Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
DIGOXIN (UNII: 73K4184T59) (DIGOXIN - UNII:73K4184T59)
General Injectables and Vaccines, Inc
DIGOXIN
DIGOXIN 0.25 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
1.1 Heart Failure in Adults Digoxin is indicated for the treatment of mild to moderate heart failure in adults. Digoxin increases left ventricular ejection fraction and imporves heart failure symptoms, as evidenced by 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, digoxin should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor. 1.2 Atrial Fibrillation in Adults Digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. Digoxin is 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 constitutes a cont
Digoxin Injection, USP is available as: 500 mcg/2 mL (250 mcg/mL) ampuls packaged in 25s (NDC 0641-1410-35) Store at 20˚-25˚C (68˚-77˚F), excursions permitted to 15˚-30˚C (59˚-86˚F) [see USP Controlled Room Temperature]. Protect from light.
Abbreviated New Drug Application
DIGOXIN- DIGOXIN INJECTION GENERAL INJECTABLES AND VACCINES, INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION DIGOXIN, INJ 250 MCG/ML INJECTION, USP 2 ML SINGLE DOSE AMPULE INITIAL U.S. APPROVAL: 1954 THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DIGOXIN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DIGOXIN. INDICATIONS AND USAGE Digoxin is a cardiac glycoside indicated for: (1) Treatment of mild to moderate heart failure in adults. (1.1) Control of resting ventricular rate in adults with chronic artial fibrillation. (1.2) 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) (2) Intravenous administration is preferable to intramuscular. Avoid bolus administration. (2) (2) DOSAGE FORMS AND STRENGTHS Digoxin Injection: Ampuls containing 500 mcg (0.5 mg) in 2 mL. (3) (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 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. Прочитать полный документ