digitek digoxin tablet
1 INDICATIONS AND USAGE DIGITEK ® (digoxin tablets) 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 DIGITEK ® (digoxin tablets) is indicated for the treatment of mild to moderate heart failure in adults. DIGITEK ® (digoxin tablets) 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, DIGITEK ® (digoxin tablets) should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor. 1.2 Heart Failure in Pediatric Patients DIGITEK ® (digoxin tablets) increases myocardial contractility in pediatric patients with heart failure. 1.3 Atrial Fibrillation in Adults DIGITEK ® (digoxin tablets) is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.
Mylan Institutional Inc.
ROUND YELLOW M 145
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digitek digoxin tablet
mylan institutional inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING DIGITEK ® (digoxin tablets, USP) is available containing 125 mcg (0.125 mg) or 250 mcg (0.25 mg) of digoxin, USP. The 125 mcg (0.125 mg) tablets are yellow, round, scored, slope-faced tablets debossed with M above the score and 145 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 42292-003-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each). The 250 mcg (0.25 mg) tablets are white, round, scored, slope-faced tablets debossed with M above the score and 147 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 42292-002-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store in a dry place. Protect from light. Keep out of reach of children.
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