perindopril + amlodipine




Zuellig Pharma
Concise Prescribing Info
Perindopril arginine 3.5 mg, amlodipine 2.5 mg
Initial therapy in patients w/ mild to moderate essential HTN for whom combination therapy is appropriate.
Dosage/Direction for Use
1 tab once daily, may be increased after at least 4 wk if BP is inadequately controlled. Moderate renal impairment (CrCl 30-60 mL/min) 1 tab every other day, may be increased to 1 tab once daily if BP is inadequately controlled.
Should be taken on an empty stomach: Preferably taken in the morning before a meal.
Hypersensitivity to perindopril arginine, amlodipine besilate, ACE inhibitors & dihydropyridines. History of angioedema associated w/ previous ACE inhibitor therapy; hereditary or idiopathic angioedema; severe hypotension; cardiogenic shock; left ventricle outflow tract obstruction; haemodynamically unstable heart failure after acute MI. Significant bilateral renal artery stenosis or artery stenosis to single functioning kidney. Concomitant use w/ sacubitril/valsartan; extracorporeal treatments. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Severe renal impairment. 2nd & 3rd trimesters of pregnancy.
Special Precautions
Hypersensitivity/angioedema; anaphylactoid reactions during LDL apheresis & desensitisation. Discontinue use if jaundice or marked hepatic enzymes elevations occur. Not recommended in dual blockade renin-angiotensin-aldosterone system; primary aldosteronism. Not to be used concomitantly in patients w/ diabetic nephropathy. Collagen vascular disease, immunosuppressant therapy; renovascular HTN; hypertensive crisis; CHF; diuretic therapy, dietary salt restriction, diarrhoea or vomiting, ischaemic heart or cerebrovascular disease; aortic & mitral valve stenosis/hypertrophic cardiomyopathy; cough; DM, intercurrent events, dehydration, acute cardiac decompensation, metabolic acidosis. Bilateral renal artery stenosis or artery stenosis to single functioning kidney. Black patients. Discontinue use 1 day prior to surgery. Not to initiate sacubitril/valsartan until 36 hr after last dose. Not recommended in combination w/ K-sparing diuretics, K supplements, K-containing salt substitutes. Concomitant use w/ NEP inhibitors eg, racecadotril; mTOR inhibitors eg, sirolimus, everolimus, temsirolimus; gliptins (eg, linagliptin, saxagliptin, sitagliptin, vildagliptin); allopurinol or procainamide; drugs increasing serum K (eg, heparin, other ACE inhibitors, AIIA, ASA ≥3 g daily, COX-2 inhibitors, nonselective NSAIDs, immunosuppressants, trimethoprim, co-trimoxazole). Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Not to be used in severe renal impairment. Not recommended in patients w/ recent kidney transplantation. Haemodialysis patients. Moderate renal & severe hepatic impairment. Not recommended during 1st trimester of pregnancy & lactation. Childn <18 yr. Elderly ≥75 yr.
Adverse Reactions
Dizziness, headache; visual impairment; cough, dyspnoea; abdominal pain, nausea, dyspepsia, diarrhoea, constipation; muscle spasms; peripheral oedema, asthenia. Amlodipine: Oedema. Somnolence; diplopia; palpitations; flushing; change of bowel habit; joint &/or ankle swelling; fatigue. Perindopril: Dysgeusia, paraesthesia; tinnitus, vertigo; hypotension; vomiting; rash, exanthema, pruritus.
Drug Interactions
Increased risk of hyperkalaemia w/ aliskiren, K salts, K-sparing diuretics, ACE inhibitors, AIIA, NSAIDs, heparins, immunosuppressants (eg, ciclosporin, tacrolimus), trimethoprim, co-trimoxazole. Increased risk of severe anaphylactoid reactions w/ extracorporeal treatments. Increased risk of angioedema w/ sacubitril/valsartan, racecadotril, mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus), gliptins (eg, linagliptin, saxagliptin, sitagliptin, vildagliptin). Increased risk of angioneurotic oedema w/ estramustine. Reversible increased serum conc & toxicity of lithium. Lethal ventricular fibrillation & CV collapse w/ verapamil, dantrolene IV. Increased blood-glucose lowering effect w/ antidiabetic medicines (insulins, oral hypoglycaemics). Increased antihypertensive effect w/ baclofen. Excessive BP reduction w/ non-K-sparing diuretics. Attenuated antihypertensive effect w/ NSAIDs eg, ASA, COX-2 inhibitors, nonselective NSAIDs. Varied amlodipine conc w/ strong CYP3A4 inducers eg, rifampicin, Hypericum perforatum. Increased amlodipine exposure w/ CYP3A4 inhibitors eg, PIs, azole antifungals, macrolides (eg, erythromycin or clarithromycin), verapamil, diltiazem. Increased risk of hypotension w/ clarithromycin. Increased hypotensive effect w/ antihypertensive agents (eg, β-blockers), vasodilators. Further BP reduction w/ TCAs, antipsychotics, anaesth. Reduced antihypertensive effect w/ sympathomimetics, corticosteroids, tetracosactide. Increased antihypertensive effect & risk of orthostatic hypotension w/ α-blockers (eg, prazosin, alfuzosin, doxazosin, tamsulosin, terazosin). Potentiated amlodipine antihypertensive effect w/ amifostine. Nitritoid reactions w/ injectable gold (Na aurothiomalate). Increased BP-lowering effects w/ grapefruit or grapefruit juice. Increased tacrolimus blood levels.
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.
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