Mibeaz Dosage/Direction for Use

Use in patients with primary hypercholesterolemia, homozygous familial hypercholesterolemia, homozygous sitosterolemia in adults and children 10 years of age and older, the recommended dosage of ezetimibe is 10 mg once daily.
For prevention of cardiovascular disease, ezetimibe 10 mg may be administered with a statin with proven cardiovascular benefit.
Ezetimibe may be used alone or in combination with a statin or fenofibrate and may be administered at the same time as a statin or fenofibrate.
In combination with bile acid sequestrants, ezetimibe should be administered at least 2 hours before or 4 hours after the drug. Ezetimibe can be administered with or without food.
The recommended dosage of ezetimibe in fixed combination with simvastatin for the management of homozygous familial hypercholesterolemia in adults is 10 mg of ezetimibe and 40 mg of simvastatin once daily in the evening.
Use in Patients with Renal Impairment/Chronic Kidney Disease: Ezetimibe monotherapy: No dosage adjustment is necessary in patients with renal impairment.
Ezetimibe combination therapy with simvastatin: In patients receiving ezetimibe in fixed combination with simvastatin, no dosage adjustment is necessary in patients with mild renal impairment (estimated GFR of 60 mL/min/ 1.73 m² or greater). In patients with chronic kidney disease and an estimated GFR of less than 60 mL/min/1.73 m², the dosage of the fixed combination preparation is 10 mg of ezetimibe and 20 mg simvastatin once daily in the evening. In such patients, higher dosage should be used with caution and close monitoring.
Use in the Elderly: No dosage adjustment is necessary in geriatric patients.
Use in Pediatric patients: Children and adolescents ≥ 6 years may be given ezetimibe at the same doses as in adults. There are no differences in the pharmacokinetics of ezetimibe between children and adolescents ≥ 6 years and adults and pharmacokinetic data are not available for pediatric patients younger than 6 years of age.
Use in Hepatic Impairment: No dosage adjustment is required in patients with mild hepatic insufficiency (Child-Pugh score 5 to 6, class A). Because the effects of increased exposure to ezetimibe in patients with moderate (Child-Pugh score 7 to 9, class B) or severe (Child-Pugh score >9, class C) hepatic impairment currently is not known, ezetimibe is not recommended in such patients.