FLUVASTATIN SODIUM tablet, film coated, extended release

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Teva Pharmaceuticals USA, Inc.

INN (الاسم الدولي):

FLUVASTATIN SODIUM

تركيب:

FLUVASTATIN 80 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 sodium extended-release tablets 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 followi

ملخص المنتج:

Fluvastatin Sodium Extended-Release Tablets are available as: 80 mg - white to off-white, film-coated, round, unscored tablets, debossed with “TV” on one side of the tablet and “7446” on the other side of the tablet, in bottles of 30 (NDC 0093-7446-56) and 100 (NDC 0093-7446-01). Store and Dispense Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Protect from light.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

FLUVASTATIN SODIUM- FLUVASTATIN SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
TEVA PHARMACEUTICALS USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUVASTATIN SODIUM EXTENDED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR FLUVASTATIN SODIUM
EXTENDED-RELEASE TABLETS.
FLUVASTATIN SODIUM EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions (5.2) 9/2020
INDICATIONS AND USAGE
Fluvastatin sodium extended-release tablets are an HMG-CoA reductase
inhibitor (statin) indicated as an adjunctive therapy
to diet to:
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)
Limitations of Use:
Fluvastatin sodium extended-release tablets 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)
DOSAGE AND ADMINISTRATION
Dose range: 20 mg to 80 mg/day. (2.1)
Fluvastatin sodium extended-release tablets can be taken with or
without food and may be taken at any time of the day.
(2.1)
Do not break, crush or chew fluvastatin sodium extended-release
tablets prior to administration. (2.1)
Adults: the recommended starting dose is 80 mg (administered as one 80
mg fluvastatin sodium extended-release
tablet once daily). (2.2)
Children with heterozygous familial hypercholesterolemia (ages 10 to
16, inclusive): the recommended starting dose is
fluvastatin capsule 20 mg once daily. (2.3)
DOSAGE FORMS AND STRENGTHS
Fluva