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FDA Labeling Changes
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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 USP 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 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 capsules USP are indicated to:
- reduce the risk of undergoing coronary revascularization procedures
- slow the progression of coronary atherosclerosis
Fluvastatin capsules USP 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).
There is currently no drug history available for this drug.
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 [R*,S*-(E)]-(±)-7-[3-(4-fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxy-6-heptenoic acid, monosodium salt. Its structural formula is:
C24H25FNNaO4 M.W. 433.46
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 (hydrated form) is a white to pale yellow, brownish-pale yellow, or reddish-pale yellow, hygroscopic powder soluble in water, ethanol, and methanol. Fluvastatin capsules USP contain fluvastatin sodium (hydrated form), equivalent to 20 mg or 40 mg of fluvastatin, for oral administration.
Active Ingredient: fluvastatin sodium (hydrated form)
Inactive Ingredients: black iron oxide, colloidal silicon dioxide, crospovidone, gelatin, lactose monohydrate, magnesium stearate, propylene glycol, red iron oxide, shellac, titanium dioxide, and yellow iron oxide. The imprinting ink may contain potassium hydroxide.