Lanoxin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Digoxin 0.25mg;  ;  ;  ;  ; Digoxin 0.25mg

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Digoxin 0.25 mg

Dosage:

0.25 mg

Pharmaceutical form:

Tablet

Composition:

Active: Digoxin 0.25mg         Excipient: Lactose monohydrate Magnesium stearate Maize starch Pregelatinised maize starch Purified water Rice starch Active: Digoxin 0.25mg Excipient: Lactose monohydrate Magnesium stearate Maize starch Purified water Rice starch Starch, oxidised

Units in package:

Blister pack, PVC/PVDC, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Glaxo Operations UK Limited t/a Glaxo Welcome Operations

Therapeutic indications:

Cardiac Failure:- LANOXIN 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. LANOXIN is specifically indicated where cardiac failure is accompanied by atrial fibrillation. Supraventricular Arrhythmias:- LANOXIN is indicated in the management of certain supraventricular arrhythmias, particularly atrial flutter and fibrillation, where a major beneficial effect is reduction of the ventricular rate.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC - 100 tablets - 3 years from date of manufacture stored at or below 25°C - Blister pack, PVC/Al foil blisters - 240 tablets - 4 years from date of manufacture stored at or below 25°C - Bottle, glass, - 250 tablets - 60 months from date of manufacture stored at or below 25°C

Authorization date:

1969-12-31

Patient Information leaflet

1 

LANOXIN
™ 
Digoxin tablets 62.5μg, 250μg; paediatric elixir 50 μg/mL 

Consumer Medicine Information 

WHAT IS IN THIS LEAFLET 

Please read this leaflet carefully 
before you start using LANOXIN 
tablets or paediatric elixir. 
. 

This leaflet answers some 
common questions about 
LANOXIN. It does not contain all 
of the available information. 

It does not take the place of 
talking to your doctor or 
pharmacist. 

All medicines have risks and 
benefits. Your doctor has 
weighed the expected benefits of 
you taking LANOXIN against the 
risks this medicine could have 
for you. 

If you have any concerns about 
taking this medicine, ask your 
doctor or pharmacist. 

Keep this leaflet with your 
medicine. You may need to read 
it again. 

WHAT LANOXIN IS 
USED FOR 

LANOXIN is used in the 
treatment of chronic heart failure 
and/or atrial fibrillation and flutter 
(irregular heart rhythms caused 
by an electrical problem in the 
upper chambers of the heart). 
Heart failure is a disease of the 
heart which develops when the 
heart muscle cannot pump blood 
strongly enough to supply all the 
blood needed throughout the 
body. 

Heart failure is not the same as 
a heart attack and does not 
mean that the heart stops. Heart 
failure may start off with no 
symptoms but, as the condition 
progresses, you may feel short 
of breath and may get tired 
easily after light physical 
activity, such as walking. Some 
patients may wake up short of 
breath at night. Fluid may collect 
in different parts of the body, 
often first noticed as swollen 
ankles and feet. 

LANOXIN contains the active 
ingredient digoxin, which 
belongs to a group of medicines 
called cardiac glycosides. 

LANOXIN works by slowing 
down the rate of the heart so 
that each heartbeat is more 
effective at pumping blood. In 
people with heart failure, it also 
helps to control the symptoms of 
tiredness, breathlessn

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1.
LANOXIN
Digoxin tablets 62.5mcg (0.0625mg) and 250mcg (0.250mg); Paediatric
Elixir
50mcg/mL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets: Each tablet contains 62.5mcg (0.0625mg), 250mcg (0.250mg)
Digoxin BP
Paediatric Elixir: 50mcg Digoxin BP in each 1mL
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablets PG 62.5mcg
Blue, round, biconvex tablets debossed “DO6” and each containing
62.5mcg
(0.0625mg) Digoxin BP.
Tablets 250mcg
White, round, biconvex tablets, bisected and debossed ‘DO25” and
each
containing 250mcg (0.250mg) Digoxin BP.
Paediatric Elixir 50mcg/mL
A clear, yellow, lime flavoured solution containing 50mcg (0.050mg)
Digoxin
BP in each 1mL of sweetened, aqueous-alcoholic vehicle.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cardiac Failure
LANOXIN 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.
LANOXIN is specifically indicated where cardiac failure is accompanied
by
atrial fibrillation.
Supraventricular Arrhythmias
LANOXIN is indicated in the management of certain supraventricular
arrhythmias, particularly atrial flutter and fibrillation, where a
major beneficial
effect is reduction of the ventricular rate.
4.2 DOSE AND METHOD OF ADMINISTRATION
The dose of LANOXIN 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.
LANOXIN PG Oral Solution, 50mcg in 1mL, is supplied with a graduated
pipette and this should be used for measurement of all doses.
ADULTS AND CHILDREN OVER 10 YEARS
Rapid Oral Loading
2
If medically appropriate, rapid digitalisation may be achieved in a
number of
ways, such as the following:
750 to 1500mcg (0.75 to 1.5mg) as a single dose.
Where there is less urgency, or greater risk of toxicity e.g. in the
elderly, the
oral loading dose should be given in divided doses 6