DIGOXIN tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Sun Pharmaceutical Industries, Inc.

INN (Nome Internazionale):

DIGOXIN

Composizione:

DIGOXIN 125 ug

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

Digoxin Tablets USP, 125 micrograms (0.125 mg): Bottles of 100 with child-resistant cap (NDC 57664-437-88) and 1000 (NDC 57664-437-18). 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 57664-441-88) and 1000 (NDC 57664-441-18). 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.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

DIGOXIN- DIGOXIN TABLET
SUN PHARMACEUTICAL INDUSTRIES, INC.
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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:
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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 microgram and 250 microgram scored (3).
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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 SUN PHARMACEUTICAL
INDUSTRIES, INC. AT
1-800-406-7984 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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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
ab