ATORVASTATIN CALCIUM- atorvastatin tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

DIRECT RX

INN (International Name):

ATORVASTATIN CALCIUM

Composition:

ATORVASTATIN 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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

Product summary:

Atorvastatin calcium tablets of 10 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘121’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ATORVASTATIN CALCIUM- ATORVASTATIN TABLET, FILM COATED
DIRECT RX
----------
ATORVASTATIN
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 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 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 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
patients with primary hypercholesterolemia (heterozygous familial and
nonfamilial) and mixed
dyslipidemia (Fredrickson Types IIa and IIb);
As an adjunct to diet for the treatment of pa