DIGOXIN tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

DIGOXIN (UNII: 73K4184T59) (DIGOXIN - UNII:73K4184T59)

זמין מ:

Northstar Rx LLC

INN (שם בינלאומי):

DIGOXIN

הרכב:

DIGOXIN 125 ug

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Digoxin is indicated for the treatment of mild to moderate heart failure in adults. Digoxin increases left ventricular ejection fraction and 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. Digoxin increases myocardial contractility in pediatric patients with heart failure. Digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. Digoxin is contraindicated in patients with: Risk Summary Experience with digoxin in pregnant women over several decades, based on published retrospective clinical studies and case reports, has not led to the identification of a drug associated risk of major birth defects, miscarriage or adverse maternal and fetal outcomes. Untreated underlying maternal conditions, suc

leaflet_short:

Digoxin Tablets USP, 125 micrograms (0.125 mg): Bottles of 100 with child-resistant cap (NDC 16714-590-01) and 1000 (NDC 16714-590-02). Round, biconvex, yellow tablets, debossed with "437" on one side and scored on other side. Digoxin Tablets USP, 250 micrograms (0.25 mg): Bottles of 100 with child-resistant cap (NDC 16714-591-01) and 1000 (NDC 16714-591-02). Round, biconvex, white tablets, debossed with "441" on one side and scored on other side. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature] in a dry place and protect from light. Keep out of reach of children. Dispense in tight, light-resistant container.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

DIGOXIN- DIGOXIN TABLET
NORTHSTAR RX LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIGOXIN TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR DIGOXIN TABLETS.
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
_Tablets: _125 micrograms and 250 micrograms scored (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 NORTHSTAR RX LLC AT
1-800-206-7821 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: 8/2020
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, impaired renal funct