SIMVASTATIN tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV)

متاح من:

Cardinal Health 107, LLC

INN (الاسم الدولي):

SIMVASTATIN

تركيب:

SIMVASTATIN 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 nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets USP can be started simultaneously with diet. In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, simvastatin tablets USP are indicated to: Simvastatin tablets USP are indicated to: Simvastatin tablets USP are indicated as an adjunct to diet to reduce total-C, LDL-C, and Apo B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with HeFH, if after an adequate tri

ملخص المنتج:

Simvastatin tablets USP, 20 mg are tan colored, oval shaped, biconvex, film-coated tablets, debossed with ‘LL’ on one side and ‘C03’ on the other side. They are supplied as follows: Overbagged with 10 tablets per bag, NDC 55154-4782-0 Storage Store between 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

SIMVASTATIN- SIMVASTATIN TABLET, FILM COATED
CARDINAL HEALTH 107, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SIMVASTATIN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SIMVASTATIN TABLETS.
SIMVASTATIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Immune-Mediated Necrotizing Myopathy ( 5.2)
                9/2020
INDICATIONS AND USAGE
Simvastatin tablets USP are an HMG-CoA reductase inhibitor (statin)
indicated as an adjunctive therapy to
diet to:
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Limitations of Use
Simvastatin tablet USP has not been studied in Fredrickson Types I and
V dyslipidemias. ( 1.4)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg; 10 mg; 20 mg; 40 mg; 80 mg ( 3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
Reduce the risk of total mortality by reducing CHD deaths and reduce
the risk of non-fatal myocardial
infarction, stroke, and the need for revascularization procedures in
patients at high risk of coronary
events. ( 1.1)
Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in
patients with primary hyperlipidemia
(heterozygous familial and nonfamilial) and mixed dyslipidemia. ( 1.2)
Reduce elevated TG in patients with hypertriglyceridemia and reduce TG
and VLDL-C in patients with
primary dysbetalipoproteinemia. ( 1.2)
Reduce total-C and LDL-C in adult patients with homozygous familial
hypercholesterolemia. ( 1.2)
Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal
girls, 10 to 17 years of age
with heterozygous familial hypercholesterolemia after failing an
adequate trial of diet therapy. ( 1.2,
1.3)
Dose range is 5 to 40 mg/day. ( 2.1)
Recommended usual starting dose is 10 or 20 mg once a day in the
evening. ( 2.1)
Recommended starting dose for patients at high risk of CHD is 40
mg/day. ( 2.1)
Due to the increased risk of myopathy, including rhabdomyolysis, use
of the 80-mg do