Lanoxin 500micrograms/2ml solution for infusion ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Digoxin

Available from:

Aspen Pharma Trading Ltd

ATC code:

C01AA05

INN (International Name):

Digoxin

Dosage:

250microgram/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02010100; GTIN: 5010706002128

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
LANOXIN INJECTION
DIGOXIN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Lanoxin is and what it is used for
2.
What you need to know before you use Lanoxin Injection
3.
How to use Lanoxin Injection
4.
Possible side effects
5.
How to store Lanoxin Injection
6.
Contents of the pack and other information
1.
WHAT LANOXIN INJECTION IS AND WHAT IT IS USED FOR
Lanoxin contains the active substance digoxin, which belongs to a
group of medicines called cardiac glycosides.
It is used to treat arrhythmias and heart failure. An arrhythmia is an
irregularity in the heart-beat, which causes
the heart to skip a beat, beat irregularly or beat at the wrong speed.
This medicine works by correcting irregular
heartbeats to a normal rhythm and strengthens the force of the
heart-beat, which is why it is useful in heart
failure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LANOXIN INJECTION
DO NOT USE LANOXIN INJECTION IF YOU:
-
Are allergic to digoxin, other cardiac glycosides or any of the other
ingredients of this medicine (listed in
section 6).
-
Have serious heart problems, such as those with the conduction of the
electrical impulses in the heart,
especially if you have a history of Stokes-Adams attacks (abrupt,
short-lived loss of consciousness
caused by a sudden change in heart rate or rhythm).
-
Have an irregular heart-beat caused by cardiac glycoside intoxication
or conditions such as Wolff-
Parkinson-White syndrome.
-
Have obstructive cardiomyopathy (en

Summary of Product characteristics

OBJECT 1
LANOXIN INJECTION
Summary of Product Characteristics Updated 03-Jan-2018 | Aspen
1. Name of the medicinal product
Lanoxin _Injection_.
2. Qualitative and quantitative composition
Digoxin 0.025 % w/v
3. Pharmaceutical form
Solution for Injection.
4. Clinical particulars
4.1 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.
4.2 Posology and method of administration
Posology:
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.
In cases where cardiac glycosides have been taken in the preceding two
weeks the recommendations for
initial dosing of a patient should be reconsidered and a reduced dose
is advised.
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
I.V. formulation the dosage should be reduced by approximately 33%.
Adults and paediatric populations over 10 years
_Parenteral loading:_
Parenteral loading should only be used in patients who have not been
given cardiac glycosides within the
preceding two weeks.
The total loading dose of parenteral digoxin is 500 to 1000 micrograms
(0.5 to 1.0 mg) depending on age,
lean body weight and renal function. The total loading dose should be
administered in divided doses with
approximately half of the total dose given as the first dose and
further fractions of the total dose given at
intervals of four to eight hours. An assessment of clinical respo