EZETROL TABLET 10 MG [SIN12375P]

Product Info

EZETROL TABLET 10 MG

[SIN12375P]

II. INDICATIONS

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) and apolipoprotein B (Apo B) 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, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia.

Homozygous Familial Hypercholesterolemia (HoFH)
EZETROL, administered with atorvastatin or simvastatin, is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

Homozygous Sitosterolemia (Phytosterolemia)
EZETROL is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia.

IV. DOSAGE AND ADMINISTRATION

The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with EZETROL.

The recommended dose of EZETROL is 10 mg once daily, used alone, with a statin, or with fenofibrate. EZETROL can be administered at any time of the day, with or without food.

Patients with Renal Impairment
Monotherapy
In patients with renal impairment, no dosage adjustment of EZETROL is necessary (see IIIb-5. Characteristics in Patients [Special Populations] – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Combination Therapy with Simvastatin
In patients with mild renal impairment (estimated GFR ≥60 mL/min/1.73 m²), no dosage adjustment of EZETROL or simvastatin is necessary. In patients with chronic kidney disease and estimated glomerular filtration rate <60 mL/min/1.73 m², the dose of EZETROL is 10 mg and the dose of simvastatin is 20 mg once a day in the evening. In such patients, the use of higher doses of simvastatin should be closely monitored (see VI. PRECAUTIONS, IIIb-5. Characteristics in Patients [Special Populations] and IIIc. CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use in the Elderly
No dosage adjustment is required for elderly patients (see IIIb-5. Characteristics in Patients [Special Populations] – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use in Pediatric Patients
Children and adolescents ≥10 years: No dosage adjustment is required (see IIIb-5. Characteristics in Patients [Special Populations] – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
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 (see VI. PRECAUTIONS and IIIb-5. Characteristics in Patients [Special Populations] – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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.

V. CONTRAINDICATIONS

Hypersensitivity to any component of this medication.

When EZETROL is to be administered with a statin or with fenofibrate, please refer to the Package Insert for that particular medication.

The combination of EZETROL with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases.

All statins and fenofibrate are contraindicated in pregnant and nursing women. When EZETROL is administered with a statin or with fenofibrate in a woman with childbearing potential, refer to the product labeling for that medication.