PRAVASTATIN SODIUM tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Sandoz Inc

INN (mednarodno ime):

PRAVASTATIN SODIUM

Sestava:

PRAVASTATIN SODIUM 10 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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: 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) ] . Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy shoul

Povzetek izdelek:

Pravastatin sodium tablets, USP are supplied as: 10 mg tablets: light brown, mottled, round tablets, debossed with HLP 10 on one side and plain on the other side. 20 mg tablets: light brown, mottled, round tablets, debossed with HLP 20 on one side and plain on the other side. 40 mg tablets: light brown, mottled, round tablets, debossed with HLP 40 on one side and plain on the other side. 80 mg tablets: light brown, mottled, oval, debossed with HLP 80 on one side, unscored. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET
SANDOZ INC
REFERENCE LABEL SET ID: D47B7E25-1DD3-41DC-886D-98F6EFC0C0BA
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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
INDICATIONS AND USAGE
Pravastatin sodium tablets are 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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Patients with Renal Impairment (2.3) 7/2016
Contraindications
Pregnancy (4.3), Lactation (4.4) 7/2016
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 sodium tablets have 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)
Childre