ATORVASTATIN CALCIUM tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Osta se nyt

Valmisteyhteenveto Valmisteyhteenveto (SPC)
10-10-2019

Aktiivinen ainesosa:

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

Saatavilla:

DirectRX

INN (Kansainvälinen yleisnimi):

ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE

Koostumus:

ATORVASTATIN 80 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

- 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 clini

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

                                ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET, FILM COATED
DIRECTRX
----------
ATORVASTATIN CALCIUM
INDICATIONS & USAGE SECTION
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 
                                
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