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:

Preferred Pharmaceuticals Inc.

INN (International Name):

PRAVASTATIN SODIUM

Composition:

PRAVASTATIN SODIUM 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: In patients with clinically evident CHD, pravastatin sodium tablets are indicated to: Pravastatin sodium tablets are indicated: Pravastatin sodium tablets have not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons ( Fredrickson Types I and V). Hypersensitivity to any component of this medication. Active liver disease or unexplained, persistent elevations of serum transaminases [see Warnings and Precautions (5.2)

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 canister as follows. NDC Number Size 68788-7013-3 Bottle of 30 68788-7013-6 Bottle of 60 68788-7013-9 Bottle of 90 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
PREFERRED PHARMACEUTICALS INC.
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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
Dosage and Administration
Patients with Renal Impairment (2.3) 7/2016
Contraindications
Pregnancy (4.3), Lactation (4.4) 7/2016
INDICATIONS AND USAGE
Pravastatin is an HMG-CoA reductase inhibitor (statin) indicated as an
adjunctive therapy to diet to:
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Limitations of use:
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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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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)
Pravastatin has not been studied in _Fredrickson_ Types I and V
dyslipidemias. (1.3)
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