SIMVASTATIN- simvastatin tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Safecor Health, LLC

Designació comuna internacional (DCI):

SIMVASTATIN

Composición:

SIMVASTATIN 20 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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, USP 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, USP are indicated to:  Simvastatin tablets, USP are indicated to: Simvastatin tablets, USP 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 adequat

Resumen del producto:

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:             Box of 100 Robot-Rx® 1 Unit Dose                 NDC 48433-311-01 For Institutional Use Only The product contained in this package is from NDC# 16714-0683 Northstar Rx LLC Memphis, TN 38141 Packaged and Distributed by: SAFECOR HEALTH, LLC 317 New Boston Street Woburn, MA 01801 SAFECOR HEALTH, LLC 4060 Business Park Drive Columbus, OH 43204 Questions or Comments? Call 1-800-447-1006. Rev: 311-00 08/2014 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]. Packaging meets USP specifications for light resistance.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

SIMVASTATIN- SIMVASTATIN TABLET, FILM COATED
SAFECOR HEALTH, LLC
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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, USP.
SIMVASTATIN TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Dosage and Administration
Patients with Homozygous Familial
Hypercholesterolemia (2.4) 10/2013
Contraindications (4) 02/2014
Warnings and Precautions
Myopathy/Rhabdomyolysis (5.1) 02/2014
INDICATIONS AND USAGE
Simvastatin tablets, USP are an HMG-CoA reductase inhibitor (statin)
indicated as an adjunctive therapy to diet to:
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Limitations of Use
Simvastatin tablets, USP have not been studied in Fredrickson Types I
and V dyslipidemias. (1.4)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 20 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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)
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 in