FLUVASTATIN SODIUM ER- fluvastatin sodium tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLUVASTATIN SODIUM (UNII: PYF7O1FV7F) (FLUVASTATIN - UNII:4L066368AS)

Available from:

Sandoz Inc

INN (International Name):

FLUVASTATIN SODIUM

Composition:

FLUVASTATIN 80 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 non-pharmacologic measures alone has been inadequate. Fluvastatin Sodium Capsules, USP and Fluvastatin Sodium Extended-Release Tablets, USP are indicated The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature CVD is summarized below. Category Total-C (mg/dL) LDL-C (mg/dL) Acceptable <170 <110 Borderline 170-199 110-129 High ≥200 ≥130 Children treated with fluvastatin in adolescence should be re-evaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult treatment goals. In patients with clinically evident CHD, Fluvastatin Sodium Capsules, USP and Fluvas

Product summary:

Fluvastatin Sodium Extended-Release Tablets, USP 80 mg Yellow, round, slightly biconvex film-coated tablet with beveled edges debossed with “LESCOL XL” on one side and “80” on the other. Bottles of 30 tablets………………………………………………………………………………….....NDC 0781-5370-31 Bottles of 100 tablets…………………………………………………………………………………...NDC 0781-5370-01 Store and Dispense Store at 25ºC (77ºF); excursions permitted to 15 -30ºC (59 -86ºF) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from light.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

FLUVASTATIN SODIUM ER- FLUVASTATIN SODIUM TABLET, EXTENDED RELEASE
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUVASTATIN SODIUM EXTENDED-RELEASE
TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR FLUVASTATIN SODIUM EXTENDED-RELEASE
TABLETS, USP
FLUVASTATIN SODIUM EXTENDED-RELEASE TABLETS, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1993/ 2000
INDICATIONS AND USAGE
Fluvastatin Sodium Capsules, USP / Fluvastatin Sodium Extended-Release
Tablets, USP 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
Fluvastatin sodium extended-release tablets: 80 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Reduce elevated TC, LDL-C, Apo B, and TG, and to increase HDL-C in
adult patients with primary
hypercholesterolemia and mixed dyslipidemia (1.1)
Reduce elevated TC, LDL-C, and Apo B levels in boys and post-menarchal
girls, 10 to 16 years of age, with
heterozygous familial hypercholesterolemia after failing an adequate
trial of diet therapy (1.1)
Reduce the risk of undergoing revascularization procedures in patients
with clinically evident CHD (1.2)
Slow the progression of atherosclerosis in patients with CHD (1.2)
Neither Fluvastatin Sodium Capsules, USP nor Fluvastatin Sodium
Extended-Release Tablets, USP have been
studied in conditions where the major abnormality is elevation of
chylomicrons, VLDL, or IDL (i.e.,
hyperlipoproteinemia Types I, III, IV, or V) (1.3)
Dose range: 20 mg to 80 mg/ day (2.1)
Fluvastatin sodium capsules / fluvastatin sodium extended-release
tablets can be taken with or without food. Only
fluvastatin sodium extended-release tablets may be taken at any time
of the day (2.1)
Do not break, crush or chew fluvastatin sodium extended-release
tablets or open fluvastatin sodium capsules prior to
administration (2.1)
Adults: th