PRAVASTATIN SODIUM tablet PRAVASTATIN SODIUM- pravatatin tablet

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

NCS HealthCare of KY, LLC dba Vangard Labs

INN (Alþjóðlegt nafn):

PRAVASTATIN SODIUM

Samsetning:

PRAVASTATIN SODIUM 20 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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: - reduce the risk of myocardial infarction (MI). - reduce the risk of undergoing myocardial revascularization procedures. - reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes. In patients with clinically evident CHD, pravastatin sodium tablets are indicated to: - reduce the risk of total mortality by reducing coronary death. - reduce the risk of MI. - reduce the risk of undergoing myocardial revascularization procedures. - reduce the risk

Vörulýsing:

Pravastatin sodium tablets, USP are supplied as: 10 mg tablets: Yellow colored, circular shaped, flat faced tablets, with “G5” debossed on one side and “10” debossed on the other side. They are supplied in blistercards of 30 (NDC 0615-8158-39). 20 mg tablets: Yellow rounded-rectangular, biconvex tablets with “G5” debossed on one side and “20” debossed on the other side. They are supplied in blistercards of 30 (NDC 0615-8029-39) and in blistercards of 15 (NDC 0615-8029-05). 40 mg tablets: Green rounded-rectangular, biconvex tablets with “G5” debossed on one sideand “40” debossed on the other side. They are supplied in blistercards of 30 (NDC 0615-8030-39) and in blistercards of 15 (NDC 0615-8030-05). 80 mg tablets: Yellow oval, biconvex tablets with “G5” debossed on one side and “80” debossed on the other side. Store at 20o C to 25o C (68o F to 77o F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
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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
Warnings and Precautions
Immune-Mediated Necrotizing Myopathy (5.2)
INDICATIONS AND USAGE
Pravastatin sodium tablets are an HMG-CoA reductase inhibitor (statin)
indicated as an adjunctive therapy
to diet to:
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 patient 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)
Limitations of use:
Pravastatin sodium tablets USP have not been studied in _Fredrickson
_Types I and V dyslipidemias. (1.3)
DOSAGE AND ADMINISTRATION
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)
Children (ages 8 to 13 years, inclusive): the recommended starting
dose is 20 mg once daily. (2.4)
Adolescents (ages 14 to 18 years): the recommended starting dose is 40
mg once daily. (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 10 m