LANOXIN digoxin injection solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Covis Pharmaceuticals, Inc.

INN (International Name):

DIGOXIN

Composition:

DIGOXIN 250 ug in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

LANOXIN- DIGOXIN INJECTION, SOLUTION
COVIS PHARMACEUTICALS, INC.
REFERENCE LABEL SET ID: 58678FD6-AFE3-4A4C-A37F-356444194CD6
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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) INJECTION, FOR INTRAVENOUS OR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1954
INDICATIONS AND USAGE
LANOXIN is a cardiac glycoside indicated for:
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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)
Intravenous administration is preferable to intramuscular. Avoid bolus
administration. (2)
DOSAGE FORMS AND STRENGTHS
LANOXIN Injection: Ampules containing 500 mcg (0.5 mg) in 2 mL. (3)
LANOXIN Injection Pediatric: Ampules of 100 mcg (0.1 mg) in 1 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 COVIS PHARMACEUTICALS
INC AT 1-866-488-4423 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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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 adults with chronic atrial
fibrillation. (1.3)
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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 comple