Amlomed 5(Amlodipine 5mg Tablet)

Riik: Malaisia

keel: inglise

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

Toimeaine:

AMLODIPINE BESILATE

Saadav alates:

MEDIDATA SDN BHD

INN (Rahvusvaheline Nimetus):

AMLODIPINE BESILATE

Ühikuid pakis:

30Tablet Tablets; 500 Tablet Tablets; 100 Tablet Tablets

Valmistatud:

SAI MIRRA INNOPHARM. PVT. LTD

Infovoldik

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_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
AMLOMED 5 TABLET
AMLOMED 10 TABLET
Amlodipine (5mg)
Amlodipine (10mg)
1
WHAT IS IN THIS LEAFLET
1.
What Amlodipine Tablet is used for
2.
How Amlodipine Tablet works
3.
Before you use Amlodipine Tablet
4.
How to use Amlodipine Tablet
5.
While
you
are
using
Amlodipine
Tablet
6.
Side Effects
7.
Storage and disposal of Amlodipine
Tablet
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10. Date of Revision
1. WHAT AMLODIPINE TABLET IS USED FOR
For the treatment
for chest discomfort,
chest pain/ to decrease blood pressure
2. HOW AMLODIPINE TABLET WORKS
Amlodipine Tablet is a dihydropyridine
calcium-channel blocker. It is used in the
management of high blood pressure and
chest pain.
3. BEFORE YOU USE AMLODIPINE TABLET
_-_
_ _
_When you must not use it_
Amlodipine Tablet is contra-indicated in
patients
with
hypersensitivity
to
amlodipine,
dihydropyridine
derivatives
or to any of the excipients.
_Heart failure _
Amlodipine Tablet was less effective than
the diuretic Chlorthalidone in preventing
the development of heart failure.
_Porphyria _
With use of Amlodipine
Tablet in patients
with
porphyria
(a
group
of
inherited
or
acquired
disorders
of
certain
enzymes),
acute
exacerbation
(increase
in
the
seriousness of a disease) has also occurred.
_-_
_ _
_Before you start to use it _
Consult your Doctor
_-_
_ _
_Taking other medicines _
Amlodipine Tablet can be taken together
with:
Thiazide,
Alpha-blockers,
Beta-
blockers,
ACE
inhibitors,
Long-acting
nitrates,
Sublingual
glyceryl
trinitrate,
NSAIDs, antibiotics and oral antidiabetics.
Medicines
that
cannot
be
taken
with
Amlodipine Tablet:
Cimetidine,
grapefruit
juice,
Aluminium/Magnesium
(antacids),
Sildenafil, Atorvastatin, Digoxin, Ethanol
(alcohol), Warfarin, Cyclosporine.
4. HOW TO USE AMLODIPINE TABLET
Amlodipine Tablet is usually to be taken
orally.
Follow all directions given to you by your
doctor or pharmacist.
They
may
differ
from
the
information
contained in th

Toote omadused

DESCRIPTION
Tablet
AMLOMED 5: White to off white circular uncoated tablets.
AMLOMED 10: White to off white circular uncoated tablets with a
breakline on one side
and plain on the other side.
COMPOSITION
Each Uncoated Tablet Contains:
AMLOMED 5: Amlodipine Besylate USP equivalent to Amlodipine 5 mg
AMLOMED 10: Amlodipine Besylate USP equivalent to Amlodipine 10 mg
MODE OF ACTION
Amlodipine
is
a
dihydropyridine
calcium-ion
influx
inhibitor
that
inhibits
the
transmembrane influx of calcium ions into cardiac and vascular smooth
muscle tissues.
It’s antihypertensive action is as a result of it’s direct
relaxant effect on vascular smooth
muscle. It is used in the management of hypertension and stable angina
in adults, binds
to both dihydropyridine and nondihydropyridine binding sites. The
contractile process of
cardiac muscle and vascular smooth muscle are dependent upon the
movement of extra
cellular calcium ions into these cells through specific ion channels,
inhibits calcium ion
influx across cell membranes selectively with a great effect on
vascular smooth muscle
cells than on cardiac muscle cells. Serum calcium concentration is not
affected by it’s
kinetic interaction with calcium channel receptor is characterized by
a gradual rate of
association and dissociation with the receptor binding site, resulting
in gradual onset
of action.
Amlodipine is a peripheral arterial vasodilator that acts directly on
vascular smooth
muscle causing reduction of blood pressure. The precise mechanisms of
action in
relieving the angina have not been fully delineated.
SUMMARY OF PHARMACODYNAMICS AND PHARMACOKINETICS
Amlodipine is well absorbed following oral administration with peak
blood concentrations
occurring after 6 to 12 hours, The bioavailability has been estimated
between 64 to
90% and it is not altered by the presence of food. 93% of the drug is
bound to plasma
proteins. It has a prolonged terminal elimination half life of 35 to
50 hours and steady-
state of plasma concentrations are achieved after 7 to 8 days of
adminis