United Kingdom - English - myHealthbox

glenmark pharmaceuticals europe limited - ezetimibe - tablets - 10mg - other lipid modifying agents - primary hypercholesterolaemia homozygous familial hypercholesterolaemia (hofh) homozygous sitosterolaemia (phytosterolaemia)

United States - English - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - ezetimibe (unii: eor26lqq24) (ezetimibe - unii:eor26lqq24) - ezetimibe 10 mg - ezetimibe tablets are indicated: when ezetimibe tablet is used in combination with a statin, fenofibrate, or other ldl-c lowering therapies, refer to the prescribing information of these products for information on the safe and effective use. risk summary there are insufficient data on ezetimibe use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse developmental effects were observed in pregnant rats and rabbits orally administered ezetimibe during the period of organogenesis at doses that resulted in up to 10 and 150 times, respectively, the human exposure at the mrhd, based on auc (see data) . ezetimibe should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. when ezetimibe is administered with a statin, refer to the prescribing information for the statin. the estimated background risk of major birth defects and miscarriage for the indic

Ireland - English - HPRA (Health Products Regulatory Authority)

glenmark pharmaceuticals europe limited - ezetimibe - tablet - 10 milligram(s) - other lipid modifying agents; ezetimibe

Canada - English - Health Canada

glenmark pharmaceuticals canada inc. - ezetimibe - tablet - 10mg - ezetimibe 10mg - cholesterol absorption inhibitors

Singapore - English - HSA (Health Sciences Authority)

glenmark pharmaceuticals singapore pte. ltd. - ezetimibe - tablet - ezetimibe 10 mg

United States - English - NLM (National Library of Medicine)

par pharmaceutical inc - ezetimibe (unii: eor26lqq24) (ezetimibe - unii:eor26lqq24) - ezetimibe 10 mg - 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. monotherapy ezetimibe, administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-c), low-density lipoprotein cholesterol (ldl-c), apolipoprotein b (apo b), and non-high-density lipoprotein cholesterol (non-hdl-c) in patients with primary (heterozygous familial and non-familial) hyperlipidemia. combination therapy with hmg-coa reductase inhibitors (statins) ezetimibe, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme a (hmg-coa) reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of elevated total-c, ld

United States - English - NLM (National Library of Medicine)

a-s medication solutions - ezetimibe (unii: eor26lqq24) (ezetimibe - unii:eor26lqq24) - ezetimibe 10 mg - 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. monotherapy ezetimibe, administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-c), low-density lipoprotein cholesterol (ldl-c), apolipoprotein b (apo b), and non-high-density lipoprotein cholesterol (non-hdl-c) in patients with primary (heterozygous familial and non-familial) hyperlipidemia. combination therapy with hmg-coa reductase inhibitors (statins) ezetimibe, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme a (hmg-coa) reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of elevated total-c, ld

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

glenmark pharmaceuticals europe ltd - ezetimibe - oral tablet - 10mg

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

glenmark pharmaceuticals (malaysia) sdn. bhd. - ezetimibe -

United States - English - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - ezetimibe (unii: eor26lqq24) (ezetimibe - unii:eor26lqq24), simvastatin (unii: agg2fn16ev) (simvastatin - unii:agg2fn16ev) - 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 )] .