Siam Bheasach


Siam Pharmaceutical


Siam Pharmaceutical
Concise Prescribing Info
Alone or in combination w/ HMG-CoA reductase inhibitors (statins) as adjunct to dietary therapy to decrease elevated serum total cholesterol (total-C), LDL cholesterol (LDL-C), apolipoprotein B (apo B), triglyceride (TG) & non-HDL cholesterol (non-HDL-C) conc & to increase HDL-C in adult & adolescent 10-17 yr patients w/ primary hyperlipidemia (heterozygous familial & nonfamilial). In combination w/ fenofibrate as adjunctive therapy to diet for the reduction of evaluated total-C, LDL-C, apo B & non-HDL-C in adults w/ mixed hyperlipidemia. In combination w/ a statin to reduce risk of CV events in patient w/ CHD. In combination w/ simvastatin to reduce the risk of major vascular & CV events in patient w/ chronic kidney disease. In combination w/ a statin for the reduction of elevated total-C & LDL-C levels in adult & adolescent 10-17 yr patients w/ homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments eg, LDL apheresis. Adjunct to dietary therapy to decrease elevated serum sitosterol & campesterol conc in patients w/ homozygous familial sitosterolemia.
Dosage/Direction for Use
Adult & childn ≥10 yr Primary hyperlipidemia, homozygous familial hypercholesterolemia, homozygous familial sitosterolemia 10 mg once daily. Prevention of CV disease 10 mg w/ a statin. May be used alone or in combination w/ a statin or fenofibrate & administered at the same time as statin or fenofibrate. In combination w/ bile acid sequestrants Administer ezetimibe at least 2 hr before or 4 hr after. Adult Fixed combination w/ simvastatin for management of homozygous familial hypercholesterolemia 10 mg ezetimibe & 40 mg simvastatin once daily in the evening. Chronic kidney disease & an estimated GFR <60 mL/min/1.73 m2 10 mg ezetimibe & 20 mg simvastatin once daily in the evening.
May be taken with or without food.
Hypersensitivity. Patients w/ active liver disease or unexplained, persistent increases in serum aminotransferase (transaminase) conc (when in combination w/ HMG-CoA reductase inhibitors). Concomitant use w/ potent CYP450 3A4 inhibitors eg, cyclosporine, danazol, gemfibrozil, when in fixed combination w/ simvastatin.
Special Precautions
Elevated hepatic transaminase in concomitant use of statins. Increased risk of myopathy & rhabdomyolysis w/ concomitant use w/ statin or fibrate in patients >65 yr, w/ hypothyroidism & higher dosage of statin. Discontinue if myopathy is suspected or confirmed (symptomatic patient w/ creatinine phosphokinase >10 x ULN). Mild hepatic impairment (Child-Pugh class A). Not recommended in moderate or severe hepatic impairment (Child-Pugh class B & C). Severe renal impairment (CrCl ≤30 mL/min/1.73 m2). Contraindicated in pregnant women required to take combination of ezetimibe w/ HMG-CoA reductase inhibitor. Lactation.
Adverse Reactions
Fatigue; diarrhea; increased serum transaminase (w/ HMG-CoA reductase inhibitors; ≥3 x ULN); influenza; arthralgia, pain in extremity; sinusitis, upper resp infection; abdominal pain, anaphylaxis, angioedema, cholecystitis, cholelithiasis, depression, dizziness, headache, hepatitis, hypersensitivity reaction, myalgia, nausea, pancreatitis, paresthesia, rhabdomyolysis, skin rash, thrombocytopenia, urticaria.
Drug Interactions
Adverse/toxic effect may be enhanced w/ bezafibrate, fenofibrate & derivatives, gemfibrozil. Absorption may be decreased w/ bile acid sequestrants. May increase serum conc of cyclosporine. Decreased AUC & peak plasma conc w/ Al- & Mg hydroxide containing antacids. Decreased AUC & increased peak plasma conc w/ statins eg, atorvastatin, fluvastatin, lovastatin, pravastatin or rosuvastatin. Increased INR w/ warfarin.
ATC Classification
C10AX09 - ezetimibe ; Belongs to the class of other lipid modifying agents.
Mibeaz tab 10 mg
3 × 10's
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