- Approval Id
- 93a0af6ba477fb0f
- Drug Name
- VIACORAM TABLET 14 MG/10 MG
- Product Name
- VIACORAM TABLET 14 MG/10 MG
- Approval Number
- SIN15557P
- Approval Date
- 2018-10-01
- Registrant
- SERVIER (S) PTE LTD
- Licence Holder
- SERVIER (S) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong></p>
<p><u><strong>Dosing Considerations</strong></u><br>
VIACORAM® is a combination product containing perindopril as an arginine salt (perindopril arginine) and amlodipine expressed as free base (amlodipine besylate) and is available in three fixed-dose perindopril arginine/amlodipine combinations of 3.5 mg/2.5 mg, 7 mg/5 mg, and 14 mg/10 mg.</p>
<p>VIACORAM® should be initiated at the recommended starting dose of 3.5 mg/2.5mg once daily in hypertensive patients for whom combination therapy is appropriate.</p>
<p>Dosages of the perindopril arginine in VIACORAM® are not marketed individually.<br>
Patients cannot be titrated with the individual drugs currently on the market prior to the initiation of VIACORAM®, since dosages of perindopril arginine in VIACORAM® are not equivalent to those marketed individually (perindopril as erbumine or arginine salt).</p>
<p><u><strong>Recommended Dose and Dosage Adjustment</strong></u><br>
The recommended starting dose of VIACORAM® is 3.5 mg/2.5 mg once daily.</p>
<p>After four weeks of treatment, the dose may be increased to 7 mg/5 mg once daily in adult patients whose blood pressure is not at appropriate target.</p>
<p>If necessary, titration to 14 mg/10 mg once daily may be considered in adult patients insufficiently controlled after four weeks of treatment with 7 mg/5 mg.</p>
<p><strong>Elderly:</strong><br>
VIACORAM® is not indicated for the initiation of treatment in elderly patients (> 65 years of age).</p>
<p><strong>Hepatic Impairment:</strong><br>
VIACORAM® is not recommended in patients with hepatic impairment (see WARNINGS AND PRECAUTIONS – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Renal Impairment:</strong><br>
VIACORAM® is contraindicated in patients with renal impairment (creatinine clearance <60 ml/min) (see CONTRAINDICATIONS).</p>
<p><strong>Use with Diuretics:</strong> In patients who are currently being treated with a diuretic, symptomatic hypotension can occur following the initial dose of VIACORAM®. Consider reducing the dose of diuretic prior to starting VIACORAM® (see DRUG INTERACTIONS, Drug-Drug Interactions – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><u><strong>Missed Dose</strong></u><br>
If a dose is missed, a double dose should not be taken, but just carry on with the next dose at the normal time.</p>
<p><u><strong>Administration</strong></u><br>
VIACORAM® should be taken as a single dose, preferably in the morning and before a meal.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATIONS AND CLINICAL USE</strong></p>
<p>VIACORAM® (perindopril arginine and amlodipine) is indicated for the treatment of mild to moderate essential hypertension in patients for whom combination therapy is appropriate.</p>
<p>VIACORAM® START 3.5 mg/2.5 mg is indicated for initial therapy in patients with mild to moderate essential hypertension.</p>
<p>VIACORAM® is not indicated for switching therapy from the individual drugs currently on the market (perindopril as erbumine or arginine salt, amlodipine) (see DOSAGE AND ADMINISTRATION section).</p>
<p><strong>Geriatrics (> 65 years of age):</strong><br>
VIACORAM® is not indicated for the initiation of treatment in elderly patients. There is no sufficient clinical experience to justify the use in the elderly (> 65 years).</p>
<p><strong>Pediatrics (< 18 years of age):</strong><br>
VIACORAM® is not indicated in pediatric patients <18 years of age. The efficacy and safety have not been studied in this population.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong></p>
<p>VIACORAM® (perindopril arginine and amlodipine) is contraindicated in:</p>
<ul class="dash">
<li>Patients who are hypersensitive to the active ingredients of this drug, to any ingredient in the formulation or component of the container, to any other angiotensin converting enzyme inhibitor (ACE-inhibitor), or to any other dihydropyridine derivatives. For a complete listing, see DOSAGE FORMS, COMPOSITION and PACKAGING section of the product monograph – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</li>
<li>Patients with renal impairment (creatinine clearance < 60 ml/min) (see WARNINGS and PRECAUTIONS, Renal – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>Patients with a history of hereditary/idiopathic angioedema, or angioedema related to previous treatment with an ACE-inhibitor (see WARNINGS and PRECAUTIONS, Immune – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>Women who are pregnant, intend to become pregnant, or of childbearing potential who are not using adequate contraception. (see WARNINGS and PRECAUTIONS, Special Populations, Pregnant Women – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>Nursing women (see WARNINGS AND PRECAUTIONS, Special Populations, Nursing Women – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>Patients with mitral valve stenosis and left ventricular outflow tract obstruction (e.g. aortic stenosis, hypertrophic cardiomyopathy).</li>
<li>Patients with heart failure.</li>
<li>Concomitant use of angiotensin converting enzyme (ACE) inhibitors, including VIACORAM®, with aliskiren-containing drugs in patients with diabetes mellitus (type 1 or 2) or moderate to severe renal impairment (GFR < 60ml/min/1.73m<sup>2</sup>) (see WARNINGS AND PRECAUTIONS, Dual Blockade of the Renin-Angiotensin System (RAS) and Renal, and DRUG INTERACTIONS, Dual Blockade of the Renin-Angiotensin System (RAS) with ACE inhibitors, ARBs or aliskiren-containing drugs – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>Patients with hereditary problems of galactose intolerance, glucose-galactose malabsorption, or the total lactase deficiency as VIACORAM® contains lactose (see WARNINGS AND PRECAUTIONS, Sensitivity/Resistance – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>Patients with extracorporeal treatments leading to contact of blood with negatively charged surfaces.</li>
<li>Patients with bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney.</li>
<li>Concomitant use with sacubitril/valsartan therapy, Perindopril must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan. (see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</li>
</ul>
- Atc Code
- C09BB04
- Atc Item Name
- perindopril and amlodipine
- Pharma Manufacturer Name
- SERVIER (S) PTE LTD
