LANOXIN-PG PAEDIATRICGERIATRIC TABLET 0.0625 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

DIGOXIN

Available from:

DCH AURIGA SINGAPORE

ATC code:

C01AA05

Dosage:

0.0625 mg

Pharmaceutical form:

TABLET

Composition:

DIGOXIN 0.0625 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

ASPEN BAD OLDESLOE GMBH

Authorization status:

ACTIVE

Authorization date:

1988-05-13

Patient Information leaflet

LANOXIN
™ 

10000000067288
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. Several post 
hoc analyses of heart failure patients in the Digitalis Investigation
Group trial s

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