SIMVASTATIN tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Rebel Distributors Corp

INN (שם בינלאומי):

SIMVASTATIN

הרכב:

SIMVASTATIN 5 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 can be started simultaneously with diet. 1.1 Reductions in Risk of CHD Mortality and Cardiovascular Events 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: - 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. 1.2 Hyperlipid

leaflet_short:

Simvastatin tablets, USP 5 mg are cream, round tablets, with “SV” over "5" on one side and “>” on the other side. They are supplied as follows: NDC 21695-738-90 Bottles of 90 Simvastatin tablets, USP 10 mg are pink, round tablets, with “SV” over "10" on one side and “>” on the other side. They are supplied as follows: NDC 21695-739-30 Bottles of 30 NDC 21695-739-90 Bottles of 90 Simvastatin tablets, USP 20 mg are tan, round tablets, with “SV” over "20" on one side and “>” on the other side. They are supplied as follows:                                                                                                  NDC 21695-740-30 Bottles of 30 NDC 21695-740-90 Bottles of 90 Simvastatin tablets, USP 40 mg are pink, round tablets, with “SV” over "40" on one side and “>” on the other side. They are supplied as follows: NDC 21695-741-30 Bottles of 30 NDC 21695-741-90 Bottles of 90 Simvastatin tablets, USP 80 mg are pink, capsule-shaped tablets, with “SV80” on one side and “>” on the other side.They are supplied as follows: NDC 21695-742-30 Bottles of 30 NDC 21695-742-90 Bottles of 90 Storage Store between 15-30°C (59-86°F).

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

SIMVASTATIN- SIMVASTATIN TABLET
REBEL DISTRIBUTORS CORP
----------
SIMVASTATIN
1. INDICATIONS AND USAGE
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 can be
started simultaneously with diet.
1.1 Reductions in Risk of CHD Mortality and Cardiovascular Events
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:
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.
1.2 Hyperlipidemia
Simvastatin tablets, USP are indicated to:
Reduce elevated total cholesterol (total-C), low-density lipoprotein
cholesterol (LDL-C),
apolipoprotein B (Apo B), and triglycerides (TG), and to increase
high-density lipoprotein
cholesterol (HDL-C) in patients with primary hyperlipidemia
(Fredrickson type IIa, heterozygous
familial and nonfamilial) or mixed dyslipidemia (Fredrickson type
IIb).
Reduce elevated TG in patients with hypertriglyceridemia (Fredrickson
type lV hyperlipidemia).
Reduce elevated TG and VLDL-C in patients with primary
dysbetalipoproteinemia (Fredrickson
type III hyperlipidemia).
Reduce total-C and LDL-C in patients with homozygous familial
hypercholesterolemia as an adjunct
to other lipid-lowering treatments (e.g., LDL apheresis) or if such
treatments are unavailable.
1.3 Adolescent Patients with Heterozygous Familial
Hypercholesterolemia (HeFH)
Simvastatin tablets, USP are indicated as an