlipidemia
Atorvastatin Calcium Tablets is indicated:
As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG
levels and to increase HDL-C in
patients with primary hypercholesterolemia (heterozygous familial and
nonfamilial) and mixed
dyslipidemia (Fredrickson Types IIa and IIb);
As an adjunct to diet for the tre