FLUVASTATIN SODIUM- fluvastatin capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Carilion Materials Management

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 capsules 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 to 199 110 to 129 High ≥ 200 ≥ 130 Children treated with fluvastatin in adolescence should be reevaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult treatment goals. In patients with clinically evident CHD, fluvastatin capsules are indicated to: Fluvastatin capsules have not been studied in conditions wh

Product summary:

NDC:68151-1326-9 in a PACKAGE of 1 CAPSULES

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUVASTATIN SODIUM- FLUVASTATIN CAPSULE
CARILION MATERIALS MANAGEMENT
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUVASTATIN CAPSULES SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR FLUVASTATIN CAPSULES. FLUVASTATIN
CAPSULES, USP FOR ORAL USE INITIAL U.S.
APPROVAL: 1993
INDICATIONS AND USAGE
Fluvastatin capsules 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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ADVERSE REACTIONS
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 capsules 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 capsules can be taken with or without food.
Do not open fluvastatin capsules 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). ( ) 2.2
Do not take two fluvastatin 40 mg capsules at one time.
Children with heterozygous familial hypercholesterolemia (ages 10 to
16, inclusive): the recommended starting dose
is fluvastatin capsule 20 mg once daily. ( ) 2.3
Fluvastatin Capsules: 20 mg, 40 mg ( ) 3
Hypersensitivity to any component of this medication ( ) 4
Active liver disease or