SIMVASTATIN- simvastatin tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

SIMVASTATIN

Composition:

SIMVASTATIN 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: - 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 USP are indicated to: - Reduce elevated total cho

Product summary:

Simvastatin Tablets USP, 5 mg are tan colored, round, biconvex, film-coated tablets, debossed with 'LL' on one side and 'C01' on the other side. They are supplied as follows: NDC 68180-482-06                       Bottles of 30  NDC 68180-482-09                       Bottles of 90 NDC 68180-482-03                       Bottles of 1000 Simvastatin Tablets USP, 10 mg are peach colored, oval shaped, biconvex, film-coated tablets, debossed with 'LL' on one side and 'C02' on the other side. They are supplied as follows: NDC 68180-478-01                       Bottles of 30 NDC 68180-478-02                       Bottles of 90 NDC 68180-478-03                       Bottles of 1000 Simvastatin tablets USP, 20 mg are tan colored, oval shaped, biconvex, film-coated tablets, debossed with 'LL' on one side and 'C03' on the other side. They are supplied as follows: NDC 68180-479-01                       Bottles of 30 NDC 68180-479-02                       Bottles of 90 NDC 68180-479-03                       Bottles of 1000 Simvastatin tablets USP, 40 mg are brick red colored, round shaped, biconvex, film-coated tablets, debossed with 'LL' on one side and 'C04' on the other side. They are supplied as follows: NDC 68180-464-06                       Bottles of 30 NDC 68180-464-09                       Bottles of 90 NDC 68180-464-03                       Bottles of 1000 Simvastatin tablets USP, 80 mg are brick red colored, capsule shaped, biconvex, film-coated tablets, debossed with 'LL' on one side and 'C05' on the other side. They are supplied as follows: NDC 68180-465-06                       Bottles of 30 NDC 68180-465-09                       Bottles of 90 NDC 68180-465-03                       Bottles of 1000 Storage Store between 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Preserve in tight container as defined in USP.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SIMVASTATIN- SIMVASTATIN TABLET, FILM COATED
REMEDYREPACK INC.
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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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Dosage and Administration
Chinese Patients Taking Lipid-Modifying Doses (greater than or equal
to 1 g/day Niacin) of Niacin-Containing Products -
removal (2.7) 3/2019
Warnings and Precautions
Myopathy/Rhabdomyolisis ( 5.1) 3/2019
INDICATIONS AND USAGE
Simvastatin tablets USP 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
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 tablets USP has not been studied in Fredrickson Types I
and V dyslipidemias. ( 1.4)
DOSAGE AND ADMINISTRATION
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 USP
should be restricted to patients