DIGOXIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, LLC dba Vangard Labs

INN (International Name):

DIGOXIN

Composition:

DIGOXIN 125 ug

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Digoxin Tablets are indicated for the treatment of mild to moderate heart failure in adults. Digoxin Tablets 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 should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor. Digoxin Tablets increase myocardial contractility in pediatric patients with heart failure. Digoxin Tablets are indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. Digoxin Tablets are contraindicated in patients with: - Ventricular fibrillation [see Warnings and Precautions (5.1)] - Known hypersensitivity to digoxin (reactions seen include unexplained rash, swelling of the mouth, lips or throat or a difficulty in breathing). A hypersensitivity reaction to other digitalis preparations usually

Product summary:

Digoxin Tablets, USP 0.125 mg are Yellow, Round, Scored Tablets, Debossed "W 40" on Scored Side NDC 0615-8202-39: Blistercards of 30 tablets. NDC 0615-8202-05: Blistercards of 15 tablets. NDC 0615-8202-30: Unit-Dose Boxes of 30 tablets Digoxin Tablets, USP 0.25 mg are White, Round, Scored Tablets, Debossed "WW41" on Scored Side 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
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
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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.
DIGOXIN TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1954
INDICATIONS AND USAGE
Digoxin Tablets are a cardiac glycoside indicated for:
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)
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
Ventricular fibrillation. (4)
Known hypersensitivity to digoxin or other forms of digitalis. (4)
WARNINGS AND PRECAUTIONS
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
age, low body weight, impaired renal function and electrolyte
abnormalities predispose to toxicity. (5.3)
Risk of ventricular arrhythmias during electrical cardioversion. (5.4)
Not recommended in patients with acute myocardial infarction. (5.5)
Avoid Digoxin Tablets in patients with myocarditis. (5.6)
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 SUSPE