Digoxin Digoxin 0.125 MG Oral Tablet
1 INDICATIONS AND USAGE Digoxin tablets are 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 tablets are indicated for the treatment of mild to moderate heart failure in adults. Digoxin tablets increase left ventricular ejection fraction and improve 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 tablets should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor. 1.2 Heart Failure in Pediatric Patients Digoxin tablets increase myocardial contractility in pediatric patients with heart failure. 1.3 Atrial Fibrillation in Adults Digoxin tablets are indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.
Global Pharmaceuticals, Division of Impax Lab
ROUND YELLOW 981
981 ROUND YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING
DIGOXIN tablets USP, 125 mcg (0.125 mg) are light yellow, round, flat-faced beveled edge tablets debossed with “981” on top of bisect on one side and plain on the other side. Bottles of 100: NDC 0115-9811-01 Bottles of 500: NDC 0115-9811-02 Bottles of 1000: NDC 0115-9811-03
DIGOXIN tablets USP, 250 mcg (0.25 mg) are off-white to light tan, round, convex tablets debossed with “982” on top of bisect on one side and plain on the other side. Bottles of 100: NDC 0115-9822-01 Bottles of 500: NDC 0115-9822-02 Bottles of 1000: NDC 0115-9822-03 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Dispense in tightly-closed, light-resistant container as defined in the USP, with child-resistant closure, as required.
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