FLUVASTATIN SODIUM- fluvastatin capsule

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

FLUVASTATIN SODIUM (UNII: PYF7O1FV7F) (FLUVASTATIN - UNII:4L066368AS)

متاح من:

Mylan Pharmaceuticals Inc.

INN (الاسم الدولي):

FLUVASTATIN SODIUM

تركيب:

FLUVASTATIN 20 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 are indicated 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 capsules are indicated to: Fluvastatin capsules have not been studied in conditions where th

ملخص المنتج:

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. They are available as follows: NDC 0378-8020-93 bottles of 30 capsules NDC 0378-8020-77 bottles of 90 capsules 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. They are available as follows: NDC 0378-8021-93 bottles of 30 capsules NDC 0378-8021-77 bottles of 90 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

FLUVASTATIN SODIUM- FLUVASTATIN CAPSULE
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUVASTATIN CAPSULES SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUVASTATIN
CAPSULES.
FLUVASTATIN CAPSULES FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
Fluvastatin capsules are an HMG-CoA reductase inhibitor (statin)
indicated as an adjunctive therapy to diet to:
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Limitations of Use:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Reduce elevated TC, LDL-C, Apo B, and TG, and to increase HDL-C in
adult patients with primary
hypercholesterolemia and mixed dyslipidemia (1.1)
Reduce elevated TC, LDL-C, and Apo B levels in boys and post-menarchal
girls, 10 to 16 years of age, with
heterozygous familial hypercholesterolemia after failing an adequate
trial of diet therapy (1.1)
Reduce the risk of undergoing revascularization procedures in patients
with clinically evident CHD (1.2)
Slow the progression of atherosclerosis in patients with CHD (1.2)
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) (1.3)
Dose range: 20 mg to 80 mg/day (2.1)
Fluvastatin capsules can be taken with or without food
Do not open fluvastatin capsules prior to administration (2.1)
Adults: the recommended starting dose is 40 mg to 80 mg (administered
as one fluvastatin 40 mg capsule twice daily)
(2.2)
Do not take two fluvastatin 40 mg capsules at one time
Children with heterozygous familial hypercholesterolemia (ages 10 to
16, inclusive): the recommended starting dose
is fluvastatin capsule 20 mg once daily (2.3)
Fluvastatin Capsules: 20 mg, 40 mg (3)
Hypersensitivity to any component of this medication (4)
Active liver disease or unexplained, persistent elevations in serum
transam