PRAVASTATIN SODIUM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

PRAVASTATIN SODIUM

Composition:

PRAVASTATIN SODIUM 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pravastatin sodium tablet is 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

Product summary:

Pravastatin sodium tablets, USP are supplied as: 20 mg tablets: Yellow coloured, mottled, rounded rectangular shaped, biconvex, uncoated tablets, debossed ‘PB’ on one side and ‘2’ on other side. They are supplied in bottles containing desiccant as follows. Store at 25°C (77°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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET
PD-RX PHARMACEUTICALS, 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
Contraindications, Pregnancy and Lactation Removed (4)
05/2022
Warnings and Precautions,
Immune-Mediated Necrotizing Myopathy Updated (5.2)
05/2022
INDICATIONS AND USAGE
Pravastatin 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 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, and adjust the
dosage if necessary (2.1).
Adults: recommended starting dosage is pravastatin 40 mg to 80 mg once
daily. (2.2)
Pediatric Patients (2.3):
aged 8 to 13 years, the recommended dosage is 20 mg once daily.
aged 14 to 18 years, the