Fluvastatin Sodium

Fluvastatin Sodium

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Questions & Answers

Side Effects & Adverse Reactions

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Manufacturer Warnings

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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.

1.1 Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia

Fluvastatin capsules are indicated:

as an adjunct to diet to reduce elevated total cholesterol (Total-C), low density lipoprotein cholesterol (LDL-C), triglyceride (TG) and apolipoprotein B (Apo B) levels, and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb).
as an adjunct to diet to reduce Total-C, LDL-C, and Apo B levels in adolescent boys and adolescent girls who are at least one year post-menarche, 10 to 16 years of age, with heterozygous familial hypercholesterolemia and the following findings are present:
LDL-C remains ≥ 190 mg/dL or
LDL-C remains ≥ 160 mg/dL and:
there is a positive family history of premature cardiovascular disease or
two or more other cardiovascular disease risk factors are present

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.

1.2 Secondary Prevention of Cardiovascular Disease

In patients with clinically evident CHD, fluvastatin capsules are indicated to:

reduce the risk of undergoing coronary revascularization procedures
slow the progression of coronary atherosclerosis
1.3 Limitations of Use

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).

History

There is currently no drug history available for this drug.

Other Information

Fluvastatin sodium is a water-soluble cholesterol lowering agent which acts through the inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase.

Fluvastatin sodium is sodium (±)-(3R*, 5S*, 6E)-7-[3-(p-fluorophenyl)-1-isopropylindol-2-yl]-3,5-dihydroxy-6-heptanoate. The molecular formula of fluvastatin sodium is C24H25FNNaO4, its molecular weight is 433.45 and its structural formula is:

Fluvastatin Structural Formula

This molecular entity is the first entirely synthetic HMG-CoA reductase inhibitor, and is in part structurally distinct from the fungal derivatives of this therapeutic class.

Fluvastatin sodium, USP is an off-white to yellow, hygroscopic powder soluble in water, ethanol and methanol. Fluvastatin capsules contain fluvastatin sodium, equivalent to 20 mg or 40 mg of fluvastatin, for oral administration.

Active ingredient: fluvastatin sodium

Inactive ingredients in capsules: corn starch, crospovidone, gelatin, magnesium stearate, red iron oxide, sodium lauryl sulfate, talc, titanium dioxide and yellow iron oxide.

The imprinting ink contains the following: ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze.

Fluvastatin Sodium Manufacturers


  • Mylan Pharmaceuticals Inc.
    Fluvastatin Sodium (Fluvastatin) Capsule [Mylan Pharmaceuticals Inc.]
  • Carilion Materials Management
    Fluvastatin Sodium (Fluvastatin) Capsule [Carilion Materials Management]
  • Carilion Materials Management
    Fluvastatin Sodium (Fluvastatin) Capsule [Carilion Materials Management]
  • Mylan Pharmaceuticals Inc.
    Fluvastatin Sodium (Fluvastatin) Tablet, Film Coated, Extended Release [Mylan Pharmaceuticals Inc.]

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