Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
DIGOXIN (UNII: 73K4184T59) (DIGOXIN - UNII:73K4184T59)
Major Pharmaceuticals
ORAL
PRESCRIPTION DRUG
Digoxin Tablets, USP are indicated for the treatment of mild to moderate heart failure in adults. Digoxin Tablets, USP 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, USP should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor. Digoxin Tablets, USP increase myocardial contractility in pediatric patients with heart failure. Digoxin Tablets, USP are indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. Digoxin Tablets are contraindicated in patients with: Digoxin Tablets should be given to a pregnant woman only if clearly needed. It is also not known whether digoxin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Animal reproduction studies have not been co
Digoxin Tablets, USP 0.125 mg are Yellow, Round, Scored Tablets, Debossed "W 40" on Scored Side Bottle of 100 tablets, NDC 0904-6886-60 Bottle of 1000 tablets, NDC 0904-6886-80 Store in a dry place at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature] and protect from light. Keep out of reach of children. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Abbreviated New Drug Application
DIGOXIN- DIGOXIN TABLET MAJOR PHARMACEUTICALS ---------- 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, USP. DIGOXIN TABLETS, USP FOR ORAL USE INITIAL U.S. APPROVAL: 1954 INDICATIONS AND USAGE Digoxin Tablets, USP are a cardiac glycoside indicated for: • • • 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 • • WARNINGS AND PRECAUTIONS • • • • • • 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 REACTIONS, CONTACT WEST-WARD PHARMACEUTICALS CORP. AT 1-877-233-2001, OR THE FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • • USE IN SPECIFIC POPULATIONS • • • • SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 3/2019 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 Prečítajte si celý dokument