ZOCOR- simvastatin tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Merck Sharp & Dohme Corp.

INN (nemzetközi neve):

SIMVASTATIN

Összetétel:

SIMVASTATIN 5 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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, ZOCOR® 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, ZOCOR 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. ZOCOR is indicated to: - Reduce elevated total cholesterol (total-C), low-density lipoprotein cholestero

Termék összefoglaló:

No. 8146 — Tablets ZOCOR 10 mg are peach, oval, film-coated tablets, coded MSD 735 on one side and plain on the other. They are supplied as follows: NDC 0006-0735-31 unit of use bottles of 30 NDC 0006-0735-54 unit of use bottles of 90. No. 8147 — Tablets ZOCOR 20 mg are tan, oval, film-coated tablets, coded MSD 740 on one side and plain on the other. They are supplied as follows: NDC 0006-0740-31 unit of use bottles of 30 NDC 0006-0740-54 unit of use bottles of 90. No. 8148 — Tablets ZOCOR 40 mg are brick red, oval, film-coated tablets, coded MSD 749 on one side and plain on the other. They are supplied as follows: NDC 0006-0749-31 unit of use bottles of 30 NDC 0006-0749-54 unit of use bottles of 90. No. 6577 — Tablets ZOCOR 80 mg are brick red, capsule-shaped, film-coated tablets, coded 543 on one side and 80 on the other. They are supplied as follows: NDC 0006-0543-31 unit of use bottles of 30 NDC 0006-0543-54 unit of use bottles of 90. Storage Store between 5-30°C (41-86°F).

Engedélyezési státusz:

New Drug Application

Termékjellemzők

ZOCOR- SIMVASTATIN TABLET, FILM COATED
MERCK SHARP & DOHME CORP.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOCOR SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ZOCOR.
ZOCOR (SIMVASTATIN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions
Immune-Mediated Necrotizing Myopathy (5.2)
9/2020
INDICATIONS AND USAGE
ZOCOR 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 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
ZOCOR 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 ZOCOR should be
restricted to patients who have been taking simvastatin 80 mg
chronically (e.g., for 12 months or more) without
evidence of muscle toxicity. (2.2)
Patients who are currently tolerating the 80-mg dose of ZOCOR who need
to be initiated on an interacting drug