PRAVASTATIN SODIUM tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G)

Sẵn có từ:

Cardinal Health 107, LLC

INN (Tên quốc tế):

PRAVASTATIN SODIUM

Thành phần:

PRAVASTATIN SODIUM 20 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 indicated 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 hypercholesterolemic patients without clinically evident coronary heart disease (CHD), pravastatin sodium tablets are indicated to: In patients with clinically evident CHD, pravastatin sodium tablets are indicated to: Pravastatin sodium tablets are indicated: Pravastatin sodium tablets have not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons ( Fredrickson Types I and V). Hypersensitivity to any component of this medication. Active liver disease or unexplained, persistent elevations of serum transaminases [ see Warnings and Precautions (

Tóm tắt sản phẩm:

Pravastatin sodium tablets USP are supplied as: 20 mg tablets: Light-yellow, unscored, round tablet, debossed “TEVA” on one side and “7201” on the other side. They are available as follows: Overbagged with 10 tablets per bag, NDC 55154-5365-0 40 mg tablets: Light-green, unscored, round tablet, debossed “TEVA” on one side and “7202” on the other side. They are available as follows: Overbagged with 10 tablets per bag, NDC 55154-5370-0 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET
CARDINAL HEALTH 107, LLC
REFERENCE LABEL SET ID: 24B45003-6E3E-4AEB-A091-2DA8A9F8D4F8
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRAVASTATIN SODIUM
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PRAVASTATIN SODIUM
TABLETS.
PRAVASTATIN SODIUM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Dosage and Administration
Patients with Renal Impairment ( 2.3)
7/2016
Contraindications
Pregnancy ( 4.3), Lactation ( 4.4)
7/2016
INDICATIONS AND USAGE
Pravastatin sodium tablets are an HMG-CoA reductase inhibitor (statin)
indicated as an adjunctive therapy
to diet to:
7.
8.
9.
10.
11.
12.
Limitations of use:
2.
DOSAGE AND ADMINISTRATION
5.
6.
7.
8.
DOSAGE FORMS AND STRENGTHS
2.
CONTRAINDICATIONS
5.
6.
7.
8.
WARNINGS AND PRECAUTIONS
Reduce the risk of MI, revascularization, and cardiovascular mortality
in hypercholesterolemic patients
without clinically evident CHD. ( 1.1)
Reduce the risk of total mortality by reducing coronary death, MI,
revascularization, stroke/TIA, and
the progression of coronary atherosclerosis in patients with
clinically evident CHD. ( 1.1)
Reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase
HDL-C in patients with primary
hypercholesterolemia and mixed dyslipidemia. ( 1.2)
Reduce elevated serum TG levels in patients with hypertriglyceridemia.
( 1.2)
Treat patients with primary dysbetalipoproteinemia who are not
responding to diet. ( 1.2)
Treat children and adolescent patients ages 8 years and older with
heterozygous familial
hypercholesterolemia after failing an adequate trial of diet therapy.
( 1.2)
Pravastatin sodium tablets have not been studied in _Fredrickson_
Types I and V dyslipidemias. ( 1.3)
Adults: the recommended starting dose is 40 mg once daily. Use 80 mg
dose only for patients not
reaching LDL-C goal with 40 mg. ( 2.2)
Significant renal impairment: the recommended starting dose is
pravastatin 10 mg once daily. ( 2.3