BETATAB 100MG TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

METOPROLOL TARTRATE

Boleh didapati daripada:

IDAMAN PHARMA MANUFACTURING SDN BHD

INN (Nama Antarabangsa):

METOPROLOL TARTRATE

Unit dalam pakej:

100 Tablets; 500 Tablets

Dikeluarkan oleh:

IDAMAN PHARMA MANUFACTURING SDN BHD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
BETATAB 100MG TABLET
Metoprolol Tartrate 100mg
1
WHAT IS IN THIS LEAFLET
1.
What Betatab 100mg Tablet is used
for
2.
How Betatab 100mg Tablet works
3.
Before you use Betatab Tablet
100mg
4.
How to use Betatab Tablet 100mg
5.
While you are using Betatab 100mg
Tablet
6.
Side Effects
7.
Storage and Disposal of Betatab
100mg Tablet
8.
Product Description
9.
Product Registration Holder and
Manufacturer
10.
Date of Revision
WHAT BETATAB 100MG TABLET IS USED
FOR
Betatab Tablet 100mg is used to treat:
•
Hypertension: to reduce blood
pressure and to reduce the risk of
cardiovascular and coronary mortality
(including sudden death), and
morbidity.
•
Angina pectoris (chest pain)
•
Disturbances of cardiac rhythm
including especially supraventricular
tachycardia (irregular heartbeat or
abnormal heart rhythm)
•
Confirmed or suspected myocardial
infarction (heart attack) - prevention of
cardiac death and reinfarction.
•
Functional heart disorders with
palpitations (a fast-beating, fluttering
or pounding heart).
•
Migraine prophylaxis (treatment for
migraine)
•
Hyperthyroidism (overproduction of
thyroid hormone by thyroid gland).
HOW BETATAB 100MG TABLET WORKS
Betatab 100mg Tablet slows the
heartbeat, lessen the force with which
the heart muscle contracts and reduce
blood vessel contraction in the heart,
brain, and throughout the body.
BEFORE YOU USE BETATAB 100MG TABLET
_-WHEN YOU MUST NOT USE IT _
Do not use Betatab 100mg Tablet and
tell your doctor if you:
•
allergic (hypersensitive) to metoprolol,
other beta-blockers (drugs to treat high
blood pressure and heart failure) or
any of the other ingredients contained
in Betatab Tablet 100mg.
•
Have a heart block (the electrical
signal that controls the heartbeat is
partially or completely blocked)
•
Have severe or uncontrolled heart
failure
•
Have a slow, regular heartbeat.
•
Have a sick sinus syndrome (irregular
heartbeat).
•
Suffer from a tight, painful feeling in
the chest in periods of rest (Prinz
met

Ciri produk

IDAMAN PHARMA MANUFACTURING
BETATAB 100MG TABLET
DESCRIPTION
A white to off white, round, biconvex tablet with scoreline on one
side.
COMPOSITION
Each tablet contains Metoprolol Tartrate 100mg.
PHARMACODYNAMICS
Metoprolol tartrate is a cardio-selective beta-adrenergic blocking
agent. It has a relatively greater blocking effect on
beta
1
-receptors (ie
those mediating adregenic stimulation of heart rate and contractility
and release of free fatty acids from fat stores) than on
beta
2
-
receptors, which are chiefly involved in broncho and vasodilation.
PHARMACOKINETICS
Absorption
Metoprolol
is
readily
and
completely
absorbed
from
the
gastrointestinal
tract.
Metoprolol
is
absorbed
fully
after
oral
administration. Within the therapeutic dosage range, the plasma
concentrations increase in a linear manner in relation to dosage. Peak
plasma levels are achieved after approx. 1.5–2 hours. Even though
the plasma profile displays a broader interindividual variability,
this
appears to be easily reproducible on an individual basis. Due to the
extensive first-pass effect, bioavailability after a single oral dose
is
approx. 50%. After repeated administration, the systemic availability
of the dose increases to approx. 70%. After oral intake with food, the
systemic availability of an oral dose increases by [SIC] approx. 30–
40%.
Distribution
Peak plasma concentrations occur about 1½ hours after a single oral
dose. Peak plasma metoprolol concentrations at steady state with
usual doses have been reported as 20-340ng/ ml. Metoprolol is
widely distributed, it crosses the bloodbrain barrier, the placenta.
It
is slightly bound to plasma protein.
Biotransformation
Metoprolol is metabolised through oxidation in the liver mainly by the
CYP2D6 isoenzyme. Even though three main metabolites have been
identified, none of them has a clinically significant beta-blocking
effect. Generally, 95% of an oral dose is found in the urine. Only 5%
of the dose is excreted unmodified via the kidneys; in isolated cases,
this figure can reach as high a