SIMVASTATIN tablet, film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Proficient Rx LP

INN (Tên quốc tế):

SIMVASTATIN

Thành phần:

SIMVASTATIN 20 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 tablets are indicated to: Simvastatin tablets are indicated to: Simvastatin tablets 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 trial of diet thera

Tóm tắt sản phẩm:

Simvastatin Tablets 20 mg are brick red coloured oval shaped, biconvex, film-coated tablets, debossed "S 5" on one side and plain on other side. Bottles of 30 Tablets NDC 63187-075-30 Bottles of 60 Tablets NDC 63187-075-60 Bottles of 90 Tablets NDC 63187-075-90 Simvastatin tablets USP 10 mg are brick red coloured, oval shaped, biconvex, film-coated tablets, debossed "S 4" on one side and plain on other side. Bottles of 30 Tablets NDC 63187-191-30 Bottles of 60 Tablets NDC 63187-191-60 Bottles of 90 Tablets NDC 63187-191-90 Simvastatin Tablets 40 mg are brick red coloured, oval shaped, biconvex, film-coated tablets, debossed "S 6" on one side and plain on other side. Bottles of 30 Tablets NDC 63187-449-30 Bottles of 60 Tablets NDC 63187-449-60 Bottles of 90 Tablets NDC 63187-449-90 Storage Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. "Dispense in tight containers as defined in the USP"

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

SIMVASTATIN- SIMVASTATIN TABLET, FILM COATED
PROFICIENT RX LP
----------
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 FOR ORAL USE
INITIAL U.S. APPROVAL:1991
RECENT MAJOR CHANGES
Dosage and Administration
Coadministration with Other Drugs
(2.3)
10/2012
Contraindications (4)
10/2012
Warnings and Precautions
INDICATIONS AND USAGE
Simvastatin tablets are an HMG-CoA reductase inhibitor (statin)
indicated as an adjunctive therapy to diet
to:
•
•
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
•
•
•
•
•
•
Myopathy/Rhabdomyolysis
(5.1) 10/2012
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
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 dose of
simvastatin tablets should be restricted to patients who have been
taking simvastatin 80 mg
chronically (e