DIGOXIN tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Major Pharmaceuticals

DCI (Dénomination commune internationale):

DIGOXIN

Composition:

DIGOXIN 125 ug

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Digoxin Tablets are indicated for the treatment of mild to moderate heart failure in adults. Digoxin Tablets 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 should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor. Digoxin Tablets increase myocardial contractility in pediatric patients with heart failure. Digoxin Tablets are indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. Digoxin Tablets are contraindicated in patients with: Pregnancy 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 fet

Descriptif du produit:

Digoxin Tablets, USP 0.125 mg are Yellow, Round, Scored Tablets, Debossed "W 40" on Scored Side Carton of 100 tablets (10 tablets each blister pack x 10), NDC 0904-5921-61 Digoxin Tablets, USP 0.25 mg are White, Round, Scored Tablets, Debossed "WW 41" on Scored Side Carton of 100 tablets (10 tablets each blister pack x 10), NDC 0904-5922-61 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.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

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.
DIGOXIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1954
INDICATIONS AND USAGE
Digoxin Tablets 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-
800-962-8364, OR THE FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
USE IN SPECIFIC POPULATIONS
•
•
•
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 function and electrolyte
abnormalities