Fluvastatin
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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.
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).
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 [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.
Sources
Fluvastatin Manufacturers
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Teva Pharmaceuticals Usa Inc
![Fluvastatin Capsule [Teva Pharmaceuticals Usa Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Fluvastatin | Teva Pharmaceuticals Usa Inc
2.1 General Dosing InformationDose range: 20 mg to 80 mg/day.
Fluvastatin capsules USP can be administered orally as a single dose, with or without food.
Do not open fluvastatin capsules USP prior to administration.
Do not take two fluvastatin capsules USP, 40 mg at one time.
Since the maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted according to the patient’s response to therapy and established treatment guidelines.
For patients requiring LDL-C reduction to a goal of ≥ 25%, the recommended starting dose is 40 mg as one capsule in the evening, or 80 mg in divided doses of the 40 mg capsule given twice daily. For patients requiring LDL-C reduction to a goal of < 25% a starting dose of 20 mg may be used.
2.2 Adult Patients With Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed DyslipidemiaAdult patients can be started on fluvastatin capsules USP. The recommended starting dose for fluvastatin capsules USP is one 40 mg capsule in the evening, or one fluvastatin capsule USP, 40 mg twice daily. Do not take two fluvastatin capsules USP, 40 mg at one time.
2.3 Pediatric Patients (10 to 16 Years of Age) With Heterozygous Familial HypercholesterolemiaThe recommended starting dose is one fluvastatin capsule USP, 20 mg. Dose adjustments, up to a maximum daily dose administered as fluvastatin capsules USP, 40 mg twice daily should be made at 6 week intervals. Doses should be individualized according to the goal of therapy [see NCEP Pediatric Panel Guidelines and CLINICAL STUDIES (14)]1.
1 National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Pediatrics. 89(3):495-501. 1992.
2.4 Use With CyclosporineDo not exceed a dose of 20 mg b.i.d. fluvastatin capsules USP in patients taking cyclosporine [see Drug Interactions (7.1)].
2.5 Use With FluconazoleDo not exceed a dose of 20 mg b.i.d. fluvastatin capsules USP in patients taking fluconazole [see Drug Interactions (7.2)].
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