Digoxin tablets

Země: Arménie

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivní složka:

digoxin

Dostupné s:

Arpimed LLC

ATC kód:

C01AA05

INN (Mezinárodní Name):

digoxin

Dávkování:

0,25mg

Léková forma:

tablets

Jednotky v balení:

(40/1x40/) in blister

Druh předpisu:

Prescription

Stav Autorizace:

Registered

Datum autorizace:

2020-09-25

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
DIGOXIN
0.25 mg Tablets
1.
NAME OF THE MEDICINAL PRODUCT
Digoxin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
_ACTIVE INGREDIENT:_ digoxin 0.25 mg
_INACTIVE INGREDIENTS: _see 6.1 list of excipient_ _
3.
PHARMACEUTICAL FORM
Tablet
White flat scored tablets
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
Rapid oral loading:
If medically appropriate, rapid digitalisation may be achieved in a
number of ways, such as 750
to 1500 micrograms (0.75 to 1.5 mg) 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 six hours apart, with approximately
half the total dose given as
the first dose.
Clinical response should be assessed before giving each additional
dose (see Section 4.4).
S