Amlopres-5 (Amlodipine Besylate Tablets USP 5mg)

국가: 말레이시아

언어: 영어

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

유효 성분:

AMLODIPINE BESILATE

제공처:

CIPLA MALAYSIA SDN BHD

INN (International Name):

AMLODIPINE BESILATE

패키지 단위:

10 X 10 Tablets

Manufactured by:

CIPLA LTD

환자 정보 전단

AMLOPRES
CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)
AMLODIPINE BESYLATE USP 5 MG & 10 MG TABLETS
__________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What AMLOPRES is used for
2.
How AMLOPRES works
3.
Before you use AMLOPRES
4.
How to use AMLOPRES
5.
While you are using AMLOPRES
6.
Side effects
7.
Storage and Disposal of
AMLOPRES
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT AMLOPRES IS USED FOR
AMLORPES is used to treat high blood
pressure (hypertension) or a certain type
of chest pain called angina, a rare form of
which is Prinzmetal’s or variant angina.
HOW AMLOPRES WORKS
Amlodipine is one of a group of
medicines called calcium antagonists.
In patients with high blood pressure your
medicine works by relaxing blood
vessels, so that blood passes through them
more easily. In patients with angina
amlodipine works by improving blood
supply to the heart muscle which then
receives more oxygen and as a result
chest pain is prevented. Your medicine
does not provide immediate relief of chest
pain from angina.
BEFORE YOU USE AMLOPRES
_- When you must not use it _
•
if you are allergic (hypersensitive) to
Amlodipine, or any of the other
ingredients of your medicine, or to
any other calcium antagonists. This
may be itching, reddening of the
skin or difficulty in breathing.
•
if you have narrowing of the aortic
heart valve (aortic stenosis),
unstable angina or cardiogenic
shock;
•
If you are pregnant or breast
feeding.
_- Before you start to use it _
You should inform your Doctor if you
have or have had any of the following
conditions:
•
Recent heart attack Heart failure
•
Severe increase in blood pressure
(Hypertensive crisis).
•
Liver disease.
•
You are elderly and your dose needs
to be increased
PREGNANCY
The safety of AMLOPRES
in human
pregnancy has not been established.
If you think you might be pregnant, or are
planning to get pregnant, tell your doctor
before you take AMLOPRES.
Women of
c

제품 특성 요약

CIPLA
_FOR THE USE OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR A
LABORATORY ONLY _
AMLOPRES-5 (AMLODIPINE BESYLATE TABLETS USP 5MG)
COMPOSITION
Each uncoated tablet contains:
Amlodipine Besylate USP equivalent to Amlodipine………..5mg
DOSAGE FORM
Tablets
DESCRIPTION
White to off white round tablets with ‘’5’’ debossed on one
side and plain on other side.
PHARMACOLOGY
_PHARMACODYNAMICS _
Amlodipine is a calcium ion influx inhibitor of the dihydropyridine
group (slow channel
blocker or calcium ion antagonist) and inhibits the transmembrane
influx of calcium ions
into cardiac and vascular smooth muscle.
The mechanism of the antihypertensive action of amlodipine is due to a
direct relaxant
effect on vascular smooth muscle. The precise mechanism by which
amlodipine relieves
angina has not been fully determined but amlodipine reduces total
ischaemic burden by
the following two actions.
1)
Amlodipine dilates peripheral arterioles and thus, reduces the total
peripheral
resistance (afterload) against which the heart works. Since the heart
rate remains stable,
this
unloading
of
the
heart
reduces
myocardial
energy
consumption
and
oxygen
requirements.
2)
The mechanism of action of amlodipine also probably involves
dilatation of the
main coronary arteries and coronary arterioles, both in normal and
ischaemic regions.
This dilatation increases myocardial oxygen delivery in patients with
coronary artery
spasm (Prinzmetal's or variant angina).
CIPLA
Amlodipine provides significant 24 hour blood pressure reduction in
hypertensive patients.
Due to the slow onset of action, acute hypotension is not a feature of
amlodipine
administration.
Amlodipine has been shown to increase exercise time, time to angina
onset, and time to
1 mm ST segment depression, and decrease both angina attack frequency
and glyceryl
trinitrate tablet consumption in patients with angina.
Amlodipine has not been associated with any adverse metabolic effects
or changes in
plasma lipids and is suitable for use in patients with asthma,
diabetes