Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
DIGOXIN (UNII: 73K4184T59) (DIGOXIN - UNII:73K4184T59)
Covis Pharmaceuticals, Inc.
DIGOXIN
DIGOXIN 0.125 mg
PRESCRIPTION DRUG
New Drug Application
LANOXIN- DIGOXIN TABLET COVIS PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LANOXIN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LANOXIN. LANOXIN (DIGOXIN) TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1954 INDICATIONS AND USAGE LANOXIN 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) DOSAGE AND ADMINISTRATION LANOXIN 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 Unscored Tablets: 62.5 and 187.5 mcg. Scored Tablets 125 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 LANOXIN in patients with myocarditis. (5.6) ADVERSE REACTIONS The overall incidence of adverse reactions with digoxin has been reported as 5-20%, with 15-20% 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 Izlasiet visu dokumentu