EZETIMIBE AND SIMVASTATIN tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

EZETIMIBE (UNII: EOR26LQQ24) (EZETIMIBE - UNII:EOR26LQQ24), SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV)

Tillgänglig från:

Golden State Medical Supply, Inc.

INN (International namn):

EZETIMIBE

Sammansättning:

EZETIMIBE 10 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska 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. Ezetimibe and simvastatin tablets are indicated for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. Ezetimibe and simvastatin tablets are indicated for the reduction of elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments

Produktsammanfattning:

Ezetimibe and simvastatin tablets are available as follows: 10 mg/10 mg- white to off-white, capsule-shaped tablets, debossed with "TEVA" on one side of the tablet and with "7584" on the other side. They contain 10 mg of ezetimibe and 10 mg of simvastatin. They are available in : Bottles of 30 NDC 60429-879-30 Bottles of 90 NDC 60429-879-90 Bottles of 1000 NDC 60429-879-10 10 mg/20 mg- white to off-white, capsule-shaped tablets, debossed with "TEVA" on one side of the tablet and with "7585" on the other side. They contain 10 mg of ezetimibe and 20 mg of simvastatin. They are available in : Bottles of 30 NDC 60429-880-30 DISCONTINUED Bottles of 90 NDC 60429-880-90 Bottles of 1000 NDC 60429-880-10 DISCONTINUED 10 mg/40 mg- white to off-white, capsule-shaped tablets, debossed with "TEVA" on one side of the tablet and with "7586" on the other side. They contain 10 mg of ezetimibe and 40 mg of simvastatin. They are available in : Bottles of 30 NDC 60429-881-30 DISCONTINUED Bottles of 90 NDC 60429-881-90 Bottles of 500 NDC 60429-881-05 Bottles of 1000 NDC 60429-881-10 10 mg/80 mg- white to off-white, capsule-shaped tablets, debossed with "TEVA" on one side of the tablet and with "7587" on the other side. They contain 10 mg of ezetimibe and 80 mg of simvastatin. They are available in : Bottles of 30 NDC 60429-882-30 DISCONTINUED Bottles of 90 NDC 60429-882-90 Bottles of 500 NDC 60429-882-05 Storage Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

EZETIMIBE AND SIMVASTATIN- EZETIMIBE AND SIMVASTATIN TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
EZETIMIBE AND SIMVASTATIN TABLETS
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EZETIMIBE AND SIMVASTATIN TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EZETIMIBE AND
SIMVASTATIN TABLETS .
EZETIMIBE AND SIMVASTATIN TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Ezetimibe and simvastatin tablets, which contain a cholesterol
absorption inhibitor and an HMG-CoA reductase inhibitor (statin), are
indicated as adjunctive therapy to diet to:
reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to
increase HDL-C in patients with primary (heterozygous familial
and non-familial) hyperlipidemia or mixed hyperlipidemia. ( 1.1)
reduce elevated total-C and LDL-C in patients with homozygous familial
hypercholesterolemia (HoFH), as an adjunct to other lipid-
lowering treatments. ( 1.2)
Limitations of Use ( 1.3)
No incremental benefit of ezetimibe and simvastatin tablets on
cardiovascular morbidity and mortality over and above that
demonstrated for simvastatin has been established.
Ezetimibe and simvastatin tablets have not been studied in Fredrickson
Type I, III, IV, and V dyslipidemias.
DOSAGE AND ADMINISTRATION
Dose range is 10 mg/10 mg/day to 10 mg/40 mg/day. ( 2.1)
Recommended usual starting dose is 10 mg/10 mg or 10 mg/20 mg/day. (
2.1)
Due to the increased risk of myopathy, including rhabdomyolysis, use
of the 10 mg/80 mg dose of ezetimibe and simvastatin
tablets should be restricted to patients who have been taking
ezetimibe and simvastatin tablets 10 mg/80 mg chronically (e.g., for
12 months or more) without evidence of muscle toxicity. ( 2.2)
Patients who are currently tolerating the 10 mg/80 mg dose of
ezetimibe and simvastatin tablets who need to be initiated on an
interacting drug that is contraindicated or is associated with a dose
cap for simvastatin should be switched to an alternative statin
or stat