DIGOXIN- digoxin tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

DIGOXIN

Composition:

DIGOXIN 0.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

DIGOXIN is indicated for the treatment of mild to moderate heart failure in adults. DIGOXIN 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, DIGOXIN should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor. Digoxin increases myocardial contractility in pediatric patients with heart failure. DIGOXIN is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. DIGOXIN is 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 constitutes a contraindication to digoxin. D

Product summary:

DIGOXIN Tablets have “LANOXIN” on one side and are supplied as follows: Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [See USP controlled Room Temperature] in a dry place and protect from light. Keep out of reach of children. Dispense in tight, light-resistant container.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

DIGOXIN- DIGOXIN TABLET
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIGOXIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DIGOXIN.
DIGOXIN (DIGOXIN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1954
INDICATIONS AND USAGE
DIGOXIN is 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 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 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 in patients with myocarditis. ( 5.6)
ADVERSE REACTIONS
The overall incidence of adverse reactions with digoxin has been
reported as 5-20%, with 15-20% 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 PAR PHARMACEUTICAL AT
1-