DIGOX- digoxin tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Lannett Company, Inc.

INN (Tarptautinis Pavadinimas):

DIGOXIN

Sudėtis:

DIGOXIN 125 ug

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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.

Produkto santrauka:

Digox® (digoxin tablets), 125 mcg (0.125 mg), Scored I.D. Imprint JSP-544 (yellow): Bottles of 100 (NDC 50564-544-01) and 1000 (NDC 50564-544-10). Digox® (digoxin tablets), 250 mcg (0.250 mg), Scored I.D. Imprint JSP-545 (white): Bottles of 100 (NDC 50564-545-01) and 1000 (NDC 50564-545-10). 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 Manufactured by: Jerome Stevens Pharmaceuticals, Inc. Bohemia, NY 11716 Rev. 11/09 MG #28531

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

DIGOX- DIGOXIN TABLET
LANNETT COMPANY, INC.
----------
DIGOX
(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 #10, lactose
anhydrous, magnesium stearate, microcrystalline cellulose, stearic
acid.
41
64
14
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 dir