EZETIMIBE SANDOZ TABLET 10MG [SIN15179P]

Product Info

EZETIMIBE SANDOZ TABLET 10MG

[SIN15179P]

Indication

4.1 Therapeutic indications

Primary hypercholesterolemia

EZETIMIBE SANDOZ, 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.

EZETIMIBE SANDOZ 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)

EZETIMIBE SANDOZ 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)

EZETIMIBE SANDOZ is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia.

Dosing

4.2 Posology and method of administration

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

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

Co-administration with bile acid sequestrants

Dosing of EZETIMIBE SANDOZ should occur either ≥ 2 hours before or ≥ 4 hours after administration of a bile acid sequestrant.

Use in the elderly

No dosage adjustment is required for elderly patients (see section 5.2 – 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 section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Children < 10 years: Treatment with EZETIMIBE SANDOZ 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 SANDOZ is not recommended in patients with moderate (Child Pugh score 7 to 9) or severe (Child Pugh score>9) liver dysfunction(see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with renal impairment

Monotherapy:
In patients with renal impairment, no dosage adjustment of EZETIMIBE SANDOZ is necessary (see section 5.2 – 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 EZETIMIBE SANDOZ or simvastatin is necessary. In patients with chronic kidney disease and estimated glomerular filtration rate <60 mL/min/1.73 m², the dose of EZETIMIBE SANDOZ 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 sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindications

4.3 Contraindications

Hypersensitivity to any component of this medication.

When EZETIMIBE SANDOZ is co-administered with a statin or with fenofibrate, please refer to the Package Insert for that particular medicinal product.

The combination of EZETIMIBE SANDOZ 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 EZETIMIBE SANDOZ is administered with a statin or with fenofibrate in a woman with childbearing potential, refer to the product labeling for that medication.