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:

MedVantx, Inc.

INN (الاسم الدولي):

SIMVASTATIN

تركيب:

SIMVASTATIN 40 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 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:    - 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 tablets are indicated to:   - Reduce elevated total cholestero

ملخص المنتج:

Simvastatin Tablets USP, 5 mg are yellow colored, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘15’ on the other side. They are supplied as follows:             Bottles of 30                 NDC 16714-681-01 (Child Resistant Closure)             Bottles of 90                 NDC 16714-681-02 (Child Resistant Closure) Simvastatin Tablets USP, 10 mg are light pink colored, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘01’ on the other side. They are supplied as follows:             Bottles of 30                 NDC 16714-682-01 (Child Resistant Closure)             Bottles of 90                 NDC 16714-682-02 (Child Resistant Closure)             Bottles of 1000             NDC 16714-682-03 (Non-Child Resistant Closure) Simvastatin Tablets USP, 20 mg are light pink colored, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘02’ on the other side. They are supplied as follows:             Bottles of 30                 NDC 16714-683-01 (Child Resistant Closure)             Bottles of 90                 NDC 16714-683-02 (Child Resistant Closure)             Bottles of 1000             NDC 16714-683-03 (Non-Child Resistant Closure) Simvastatin Tablets USP, 40 mg are pink colored, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘03’ on the other side. They are supplied as follows:             Bottles of 30                 NDC 16714-684-01 (Child Resistant Closure)             Bottles of 90                 NDC 16714-684-02 (Child Resistant Closure)             Bottles of 1000             NDC 16714-684-03 (Non-Child Resistant Closure) Simvastatin Tablets USP, 80 mg are pink colored, capsule shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘04’ on the other side. They are supplied as follows:             Bottles of 30                 NDC 16714-685-01 (Child Resistant Closure)             Bottles of 90                 NDC 16714-685-02 (Child Resistant Closure)             Bottles of 1000             NDC 16714-685-03 (Non-Child Resistant Closure) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

SIMVASTATIN- SIMVASTATIN TABLET, FILM COATED
MEDVANTX, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SIMVASTATIN 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
Warnings and Precautions
Myopathy/Rhabdomyolysis
(5.1)
03/2010
INDICATIONS AND USAGE
Simvastatin tablets are 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 tablets have 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 STRENGTHS
Tablets: 5 mg; 1