Fluvastatin Sodium Er
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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 Sodium Capsules, USP and Fluvastatin Sodium Extended-Release Tablets, 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, 10-16 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
- there is a positive family history of premature cardiovascular disease or
- LDL-C remains ≥ 190 mg/dL or
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 Capsules, USP and Fluvastatin Sodium Extended-Release Tablets, USP are indicated to:
- reduce the risk of undergoing coronary revascularization procedures
- slow the progression of coronary atherosclerosis
Neither Fluvastatin Sodium Capsules, USP nor Fluvastatin Sodium Extended-Release Tablets, USP have 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. The empirical formula of fluvastatin sodium is C24H25FNO4•Na, its molecular weight is 433.46 and its structural formula is:
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 is a white to pale yellow, hygroscopic powder soluble in water, ethanol and methanol. Fluvastatin Sodium Extended-Release Tablets, USP are supplied as extended-release tablets containing fluvastatin sodium, equivalent to 80 mg of fluvastatin, for oral administration.
Active Ingredient: fluvastatin sodium, USP
Inactive Ingredients in extended-release tablets: microcrystalline cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, potassium bicarbonate, povidone, magnesium stearate, yellow iron oxide, titanium dioxide and polyethylene glycol 8000.
Sources
Fluvastatin Sodium Er Manufacturers
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Sandoz Inc
![Fluvastatin Sodium Er (Fluvastatin Sodium) Tablet, Extended Release [Sandoz Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Fluvastatin Sodium Er | Sandoz Inc
2.1 General Dosing InformationDose range: 20 mg to 80 mg/ day.
Fluvastatin sodium capsules / fluvastatin sodium extended-release tablets can be administered orally as a single dose, with or without food.
Do not break, crush or chew fluvastatin sodium extended-release tablets or open fluvastatin sodium capsules prior to administration.
Do not take two fluvastatin sodium capsules 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, 80 mg as one fluvastatin sodium extended-release tablet administered as a single dose at any time of the day 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 either fluvastatin sodium capsules or fluvastatin sodium extended-release tablets. The recommended starting dose for fluvastatin sodium capsules is one 40 mg capsule in the evening, or one fluvastatin sodium capsule 40 mg twice daily. Do not take two fluvastatin sodium capsules 40 mg at one time.
The recommended starting dose for fluvastatin sodium extended-release tablets is one 80 mg tablet administered as a single dose at any time of the day.
2.3 Pediatric Patients (10-16 years of age) with Heterozygous Familial HypercholesterolemiaThe recommended starting dose is one fluvastatin sodium capsule 20 mg. Dose adjustments, up to a maximum daily dose administered either as fluvastatin sodium capsules 40 mg twice daily or one fluvastatin sodium extended-release tablet 80 mg once 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.
1National 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 sodium capsules 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 sodium capsules in patients taking fluconazole [see Drug Interactions 7.2].
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