DIGOXIN tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

NCS HealthCare of KY, Inc dba Vangard Labs

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Heart Failure: Digoxin Tablets are indicated for the treatment of mild to moderate heart failure. Digoxin Tablets increase left ventricular ejection fraction and improve 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 Tablets should be used with a diuretic and an angiotensin-converting enzyme inhibitor, but an optimal order for starting these three drugs cannot be specified. Atrial Fibrillation: Digoxin Tablets are 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, 0.125 mg are Yellow, Round, Scored Tablets, Debossed "W 40" on Scored Side Digoxin Tablets USP, 0.25 mg are White, Round, Scored Tablets, Debossed "W 41" on Scored Side. Store at 20-25ºC (68-77ºF) [See USP Controlled Room Temperature] in a dry place. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

DIGOXIN- DIGOXIN TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
DIGOXIN TABLETS, USP
REVISED 07/10
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, USP 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 f