LIPEZ TABLET 10 MG [SIN15740P]

Product Info

LIPEZ TABLET 10 MG

[SIN15740P]

iv. Indication:

Primary Hypercholesterolemia
LIPEZ, 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.

Homozygous Familial Hypercholesterolemia (HoFH)
LIPEZ, 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)
LIPEZ, is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia.

v. Recommended Dosage:

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

The recommended dose of LIPEZ is 10 mg once daily, used alone, or with a statin.

LIPEZ 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 LIPEZ 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 LIPEZ or simvastatin is necessary. In patients with chronic kidney disease and estimated glomerular filtration rate <60 mL/min/1.73 m², the dose of LIPEZ 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.

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 LIPEZ 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.

Co-administration with bile acid sequestrants
Dosing of LIPEZ should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.

vii. Contraindication:

Hypersensitivity to any component of this medication.

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

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

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