Previous Page  32 / 32
Information
Show Menu
Previous Page 32 / 32
Page Background

nebivolol hydrochloride

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 imp

airment; acute

heart failure; cardiogenic shock or episodes of heart failure decompensation requiring IV inotropic the

rapy; 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 If it must be withdrawn abruptly, close observation is required.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.

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

NEBILET: Age proven in elderly (

70 years) CHF patients

1,2

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

CHF= Chronic Heart Failure

N bilet

®

( ebivolol hydrochloride) tablets 1.25 mg, 5 mg, 10 mg.

INDICATIONS:

Essential hypertension

. Stable chronic heart failure (CHF) as an adjun

ct 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 imp

airment; 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 gluc se 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 (di ydropyridine

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.

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, 7 lbert Avenue, Chatswood NSW 2067

Medical Information 1800 644 542. NEB-AU-0501 April 2016 • ALMIN.1.2

NEBILET: Age proven in elderly (

70 years) CHF patients

1,2

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

CHF= Chronic Heart Failure

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 Informatio

n before prescribing.

The Pr duct Information can be accessed at

www.menarini.com.au/pi

NEBILET: Age proven in elderly (

70 y rs) CHF patients

1,2

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

F= Chronic Heart Failure