PRAVASTATIN SODIUM tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Northwind Pharmaceuticals, LLC

Designación común internacional (DCI):

PRAVASTATIN SODIUM

Composición:

PRAVASTATIN SODIUM 40 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Pravastatin sodium tablets are indicated: - To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD). - To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD. - As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. - As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH). - As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia. - Primary dysbetalipoproteinemia. - Hypertriglyceridemia. - Acute liver failure or decompensated cirrhosis [see Warning

Resumen del producto:

Pravastatin sodium tablets, USP are supplied as: 40 mg tablets: Light-green, unscored, round tablet, debossed “TEVA” on one side and “7202” on the other side in bottles of 30 (NDC 51655-073-52). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. 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.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET
NORTHWIND PHARMACEUTICALS, LLC
----------
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
Contraindications, Pregnancy and Lactation Removed ( 4)
05/2022
Warnings and Precautions,
Immune-Mediated Necrotizing Myopathy Updated ( 5.2)
05/2022
INDICATIONS AND USAGE
Pravastatin sodium is an HMG-CoA reductase inhibitor (statin)
indicated ( 1):
To reduce the risk of myocardial infarction, myocardial
revascularization procedures, and cardiovascular
mortality in adults with elevated low-density lipoprotein cholesterol
(LDL-C) without clinically evident
coronary heart disease (CHD).
To reduce the risk of coronary death, myocardial infarction,
myocardial revascularization procedures,
stroke or transient ischemic attack, and slow the progression of
coronary atherosclerosis in adults with
clinically evident CHD.
As an adjunct to diet to reduce LDL-C in adults with primary
hyperlipidemia.
As an adjunct to diet to reduce LDL-C in pediatric patients ages 8
years and older with heterozygous
familial hypercholesterolemia (HeFH).
As an adjunct to diet for the treatment of adults with:
Primary dysbetalipoproteinemia.
Hypertriglyceridemia.
DOSAGE AND ADMINISTRATION
Take orally once daily at any time of the day, with or without food (
2.1).
For patients that require a high-intensity statin or are unable to
achieve their LDL-C goal receiving
pravastatin sodium tablets 80 mg daily, prescribe alternative
LDL-C-lowering treatment ( 2.1).
Assess LDL-C when clinically appropriate, as early as 4 weeks after
initiating pravastatin sodium tablets,
and adjust the dosage if necessary ( 2.1).
Adults: recommended starting dosage is pravastatin sodium tablets
40 mg to 80 mg once daily. ( 2.2)
Pediatric Patients ( 2.3):
aged 8 to 13 years, the rec