# Primary Hypercholesterolemia:
– EZETROL, administered with an HMG-CoA reductase inhibitor (statin) or 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 triglycerides (TG) and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous
familial and non-familial) hypercholesterolemia.
– EZETROL, administered in combination with fenofibrate, is indicated as adjunctive therapy to diet for the reduction of elevated
total-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia.
# Homozygous Familial Hypercholesterolemia (HoFH): EZETROL, administered with a statin, is indicated for the reduction of
elevated total-C and LDL-C levels in patients with HoFH. Patients may also receive adjuctive treatments (e.g., LDL apheresis).
# Homozygous Sitosterolemia (Phytosterolemia): EZETROL is indicated for the reduction of elevated sitosterol & campesterol
levels in patients with homozygous familial sitosterolemia.
* Dosage and Administration:
– The patient should be placed on an appropriate lipid-lowering diet and should continue on this diet during treatment with EZETROL.
– The recommended dose of EZETROL is 10mg once daily, used alone, with a statin, or with fenofibrate. EZETROL can be
administered at any time of the day, with or without food.
– Use in the Elderly: No dosage adjustment is required for elderly patients.
– Use in Pediatric Patients: Children and adolescents >/= 10 years: No dosage adjustment is required.
Children < 10 years: treatment with EZETROL is not recommended.
– Use in Hepatic Impairment: No dosage adjustment is required in patients with mild hepatic insufficiency (Child-Pugh score 5 to 6).
Treatment with ezetimibe is not recommended in patients with moderate (Child-Pugh score 7 to 9)
or severe (Child-Pugh score > 9) liver dysfunction.
– Use in Renal Impairment: No dosage adjustment is required for renally impaired patients:
– Co-administration with bile acid sequestrants: Dosing of EZETROL should occur either >/= 2 hours before or >/= 4 hours
after administration of a bile acid sequestrant.
* Store in a dry place at temperature between 15 – 30 degrees C. Protected from moisture & light.
Do not store above 30 degrees C (86 degrees F). Store in the original package.
* Manufactured by: Schering Plough Products Inc. – Puerto Rico.
Packed by: Global Napi Pharmaceuticals (GNP) – Egypt.
For: MSD – SP Limited – U.K. (MA Holder)
For: Merck Sharp & Dohme – U.K.
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