PRAVASTATIN SODIUM- pravastatin sodium tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

REMEDYREPACK INC.

INN (mednarodno ime):

PRAVASTATIN SODIUM

Sestava:

PRAVASTATIN SODIUM 20 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

Pravastatin sodium tablets USP are supplied as: 10 mg tablets: Yellow colored, circular shaped tablets having flat surface, with “G5” debossed on one surface and “10” debossed on the other surface. They are supplied in bottles of 90 (NDC 68462-195-90) and bottles of 500 (NDC 68462-195-05). Bottles contain a desiccant canister. 20 mg tablets: Yellow rounded-rectangular tablets having biconvex surface, with “G5” debossed on one surface and “20” debossed on the other surface. They are supplied in bottles of 90 (NDC 68462-196-90) and bottles of 500 (NDC 68462-196-05). Bottles contain a desiccant canister. 40 mg tablets: Green rounded-rectangular tablets having biconvex surface, with “G5” debossed on one surface and “40” debossed on the other surface. They are supplied in bottles of 90 (NDC 68462-197-90) and bottles of 500 (NDC 68462-197-05). Bottles contain a desiccant canister. 80 mg tablets: Yellow oval tablets having biconvex surface, with “G5” debossed on one surface and “80” debossed on the other surface. They are supplied in bottles of 90 (NDC 68462-198-90) and bottles of 500 (NDC 68462-198-05). Bottles contain a desiccant canister. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET
REMEDYREPACK INC.
----------
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:
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)
Limitations of use:
Pravastatin sodium tablets 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. (