ATORVASTATIN CALCIUM tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

RedPharm Drug, Inc.

INN (Tên quốc tế):

ATORVASTATIN CALCIUM

Thành phần:

ATORVASTATIN 40 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 wi

Tóm tắt sản phẩm:

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. Bottles of 30 NDC 55111-121-30 Bottles of 60 NDC 55111-121-60 Bottles of 90 NDC 55111-121-90 Bottles of 500 NDC 55111-121-05 Bottles of 1000 NDC 55111-121-10 Atorvastatin calcium tablets of 20 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘122’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s. Bottles of 30 NDC 55111-122-30 Bottles of 60 NDC 55111-122-60 Bottles of 90 NDC 55111-122-90 Bottles of 500 NDC 55111-122-05 Bottles of 1000 NDC 55111-122-10 Atorvastatin calcium tablets of 40 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘123’ on other side and are supplied in bottles of 30’s, 60’s, 90’s, 500's and 1000’s. Bottles of 30 NDC 55111-123-30 Bottles of 60 NDC 55111-123-60 Bottles of 90 NDC 55111-123-90 Bottles of 500 NDC 55111-123-05 Bottles of 1000 NDC 55111-123-10 Storage Store atorvastatin calcium tablets at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

ATORVASTATIN CALCIUM- ATORVASTATIN CALCIUM TABLET
REDPHARM DRUG, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ATORVASTATIN
CALCIUM TABLETS safely and effectively. See full prescribing
information for
ATORVASTATIN CALCIUM TABLETS.
ATORVASTATIN CALCIUM tablets, for oral administration
Initial U.S. Approval: 1996
INDICATIONS AND USAGE
Atorvastatin calcium tablet is an inhibitor of HMG-CoA reductase
(statin) indicated as an
adjunct therapy to diet to:
Reduce the risk of MI, stroke, revascularization procedures, and
angina in patients
without CHD, but with multiple risk factors (1.1).
Reduce the risk of MI and stroke in patients with type 2 diabetes
without CHD, but with
multiple risk factors (1.1).
Reduce the risk of non-fatal MI, fatal and non-fatal stroke,
revascularization procedures,
hospitalization for CHF, and angina in patients with CHD (1.1).
Reduce elevated total-C, LDL-C, apo B, and TG levels and increase
HDL-C in adult
patients with primary hyperlipidemia (heterozygous familial and
nonfamilial) and mixed
dyslipidemia (1.2).
Reduce elevated TG in patients with hypertriglyceridemia and primary
dysbetalipoproteinemia (1.2).
Reduce total-C and LDL-C in patients with homozygous familial
hypercholesterolemia
(HoFH) (1.2).
Reduce elevated total-C, LDL-C, and apo B levels in boys and
postmenarchal girls, 10 to
17 years of age, with heterozygous familial hypercholesterolemia after
failing an
adequate trial of diet therapy (1.2).
Limitations of Use
Atorvastatin calcium tablets have not been studied in Fredrickson
Types I and V
dyslipidemias.
DOSAGE AND ADMINISTRATION
Dose range: 10 to 80 mg once daily (2.1).
Recommended start dose: 10 or 20 mg once daily (2.1).
Patients requiring large LDL-C reduction (>45%) may start at 40 mg
once daily (2.1).
Pediatric starting dose: 10 mg once daily; maximum recommended dose:
20 mg once
daily (2.2).
DOSAGE FORMS AND STRENGTHS
10, 20 and 40 mg tablets (3).
CONTRAINDICATIONS
Active liver disease, which may i