IMDUR DURULES TABLET 60 mg

국가: 싱가포르

언어: 영어

출처: HSA (Health Sciences Authority)

유효 성분:

Isosorbide-5-mononitrate

제공처:

ZUELLIG PHARMA PTE. LTD.

ATC 코드:

C01DA14

복용량:

60 mg

약제 형태:

TABLET, FILM COATED

구성:

Isosorbide-5-mononitrate 60 mg

관리 경로:

ORAL

처방전 유형:

Prescription Only

Manufactured by:

AstraZeneca Pharmaceutical Co. Ltd

승인 상태:

ACTIVE

승인 날짜:

1988-06-24

환자 정보 전단

IMDUR
® 60 MG
Isosorbide-5-mononitrate in a controlled
release formulation (Durules
®
)
DESCRIPTION
Imdur
®
Durules
®
contain isosorbide mononitrate
(AAN) in a sustained release formulation.
The chemical name is 1,4:3,6-Dianhydro -D-glucitol
5-nitrate. Molecular formula C
6
H
9
NO
6
; m.w. 191.14.
Isosorbide mononitrate is a white to pale yellow
crystalline powder and is freely soluble in water.
CAS 16051-77-7.
The chemical structure of isosorbide mononitrate
is:
Imdur Durules contain the active drug embedded
in a porous inert matrix consisting of paraffin-
synthetic, aluminium sodium silicate, magnesium
stearate, hydroxypropylcellulose and silica-colloidal
anhydrous. In addition the tablet coating contains
hypromellose, macrogol, titanium dioxide, hydrogen
peroxide, paraffin-synthetic and water-purified.
PHARMACOLOGY
Isosorbide mononitrate is an active metabolite
of isosorbide dinitrate and exerts qualitatively
similar effects. Isosorbide mononitrate reduces
the workload of the heart by producing venous and
arterial dilatation. By reducing the end diastolic
pressure and volume, isosorbide mononitrate
lowers the intramural pressure, hence leading
to an improvement in the subendocardial blood
flow. The net effect when administering isosorbide
mononitrate is therefore a reduced workload for the
heart and an improvement in the oxygen supply/
demand balance of the myocardium.
Nitrates are highly effective in the prophylaxis
of symptomatic and asymptomatic myocardial
ischaemia. Nitrates dilate coronary arteries not
only in pre- and post-stenotic vessels, but also in
eccentric lesions. The natural initiator of vascular
relaxation is thought to be endothelium-derived
relaxing factor (EDRF), which has both the clinical
and biological characteristics of nitric oxide (NO).
Organic nitrates are metabolised to NO in the
muscle cell via a sulfhydryl dependent mechanism.
They are therefore thought to be the physiological
substitute for EDRF.
PHARMACOKINETICS
Isosorbide mononitrate has an elimination half-
life of around fi

제품 특성 요약

IMDUR
® 60 MG
Isosorbide-5-mononitrate in a controlled
release formulation (Durules
®
)
DESCRIPTION
Imdur
®
Durules
®
contain isosorbide mononitrate
(AAN) in a sustained release formulation.
The chemical name is 1,4:3,6-Dianhydro
-D-glucitol 5-nitrate. Molecular formula C
6
H
9
NO
6
;
m.w. 191.14. Isosorbide mononitrate is a white
to pale yellow crystalline powder and is freely
soluble in water. CAS 16051-77-7.
The chemical structure of isosorbide mononitrate
is:
Imdur Durules contain the active drug embedded
in a porous inert matrix consisting of paraffin-
synthetic, aluminium sodium silicate, magnesium
stearate, hydroxypropylcellulose and silica-
colloidal anhydrous. In addition the tablet
coating contains hypromellose, macrogol,
titanium dioxide, hydrogen peroxide, paraffin-
synthetic and water-purified.
PHARMACOLOGY
Isosorbide mononitrate is an active metabolite
of isosorbide dinitrate and exerts qualitatively
similar effects. Isosorbide mononitrate reduces
the workload of the heart by producing venous
and arterial dilatation. By reducing the end
diastolic pressure and volume, isosorbide
mononitrate lowers the intramural pressure,
hence leading to an improvement in the
subendocardial blood flow. The net effect
when administering isosorbide mononitrate is
therefore a reduced workload for the heart and
an improvement in the oxygen supply/demand
balance of the myocardium.
Nitrates are highly effective in the prophylaxis
of symptomatic and asymptomatic myocardial
ischaemia. Nitrates dilate coronary arteries
not only in pre- and post-stenotic vessels, but
also in eccentric lesions. The natural initiator of
vascular relaxation is thought to be endothelium-
derived relaxing factor (EDRF), which has both
the clinical and biological characteristics of nitric
oxide (NO). Organic nitrates are metabolised to
NO in the muscle cell via a sulfhydryl dependent
mechanism. They are therefore thought to be
the physiological substitute for EDRF.
PHARMACOKINETICS
Isosorbide mononitrate has an elimination
half-life of around f