- Approval Id
- e88d3b6cb250304b
- Drug Name
- TRIPLIXAM FILM COATED TABLET 5 mg/ 1.25 mg/ 5 mg
- Product Name
- TRIPLIXAM FILM COATED TABLET 5 mg/ 1.25 mg/ 5 mg
- Approval Number
- SIN15011P
- Approval Date
- 2016-05-23
- Registrant
- SERVIER (S) PTE LTD
- Licence Holder
- SERVIER (S) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u><br>
One Triplixam film-coated tablet per day as a single dose, preferably to be taken in the morning and before a meal.</p>
<p>The fixed dose combination is not suitable for initial therapy.<br>
If a change of the posology is required, titration should be done with the individual components.</p>
<p><u>Special population</u></p>
<p><em>Renal impairment (see section 4.3 and 4.4</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>)</em><br>
In severe renal impairment (creatinine clearance below 30 mL/min), treatment is contraindicated.<br>
In patients with moderate renal impairment (creatinine clearance 30–60 mL/min), Triplixam at the doses 10mg/2.5mg /5mg and 10mg/2.5mg/10mg is contraindicated. It is recommended to start treatment with the adequate dosage of the free combination.<br>
Usual medical follow-up will include frequent monitoring of creatinine and potassium.<br>
Concomitant use of perindopril with aliskiren-containing products is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m<sup>2</sup>) (see section 4.3).</p>
<p><em>Hepatic impairment (see sections 4.3, 4.4 and 5.2</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>)</em><br>
In severe hepatic impairment, Triplixam is contraindicated.</p>
<p>In patients with mild to moderate hepatic impairment, Triplixam should be administrated with caution, as dosage recommendations for amlodipine in these patients have not been established.</p>
<p><em>Elderly (see section 4.4</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>)</em><br>
Elimination of perindoprilat is decreased in the elderly (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).<br>
Elderly can be treated with Triplixam according to renal function (see section 4.3).</p>
<p><em>Paediatric population</em><br>
The safety and efficacy of Triplixam in children and adolescents have not been established. No data are available.</p>
<p><u>Method of administration</u></p>
<p>Oral use.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Triplixam is indicated as substitution therapy for treatment of essential hypertension, in patients already controlled with perindopril/indapamide fixed dose combination and amlodipine, taken at the same dose level.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul class="dash">
<li>Dialysis patients</li>
<li>Patients with untreated decompensated heart failure</li>
<li>Severe renal impairment (creatinine clearance below 30 mL/min)</li>
<li>Moderate renal impairment (creatinine clearance below 60 mL/min) for Triplixam doses containing 10mg/2.5mg of perindopril/indapamide combination (i.e., Triplixam 10mg/2.5mg/5mg and 10mg/2.5mg/10mg)</li>
<li>Hypersensitivity to the active substances, to other sulfonamides, to dihydropyridine derivatives, any other ACE-inhibitor or to any of the excipients listed in section 6.1. – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em></li>
<li>History of angioedema (Quincke’s oedema) associated with previous ACE inhibitor therapy (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</li>
<li>Hereditary/idiopathic angioedema</li>
<li>Second and third trimesters of pregnancy (see sections 4.4 and 4.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</li>
<li>Hepatic encephalopathy</li>
<li>Severe hepatic impairment</li>
<li>Hypokalaemia</li>
<li>Severe hypotension</li>
<li>Shock, including cardiogenic shock</li>
<li>Obstruction of the outflow-tract of the left ventricle (e.g. high grade aortic stenosis)</li>
<li>Haemodynamically unstable heart failure after acute myocardial infarction</li>
<li>Concomitant use of Triplixam with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60mL/min/1.73m<sup>2</sup>) (see sections 4.5 and 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</li>
<li>Concomitant use with sacubitril/valsartan therapy, Triplixam must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan (see sections 4.4 and 4.5 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</li>
<li>Extracorporeal treatments leading to contact of blood with negatively charged surfaces (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>Significant bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney (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
- C09BX01
- Atc Item Name
- perindopril, amlodipine and indapamide
- Pharma Manufacturer Name
- SERVIER (S) PTE LTD
