Digoxin 0.125 MG Oral Tablet
1 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) . 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 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 Heart Failure in Pediatric Patients Digoxin increases myocardial contractility in pediatric patients with heart failure. 1.3 Atrial Fibrillation in Adults Digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.
sun pharmaceutical industries, inc.
ROUND YELLOW 437
437 ROUND YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING
DIGOXIN Tablets USP, 125 micrograms (0.125 mg): Bottles of 100 with child-resistant cap (NDC 57664-437-88) and 1000 (NDC 57664-437-18). round, biconvex, yellow tablets, debossed with "437" on one side and scored on other side.
DIGOXIN Tablets USP, 250 micrograms (0.25 mg): Bottles of 100 with child-resistant cap (NDC 57664-441-88) and 1000 (NDC 57664-441-18). round, biconvex, white tablets, debossed with "441" on one side and scored on other side. 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.
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