FLUVASTATIN SODIUM- fluvastatin tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals 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 extended-release tablets 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 extended-release tablets are indicated to: Fluvastatin sodium

Product summary:

Fluvastatin Sodium Extended-Release Tablets are available containing fluvastatin sodium, USP equivalent to 80 mg of fluvastatin. The 80 mg tablets are rust, film-coated, round, unscored tablets debossed with M on one side of the tablet and F21 on the other side. They are available as follows: NDC 0378-5121-93 bottles of 30 tablets NDC 0378-5121-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUVASTATIN SODIUM- FLUVASTATIN TABLET, FILM COATED, EXTENDED RELEASE
MYLAN PHARMACEUTICALS 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 SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR FLUVASTATIN SODIUM
EXTENDED-RELEASE TABLETS.
FLUVASTATIN SODIUM EXTENDED-RELEASE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Fluvastatin sodium extended-release 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
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)
Fluvastatin sodium extended-release tablets have not 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 extended-release tablets can be taken with or
without food. 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 prior to administration (2.1)
Adults: the recommended starting dose is 40 mg to 80 mg (administered
as one fluvastatin 40 mg capsule twice daily,
or one 80 mg fluvastatin sodium extended-release ta