ATORVASTATIN CALCIUM tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

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下载 资料单张 (PIL)
01-12-2017
下载 产品特点 (SPC)
01-12-2017

有效成分:

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

可用日期:

H. J. Harkins Company Inc.

INN(国际名称):

ATORVASTATIN CALCIUM TRIHYDRATE

组成:

ATORVASTATIN 80 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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

產品總結:

80 mg Tablets: Yellow, oval shape, biconvex, film coated tablets, debossed with SG on one side and 155 on other side. Bottles of 90         NDC 69097-947-05 Bottles of 500       NDC 69097-947-12 Storage Store at 20°C to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, child-resistant container.

授权状态:

Abbreviated New Drug Application

资料单张

                                ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET, FILM COATED
H. J. Harkins Company Inc.
----------
SPL MEDGUIDE
PATIENT INFORMATION
Atorvastatin Calcium Tablets
(a tor″ va stat′ in kal′ see um)
Read the Patient Information that comes with atorvastatin calcium
tablets before you start taking it and
each time you get a refill. There may be new information. This leaflet
does not take the place of talking
with your doctor about your condition or treatment.
If you have any questions about atorvastatin calcium tablets, ask your
doctor or pharmacist.
What is Atorvastatin Calcium Tablet?
Atorvastatin calcium tablets is a prescription medicine that lowers
cholesterol in your blood. It lowers the
LDL-C ("bad" cholesterol) and triglycerides in your blood. It can
raise your HDL-C ("good" cholesterol)
as well. Atorvastatin calcium tablets are for adults and children over
10 whose cholesterol does not come
down enough with exercise and a low-fat diet alone.
Atorvastatin calcium tablets can lower the risk for heart attack,
stroke, certain types of heart surgery, and
chest pain in patients who have heart disease or risk factors for
heart disease such as:
age, smoking, high blood pressure, low HDL-C, heart disease in the
family.
Atorvastatin calcium tablets can lower the risk for heart attack or
stroke in patients with diabetes and risk
factors such as:
eye problems, kidney problems, smoking, or high blood pressure.
Atorvastatin calcium tablets starts to work in about 2 weeks.
What is Cholesterol?
Cholesterol and triglycerides are fats that are made in your body.
They are also found in foods. You need
some cholesterol for good health, but too much is not good for you.
Cholesterol and triglycerides can clog
your blood vessels. It is especially important to lower your
cholesterol if you have heart disease, smoke,
have diabetes or high blood pressure, are older, or if heart disease
starts early in your family.
Who Should Not Take Atorvastatin Calcium Tablets?
Do not take Atorvastatin Calcium Tablets if you:
are pregnant or t
                                
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产品特点

                                ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET, FILM COATED
H. J. HARKINS COMPANY INC.
----------
INDICATIONS AND USAGE
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 (heterozygous
familial and nonfamilial) and mixed
dyslipidemia (Fredrickson Typ
                                
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