LANOXIN PG 62.5MCG TABLETS

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DIGOXIN

Boleh didapati daripada:

Aspen Medical Products Malaysia Sdn Bhd

INN (Nama Antarabangsa):

DIGOXIN

Unit dalam pakej:

300 Tablet Tablets

Dikeluarkan oleh:

ASPEN BAD OLDESLOE GMBH

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
1
LANOXIN TABLETS / PG TABLETS
Digoxin (250mcg, PG 62.5mcg)
WHAT IS IN THE LEAFLET
1.
What Lanoxin Tablet is
used for
2.
How Lanoxin Tablet works
3.
Before you use Lanoxin
Tablet
4.
How to use Lanoxin Tablet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Lanoxin Tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT LANOXIN TABLET IS USED FOR
Lanoxin Tablet is used to treat
arrhythmias and heart failure. An
arrhythmia is an irregularity in
the heartbeat, which causes the
heart to skip a beat, beat
irregularly or beat at the wrong
speed.
HOW LANOXIN TABLET WORKS
Lanoxin Tablet contains the
active ingredient digoxin which
belongs to a group of medicines
called cardiac glycosides.
Lanoxin Tablet works by
correcting irregular heartbeats
to a normal rhythm and
strengthens the force of the
heartbeat, which is why it is
useful in heart failure.
BEFORE YOU USE LANOXIN TABLET
-
_When you must not use it _
You must not take Lanoxin
Tablet if you are allergic to
digoxin, to other cardiac
glycosides or to any of the
other ingredients in this
medicine.
Lanoxin Tablet must not be
used in patients with certain
heart problems. Your doctor
will have checked your
medical history before treating
you with this medicine. If you
have any concerns you should
discuss these with your doctor.
-
_Before you start to use it _
If you are pregnant or are
intending to become pregnant
or breastfeeding you must
discuss this with your doctor.
Your doctor will discuss the
possible risks and benefits
involved.
-
_Taking other medicines _
You
MUST
tell your doctor or
pharmacist about all the
medicines you are taking, even
those which you have bought
for yourself without a doctor's
prescription, including herbal
remedies such as St John's wort
and vitamins. Digoxin interacts
with lots of different
medicines. The other
medicines that you may be
taking may increase or
decrease the effect of Lanoxin
Tablet. This can cause Lanoxin

Ciri produk

1
LANOXIN
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lanoxin Tablets contain the active ingredient Digoxin in 62.5
micrograms or 250 micrograms.
PHARMACEUTICAL FORM
Lanoxin PG Tablets are blue, round, biconvex tablets, debossed
“DO6” on the one side and
plain on the other side. Each tablet contains 62.5mcg (0.0625mg) of
Digoxin BP.
Lanoxin Tablets 250mcg are white, round, biconvex tablets, bisected
and debossed “DO25”
on the same side and plain on the other side. Each tablet contains
250mcg (0.250mg) of
Digoxin BP.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
CARDIAC FAILURE
Digoxin is indicated in the management of chronic cardiac failure
where the dominant problem
is systolic dysfunction. Its therapeutic benefit is greatest in those
patients with ventricular
dilatation.
Digoxin is specifically indicated where cardiac failure is accompanied
by atrial fibrillation.
SUPRAVENTRICULAR ARRHYTHMIAS
Digoxin is indicated in the management of certain supraventricular
arrhythmias, particularly
chronic atrial flutter and fibrillation.
POSOLOGY AND METHOD OF ADMINISTRATION
The dose of digoxin for each patient has to be tailored individually
according to age, lean body
weight and renal function.
Suggested doses are intended only as an initial guide.
The difference in bioavailability between injectable digoxin and oral
formulations must be
considered when changing from one dosage form to another. For example
if patients are
switched
from
oral
to
the
intravenous
formulation
the
dosage
should
be
reduced
by
approximately 33%.
2
MONITORING
The serum concentration of digoxin can be determined by
radioimmunoassay.
Blood should be taken 6 hours or more after the last dose of digoxin.
There are no rigid guidelines as to the range of serum concentrations
that are most efficacious.
Several _post hoc_ analyses of heart failure patients in the Digitalis
Investigation Group trial
demonstrated that at low serum digoxin concentrations (0.5 – 0.9
ng/mL), the use of digoxin
was associated with reductions in mortality and hospitalizati