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:

Glenmark Pharmaceuticals Inc., USA

INN (International Name):

PRAVASTATIN SODIUM

Composition:

PRAVASTATIN SODIUM 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Acute liver failure or decompensated cirrhosis [see Warnings and Precautions ( 5.3) ]. Hypersensitivity to any pravastatin or any excipients in pravastatin sodium tablets. Risk Summary Discontinue pravastatin sodium when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. pravastatin sodium decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, pravastatin sodium may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1)]. In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid- lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades o

Product summary:

Pravastatin Sodium Tablets, USP are supplied as: Strength How Supplied NDC Tablet Description 10 mg of pravastatin sodium, USP bottles of 90 68462-195-90 yellow colored, circular shaped, flat faced tablets with “G5” debossed on one side and “10” debossed on the other side. Bottles contain a desiccant canister. bottles of 500 68462-195-05 20 mg of pravastatin sodium, USP bottles of 90 68462-196-90 yellow, rounded-rectangular, biconvex tablets with “G5” debossed on one side and “20” debossed on the other side. Bottles contain a desiccant canister. bottles of 500 68462-196-05 40 mg of pravastatin sodium, USP bottles of 90 68462-197-90 green, rounded-rectangular, biconvex tablets with “G5” debossed on one side and “40” debossed on the other side. Bottles contain a desiccant canister. bottles of 500 68462-197-05 80 mg of pravastatin sodium, USP bottles of 90 68462-198-90 yellow, oval, biconvex tablets with “G5” debossed on one side and “80” debossed on the other side. Bottles contain a desiccant canister. bottles of 500 68462-198-05 Store at 20°C to 25°C (68°F to 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
GLENMARK PHARMACEUTICALS INC., USA
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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
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 tablets are an HMG-CoA reductase inhibitor (statin)
indicated (1):
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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.
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, and
adjust the dosage if necessary (2.1).
Adult