LANOXIN digoxin tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Covis Pharmaceuticals, Inc.

INN (International Adı):

DIGOXIN

Kompozisyon:

DIGOXIN 0.125 mg

Reçete türü:

PRESCRIPTION DRUG

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

LANOXIN- DIGOXIN TABLET
COVIS PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LANOXIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LANOXIN.
LANOXIN (DIGOXIN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1954
INDICATIONS AND USAGE
LANOXIN 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
LANOXIN 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
Unscored Tablets: 62.5 and 187.5 mcg. Scored Tablets 125 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 LANOXIN in patients with myocarditis. (5.6)
ADVERSE REACTIONS
The overall incidence of adverse reactions with digoxin has been
reported as 5-20%, with 15-20% 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 REACTION