Digoxin — 500MCG, Solution for injection, carton of 10 × 2 mL ampules

Digoxin — 500MCG, Solution for injection, carton of 10 × 2 mL ampules

Digoxin is a solution for injection for intramuscular; intravenous; parenteral use. 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 ) 1.1 Heart Failure in Adults 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.

• Active ingredient or product type: DIGOXIN
• Strength/concentration: 500MCG
• Dosage form and route: Solution for injection, Intramuscular; Intravenous; Parenteral
• Exact package presentation: carton of 10 × 2 mL ampules
• NDC/item number: 0781-3059-95
• Manufacturer: SANDOZ
• Storage/handling: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] and protect from light. Discard unused portion.
• Status: Rx only

Important safety information: • 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.

Refer to the current product labeling for complete indications, preparation or administration instructions, contraindications, warnings, precautions, and storage requirements.