Duopharma Manufacturing (Bangi)


Duopharma Marketing
Concise Prescribing Info
Perindopril erbumine
HTN; symptomatic heart failure. Stable CAD: Reduce risk of cardiac events in patients w/ history of MI &/or revascularisation.
Dosage/Direction for Use
HTN Initially 4 mg once daily, may be increased to 8 mg once daily after 1 mth of treatment. Elderly Initially 2 mg once daily, may be progressively increased to 4 mg after 1 mth & then to 8 mg once daily if necessary. Symptomatic heart failure Initially 2 mg once daily, may be increased after 2 wk to 4 mg once daily if tolerated. Stable CAD Initially 4 mg once daily for 2 wk then increased to 8 mg once daily if necessary. Elderly Initially 2 mg once daily for 1 wk, then increased to 4 mg once daily the next wk & then further increased to 8 mg once daily. Renal impairment CrCl ≥60 mL/min 4 mg daily, >30 to <60 mL/min 2 mg daily, >15 to <30 mL/min 2 mg every other day. Hemodialysed patient 2 mg on dialysis day.
Should be taken on an empty stomach: Take in the morning before a meal.
Hypersensitivity to perindopril erbumine or any other ACE inhibitor. History of angioedema associated w/ previous ACE inhibitor therapy, hereditary or idiopathic angioedema, significant bilateral renal artery stenosis or artery stenosis to single functioning kidney. Extracorporeal treatments leading to blood contact w/ negatively charged surfaces. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2); sacubitril/valsartan. 2nd & 3rd trimesters of pregnancy.
Special Precautions
Hypersensitivity/angioedema. Not recommended in dual blockade of renin-angiotensin-aldosterone system; primary aldosteronism. Risk of hypotension in vol-depleted patients eg, by diuretic therapy, dietary salt restriction, dialysis, diarrhea or vomiting, severe renin-dependent HTN; symptomatic heart failure w/ or w/o associated renal insufficiency; severe heart failure eg, use of high-dose loop diuretics, hyponatraemia or functional renal impairment; ischemic heart or cerebrovascular disease; mitral valve stenosis, left ventricle outflow tract obstruction eg, aortic stenosis or hypertrophic cardiomyopathy; collagen vascular disease; cough; DM, intercurrent events, dehydration, acute cardiac decompensation, metabolic acidosis. Anaphylactoid reactions in patients dialysed w/ high-flux membranes, during LDL apheresis w/ dextran sulfate or desensitisation treatment eg, hymenoptera venom. Perform routine monitoring of serum K & creatinine. Closely monitor diabetic control during 1st mth of treatment. Black patients. Galactose intolerance, glucose-galactose malabsorption, Lapp lactase deficiency. Discontinue 1 day prior to surgery/anaesth. Not to be initiated w/ sacubitril/valsartan until 36 hr after last dose. Not to be used concomitantly w/ ARBs in patients w/ diabetic nephropathy. Not recommended in combination w/ K-sparing diuretics (eg, spironolactone, eplerenone, triamterene, amiloride), K supplements or K-containing salt substitutes; lithium. Concomitant use of other NEP inhibitors eg, racecadotril; mTOR inhibitors eg, sirolimus, everolimus, temsirolimus; immunosuppressants; allopurinol or procainamide; drugs increasing serum K (eg, heparin, co-trimoxazole). May affect ability to drive & use machines. Renal impairment; hemodialysis & recent kidney transplant patients. Hepatic failure. Not recommended during 1st trimester of pregnancy & lactation. Not recommended in childn & adolescents <18 yr. Elderly >70 yr.
Adverse Reactions
Dizziness, headache, paraesthesia, vertigo; visual disturbances; tinnitus; hypotension; cough, dyspnoea; abdominal pain, constipation, diarrhoea, dysgeusia, dyspepsia, nausea, vomiting; pruritus, rash; muscle cramps; asthenia.
Drug Interactions
Hypotension, hyperkalemia & decreased renal function w/ other ACE inhibitors, ARBs or aliskiren. Increased risk of hyperkalaemia w/ aliskiren, K salts, K-sparing diuretics, ACE inhibitors, angiotensin-II receptors antagonists, NSAIDs, heparins, immunosuppressant agents eg, ciclosporin or tacrolimus, trimethoprim, co-trimoxazole. Increased CV morbidity & mortality w/ aliskiren in diabetic or renal impairment patients. Increased risk of severe anaphylactoid reactions w/ extracorporeal treatment. Increased risk of angioedema w/ sacubitril/valsartan, estramustine, racecadotril, mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus), gliptins (linagliptin, saxagliptin, sitagliptin, vildagliptin). Increased serum lithium conc & toxicity. Increased blood-glucose lowering effect of antidiabetics (insulins, oral hypoglycemic agents). Increased antihypertensive effect w/ baclofen. Excessive BP reduction w/ non-K-sparing diuretics; TCAs, antipsychotics, anaesth. Attenuated antihypertensive effect w/ NSAIDs. Increased hypotensive effects w/ nitroglycerin, other nitrates or vasodilators. Reduced antihypertensive effects w/ sympathomimetics. Nitritoid reactions w/ injectable gold (Na aurothiomalate).
MIMS Class
ACE Inhibitors/Direct Renin Inhibitors
ATC Classification
C09AA04 - perindopril ; Belongs to the class of ACE inhibitors. Used in the treatment of cardiovascular disease.
Perinace tab 4 mg
3 × 10's
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