País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
DIGOXIN (UNII: 73K4184T59) (DIGOXIN - UNII:73K4184T59)
Avera McKennan Hospital
DIGOXIN
DIGOXIN 0.125 mg
PRESCRIPTION DRUG
New Drug Application Authorized Generic
DIGOXIN- DIGOXIN TABLET AVERA MCKENNAN HOSPITAL ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DIGOXIN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DIGOXIN. DIGOXIN (DIGOXIN) TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1954 INDICATIONS AND USAGE DIGOXIN is a cardiac glycoside indicated for: • • • DOSAGE AND ADMINISTRATION DIGOXIN 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: 62.5 and 187.5 mcg. Scored Tablets 125 and 250 mcg (3) CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • • • • 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 REACTIONS, CONTACT PAR PHARMACEUTICAL, INC AT 1-800-828-9393 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • • USE IN SPECIFIC POPULATIONS • • • • SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 1/2016 ® 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) Ventricular fibrillation. (4) Known hypersensitivity to digoxin or other forms of digitalis. (4) 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, i Leer el documento completo