DIGOXIN injection, solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Sandoz Inc

INN (Internationale Bezeichnung):

DIGOXIN

Zusammensetzung:

DIGOXIN 250 ug in 1 mL

Verabreichungsweg:

INTRAMUSCULAR

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Digoxin injection is indicated for the treatment of mild to moderate heart failure in adults. Digoxin injection 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 injection should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor. Digoxin injection increases myocardial contractility in pediatric patients with heart failure. Digoxin injection is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. Digoxin injection is contraindicated in patients with: Risk Summary Experience with digoxin in pregnant women over several decades, based on published retrospective clinical studies and case reports, has not led to the identification of a drug associated risk of major birth defects, miscarriage or adverse maternal and

Produktbesonderheiten:

Digoxin Injection, USP 500 mcg (0.5 mg) in 2 mL (250 mcg [0.25 mg] per mL) is available as follows: NDC 0781-3059-95 ampules of 2 mL in boxes of 10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

DIGOXIN- DIGOXIN INJECTION, SOLUTION
SANDOZ INC
REFERENCE LABEL SET ID: 58678FD6-AFE3-4A4C-A37F-356444194CD6
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIGOXIN INJECTION SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DIGOXIN
INJECTION.
DIGOXIN INJECTION, FOR INTRAVENOUS OR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1954
INDICATIONS AND USAGE
Digoxin injection 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 adults with chronic atrial
fibrillation. ( 1.3)
DOSAGE AND ADMINISTRATION
Digoxin injection 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)
Intravenous administration is preferable to intramuscular. Avoid bolus
administration. ( 2)
DOSAGE FORMS AND STRENGTHS
Digoxin injection USP: Ampules containing 500 mcg (0.5 mg) in 2 mL. (
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 injection 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 ser