ATORVASTATIN CALCIUM tablet ATORVASTATIN CALCIUM tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

DIRECT RX

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 Adults 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

Proizvod sažetak:

Atorvastatin calcium tablets, USP 10 mg are white, elliptical, film-coated tablets, debossed with ‘RX 12’ on one side and plain on the other side. These are supplied as follows: Atorvastatin calcium tablets, USP 20 mg are white, elliptical, film-coated tablets, debossed with ‘RX 828’ on one side and plain on the other side. These are supplied as follows: Atorvastatin calcium tablets, USP 40 mg are white, elliptical, film-coated tablets, debossed with ‘RX 829’ on one side and plain on the other side. These are supplied as follows: Atorvastatin calcium tablets, USP 80 mg are white, elliptical, film-coated tablets, debossed with ‘RX 830’ on one side and plain on the other side. These are supplied as follows: Storage Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature]. Dispense in tight containers (USP).

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET
ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET, FILM COATED
DIRECT RX
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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 Adults
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, but with multiple risk factors for coronary heart disease
such as retinopathy,
albuminuria, smoking, or hypertension, atorvastatin calcium tablets
are indicated to:
•
Reduce the risk of myocardial infarction
•
Reduce the risk of stroke
In adult patients with clinically evident coronary heart disease,
atorvastatin calcium
tablets are 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 are indicated:
•
As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG
levels and to
increase HDL-C in adult patients with primary hypercholesterolemia
(he