Practice Update: Cardiology

nebivolol hydrochloride

Elderly ( ≥ 70 years) CHF patients deserve an age proven blocker 1,2 NEBILET reduced the risk of all cause mortality or cardiovascular hospitalisation in a broad range of elderly CHF patients *1,2 * vs placebo P= 0.039; patients ≥ 70 years regardless of age, gender or left ventricular ejection fraction Elderly ( ≥ 70 years) CHF patients deserve an age proven blocker 1,2 NEBILET reduced the risk of all cause mortality or cardiovascular hospitalisation in a broad range of elderly CHF patients *1,2 * vs placebo P= 0.039; patients ≥ 70 years regardless of age, gender or left ventricular ejection fraction Elderly ( ≥ 70 years) CHF patients deserve an age proven blocker 1,2 NEBILET reduced the risk of all cause mortality or cardiovascular hospitalisation in a broad range of lderly CHF patients *1,2 * vs placebo P= 0.039; patients ≥ 70 years regardless of age, gender or left ventricular ejection fraction

NEBILET: Age proven in elderly ( ≥ 70 years) CHF patients 1,2 NEBILET: Age proven in elderly ( ≥ 70 years) CHF patients 1,2 NEBILET: Age proven in elderly ( ≥ 70 y rs) CHF patients 1,2

