DIGOXIN tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Golden State Medical Supply

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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: - 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 contraindication

ملخص المنتج:

Digoxin Tablets USP, 125 micrograms (0.125 mg): Bottles of 100 with child-resistant cap (NDC 51407-125-01) and 1000 (NDC 51407-125-10). Round, biconvex, yellow tablets, debossed with "437" 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.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

DIGOXIN- DIGOXIN TABLET
GOLDEN STATE MEDICAL SUPPLY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
DIGOXIN TABLETS.
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:
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).
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
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 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 ADVE