DIGOXIN injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Henry Schein, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

1.1 Heart Failure in Adults Digoxin is indicated for the treatment of mild to moderate heart failure in adults. Digoxin increases left ventricular ejection fraction and imporves heart failure symptoms, as evidenced by 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. 1.2 Atrial Fibrillation in Adults 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 cont

Product summary:

Digoxin Injection, USP is available as: 500 mcg/2 mL (250 mcg/mL) ampuls packaged in 25s (NDC 0641-1410-35) Store at 20˚-25˚C (68˚-77˚F), excursions permitted to 15˚-30˚C (59˚-86˚F) [see USP Controlled Room Temperature]. Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIGOXIN- DIGOXIN INJECTION
HENRY SCHEIN, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
DIGOXIN, INJ 250 MCG/ML INJECTION, USP 2 ML SINGLE DOSE AMPULE
INITIAL U.S. APPROVAL: 1954
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIGOXIN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DIGOXIN.
INDICATIONS AND USAGE
Digoxin is a cardiac glycoside indicated for: (1)
Treatment of mild to moderate heart failure in adults. (1.1)
Control of resting ventricular rate in adults with chronic artial
fibrillation. (1.2)
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) (2)
Intravenous administration is preferable to intramuscular. Avoid bolus
administration. (2) (2)
DOSAGE FORMS AND STRENGTHS
Digoxin Injection: Ampuls containing 500 mcg (0.5 mg) in 2 mL. (3) (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 SUS