Enalapril Stella

Enalapril maleate

Treatment of HTN & symptomatic heart failure. Prevention of symptomatic heart failure in patients w/ asymptomatic left ventricular dysfunction (ejection fraction ≤35%).

HTN Initial dose: 5-20 mg once daily. Maintenance dose: 20 mg daily. Max maintenance dose: 40 mg daily. Mild HTN Initial dose: 5-10 mg. Symptomatic heart failure/asymptomatic left ventricular dysfunction Dose titration: Wk 1: Days 1-3: 2.5 mg daily in a single dose; days 4-7: 5 mg daily in 2 divided doses. Wk 2: 10 mg daily in a single dose or in 2 divided doses. Wk 3 & 4: 20 mg daily in a single dose or in 2 divided doses. Max dose: 40 mg daily in 2 divided doses. Hypertensive paed patient ≥50 kg Initial dose: 5 mg once daily. Max dose: 40 mg daily, 20-<50 kg Initial dose: 2.5 mg once daily. Max dose: 20 mg daily. Patient w/ strongly activated renin-angiotensin-aldosterone system (RAAS); patient w/ prior treatment w/ high-dose diuretics Starting dose: ≤5 mg. Patient w/ CrCl 30-80 mL/min Initial dose: 5-10 mg daily, 10-30 mL/min 2.5 mg daily, ≤10 mL/min 2.5 mg on dialysis days. Other prep should be used for 2.5 mg dose.

May be taken with or without food.

Hypersensitivity to enalapril maleate or any other ACE inhibitors. 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). Combination w/ sacubitril/valsartan; do not administer w/in 36 hr of switching to or from sacubitril/valsartan (neprilysin inhibitor-containing product). 2nd & 3rd trimesters of pregnancy.

Promptly discontinue & institute appropriate monitoring in case of hypersensitivity/angioneurotic oedema. Anaphylactoid reactions during desensitisation w/ hymenoptra venom; during LDL apheresis w/ dextran sulfate; in patients dialysed w/ high-flux membranes (eg, AN 69). Increased risk of symptomatic hypotension in vol-depleted hypertensive patients. Give w/ caution in patients w/ left ventricular valvular & outflow tract obstruction. Avoid in cases of cardiogenic shock & haemodynamically significant obstruction. Routine monitoring of K & creatinine in patients w/ renal impairment. Reports of renal failure mainly in patients w/ severe heart failure or underlying renal disease, including renal artery stenosis. Increased risk of hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Not recommended in patients w/ recent kidney transplantation. Discontinue in patients who develop jaundice or marked elevations of hepatic enzymes. Neutropenia/agranulocytosis, thrombocytopenia & anaemia have been reported. Use w/ extreme caution in patients w/ collagen vascular disease, immunosuppressant therapy, treatment w/ allopurinol or procainamide, or a combination of these complicating factors, especially if there is pre-existing impaired renal function; periodic monitoring of WBC counts is advised. Diabetic patients treated w/ oral antidiabetic agents or insulin should be closely monitored for hypoglycemia, especially during the 1st mth of combined use w/ ACE inhibitor. Non-productive, persistent cough may occur & will resolve after discontinuation of therapy. Hypotension in patients undergoing major surgery or during anesth w/ agents that produce hypotension. Elevations in serum K. Not recommended w/ lithium. Dual blockade of RAAS through combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren is not recommended. Do not concomitantly use ACE inhibitors & angiotensin II receptor blockers in patients w/ diabetic nephropathy. Less BP-lowering effect & higher incidence of angioedema in patients of African American ethnicity. Should not be used by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May impair ability to drive or operate machinery. Patients w/ renal impairment. Not recommended during the 1st trimester of pregnancy. Not recommended for use during breastfeeding of preterm infants & for the 1st few wk after delivery. Use may be considered during breastfeeding of older infants. Limited efficacy & safety experience in hypertensive childn >6 yr. Limited pharmacokinetic data in childn >2 mth. Not recommended in childn in other indications than HTN. Not recommended in neonates & in paed patients w/ GFR <30 mL/min/1.73 m².

Dizziness; blurred vision; cough; nausea; asthenia. Depression; headache, syncope, taste alteration; chest pain, rhythm disturbances, angina pectoris, tachycardia; hypotension (including orthostatic hypotension); dyspnea; diarrhoea, abdominal pain; rash, hypersensitivity/angioneurotic oedema (angioneurotic oedema of the face, extremities, lips, tongue, glottis &/or larynx); fatigue; hyperkalaemia, increased serum creatinine.

Higher frequency of adverse events w/ combined use of ACE inhibitors, angiotensin II receptor blockers, or aliskiren. Increased serum K w/ K-sparing diuretics (eg, spironolactone, eplerenone, triamterene or amiloride), K supplements, K-containing salt substitutes or other drugs that may increase serum K (eg, heparin, trimethoprim-containing products eg, cotrimoxazole). Vol depletion & risk of hypotension w/ high-dose diuretics. Increased hypotensive effects w/ other antihypertensive agents. Reduced BP w/ nitroglycerine & other nitrates or other vasodilators; certain anaesth, TCAs & antipsychotics. Reversible increases in serum lithium conc & toxicity. Attenuated antihypertensive effect w/ NSAIDs including selective COX-2 inhibitors. Co-administration of NSAIDs (including COX-2 inhibitors) & AIIA or ACE inhibitors exert an additive effect on serum K increase & may result in a deterioration of renal function. Nitritoid reactions in patients on therapy w/ injectable gold. Increased risk of angioedema w/ mTOR inhibitor (eg, temsirolimus, sirolimus, everolimus); neprilysin inhibitor (eg, sacubitril, racecadotril). Reduced antihypertensive effects w/ sympathomimetics. Increased blood-glucose-lowering effect (risk of hypoglycaemia) of antidiabetic medicines (insulins, oral hypoglycaemic agents). Enhanced hypotensive effect w/ alcohol.

ACE Inhibitors/Direct Renin Inhibitors

C09AA02 - enalapril ; Belongs to the class of ACE inhibitors. Used in the treatment of cardiovascular disease.

P₁S₁S₃