PRAVASTATIN SODIUM tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Proficient Rx LP

INN (इंटरनेशनल नाम):

PRAVASTATIN SODIUM

रचना:

PRAVASTATIN SODIUM 20 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 USP are indicated to: Pravastatin sodium tablets USP are indicated: Pravastatin sodium tablets USP 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 sho

उत्पाद समीक्षा:

Pravastatin sodium tablets USP are supplied as: 20 mg tablets: White to off-white, capsule-shaped tablet with “PV20” on one side and “” on the other side. They are supplied as follow: NDC 63187-731-30-Bottles of 30 NDC 63187-731-60-Bottles of 60 NDC 63187-731-90-Bottles of 90 40 mg tablets: White to off-white, capsule-shaped tablet with “” on one side and “PV40” on the other side.  They are supplied as follow: NDC 63187-732-30-Bottles of 30 NDC 63187-732-60-Bottles of 60 NDC 63187-732-90-Bottles of 90 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

PRAVASTATIN SODIUM- PRAVASTATIN SODIUM TABLET
PROFICIENT RX LP
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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 USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
Pravastatin sodium tablets USP are HMG-CoA reductase inhibitors
(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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ADVERSE REACTIONS
In short-term clinical trials, the most commonly reported adverse
reactions (≥2% and > placebo) regardless of causality
were: musculoskeletal pain, nausea/vomiting, upper respiratory
infection, diarrhea, and headache. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT WATSON LABORATORIES,
INC. AT 1-800-272-5525 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Reduce the risk of MI, revascularization, and cardiovascular mortality
in hypercholesterolemic patients without
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 USP 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 10 mg
once daily. (2.2)
Child