DIGOXIN tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

State of Florida DOH Central Pharmacy

INN (International Name):

DIGOXIN

Sammensætning:

DIGOXIN 250 ug

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Digoxin is indicated for the treatment of mild to moderate heart failure. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by exercise capacity and heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used with a diuretic and an angiotensin converting enzyme inhibitor, but an optimal order for starting these 3 drugs cannot be specified. Digoxin is indicated for the control of ventricular response rate in patients with chronic atrial fibrillation. Digitalis glycosides are contraindicated in patients with ventricular fibrillation or in patients with a known hypersensitivity to digoxin. A hypersensitivity reaction to other digitalis preparations usually constitutes a contraindication to digoxin.

Produkt oversigt:

Digoxin tablets USP, 125 mcg (0.125 mg) are light yellow, round, flat-faced beveled edge tablets debossed with "981" on top of bisect on one side and plain on the other side. Digoxin tablets USP, 250 mcg (0.25 mg) are off-white to light tan, round, convex tablets debossed with "982" on top of bisect on one side and plain on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

DIGOXIN - DIGOXIN TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
----------
DIGOXIN TABLETS, USP
125 MCG (0.125 MG) AND 250 MCG (0.25 MG)
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 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.
Digoxin 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: lactose
monohydrate, magnesium stearate, microcrystalline cellulose, corn
starch. The 125-mcg (0.125-mg)
strength contains FD&C Yellow #5 (tartrazine).
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 cardiovascular system
mediated by effects on the autonomic
nervous system. The autonomic e