- Approval Id
- 3f648c023bcdf32f
- Drug Name
- CHOLIB FILM-COATED TABLET 145MG/20MG
- Product Name
- CHOLIB FILM-COATED TABLET 145MG/20MG
- Approval Number
- SIN15664P
- Approval Date
- 2019-04-09
- Registrant
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
- Licence Holder
- ABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>4.2 Posology and Method of Administration</strong></p>
<p>Secondary causes of hyperlipidaemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, pharmacological treatment (like oral oestrogens), alcoholism should be adequately treated, before Cholib® therapy is considered and patients should be placed on a standard cholesterol and triglycerides-lowering diet which should be continued during treatment.</p>
<p><u>Posology</u><br>
The recommended dose is one tablet per day. Grapefruit juice should be avoided (see section 4.5 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Response to therapy should be monitored by determination of serum lipid values (total cholesterol (TC), LDL-C, triglycerides (TG)).</p>
<p><em>Elderly patients (≥ 65 years old)</em><br>
No dose adjustment is necessary. The usual dose is recommended, except for decreased renal function with estimated glomerular filtration rate < 60 mL/min/1.73 m<sup>2</sup> where Cholib® is contraindicated (see section 4.3).</p>
<p><em>Patients with renal impairment</em><br>
Cholib® is contraindicated in patients with moderate to severe renal insufficiency whose estimated glomerular filtration rate is < 60 mL/min/1.73 m<sup>2</sup> (see section 4.3).</p>
<p>Cholib® should be used with caution in patients with mild renal insufficiency whose estimated glomerular filtration rate is 60 to 89 mL/min/1.73 m<sup>2</sup> (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Patients with hepatic impairment</em><br>
Cholib® has not been studied in patients with hepatic impairment and is therefore contraindicated in this population (see section 4.3).</p>
<p><em>Paediatric population</em><br>
Cholib® is contraindicated in children and adolescents up to 18 years old. (see section 4.3).</p>
<p><u>Method of administration</u><br>
Each tablet should be swallowed whole with a glass of water. The tablets should not be crushed or chewed. They may be taken with or without food (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic Indications</strong></p>
<p>Cholib® is indicated as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia to reduce triglycerides and increase HDL-C levels when LDL-C levels are adequately controlled with the corresponding dose of simvastatin monotherapy.</p>
<p>A beneficial effect of Cholib® on cardiovascular morbidity and mortality has not yet been demonstrated.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul>
<li>Hypersensitivity to the active substances, peanut, soya or to any of the excipients listed in section 6.1 (see also section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</li>
<li>Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen</li>
<li>Active liver disease or unexplained persistent elevations of serum transaminases</li>
<li>Known gallbladder disease</li>
<li>Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridaemia</li>
<li>Moderate to severe renal insufficiency (estimated glomerular filtration rate < 60 mL/min/1.73 m<sup>2</sup>)</li>
<li>Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin and nefazodone) (see section 4.5 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</li>
<li>Concomitant administration of gemfibrozil, ciclosporine, or danazol (see section 4.5 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</li>
<li>Concomitant administration of glecaprevir/ pibrentasvir (see section 4.5 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</li>
<li>Paediatric population (age below 18 years)</li>
<li>Pregnancy and breast-feeding (see section 4.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</li>
<li>Personal history of myopathy and/or rhabdomyolysis with statins and/or fibrates or confirmed creatine phosphokinase elevation above 5 times the upper limit of normal (ULN) under previous statin treatment (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</li>
</ul>
- Atc Code
- C10BA04
- Atc Item Name
- simvastatin and fenofibrate
- Pharma Manufacturer Name
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
- Company Detail Path
- /organization/abbott-laboratories-singapore-private-limited
