LANOXIN- digoxin tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Concordia Pharmaceuticals Inc.

INN (International Name):

DIGOXIN

Composition:

DIGOXIN 0.125 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

LANOXIN 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

Summary of Product characteristics

LANOXIN - DIGOXIN TABLET
CONCORDIA PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LANOXIN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LANOXIN.
LANOXIN (DIGOXIN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1954
INDICATIONS AND USAGE
LANOXIN 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
LANOXIN 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
Unscored Tablets: 62.5 mcg. 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 LANOXIN 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, CON