LANOXIN PAEDIATRICGERIATRIC ELIXIR 0.05 mgml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

DIGOXIN

Available from:

DCH AURIGA SINGAPORE

ATC code:

C01AA05

Dosage:

0.05 mg/ml

Pharmaceutical form:

ELIXIR

Composition:

DIGOXIN 0.05 mg/ml

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Aspen Bad Oldesloe GmbH

Authorization status:

ACTIVE

Authorization date:

1988-04-29

Patient Information leaflet

 
1
12000000100292
GSK-CONTRACTMFG-EUR-DEU-GERMANY-ASPEN-BAD OLDESLOE
ASPEN; SINGAPORE-SGP
B-ASP LANOXIN (SG)
 1

K

BE66_170X594

ASPEN BAD OLDESLOE
ADDITIONAL INFORMATION PANEL
REPLACEMENT: 10000000075059
FRONT
PAGE 1 OF 2

1
12000000100292
GSK-CONTRACTMFG-EUR-DEU-GERMANY-ASPEN-BAD OLDESLOE
ASPEN; SINGAPORE-SGP
B-ASP LANOXIN (SG)
 1

K

BE66_170X594

ASPEN BAD OLDESLOE
ADDITIONAL INFORMATION PANEL
REPLACEMENT: 10000000075059
BACK
PAGE 2 OF 2

Summary of Product characteristics

LANOXIN™
DIGOXIN
QUALITATIVE AND QUANTITATIVE COMPOSITION
Injections containing 25, 50, 100 or 250 micrograms digoxin per ml.
Tablets containing 62.5, 125 or 250 micrograms digoxin.
Oral solutions containing 50 or 500 micrograms digoxin in 1 ml.
PHARMACEUTICAL FORM
Injection.
Tablets.
Oral solution.
CLINICAL PARTICULARS
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
chronic atrial_ _flutter and fibrillation.
DOSAGE AND 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.
The difference in bioavailability between injectable _LANOXIN_ 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 %.
_LANOXIN _Oral Solution, 50 micrograms in 1 ml, is supplied with a
graduated pipette and this should
be used for_ _measurement of all doses.
MONITORING
Serum concentrations of _LANOXIN_ may be expressed in Conventional
Units of ng/ml or SI Units of
nmol/l. To convert ng/ml to nmol/l, multiply ng/ml by 1.28. The serum
concentration of digoxin can be
determined by radioimmunoassay. Blood should be taken 6 hours or more
after the last dose of
_LANOXIN_.
There are no rigid guidelines as to the range of serum concentrations
that are most efficacious. A post
hoc analysis 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