DIGOXIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

McKesson Contract Packaging

INN (International Name):

DIGOXIN

Composition:

DIGOXIN 125 ug

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIGOXIN- DIGOXIN TABLET
MCKESSON CONTRACT PACKAGING
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DIGOXIN TABLETS, USP
Rx Only
DESCRIPTION:
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 two 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. lts 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.
Digoxin Tablets are 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:
125 MCG (0.125 MG): anhydrous lactose, colloidal silicon dioxide, corn
starch, D&C yellow #10
aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate,
magnesium stearate and starch
1500.
250 MCG (0.25 MG): anhydrous lactose, colloidal silicon dioxide, corn
starch, lactose monohydrate,
magnesium stearate and starch 1500.
CLINICAL PHARMACOLOGY:
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