DIGOXIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals NY LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Heart Failure: 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 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 three drugs cannot be specified. Atrial Fibrillation: 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.

Product summary:

Digoxin Tablets, USP, 125 mcg (0.125 mg), Scored I.D. Imprint JSP-544 (yellow): Bottles of 100 (NDC 69238-1991-1) and 1000 (NDC 69238-1991-7). Digoxin Tablets, USP, 250 mcg (0.250 mg), Scored I.D. Imprint JSP-545 (white): Bottles of 100 (NDC 69238-1992-1) and 1000 (NDC 69238-1992-7). Store at controlled room temperature 15°-25°C (59°-77°F) in a dry place and protect from light. Dispense in a tight, light-resistant container as defined in the USP. Rx ONLY Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Manufactured by: Jerome Stevens Pharmaceuticals, Inc. Bohemia, NY 11716 Rev. 02/19 MG #45109

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIGOXIN- DIGOXIN TABLET
AMNEAL PHARMACEUTICALS NY LLC
----------
DIGOXIN TABLETS, USP
125 MCG (0.125 MG)
250 MCG (0.25 MG)
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-[(_0_-2,6-dideoxy-β-_D-ribo_-
hexopyranosyl-(1→4)-_0_-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: 0.250 mg - colloidal silicon dioxide,
croscarmellose sodium, lactose
anhydrous, magnesium stearate, microcrystalline cellulose, stearic
acid.
0.125 mg - colloidal silicon dioxide, croscarmellose sodium, D&C
yellow aluminum lake
41
64
14
#10, lactose anhydrous, magnesium stearate, microcrystalline
cellulose, stearic acid.
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