EZETIMIBE AND SIMVASTATIN tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

ezetimibe (UNII: EOR26LQQ24) (ezetimibe - UNII:EOR26LQQ24), simvastatin (UNII: AGG2FN16EV) (simvastatin - UNII:AGG2FN16EV)

可用日期:

Glenmark Pharmaceuticals Inc., USA

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Simvastatin Simvastatin, when used as a component of ezetimibe and simvastatin tablets, is indicated to reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. Ezetimibe and simvastatin tablets are contraindicated in the following conditions: Ezetimibe and simvastatin tablets The safety and effectiveness of ezetimibe in combination with a statin as an adjunct to diet to reduce LDL-C have been established in pediatric patients 10 years of age and older with HeFH. Use of ezetimibe and simvastatin tablets for this indication is based on a double-blind, placebo-controlled clinical trial in 248 pediatric patients (142 males and 106 postmenarchal females) 10 years of age and older with HeFH [see Clinical Studies (14)]. In this limited controlled trial, there was no significant effect on growth or sexual maturation in the adolescent males or females, or on menstrual cycle length in females. The safety and effectiveness of ezetimibe and simvastatin tablets have not been established in pediatric patients younger than 10 years of age with HeFH, or in pediatric patients with other types of hyperlipidemia. In a clinical trial in which patients at high risk of CVD were treated with simvastatin 40 mg/day (median follow-up 3.9 years), the incidence of myopathy was approximately 0.05% for non-Chinese patients (n=7367) compared with 0.24% for Chinese patients (n=5468). In this trial the incidence of myopathy for Chinese patients on simvastatin 40 mg/day or ezetimibe and simvastatin 10/40 mg/day coadministered with extended-release niacin 2 g/day was 1.24%. Chinese patients may be at higher risk for myopathy, monitor these patients appropriately. Coadministration of ezetimibe and simvastatin tablets with lipid-modifying doses of niacin-containing products (≥1 g/day niacin) is not recommended in Chinese patients [see Warnings and Precautions ( 5.1) and Drug Interactions ( 7.1 )] .

產品總結:

Storage Store at 68°F to 77°F (20°C to 25°C) [see USP Controlled Room Temperature]. Keep container tightly closed.

授权状态:

Abbreviated New Drug Application

产品特点

EZETIMIBE AND SIMVASTATIN- EZETIMIBE AND SIMVASTATIN TABLET
GLENMARK PHARMACEUTICALS INC., USA
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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
Indications and Usage (1) 2/2024
Dosage and Administration (2.1, 2.2, 2.3, 2.4, 2.5) 2/2024
Contraindications, Pregnancy and Lactation (4) Removed 2/2024
Warnings and Precautions (5.1, 5.2, 5.3) 2/2024
INDICATIONS AND USAGE
Ezetimibe and simvastatin tablets are combination of simvastatin and
ezetimibe indicated: (1)
• As an adjunct to diet to reduce elevated low density lipoprotein
cholesterol (LDL-C):
o In adults with primary hyperlipidemia.
o In adults and pediatric patients aged 10 years and older with
heterozygous familial hypercholesterolemia
(HeFH).
• As an adjunct to other LDL-C lowering therapies to reduce LDL-C in
adults with homozygous familial
hypercholesterolemia (HoFH).
Simvastatin
Simvastatin, when used as a component of ezetimibe and simvastatin
tablets, is indicated to reduce the
risk of total mortality by reducing risk of coronary heart disease
death, non-fatal myocardial infarction and
stroke, and the need for coronary and non-coronary revascularization
procedures in adults with
established coronary heart disease, cerebrovascular disease,
peripheral vascular disease, and/or diabetes,
who are at high risk of coronary heart disease events.
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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_Important Dosage and Administration Information:_ (2.1)
Take ezetimibe and simvastatin tablets orally once daily in the
evening with or without food.
Maximum recommended dosage is ezetimibe and simvastatin tablets 10/40
mg once daily. Ezetimibe
and simvastatin tablets 10/80 mg daily dosage is restricted to
patient