Fluvastatin Sodium

FLUVASTATIN SODIUM- fluvastatin sodium capsule
Mylan Pharmaceuticals Inc.

1 INDICATIONS AND USAGE

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, 10-16 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

170-199

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.

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).

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Information

Dose range: 20 mg to 80 mg/day.

Fluvastatin capsules can be administered orally as a single dose, with or without food.

Do not open fluvastatin capsules prior to administration.

Do not take two fluvastatin 40 mg capsules 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 Dyslipidemia

Adult patients can be started on fluvastatin capsules. The recommended starting dose for fluvastatin capsules is one 40 mg capsule in the evening, or one fluvastatin 40 mg capsule twice daily. Do not take two fluvastatin 40 mg capsules at one time.

2.3 Pediatric Patients (10-16 Years of Age) with Heterozygous Familial Hypercholesterolemia

The recommended starting dose is one 20 mg fluvastatin capsule. Dose adjustments, up to a maximum daily dose administered as fluvastatin capsules 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 Cyclosporine

Do not exceed a dose of 20 mg b.i.d. fluvastatin in patients taking cyclosporine [see Drug Interactions (7.1)].

2.5 Use with Fluconazole

Do not exceed a dose of 20 mg b.i.d. fluvastatin in patients taking fluconazole [see Drug Interactions (7.2)].

3 DOSAGE FORMS AND STRENGTHS

Fluvastatin Capsules, USP are available containing fluvastatin sodium, USP equivalent to 20 mg or 40 mg of fluvastatin.

The 20 mg capsules are hard-shell gelatin capsules with a pink opaque cap and an ivory opaque body filled with a light-yellow powder. The capsules are axially printed with MYLAN over 8020 in black ink on both the cap and the body.
The 40 mg capsules are hard-shell gelatin capsules with a pink opaque cap and an orange opaque body filled with a light-yellow powder. The capsules are axially printed with MYLAN over 8021 in black ink on both the cap and the body.

4 CONTRAINDICATIONS

4.1 Hypersensitivity to Any Component of This Medication

Fluvastatin capsules are contraindicated in patients with hypersensitivity to any component of this medication.

4.2 Active Liver Disease

Fluvastatin capsules are contraindicated in patients with active liver disease or unexplained, persistent elevations in serum transaminases [see Warnings and Precautions (5.2)].

4.3 Pregnancy

Fluvastatin capsules are contraindicated in women who are pregnant or may become pregnant. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol or cholesterol derivatives are essential for fetal development. Fluvastatin may cause fetal harm when administered to pregnant women. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia.

Fluvastatin capsules should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the patient becomes pregnant while taking this drug, fluvastatin capsules should be discontinued and the patient should be apprised of the potential hazard to the fetus [see Use In Specific Populations (8.1)].

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