NEBILET TABLET 5 mg

Страна: Сингапур

Език: английски

Източник: HSA (Health Sciences Authority)

Активна съставка:

Nebivolol hydrochloride 5.45mg (equivalent to nebivolol)

Предлага се от:

A. MENARINI SINGAPORE PTE. LTD.

АТС код:

C07AB12

дозиране:

5mg

Лекарствена форма:

TABLET

Композиция:

Nebivolol hydrochloride 5.45mg (equivalent to nebivolol) 5mg

Начин на приложение:

ORAL

Вид предписание :

Prescription Only

Произведено от:

BERLIN-CHEMIE AG (granulation)

Статус Оторизация:

ACTIVE

Дата Оторизация:

2001-11-19

Листовка

COMPOSITION
One tablet contains:
Active ingredients: nebivolol hydrochloride 5.45
mg (equal to 5 mg nebivolol).
Excipients: Polysorbate 80, hypromellose, lactose
monohydrate, maize starch, croscarmellose sodi-
um, microcristalline cellulose, colloidal anhydrous
silica, magnesium stearate
PHARMACEUTICAL FORM
Tablets.
White, round, cross-scored tablets
THERAPEUTIC CLASS
Beta blocking agent, selective
.
PHARMACODYNAMIC PROPERTIES
Nebivolol is a racemate of two enantiomers,
SRRR-nebivolol (or d-nebivolol) and RSSS-
nebivolol (or l-nebivolol). It combines two pharma-
cological activities:
• It is a competitive and selective beta-receptor
antagonist: this effect is attributed to the SRRR-
enatiomer (d-enantiomer).
• It has mild vasodilating properties due to an
interaction with the L-arginine/nitric oxide path-
way.
Single  and  repeated  doses  of  nebivolol  reduce
heart rate and blood pressure at rest and during
exercise,  both  in  normotensive  subjects  and  in
hypertensive patients. The antihypertensive effect
is maintained during chronic treatment.
At therapeutic doses, nebivolol is devoid of alpha-
adrenergic antagonism.
During acute and chronic treatment with nebivolol
in hypertensive patients systemic vascular resist-
ance  is  decreased. Despite  heart  rate  reduction,
reduction  in  cardiac  output  during  rest  and  exer-
cise may be limited due to an increase in stroke
volume. The clinical relevance of these haemody-
namic  differences  as  compared  to  other  beta1
receptor  antagonists  has  not  been  fully  estab-
lished.
In hypertensive patients, nebivolol increases the
NO-mediated vascular response to acetylcholine
(ACh) which is reduced in patients with endothe-
lial dysfunction.
In a mortality–morbidity, placebo-controlled trial
performed in 2128 patients ≥ 70 

Данни за продукта

NEBILET®
Nebivolol
COMPOSITION
Each Nebilet tablet contains 5 mg of nebivolol (as nebivolol
hydrochloride): 2.5 mg of
SRRR-nebivolol (or d-nebivolol) and 2.5 mg of RSSS-nebivolol (or
l-nebivolol).
Excipients:
Polysorbate 80, hypromellose, maize starch, croscarmellose sodium,
microcristalline
cellulose, colloidal anhydrous silica, magnesium stearate.
Excipient with known effect: each tablet contains 141.75 mg of lactose
monohydrate.
PHARMACEUTICAL FORM
Tablets. White, round, cross-scored tablets. The tablet can be divided
in equal quarters.
THERAPEUTIC CLASS
Beta blocking agent, selective.
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Beta-blocking agent, selective.
ATC code: C07AB12
Nebivolol is a racemate of two enantiomers, SRRR-nebivolol (or
d-nebivolol) and
RSSS-nebivolol (or l-nebivolol). It combines two pharmacological
activities:
• It is a competitive and selective beta-receptor antagonist: this
effect is attributed to the
SRRR-enantiomer (d-enantiomer).
• It has mild vasodilating properties due to an interaction with the
L-arginine/nitric oxide
Pathway
Single and repeated doses of nebivolol reduce heart rate and blood
pressure at rest and
during exercise, both in normotensive subjects and in hypertensive
patients. The
antihypertensive effect is maintained during the chronic treatment.
At therapeutic doses, nebivolol is devoid of alphaadrenergic
antagonism. During acute
and
chronic
treatment
with
nebivolol
in
hypertensive
patients
systemic
vascular
resistance is decreased. Despite heart rate reduction, reduction in
cardiac output during
rest and exercise may be limited due to an increase in stroke volume.
The clinical
relevance of these haemodynamic differences as compared to other beta1
receptor
antagonists has not been fully established. In hypertensive patients,
nebivolol increases
the NO-mediated vascular response to acetylcholine (ACh) which is
reduced in patients
with endothelial dysfunction.
In a mortality–morbidity, placebo-controlled trial performed in 2128
patients ≥ 70 years
(me