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DIGITEK® (digoxin tablets) is indicated for the treatment of mild to moderate heart failure in adults. DIGITEK® (digoxin tablets) increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, DIGITEK® (digoxin tablets) should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor.
DIGITEK® (digoxin tablets) increases myocardial contractility in pediatric patients with heart failure.
DIGITEK® (digoxin tablets) is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.
There is currently no drug history available for this drug.
DIGITEK® (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-ribohexopyranosyl) oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, 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.
DIGITEK® (digoxin tablets, USP) 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 starch, croscarmellose sodium, lactose anhydrous, lactose hydrous impalpable, microcrystalline cellulose, pregelatinized starch (corn), silicon dioxide and stearic acid. In addition, the 125 mcg (0.125 mg) tablet contains D&C Yellow No. 10 Aluminum Lake.