PRILIUM 150MG POWDER FOR ORAL SOLUTION

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

IMIDAPRIL HYDROCHLORIDE

Available from:

Gladron Chemicals Sdn Bhd

INN (International Name):

IMIDAPRIL HYDROCHLORIDE

Units in package:

0.88 mcg/mL

Manufactured by:

VIANEX S.A. - Plant C

Summary of Product characteristics

WHITE COMPACT PASTILLE.
POWDER TO BE DISSOLVED WITH WATER.
REGISTRATION NUMBER N° MALXXXX
QUALITATIVE AND QUANTITATIVE COMPOSITION
POWDER/VIAL
Imidapril hydrochloride
150 mg
Sodium benzoate Ph.Eur.
30 mg
Excipient to
0.880 g
SOLUTION AFTER RECONSTITUTION
Imidapril hydrochloride
5.0 mg
Sodium benzoate Ph.Eur.
1.0 mg
Excipient to
1 ml
PHARMACOLOGICAL PROPERTIES
Imidapril hydrochloride is a new angiotensin-converting enzyme (ACE)
inhibitor.
ATC vet code: QC09AA16
PHARMACODYNAMIC PROPERTIES:
Imidapril hydrochloride is a pro-drug which is hydrolysed in vivo to
form an active
metabolite, imidaprilat. Imidaprilat inhibits the
angiotensin-converting enzyme
(ACE). This enzyme catalyses the conversion of angiotensin I to
angiotensin II in the
blood plasma and tissues and inhibits the breakdown of bradykinin. As
angiotensin
II has a potent vasoconstrictive action, while bradykinin is a
vasodilator, the
reduced formation of angiotensin II and the inhibition of bradykinin
breakdown
lead to vasodilation.
Imidapril hydrochloride reduces heart preload and afterload and
decreases blood
pressure without any compensatory increase in the heart rate.
PHARMACOKINETIC PROPERTIES :
Following oral administration in the dog, imidapril hydrochloride is
rapidly absorbed
by the gastrointestinal tract and reaches its maximum plasma
concentration within
less than one hour. The half-life of imidapril hydrochloride is about
2 hours.
Imidapril hydrochloride is mainly hydrolysed in the liver and kidney
to its active
metabolite,
imidaprilat.
Maximum
plasma
concentrations
of
imidaprilat
are
reached within about 5 hours and decline with a half-life of more than
10 hours.
PRILIUM
®
150 MG POWDER FOR ORAL SOLUTION
The
bioavailability
of
imidapril
and
imidaprilat
is
decreased
by
the
joint
administration
of food.
The protein binding of imidapril hydrochloride and imidaprilat is
moderate, (85%
and 53%, respectively).
After oral administration of the radio-labelled compound, about 40% of
total
radioactivity is excreted in urine and about 60% in the faece