Digitek Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


1.1 Heart Failure in Adults

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.

1.2 Heart Failure in Pediatric Patients

DIGITEK® (digoxin tablets) increases myocardial contractility in pediatric patients with heart failure.

1.3 Atrial Fibrillation in Adults

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.

Other Information

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 Structural Formula

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.

Digitek Manufacturers

  • Mylan Institutional Inc.
    Digitek (Digoxin) Tablet [Mylan Institutional Inc.]

Login To Your Free Account