DIGOXIN solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Digoxin (UNII: 73K4184T59) (Digoxin - UNII:73K4184T59)

Available from:

Precision Dose, Inc.

INN (International Name):

Digoxin

Composition:

Digoxin 0.05 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

DIGOXIN- DIGOXIN SOLUTION
PRECISION DOSE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIGOXIN ORAL SOLUTION, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DIGOXIN ORAL
SOLUTION, USP.
DIGOXIN ORAL SOLUTION, USP
INITIAL U.S. APPROVAL : 1982
INDICATIONS AND USAGE
In adults, digoxin is indicated for the treatment of mild to moderate
heart failure and for the control of resting ventricular
rate in patients with chronic atrial fibrillation. (1) In pediatric
patients with heart failure, digoxin increases myocardial
contractility.
DOSAGE AND ADMINISTRATION
Toxic levels of digoxin are only slightly higher than therapeutic
levels. The pharmacokinetics of digoxin are complex and
dose determination should take into account patient-specific factors
(age, lean body weight, renal function, etc.). (2.4)(2.5)
Patients should be monitored for toxicity and therapeutic effect and
doses should be adjusted, accordingly. (2.2)
DOSAGE FORMS AND STRENGTHS
Oral Solution: Each 1 mL contains 0.05 mg (50 mcg) of digoxin. (3)
CONTRAINDICATIONS
Known hypersensitivity to digoxin or other forms of digitalis. (4)
Ventricular fibrillation. (4)
WARNINGS AND PRECAUTIONS
Accessory AV Pathway: Increased risk of rapid ventricular response
leading to ventricular fibrillation. (5.1)
Sinus node disease and AV block: Digoxin use can exacerbate the
condition and may cause advanced or complete heart
block. (5.2)
Misidentification of digoxin toxicity: Signs and symptoms of digoxin
toxicity may be mistaken for worsening symptoms
of congestive heart failure. (5.3)
Preserved left ventricular systolic function: Patients with heart
failure with preserved left ventricular ejection fraction
may be more susceptible to digoxin toxicity. (5.4)
Impaired renal function: Renal impairment results in increased digoxin
exposure and requires dosage adjustments.
(5.5)
Electrolyte disorders: Toxicity is increased by hypokalemia,
hypomagnesemia, and hypercalcemia. (5.6)
Hypermetabolic