- Approval Id
- 336f3298ab212247
- Drug Name
- LIPEZ TABLET 10 MG
- Product Name
- LIPEZ TABLET 10 MG
- Approval Number
- SIN15740P
- Approval Date
- 2019-07-10
- Registrant
- ACCORD HEALTHCARE PRIVATE LIMITED
- Licence Holder
- ACCORD HEALTHCARE PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET
- Dosage
- <p><strong>v. Recommended Dosage:</strong></p>
<p>The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with LIPEZ.</p>
<p>The recommended dose of LIPEZ is 10 mg once daily, used alone, or with a statin.</p>
<p>LIPEZ can be administered at any time of the day, with or without food.</p>
<p><strong>Patients with Renal Impairment</strong><br>
Monotherapy<br>
In patients with renal impairment, no dosage adjustment of LIPEZ is necessary (see IIIb-5 Characteristics in Patients [Special Populations] – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Combination Therapy with Simvastatin<br>
In patients with mild renal impairment (estimated GFR ≥60 mL/min/1.73 m<sup>2</sup>), 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 m<sup>2</sup>, 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.</p>
<p><em>Use in the Elderly</em><br>
No dosage adjustment is required for elderly patients.</p>
<p><em>Use in Pediatric Patients</em><br>
Children and adolescents ≥10 years: No dosage adjustment is required.</p>
<p>Children <10 years: Treatment with LIPEZ is not recommended.</p>
<p><em>Use in Hepatic Impairment</em><br>
No dosage adjustment is required in patients with mild hepatic insufficiency (Child Pugh score 5 to 6).</p>
<p>Treatment with ezetimibe is not recommended in patients with moderate (Child Pugh score 7 to 9) or severe (Child Pugh score >9) liver dysfunction.</p>
<p><em>Co-administration with bile acid sequestrants</em><br>
Dosing of LIPEZ should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>iv. Indication:</strong></p>
<p><u>Primary Hypercholesterolemia</u><br>
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.</p>
<p><u>Homozygous Familial Hypercholesterolemia (HoFH)</u><br>
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.</p>
<p><u>Homozygous Sitosterolemia (Phytosterolemia)</u><br>
LIPEZ, is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia.</p>
- Contraindications
- <p><strong>vii. Contraindication:</strong></p>
<p>Hypersensitivity to any component of this medication.</p>
<p>When LIPEZ is to be administered with a statin or with fenofibrate, please refer to the Package Insert for that particular medication.</p>
<p>The combination of LIPEZ with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases.</p>
<p>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.</p>
- Atc Code
- C10AX09
- Atc Item Name
- ezetimibe
- Pharma Manufacturer Name
- ACCORD HEALTHCARE PRIVATE LIMITED