CHF= Chronic Heart Failure CHF= Chronic Heart Failure

F= Chronic Heart Failure

Nebilet ® (nebivolol hydrochloride) tablets 1.25 mg, 5 mg, 10 mg. INDICATIONS: Essential hypertension. Stable chronic heart failure (CHF) as an adjunct to standard therapies in patients 70 years or older. CONTRAINDICATIONS: Hypersensitivity to the active or any of the excipients; liver insufficiency or liver function impairment; acute heart failure; cardiogenic shock or episodes of heart failure decompensation requiring IV inotropic therapy; sick sinus syndrome, including sino-atrial block; second and third degree heart block (without a pacemaker); history of bronchospasm (e.g. including COPD) and/or asthma; untreated phaeochromocytoma; metabolic acidosis; bradycardia (HR < 60 bpm prior to starting therapy); hypotension (systolic BP < 100 mmHg); severe peripheral circulatory disturbances. PRECAUTIONS: Avoid abrupt cessation unless clearly indicated – reduce dosage gradually over 1-2 wks; refer to full PI. If it must be withdrawn abruptly, close observation is required. Anaesthesia; untreated congestive heart failure, unless stabilised; bradycardia; peripheral circulatory disorders (e.g. Raynaud’s disease, intermittent claudication); first degree heart block; Prinzmetal’s or variant angina; lipid and carbohydrate metabolism – does not affect glucose levels in diabetic patients, but may mask symptoms of hypoglycaemia. Hyperthyroidism; COPD/asthma; phaeochromocytoma; various skin rashes; conjunctival xerosis; oculomucocutaneous syndrome; psoriasis; increased sensitivity to allergens and severity of anaphylactic reactions; galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption; driving vehicles or operating machines. Pregnancy (Cat C). Lactation. Children and adolescents. Renal and hepatic insufficiency – see Dosage and Administration. INTERACTIONS: Combination not recommended: Class I antiarrhythmics; calcium channel antagonists (verapamil/dilitiazem); centrally-acting antihypertensives; other beta-blockers (incl. eye drops). Combination to be used with caution: Class III antiarrhythmic drugs; anaesthetics (volatile); insulin and other oral diabetic medicines; calcium antagonists (dihydropyridine type); catecholamine depleting agents; baclofen; amifostine; for other combinations requiring careful consideration, see full PI. ADVERSE EFFECTS: Headache, dizziness, tiredness, fatigue, paraesthesia, constipation, nausea, diarrhoea, cardiac failure aggravated, bradycardia, hypotension, dyspnoea, oedema, slowed AV conduction/ AV-block, bronchospasm. Post-marketing reports of hypersensitivity, angioneurotic oedema, abnormal hepatic function, acute pulmonary oedema, acute renal failure, myocardial infarction, others see full PI. DOSAGE AND ADMINISTRATION: Once daily dosing, can be given with or without meals, consistent approach is recommended. Hypertension: 5 mg daily. Renal insufficiency: recommended starting dose is 2.5 mg daily, can be increased to 5 mg if needed. Patients > 65 years: recommended starting dose is 2.5 mg daily, can be increased to 5 mg if needed. Patients > 75 years: caution must be exercised and these patients monitored closely. Chronic Heart Failure: The initial up titration should be done gradually at 1-2 wk intervals based on patient tolerability starting at 1.25 mg once daily, increased to 2.5 mg, then to 5 mg and then to 10 mg once daily. Initiation of therapy and every dose increase should be done under close supervision for at least 2 h. No dose adjustment is required in patients with mild to moderate renal insufficiency. Use in patients with severe renal insufficiency (serum creatinine ≥ 250 µ mol/L) is not recommended. Date prepared 17 December 2015. References: 1. Nebilet Approved Product Information, 14 December 2015. 2. Flather MD et al. Eur Heart J 2005; 26: 215–25. N bilet ® ( ebivolol hydrochloride) tablets 1.25 mg, 5 mg, 10 mg. INDICATIONS: Essential hypertension. Stable chronic heart failure (CHF) as an adjunct to standard therapies in patients 70 years or old r. CONTRAINDICATIONS: Hypersensitivity to the active or any of the excipients; liver insufficiency or liver function impairment; acute heart failur ; cardiogenic shock or episodes of heart failure decompens tion requiring IV inotropic therapy; sick si us syndrom , including sino-atrial lock; second and third degree heart lock (with ut pacemaker); history of bronchospasm (e.g. including COPD) and/or asthma; untreated phaeochromocytoma; metabolic acidosis; bradycardia (HR < 60 bpm prior to starting therapy); hypotension (systolic BP < 100 mmHg); severe peripheral circulatory disturbances. PRECAUTIONS: void abrupt cessation unless clearly indicated – reduce dosage gradually over 1-2 wks; refer to full PI. If it must be withdrawn abruptly, close observation is required. Anaesthesia; untreated congestive heart failure, unless stabilised; bradycardi ; peripheral circulatory disorders (e.g. Raynaud’s disease, intermittent claudication); first degree heart block; Prinzmetal’s or variant angina; lipid and carb hydrate metabolism – does not affect glucose levels in diabetic patient , but may mask symptoms of hypoglycaemia. Hyperthyroidism; COPD/asthma; phaeochrom cytoma; various skin rashes; conjunctival xerosis; culomucocutane us syndrome; psoriasis; increased sensitivity to allergens and severity of anaphyl ctic reactions; galactose intolerance, Lapp-lactase defi i ncy or glucose- al ctose malabsorption; driving vehicles or operating machines. Pregnancy (Cat C). Lactation. Children and adolescents. Renal and hepatic insufficiency – see Dosage and Administration. INTERACTIONS: Combination not recommended: Class I antiarrhythmics; calcium channel antagonists (verapamil/dilitiazem); centrally-acting antihypertensives; other bet -blockers (incl. eye drops). Combin tion to be used with cautio : Class III a ti rrhythmic drugs; anaesthetics (volatile); i sulin and other oral diabetic medicines; calcium antagonists (dihydropyridine type); catecholamine depleting agent ; b cl fen; amifostine; for other combinations requiring careful consideration, see