NU-CARVEDILOL TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

CARVEDILOL

Dostopno od:

NU-PHARM INC

Koda artikla:

C07AG02

INN (mednarodno ime):

CARVEDILOL

Odmerek:

3.125MG

Farmacevtska oblika:

TABLET

Sestava:

CARVEDILOL 3.125MG

Pot uporabe:

ORAL

Enote v paketu:

100

Tip zastaranja:

Prescription

Terapevtsko območje:

BETA-ADRENERGIC BLOCKING AGENTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0122683003; AHFS:

Status dovoljenje:

CANCELLED (UNRETURNED ANNUAL)

Datum dovoljenje:

2018-03-28

Lastnosti izdelka

PRODUCT MONOGRAPH
NU-CARVEDILOL
CARVEDILOL TABLETS
3.125 MG, 6.25, 12.5 MG AND 25 MG
CONGESTIVE HEART FAILURE AGENT
NU-PHARM INC.
DATE OF PREPARATION:
50 MURAL STREET, UNITS 1 & 2
December 16, 2003
RICHMOND HILL, ONTARIO
L4B 1E4
Control #: 088609
1
PRODUCT MONOGRAPH
NU-CARVEDILOL
Carvedilol Tablets
3.125 mg, 6.25 mg, 12.5 mg and 25 mg
THERAPEUTIC CLASSIFICATION
Congestive Heart Failure Agent
A
CTIONS AND CLINICAL PHARMACOLOGY
Carvedilol is a cardiovascular agent for the treatment of congestive
heart failure that combines
beta-adrenoceptor blockade and vasodilation in a single racemic
mixture. Nonselective beta-
adrenoceptor blocking activity is present in the S(-) enantiomer and
alpha
1
-adrenoceptor blocking
activity is present at equal potency in both the R(+) and S(-)
enantiomers. Carvedilol has no
intrinsic sympathomimetic activity. Its action on beta-receptors is 10
times stronger than on
alpha
1
-receptors.
Carvedilol reduces peripheral vascular resistance by vasodilation,
thereby causing a fall in
systemic blood pressure after acute administration, predominantly
mediated through selective
alpha
1
-antagonism. Beta blockade prevents reflex tachycardia with the net
result that heart rate
is unchanged or decreased. Carvedilol reduces renin release through
beta blockade.
In two studies that compared the acute hemodynamic effects of
carvedilol to baseline
measurements in patients with congestive heart failure, there were
significant reductions in
systemic blood pressure, pulmonary artery pressure, pulmonary
capillary wedge pressure, and
heart rate. Initial effects on cardiac output, stroke volume index and
systemic vascular resistance
were small and variable.
2
In terms of chronic hemodynamic effects (12 to 14 weeks), carvedilol
significantly reduced
systemic blood pressure, pulmonary artery pressure, right atrial
pressure, systemic vascular
resistance and heart rate while stroke volume index was increased.
The mechanism for the beneficial effects of carvedilol in congestive
heart failure has not been
establish