DIGOXIN- digoxin tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Major Pharmaceuticals

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Digoxin Tablets, USP are indicated for the treatment of mild to moderate heart failure in adults. Digoxin Tablets, USP increase left ventricular ejection fraction and improve 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, Digoxin Tablets, USP should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor. Digoxin Tablets, USP increase myocardial contractility in pediatric patients with heart failure. Digoxin Tablets, USP are indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. Digoxin Tablets are contraindicated in patients with: Digoxin Tablets should be given to a pregnant woman only if clearly needed. It is also not known whether digoxin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Animal reproduction studies have not been co

Product summary:

Digoxin Tablets, USP 0.125 mg are Yellow, Round, Scored Tablets, Debossed "W 40" on Scored Side Bottle of 100 tablets, NDC 0904-6886-60 Bottle of 1000 tablets, NDC 0904-6886-80 Store in a dry place at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature] and protect from light. Keep out of reach of children. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIGOXIN- DIGOXIN TABLET
MAJOR PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIGOXIN TABLETS, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DIGOXIN TABLETS,
USP.
DIGOXIN TABLETS, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1954
INDICATIONS AND USAGE
Digoxin Tablets, USP are a cardiac glycoside indicated for:
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DOSAGE AND ADMINISTRATION
Digoxin Tablets dose is based on patient-specific factors (age, lean
body weight, renal function, etc.). See full prescribing
information. Monitor for toxicity and therapeutic effect. (2)
DOSAGE FORMS AND STRENGTHS
Scored Tablets 125 mcg and 250 mcg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The overall incidence of adverse reactions with digoxin has been
reported as 5 to 20%, with 15 to 20% of adverse events
considered serious. Cardiac toxicity accounts for about one-half,
gastrointestinal disturbances for about one-fourth, and
CNS and other toxicity for about one-fourth of these adverse events.
(6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT WEST-WARD
PHARMACEUTICALS CORP. AT 1-877-233-2001,
OR THE FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 3/2019
Treatment of mild to moderate heart failure in adults. (1.1)
Increasing myocardial contractility in pediatric patients with heart
failure. (1.2)
Control of resting ventricular rate in patients with chronic atrial
fibrillation in adults. (1.3)
Ventricular fibrillation. (4)
Known hypersensitivity to digoxin or other forms of digitalis. (4)
Risk of rapid ventricular response leading to ventricular fibrillation
in patients with AV accessory pathway. (5.1)
Risk of advanced or complete heart block in patients with sinus node
disease and AV block. (5.2)
Digoxin toxicity: Indicated by nausea, vomiting, visual disturbances,
and cardiac arrhythmias. Advanced