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June 25, 2016


Company: Actavis Ireland Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Lisinopril 2.5mg, 5mg, 10mg, 20mg.
Description: Round tablets, can be divided into equal halves. 2.5mg: White, biconvex. 5mg: White, flat, scored both sides. 10mg: Light pink, biconvex, scored one side. 20mg: Pink, biconvex, scored one side.
Presentation: 2.5mg-28; 5mg-28; 10mg-28; 20mg-28. Prices available on request.
Indications: Treatment of hypertension. Treatment of symptomatic heart failure. Short-term (6 weeks) treatment of haemodynamically stable patients within 24 hours of an acute myocardial infarction. Treatment of renal disease in hypertensive patients with Type 2 diabetes mellitus and incipient nephropathy.

Pharmacology: Lisinopril is a peptidyl dipeptidase inhibitor. It inhibits the angiotensin converting enzyme (ACE) that catalyses the conversion of angiotensin I to the vasoconstrictor peptide, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. Inhibition of ACE results in decreased concentrations of angiotensin II which results in decreased vasopressor activity and reduced aldosterone secretion. The latter decrease may result in an increase in serum potassium concentration.
Dosage: Adult: Hypertension: Initially, 10mg. Patients with highly activated reninangiotensin-aldosterone system: 2.5-5mg initially. Maintenance, 20mg (as single dose); if desired therapeutic effect not obtained within 2 to 4 weeks, the dose may be increased to 80mg/day maximum. Patients on diuretics: If possible, withdraw the diuretic 2 to 3 days before starting treatment; if not possible, start with 5mg/day and monitor serum K+ and renal function. HF: Initially 2.5mg once a day under medical supervision. Increase to highest tolerated dose, up to a maximum of 35mg once a day by increments of not more than 10mg and at intervals of not less than 2 weeks. Acute MI: Do not start if systolic arterial pressure <100mmHg. Initially (in the first 3 days after infarct), 5mg orally, followed by 5mg after 24 hours, 10mg after 48 hours and 10mg/day thereafter. Patients with low systolic arterial pressure (≤120mmHg) at start of treatment or within first 3 days of infarct: 2.5mg orally. Maintenance, 10mg once daily. Reassess patient after 6 weeks. If hypotension occurs (systolic arterial pressure ≤100mmHg), 5mg with temporary decrease to 2.5mg if necessary; withdraw if hypotension prolongs. Renal complication of diabetes mellitus: 10mg once daily; may be increased to 20mg once daily if necessary. Renal impairment, cc<10ml/min, initially 2.5mg; 10<cc<30ml/min, initially 2.5-5mg; 31<cc<80ml/min, initially 5-10mg/day. Elderly: As per adults. Children: Not recommended.
Contraindications: Hypersensitivity to lisinopril, to any of the excipients or any other angiotensin converting enzyme (ACE) inhibitor. History of angioedema associated with previous ACE inhibitor therapy. Hereditary or idiopathic angioedema. Pregnancy, lactation.
Special precautions: Caution: Acute MI (do not use if signs of renal dysfunction: serum creatinine >177mcmol/l and/or proteinuria >500mg/24hours, if systolic blood pressure ≤100mmHg, cardiogenic shock), mitral stenosis and left ventricle outflow obstruction (aortal stenosis, hypertrophic myocardiopathy), bilateral renal artery stenosis or stenosis of the artery in a single kidney (strict supervision necessary with low doses and careful dosage adjustment), pre-existing renal impairment (monitor blood K+ and creatinine concentrations), major surgery, during anaesthesia, renal insufficiency, diabetes. May occur: Systemic hypotension, angioedema (withdraw immediately if occurs), anaphylactoid reactions in haemodialysis patients or during desensitisation treatment (e.g. for bee or wasp stings), acute renal insufficiency in patients with heart failure (usually reversible), hepatic insufficiency, neutropenia/agranulocytosis, cough.
Drug interactions: Not recommended: Lithium. Caution: Diuretics, K+-sparing diuretics, K+ supplements, salt substitutes containing K+, NSAIDs (incl. acetylsalicylic acid ≥ 3g/day), other antihypertensives (nitroglycerin, other nitrates, other vasodilator agents), injectable gold (e.g. sodium aurothiomalate), certain anaesthetic drugs, tricyclic antidepressants and antipsychotic agents, sympathicomimetics, anti-diabetics.
Adverse drug reactions: Dizziness, headache, cough, diarrhoea, vomiting, renal dysfunction, orthostatic effects (incl. hypotension).
Full prescribing information and references available from Actavis Ireland Ltd. Telephone: (021) 4619040. Fax: (021) 4619049. E-mail: contact@actavis.ie