Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
DIGOXIN (UNII: 73K4184T59) (DIGOXIN - UNII:73K4184T59)
Cardinal Health
DIGOXIN
DIGOXIN 125 ug
PRESCRIPTION DRUG
New Drug Application
LANOXIN- DIGOXIN TABLET CARDINAL HEALTH ---------- LANOXIN (DIGOXIN) TABLETS, USP 125 MCG (0.125 MG) SCORED I.D. IMPRINT Y3B (YELLOW) 250 MCG (0.25 MG) SCORED I.D. IMPRINT X3A (WHITE) DESCRIPTION LANOXIN (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. LANOXIN 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: corn and potato starches, lactose, and magnesium stearate. In addition, the dyes used in the 125-mcg (0.125-mg) tablets are D&C Yellow No. 10 and FD&C Yellow No. 6. 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 cardiov Les hele dokumentet