DIGOXIN- digoxin tablet

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

NuCare Pharmaceuticals,Inc.

INN (Isem Internazzjonali):

DIGOXIN

Kompożizzjoni:

DIGOXIN 125 ug

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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: - 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 digit

Sommarju tal-prodott:

Digoxin Tablets, USP 0.125 mg are Yellow, Round, Scored Tablets, Debossed "W 40" on Scored Side. NDC 68071-4188-1 Bottles of 10 NDC 68071-4188-3 Bottles of 30 NDC 68071-4188-6 Bottles of 60 NDC 68071-4188-9 Bottles of 90 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.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

DIGOXIN- DIGOXIN TABLET
NUCARE PHARMACEUTICALS,INC.
----------
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:
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 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
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 Tablets 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)
T