Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
DIGOXIN (UNII: 73K4184T59) (DIGOXIN - UNII:73K4184T59)
State of Florida DOH Central Pharmacy
ORAL
PRESCRIPTION DRUG
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-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.
Digoxin Tablets USP, 0.125 mg are yellow, round, scored on one side with imprint "W 40". Digoxin Tablets USP, 0.25 mg are white, round, scored on one side with imprint "WW 41". They are supplied by State of Florida DOH Central Pharmacy as follows: 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. Lanoxicaps® is a registered trademark of GlaxoSmithKline. Manufactured By: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States
Abbreviated New Drug Application
DIGOXIN - DIGOXIN TABLET STATE OF FLORIDA DOH CENTRAL PHARMACY ---------- DIGOXIN TABLETS, USP 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 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: 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 pregelatinized starch. 250 MCG (0.25 MG): anhydrous lactose, colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate and pregelatinized starch. 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 digo Lire le document complet