SIMVASTATIN tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

H.J. Harkins Company, Inc.

INN (Rahvusvaheline Nimetus):

SIMVASTATIN

Koostis:

SIMVASTATIN 20 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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 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 tablet is indicated to: - Reduce the risk of total mortality by reducing CHD deaths. - Reduce the risk of non-fatal myocardial infarction and stroke. - Reduce the need for coronary and non-coronary revascularization procedures. Simvastatin tablet is indicated to: - Reduce elevated total cholesterol (total-

Toote kokkuvõte:

Simvastatin Tablets 20 mg are brick red coloured oval shaped, biconvex, film-coated tablets, debossed "S5" on one side and plain on other side. Bottles of 30 Tablets (NDC 16729-005-10) Bottles of 60 Tablets (NDC 16729-005-12) Bottles of 90 Tablets (NDC 16729-005-15) Bottles of 1000 Tablets (NDC 16729-005-17) Simvastatin Tablets 40 mg are brick red coloured, oval shaped, biconvex, film-coated tablets, debossed "S6" on one side and plain on other side. Bottles of 30 Tablets (NDC 16729-006-10) Bottles of 60 Tablets (NDC 16729-006-12) Bottles of 90 Tablets (NDC 16729-006-15) Bottles of 1000 Tablets (NDC 16729-006-17) Storage Store between 5 to 30° C (41 to 86° F). "Dispense in tight containers as defined in the USP"

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

SIMVASTATIN - SIMVASTATIN TABLET, FILM COATED
H.J. HARKINS COMPANY, INC.
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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 USP
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Dosage and Administration
Chinese Patients Taking Lipid-Modifying Doses ( ≥ 1 g/day Niacin) of
Niacin-Containing Products
(2.5) 03/2010
Coadministration with Other Drugs (2.6)
03/2010
Myopathy/Rhabdomyolysis (5.1)
Warnings and Precautions
03/2010
INDICATIONS AND USAGE
Simvastatin tablet is an HMG-CoA reductase inhibitor (statin)
indicated as an adjunctive therapy to diet to:
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 dysbeta-
lipoproteinemia. (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)
Limitations of Use
Simvastatin tablet has not been studied in Fredrickson Types I and V
dyslipidemias. (1.4)
DOSAGE AND ADMINISTRATION
Dose range is 5 to 80 mg/day. (2.1)
Recommended usual starting dose is 20 to 40 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)
Adolescents (10 to 17 years of age) with HeFH: starting dose is 10
mg/day; maximum recommended dose is 40
mg/day. (2.3)
DOSAGE FORMS AND STRENGT