Viacoram Initio/Viacoram

Viacoram Initio/Viacoram

perindopril + amlodipine

Manufacturer:

Servier

Distributor:

Zuellig
Concise Prescribing Info
Contents
Per Viacoram Initio 3.5 mg/2.5 mg tab Perindopril arginine 3.5 mg, amlodipine besilate 2.5 mg. Per Viacoram 7 mg/5 mg tab Perindopril arginine 7 mg, amlodipine besilate 5 mg
Dosage/Direction for Use
1st-line therapy in arterial HTN One (1) 3.5 mg/2.5 mg tab once daily. May be increased to 7 mg/5 mg once daily after at least 4 wk of treatment if BP is not adequately controlled. Moderate renal impairment (CrCl 30-60 mL/min) Initially 3.5 mg/2.5 mg every other day. May be increased to once daily if BP is not adequately controlled.
Administration
Should be taken on an empty stomach: Preferably taken in the morning before a meal. Avoid grapefruit & grapefruit juice.
Contraindications
Hypersensitivity to perindopril, amlodipine, ACE inhibitors, or dihydropyridines derivatives. History of angioedema associated w/ previous ACE inhibitor therapy; hereditary or idiopathic angioedema; severe hypotension; shock including cardiogenic shock; obstruction of the outflow-tract of the left ventricle (eg, high grade aortic stenosis); hemodynamically unstable heart failure after acute MI; extracorporeal treatments leading to contact of blood w/ negatively charged surfaces; significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney. Concomitant use w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2); sacubitril/valsartan. Severe renal impairment. Pregnancy (2nd & 3rd trimesters).
Special Precautions
Hypersensitivity/angioedema. Patients w/ history of angioedema unrelated to ACE inhibitors. Anaphylactoid reactions during LDL apheresis w/ dextran sulphate; during desensitization treatment (eg, hymenoptera venom). Patients dialysed w/ high flux membranes. Neutropenia/agranulocytosis/thrombocytopenia/anemia. Periodic monitoring of WBC in patients w/ collagen vascular disease, immunosuppressant therapy, treatment w/ allopurinol or procainamide, or combination of these especially if there is pre-existing impaired renal function. Not recommended in patients w/ primary aldosteronism; recent kidney transplantation; diabetic nephropathy. Bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, preexisting renal impairment; renovascular HTN; hypertensive crisis; CHF; mitral valve stenosis & obstruction in the outflow of the left ventricle (eg, aortic stenosis or hypertrophic cardiomyopathy). Symptomatic hypotension in patients who have been vol-depleted eg, diuretic therapy, dietary salt restriction, dialysis, diarrhea or vomiting or have severe renin-dependent HTN, or w/ ischemic heart or cerebrovascular disease in whom excessive fall in BP could result in MI or CVA. Discontinue if jaundice or marked elevations of hepatic enzymes develop. Non-productive & persistent cough. Discontinue 1 day prior to surgery. Risk of hyperkalemia in patients w/ renal insufficiency, worsening of renal function, >70 yr, DM, intercurrent events, in particular dehydration, acute cardiac decompensation, metabolic acidosis. Closely monitor glycemic control in diabetic patients treated w/ oral antidiabetic agents or insulin during the 1st month of treatment. Monitor K levels & creatinine in renally impaired patients. Not recommended in dual blockade of RAAS through the combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren; combination w/ K-sparing drugs (eg, spironolactone, eplerenone, triamterene, or amiloride, alone or in combination), K supplements or K-containing salt substitutes; w/ other drugs associated w/ increase in serum K (eg, heparin, other ACE inhibitors, angiotensin-II antagonists, acetylsalicylic acid ≥3 g/day, COX-2 inhibitors & non-selective NSAIDs, immunosuppressant agents eg, ciclosporin or tacrolimus, trimethoprim & co-trimoxazole). Concomitant use w/ racecadotril, mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus) & gliptins (eg, linagliptin, saxagliptin, sitagliptin, vildagpiltin). Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Minor or moderate influence on the ability to drive & use machines. Severe hepatic impairment. Not recommended during pregnancy (1st trimester) & lactation. Childn <18 yr. Elderly ≥75 yr. Black patients.
Adverse Reactions
Dizziness; headache; visual impairment; cough, dyspnea; abdominal pain, nausea, dyspepsia, diarrhea, constipation; muscle spasms; asthenia; peripheral edema. Amlodipine: Edema. Somnolence; diplopia; palpitations; flushing; change of bowel habit; joint swelling (ankle swelling); fatigue. Perindopril: Dysgeusia, paresthesia; tinnitus, vertigo; hypotension (& effects related to hypotension); vomiting; rash, exanthema, pruritus.
Drug Interactions
Hypotension, hyperkalemia & decreased renal function (including acute renal failure) w/ dual blockade of the RAAS through combined use of ACE inhibitors, angiotensin II receptor blockers, or aliskiren. Increased risk of angioedema w/ sacubitril/valsartan, racecadotril, mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus) & gliptins (eg, linagliptin, saxagliptin, sitagliptin, vildagliptin); estramustine. Increase occurrence of hyperkalemia w/ aliskiren, K salts, K-sparing diuretics (eg, triamterene, amiloride, eplerenone, spironolactone), dantrolene (infusion), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs, heparins, immunosuppressant agents (eg, ciclosporin or tacrolimus), trimethoprim & co-trimoxazole; heparin. Risk of hyperkalemia, worsening of renal function & CV morbidity & mortality w/ aliskiren in diabetic or impaired renal patients. Increased risk of severe anaphylactoid reactions w/ extracorporeal treatments. Reversible increases in serum lithium conc & toxicity. Increased blood-glucose lowering effect w/ risk of hypoglycemia w/ antidiabetic agents (insulins, oral hypoglycemic agents). Increased antihypertensive effect w/ baclofen. Excessive reduction in BP w/ non-K-sparing diuretics. Attenuation of antihypertensive effect & increased risk of worsening of renal function w/ NSAIDs including aspirin ≥3 g/day (eg, acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors & non-selective NSAIDs). May increase hypotensive effects w/ antihypertensive agents (eg, β-blockers) & vasodilators. Reduced BP w/ nitroglycerine & other nitrates or other vasodilators; certain anesth medicinal products, TCAs, antipsychotics. Reduced antihypertensive effects w/ sympathomimetics, corticosteroids, tetracosactide. Increased antihypertensive effect & risk of orthostatic hypotension w/ α-blockers (prazosin, alfuzosin, doxazosin, tamsulosin, terazosin). Nitritoid reactions w/ inj gold (Na aurothiomalate). Increased bioavailability w/ grapefruit or grapefruit juice. Amlodipine: Plasma conc may vary w/ strong CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). Increased exposure w/ strong or moderate CYP3A4 inhibitors (PIs, azole antifungals, macrolides eg, erythromycin or clarithromycin, verapamil or diltiazem). Increased risk of hypotension w/ clarithromycin. Potentiated antihypertensive effect w/ amifostine. Increased risk of tacrolimus blood levels. May increase exposure of mTOR inhibitors (eg, sirolimus, temsirolimus & everolimus).
MIMS Class
ACE Inhibitors/Direct Renin Inhibitors / Calcium Antagonists
ATC Classification
C09BB04 - perindopril and amlodipine ; Belongs to the class of ACE inhibitors and calcium channel blockers. Used in the treatment of cardiovascular diseases.
Presentation/Packing
Form
Viacoram 7 mg/5 mg tab
Packing/Price
30's (P742.5/box)
Form
Viacoram Initio 3.5 mg/2.5 mg tab
Packing/Price
30's (P615/box)
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