PRAVASTATIN SODIUM tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

AvKARE

INN (Algemene Internationale Benaming):

PRAVASTATIN SODIUM

Samenstelling:

PRAVASTATIN SODIUM 10 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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

Product samenvatting:

Pravastatin sodium tablets USP are supplied as: 10 mg tablets: Pink, unscored, round tablet, debossed “TEVA” on one side and “771” on the other side in bottles of 90 (NDC 42291-665-90) and 1000 (NDC 42291-665-10). 20 mg tablets: Light-yellow, unscored, round tablet, debossed “TEVA” on one side and “7201” on the other side in bottles of 90 (NDC 42291-667-90) and 1000 (NDC 42291-667-10). 40 mg tablets: Light-green, unscored, round tablet, debossed “TEVA” on one side and “7202” on the other side in bottles of 90 (NDC 42291-668-90) and (NDC 42291-668-10) 1000. 80 mg tablets: Off-white to mottled grey, unscored, oval-shaped tablet, debossed “TEVA” on one side and “7270” on the other side in bottles of 45 (NDC 42291-669-45) ,90 (NDC 42291-669-90) and 1000 (NDC 42291-669-10). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET
AVKARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
PRAVASTATIN SODIUM TABLETS USP
RX ONLY
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