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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 impairment; acute
heart failure; cardiogenic shock or episodes of heart failure decompensation requiring IV inotropic the
rapy; sick sinus syndrome, including sino-atrialblock; 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 If it must be withdrawn abruptly, close observation is required.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/piA. 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 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.
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/piA. 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/piNEBILET: 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