DIGOXIN tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Unit Dose Services

INN (Nama Antarabangsa):

DIGOXIN

Komposisi:

DIGOXIN 125 ug

Jenis preskripsi:

PRESCRIPTION DRUG

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

DIGOXIN- DIGOXIN TABLET
UNIT DOSE SERVICES
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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:
•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
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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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SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 3/2017
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,