SIMVASTATIN tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

Simvastatin (UNII: AGG2FN16EV) (Simvastatin - UNII:AGG2FN16EV)

Tilgængelig fra:

Contract Pharmacy Services-PA

INN (International Name):

Simvastatin

Sammensætning:

Simvastatin 20 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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. 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 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 is indicated to: - Reduce elevated total cholesterol (total-C), low-density lipopr

Produkt oversigt:

Simvastatin Tablets, USP 5 mg are brown colored, round, biconvex, film-coated tablets, debossed 'RDY' on one side and '197' on other side. They are supplied as follows: Bottles of 30                                              NDC 55111-197-30 Bottles of 60                                              NDC 55111-197-60 Bottles of 90                                              NDC 55111-197-90 Bottles of 100                                            NDC 55111-197-01 Bottles of 500                                            NDC 55111-197-05 Bottles of 1000                                          NDC 55111-197-10 Unit dose package of 100 (10 × 10)          NDC 55111-197-78 Simvastatin Tablets USP, 10 mg are brown colored, round, biconvex, film-coated tablets, debossed 'RDY' on one side and '198' on other side. They are supplied as follows: Bottles of 30                                              NDC 55111-198-30 Bottles of 60                                              NDC 55111-198-60 Bottles of 90                                              NDC 55111-198-90 Bottles of 100                                            NDC 55111-198-01 Bottles of 500                                            NDC 55111-198-05 Unit dose package of 100 (10 × 10)          NDC 55111-198-78 Simvastatin Tablets USP, 20 mg are brown colored, round, biconvex, film-coated tablets, debossed 'RDY' on one side and '199' on other side. They are supplied as follows: Bottles of 30                                              NDC 55111-199-30 Bottles of 60                                              NDC 55111-199-60 Bottles of 90                                              NDC 55111-199-90 Bottles of 100                                            NDC 55111-199-01 Bottles of 500                                            NDC 55111-199-05 Bottles of 1000                                          NDC 55111-199-10 Unit dose package of 100 (10 × 10)          NDC 55111-199-78 Simvastatin Tablets USP, 40 mg are brown colored, round, biconvex, film-coated tablets, debossed 'RDY' on one side and '200' on other side. They are supplied as follows: Bottles of 30                                              NDC 55111-200-30 Bottles of 60                                              NDC 55111-200-60 Bottles of 90                                              NDC 55111-200-90 Bottles of 100                                            NDC 55111-200-01 Bottles of 500                                            NDC 55111-200-05 Bottles of 1000                                          NDC 55111-200-10 Unit dose package of 100 (10 × 10)          NDC 55111-200-78 Simvastatin Tablets USP, 80 mg are brown colored, oval shaped, biconvex, film-coated tablets, debossed 'RDY' on one side and '268' on other side. They are supplied as follows: Bottles of 30                                              NDC 55111-268-30 Bottles of 60                                              NDC 55111-268-60 Bottles of 90                                              NDC 55111-268-90 Bottles of 100                                            NDC 55111-268-01 Bottles of 500                                            NDC 55111-268-05 Unit dose package of 100 (10 × 10)          NDC 55111-268-78 Storage Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

SIMVASTATIN- SIMVASTATIN TABLET, FILM COATED
CONTRACT PHARMACY SERVICES-PA
----------
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
Warnings and Precautions
Myopathy/Rhabdomyolysis (5.1) 03/2010
INDICATIONS AND USAGE
Simvastatin 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
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)
Limitations of Use
Simvastatin has not been studied in Fredrickson Types I and V
dyslipidemias. (1.4)
DOSAGE AND ADMINISTRATION
Dose range is 5-80 mg/day. (2.1)
Recommended usual starting dose is 20-40 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 (10-17 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; 10 mg; 2