full PI. ADVERSE EFFECTS: Hea ache, dizziness, tiredness, fatigue, raesthesia, constipation, nausea, diarrhoea, cardiac failure aggravated, bradycardia, hypotension, dyspnoea, oedema, slowed AV conduction/ AV-block, bronchospasm. Post-marketing reports of hypersensitivity, angioneurotic oedema, bnormal hepatic functi n, acute pulmonary oedema, acut renal failure, myocardial infarction, others see full PI. DOSAGE AND ADMINISTRATION: Once daily dosing, can be given with or without m als, consistent approach i reco ended. Hypertension: 5 mg daily. Renal insuffi i ncy: recommended starting dose is 2.5 mg daily, can be increased to 5 mg if needed. Patients > 65 years: recommended starting dose is 2.5 mg daily, can be increased to 5 mg if needed. Patients > 75 years: caution must be exercised and these patients monitored closely. Chronic Heart Failure: The initial up titration should be done gradu lly at 1-2 wk intervals based on patie t tolerability starting at 1.25 mg once daily, increased to 2.5 mg, then to 5 mg and then to 10 mg nce daily. Initiatio of therapy and every dose increas should be done under close supervision for at least 2 h. N dose adjustment is required in patients with mild to moderate renal insufficiency. Use in patients with severe renal insufficiency (serum creatinine ≥ 250 µ mol/L) is not recommended. Date prepared 17 December 2015. References: 1. Nebilet Approved Product Information, 14 December 2015. 2. Flather MD et al. Eur Heart J 2005; 26: 215–25. bilet ® (nebivolol hydrochloride) tablets 1.25 mg, 5 mg, 10 mg. INDICATIONS: Essential hypertension. St ble ch on c heart failure (CHF) s an j nct to stand rapies in patients 70 y ars or older. CONTRAINDICATIONS: Hypersensitivity to the active or any of the excipients; liver insufficiency or liver function impairment; ac art failure; cardiogenic shock or episodes of heart failure decompensation requiring IV inotropic therapy; sick sinus syndrome, including sino-atrial block; sec d third degree heart block (without a pacemaker); history of bronchospasm (e.g. including COPD) and/or asthma; untreated phaeochromocytoma; metabolic acido dycardia ( R < 60 bpm prior to starting therapy); hypotensi n ( ystolic BP < 100 mmHg); severe peripheral circulatory disturbances. PRECAUTIONS: Avoid abr ssation unless clearly indicated – redu e dosage gradu lly ver 1-2 wks; refer to full PI. If it must be withdrawn abruptly, close observation is required. Anaesthe treated congestive heart f ilure, unless stabilised; bradycardia; peripheral circulatory disorders (e.g. Ray aud’s di ea e, intermittent claudication); first degree he ck; Prinzmetal’s or variant angina; lipid and carbohydrate metabolism – does not affect glucose levels in diabetic patients, but may mask symptoms of hypoglycae perthyroidism; COPD/asthma; phaeochromocytoma; various skin rashes; conjunctival xerosis; oculomucocutaneous syndrome; psoriasis; increased sensitivity ergens and sev rity of anaphylactic reactions; galactose intolerance, Lapp-lactase deficienc or glucos -galactose malabsorption; driving vehicles or operat chines. Pregnan y (Cat C). Lactati n. Children and adolescents. enal and hepatic insufficiency – see Dosage and Admin t ation. INTERACTIONS: Combination ommended: Class I antiarrhythmics; calcium channel antagonists (verapamil/dilitiazem); centrally-acting antihyp rtensives; other beta-blockers (incl. eye dro mbination to be used with caution: Class III antiarrhythmic drugs; anaesthetics (volatile); insulin and other oral diabetic medicines; calcium antagonists (dihydropyrid e); catecholamine depleting agents; baclofen; amifostine; for other combinations requiring careful consideration, see full PI. ADVERSE EFFECTS: Headache, dizzine dness, fatigue, paraesthesia, constipation, nausea, diarrhoea, cardiac failure aggravate , bradycardia, hypotension, dyspn ea, oedema, slowed AV conducti -block, bronchospasm. Post- arke ing reports of h persensi vity, angion urotic oedema, abnor al hepatic function, acute pulmonary oedema, acute renal fail ocardial infarction, others see ull PI. DOSAGE AND ADMINISTRATION: Once daily dosing, can be given with or without meals, consistent approach is recommend pertension: 5 mg daily. Renal insufficiency: recommended starting dose is 2.5 mg daily, can b increased to 5 mg if needed. Patients > 65 years: recommen rting dose is 2.5 mg daily, can be increased to 5 g if needed. Patients > 75 years: caution must be exercised and these patients monitored closely. Chronic He ilure: The initial up titration should be done gradually at 1-2 wk intervals based on patient tolerability starting at 1.25 mg once daily, increased to 2.5 mg, then to 5 d then to 10 mg once daily. Initiation of therapy and every dose increase should be done under close supervision for at least 2 h. No dose adjustment is require tients with mild to moderate renal insufficiency. Use in patients with severe renal insufficiency (serum creatinine ≥ 250 µ mol/L) is not recommended. Date prepar PBS Information: Restricted benefit. Moderate to severe heart failure. Refer to PBS Schedule for full restricted ben fit information . Please review full Product Information before prescribing. The Pr duct Information can be accessed at www.menarini.com.au/pi PBS Information: Restricted benefit. Moderate to severe heart failure. Refer to PBS Schedule for full restricted benefit information . Please review full Product Information before prescribing. The Product Information can be accessed at www.menarini.com.au/pi PBS Information: Restricted benefit. Moderate to severe heart failure. Refer to PBS Schedule for full restricted benefit information . Please review full Product Information before prescribing. The Product Information can be accessed at www.menarini.com.au/pi A. Menarini Australia Pty Ltd. ABN 62 116 935 758, Level 8, 67 Albert Avenue, Chatswood NSW 2067 Medical Information 1800 644 542. NEB-AU-0501 April 2016 • ALMIN.1.2 A. Menarini Australia Pty Ltd. ABN 62 116 935 758, Level 8, 7 lbert Avenue, Chatswood NSW 2067 Medical Information 1800 644 542. NEB-AU-0501 April 2016 • ALMIN.1.2