VIACORAM TABLET 14 MG/10 MG [SIN15557P]

Product Info

VIACORAM TABLET 14 MG/10 MG

[SIN15557P]

INDICATIONS AND CLINICAL USE

VIACORAM® (perindopril arginine and amlodipine) is indicated for the treatment of mild to moderate essential hypertension in patients for whom combination therapy is appropriate.

VIACORAM® START 3.5 mg/2.5 mg is indicated for initial therapy in patients with mild to moderate essential hypertension.

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).

Geriatrics (> 65 years of age):
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).

Pediatrics (< 18 years of age):
VIACORAM® is not indicated in pediatric patients <18 years of age. The efficacy and safety have not been studied in this population.

DOSAGE AND ADMINISTRATION

Dosing Considerations
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.

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.

Dosages of the perindopril arginine in VIACORAM® are not marketed individually.
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).

Recommended Dose and Dosage Adjustment
The recommended starting dose of VIACORAM® is 3.5 mg/2.5 mg once daily.

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.

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.

Elderly:
VIACORAM® is not indicated for the initiation of treatment in elderly patients (> 65 years of age).

Hepatic Impairment:
VIACORAM® is not recommended in patients with hepatic impairment (see WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal Impairment:
VIACORAM® is contraindicated in patients with renal impairment (creatinine clearance <60 ml/min) (see CONTRAINDICATIONS).

Use with Diuretics: 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Missed Dose
If a dose is missed, a double dose should not be taken, but just carry on with the next dose at the normal time.

Administration
VIACORAM® should be taken as a single dose, preferably in the morning and before a meal.

CONTRAINDICATIONS

VIACORAM® (perindopril arginine and amlodipine) is contraindicated in:

• 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Patients with renal impairment (creatinine clearance < 60 ml/min) (see WARNINGS and PRECAUTIONS, Renal – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Patients with a history of hereditary/idiopathic angioedema, or angioedema related to previous treatment with an ACE-inhibitor (see WARNINGS and PRECAUTIONS, Immune – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Nursing women (see WARNINGS AND PRECAUTIONS, Special Populations, Nursing Women – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Patients with mitral valve stenosis and left ventricular outflow tract obstruction (e.g. aortic stenosis, hypertrophic cardiomyopathy).

• Patients with heart failure.

• 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/1.73m²) (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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Patients with extracorporeal treatments leading to contact of blood with negatively charged surfaces.

• Patients with bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney.

• 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)