EZETIMIBE AND SIMVASTATIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Dr.Reddys Laboratories Inc

INN (International Name):

EZETIMIBE

Composition:

EZETIMIBE 10 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. 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

Product summary:

Ezetimibe and simvastatin tablets are available as follows: 10 mg/10 mg- white to off-white, capsule-shaped tablets, debossed with "DRL" on one side of the tablet and with "583" on the other side. They contain 10 mg of ezetimibe and 10 mg of simvastatin. They are available in : Bottles of 30 NDC 43598-742-30 Bottles of 90 NDC 43598-742-90 Bottles of 1000 NDC 43598-742-10 10 mg/20 mg- white to off-white, capsule-shaped tablets, debossed with "DRL" on one side of the tablet and with "584" on the other side. They contain 10 mg of ezetimibe and 20 mg of simvastatin. They are available in : Bottles of 30 NDC 43598-744-30 Bottles of 90 NDC 43598-744-90 Bottles of 1000 NDC 43598-744-10 10 mg/40 mg- white to off-white, capsule-shaped tablets, debossed with "DRL" on one side of the tablet and with "585" on the other side. They contain 10 mg of ezetimibe and 40 mg of simvastatin. They are available in : Bottles of 30 NDC 43598-743-30 Bottles of 90 NDC 43598-743-90 Bottles of 500 NDC 43598-743-05 10 mg/80 mg- white to off-white, capsule-shaped tablets, debossed with "DRL" on one side of the tablet and with "586" on the other side. They contain 10 mg of ezetimibe and 80 mg of simvastatin. They are available in : Bottles of 30 NDC 43598-745-30 Bottles of 90 NDC 43598-745-90 Bottles of 500 NDC 43598-745-05 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).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

EZETIMIBE AND SIMVASTATIN- EZETIMIBE AND SIMVASTATIN TABLET
DR.REDDYS LABORATORIES INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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
RECENT MAJOR CHANGES
Warnings and Precautions
Myopathy/Rhabdomyolysis (5.1) 10/2019
Immune-Mediated Necrotizing Myopathy (5.2) 9/2020
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:
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Limitations of Use (1.3)
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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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)
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.
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
ezetimib