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Bioprexum

Bioprexum

perindopril

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Concise Prescribing Info
Contents
Perindopril arginine
Indications/Uses
HTN. Stable CAD: In patients w/ history of MI &/or revascularisation. 5 mg: Heart failure: In CHF, as adjunct to diuretic & digitalis. Stroke: Reduction of stroke recurrence in combination w/ indapamide in patient w/ history of cerebrovascular disease.
Dosage/Direction for Use
Individualised dosage. HTN Initially 5 mg once daily, may be increased to 10 mg once daily after 1 mth. Patient w/ strongly activated renin-angiotensin-aldosterone system (renovascular & severe HTN, salt &/or vol depletion, cardiac decompensation) Initially 2.5 mg daily. Patient in concomitant use w/ diuretic that cannot be discontinued Initially 2.5 mg, monitor renal function & serum K levels. Elderly Initially 2.5 mg daily, may be increased to 5 mg daily after 1 mth & then to 10 mg depending on renal function. Stable CAD Initially 5 mg once daily for 2 wk, then increased to 10 mg once daily, depending on renal function & if 5 mg is well tolerated. Elderly 2.5 mg once daily for 1 wk, then 5 mg once daily the next wk, before increasing up to 10 mg once daily depending on renal function. Symptomatic heart failure Initially 2.5 mg, may be increased to 5 mg once daily after 2 wk if tolerated. Reduction of stroke recurrence Initially 2.5 mg daily for 2 wk, then increased to 5 mg daily for a further 2 wk before introducing indapamide. Renal impairment CrCl ≥60 mL/min 5 mg daily, CrCl 30-60 mL/min 2.5 mg daily, CrCl 15-30 mL/min 2.5 mg every other day, Haemodialysed patient CrCl <15 mL/min 2.5 mg on the day of dialysis.
Administration
Should be taken on an empty stomach: Take in the morning before a meal.
Contraindications
Hypersensitivity to perindopril arginine, or other ACE inhibitor. History of angioedema associated w/ previous ACE inhibitor therapy, hereditary or idiopathic angioedema. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2); sacubitril/valsartan therapy. Extracorporeal treatments leading to contact of blood w/ -ve charged surfaces. Significant bilateral renal artery stenosis or artery stenosis to single functioning kidney. 2nd & 3rd trimesters of pregnancy.
Special Precautions
Hypersensitivity/angioedema; anaphylactoid reactions during LDL apheresis & desensitisation. Discontinue use if episode of unstable angina pectoris (major or not) during 1st mth of treatment; jaundice or marked hepatic enzymes elevation occur. Not to be used concomitantly w/ ARBs in patients w/ diabetic neuropathy. Not recommended in dual blockade of the renin-angiotensin-aldosterone system; primary hyperaldosteronism. Symptomatic hypotension in vol-depleted patients eg, diuretic therapy, dietary salt restriction, dialysis, diarrhoea, vomiting, severe renin-dependent HTN; ischaemic heart or cerebrovascular disease; CHF; renovascular HTN. Patients w/ mitral valve stenosis & left ventricle outflow obstruction (eg, aortic stenosis or hypertrophic cardiomyopathy); collagen vascular disease, on immunosuppressant therapy, treated w/ allopurinol or procainamide (periodically monitor WBC counts). Routine monitoring of K & creatinine. Risk factors for hyperkalemia include renal insufficiency, worsening renal function, patients >70 yr, DM, intercurrent events particularly dehydration, acute cardiac decompensation, metabolic acidosis, concomitant use of K-sparing diuretics (eg, spironolactone, eplerenone, triamterene, or amiloride), K supplements or K-containing salt substitutes, taking other drugs associated w/ increases in serum K (eg, heparin, co-trimoxazole). Closely monitor glycaemic control during 1st mth of treatment. Bilateral renal artery stenosis or artery stenosis to a solitary kidney, preexisting renal impairment. Non-productive & persistent cough. Black patients; diabetic patients. Discontinue use 1 day prior to surgery. Not to initiate sacubitril/valsartan until 36 hr after last dose. Not recommended in combination w/ lithium; K-sparing drugs, K supplements or K-containing salt substitutes, aliskiren. Concomitant use w/ NEP inhibitors (eg, racecadotril); mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus); gliptins (eg, linagliptin, saxagliptin, sitagliptin, vildagliptin). Not to be taken by patients w/ galactose intolerance, glucose-galactose malabsorption or total lactase deficiency. May impair ability to drive & use machines. Renal impairment (CrCl <60 mL/min). Haemodialysis; recent kidney transplantation. Hepatic impairment & failure. Not recommended during 1st trimester of pregnancy & lactation. Not recommended in childn & adolescents <18 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
Increased risk of hyperkalaemia w/ aliskiren, K salts or K-sparing diuretics (eg, spironolactone, triamterene, amiloride, eplerenone), ACE inhibitors, AIIAs, NSAIDs, heparins, immunosuppressants (eg, ciclosporin, tacrolimus), trimethoprim, co-trimoxazole. Increased risk of hyperkalaemia, worsened renal function, CV morbidity & mortality w/ aliskiren. 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). Higher frequency of hypotension, syncope, hyperkalaemia, & worsening renal function w/ ARBs. Increased risk of angioneurotic oedema w/ estramustine. Reversible increased serum conc & toxicity of lithium. Increased blood-glucose lowering effect of antidiabetic agents eg, insulins, oral hypoglycaemic agents. Increased antihypertensive effect w/ baclofen. Excessive BP reduction w/ non-K-sparing diuretics. Attenuated antihypertensive effects w/ NSAIDs eg, ASA, COX-2 inhibitors, non-selective NSAIDs. May increase hypotensive effects w/ antihypertensive agents & vasodilators. Reduced BP w/ nitroglycerin, other nitrates or vasodilators; TCAs, antipsychotics, anaesth. 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.
Presentation/Packing
Form
Bioprexum FC tab 10 mg
Packing/Price
30's (Rp658,541/pak)
Form
Bioprexum FC tab 5 mg
Packing/Price
30's (Rp502,963/pak)
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