देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
DIGOXIN (UNII: 73K4184T59) (DIGOXIN - UNII:73K4184T59)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
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. Digoxin Tablets increase myocardial contractility in pediatric patients with heart failure. Digoxin Tablets are indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. Digoxin Tablets are contraindicated in patients with: - Ventricular fibrillation [see Warnings and Precautions (5.1)] - Known hypersensitivity to digoxin (reactions seen include unexplained rash, swelling of the mouth, lips or throat or a difficulty in breathing). A hypersensitivity reaction to other digitalis preparations usually
Product: 63629-3870 NDC: 63629-3870-1 30 TABLET in a BOTTLE NDC: 63629-3870-2 60 TABLET in a BOTTLE NDC: 63629-3870-3 90 TABLET in a BOTTLE NDC: 63629-3870-4 100 TABLET in a BOTTLE
Abbreviated New Drug Application
DIGOXIN- DIGOXIN TABLET BRYANT RANCH PREPACK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DIGOXIN TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DIGOXIN TABLETS. DIGOXIN TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1954 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) DOSAGE AND ADMINISTRATION Digoxin Tablets 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) DOSAGE FORMS AND STRENGTHS Scored Tablets 125 mcg and 250 mcg (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 Tablets 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 serious. Cardiac toxicity accounts for about one-half, gastrointestinal disturbances for about one-fourth, and CNS and other toxicity for about one-fourth of these adverse events. (6.1) TO REPORT SUSPECTED ADVERSE REACTION पूरा दस्तावेज़ पढ़ें