LANOXIN digoxin tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Last ned Preparatomtale (SPC)
19-12-2017

Aktiv ingrediens:

DIGOXIN (UNII: 73K4184T59) (DIGOXIN - UNII:73K4184T59)

Tilgjengelig fra:

Cardinal Health

INN (International Name):

DIGOXIN

Sammensetning:

DIGOXIN 125 ug

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

New Drug Application

Preparatomtale

                                LANOXIN- DIGOXIN TABLET
CARDINAL HEALTH
----------
LANOXIN
(DIGOXIN) TABLETS, USP
125 MCG (0.125 MG) SCORED I.D. IMPRINT Y3B (YELLOW)
250 MCG (0.25 MG) SCORED I.D. IMPRINT X3A (WHITE)
DESCRIPTION
LANOXIN (digoxin) is one of the cardiac (or digitalis) glycosides, a
closely related group of drugs
having in common specific effects on the myocardium. These drugs are
found in a number of plants.
Digoxin is extracted from the leaves of _Digitalis lanata_. The term
“digitalis” is used to designate the
whole group of glycosides. The glycosides are composed of 2 portions:
a sugar and a cardenolide
(hence “glycosides”).
Digoxin is described chemically as
(3β,5β,12β)-3-[(_O_-2,6-dideoxy-β-_D-ribo_-hexopyranosyl-(1→4)-_O_-
2,6-dideoxy-β-_D-ribo-_hexopyranosyl-(1→4)-2,6-dideoxy-β-_D_-_ribo_-hexopyranosyl)oxy]-12,14-
dihydroxy-card-20(22)-enolide. Its molecular formula is C
H O , its molecular weight is 780.95,
and its structural formula is:
Digoxin exists as odorless white crystals that melt with decomposition
above 230°C. The drug is
practically insoluble in water and in ether; slightly soluble in
diluted (50%) alcohol and in chloroform;
and freely soluble in pyridine.
LANOXIN is supplied as 125-mcg (0.125-mg) or 250-mcg (0.25-mg) tablets
for oral administration.
Each tablet contains the labeled amount of digoxin USP and the
following inactive ingredients: corn and
potato starches, lactose, and magnesium stearate. In addition, the
dyes used in the 125-mcg (0.125-mg)
tablets are D&C Yellow No. 10 and FD&C Yellow No. 6.
CLINICAL PHARMACOLOGY
®
41
64
14
MECHANISM OF ACTION
Digoxin inhibits sodium-potassium ATPase, an enzyme that regulates the
quantity of sodium and
potassium inside cells. Inhibition of the enzyme leads to an increase
in the intracellular concentration of
sodium and thus (by stimulation of sodium-calcium exchange) an
increase in the intracellular
concentration of calcium. The beneficial effects of digoxin result
from direct actions on cardiac
muscle, as well as indirect actions on the cardiov
                                
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