DIGOXIN injection

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

digoxin (UNII: 73K4184T59) (digoxin - UNII:73K4184T59)

Disponible depuis:

Cardinal Health 107, LLC

DCI (Dénomination commune internationale):

digoxin

Composition:

digoxin 0.25 mg in 1.0 mL

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. Digoxin is contraindicated in patients with: Digoxin should be given to a pregnant woman only if clearly needed.  It is also not known whether digoxin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Animal reproduction studies have not been conducted with digoxin. There are not enough data from clinical trials to determine the safety and efficacy of digoxin during labor and delivery. Studies have shown t

Descriptif du produit:

Digoxin Injection, USP is available as: Over bagged with 5 x 500 mcg/2 mL (250 mcg/mL) ampuls per bag, NDC 55154-5106-5 Store at 20˚ to 25˚C (68˚ to 77˚F), excursions permitted to 15˚ to 30˚C (59˚ to 86˚F) [see USP Controlled Room Temperature]. Protect from light.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

DIGOXIN- DIGOXIN INJECTION
CARDINAL HEALTH 107, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIGOXIN INJECTION SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DIGOXIN
INJECTION.
DIGOXIN INJECTION, FOR INTRAVENOUS OR INTRAMUSCULAR 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)
Intravenous administration is preferable to intramuscular. Avoid bolus
administration. (2)
DOSAGE FORMS AND STRENGTHS
Digoxin Injection: Ampuls containing 500 mcg (0.5 mg) in 2 mL. (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 5-20%, 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 REACTIONS, CONTACT HIKMA PHARMACEUTICALS
USA INC. AT 1-
877-845-0689 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: 8/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Heart Failure in Adults
1.2 Atrial Fibrillation in Adults
2 DOSAGE AND ADMINISTRATION
Treatment of mild to moderate heart failure in adults. (1.1)
Control of resting ventricular rate in adults with chronic atrial
fibrillation. (1.2)
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 blo