Digoxin

Preview FDA label, Oliva Therapeutics, LLC, oral, effective 2026-01-13. Full label on DailyMed

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using. Not yet reviewed by a ClinDose pharmacist.

Dosing in kidney impairment

Renal Impairment The clearance of digoxin can be primarily correlated with the renal function as indicated by creatinine clearance. Tables 3 and 5 provide the usual daily maintenance dose requirements for digoxin based on creatinine clearance [see Dosage and Administration ] . Digoxin is primarily excreted by the kidneys; therefore, patients with impaired renal function require smaller than usual maintenance doses of digoxin [see Dosage and Administration ] .

Because of the prolonged elimination half-life, a longer period of time is required to achieve an initial or new steady-state serum concentration in patients with renal impairment than in patients with normal renal function. If appropriate care is not taken to reduce the dose of digoxin, such patients are at high risk for toxicity, and toxic effects will last longer in such patients than in patients with normal renal function.

CorrectedCreatinine ClearancecLean Body WeightNumber of DaysBefore Steady State Achieved d
kg2030405060
10 mL/min-62.562.5*12512519
20 mL/min62.562.512512512516
30 mL/min62.562.5*125125187.514
40 mL/min62.562.5*125187.5187.513
50 mL/min62.5125125187.5187.512
60 mL/min62.5125125187.525011
70 mL/min62.5125187.5187.525010
80 mL/min62.5*125187.5187.52509
90 mL/min62.5*125187.52502508
100 mL/min62.5*125187.5250312.57

Dosing in liver impairment

Hepatic Impairment Plasma digoxin concentrations in patients with acute hepatitis generally fall within the range of profiles in a group of healthy subjects.

Preparation and administration

Important Dosing and Administration Information In selecting a digoxin dosing regimen, it is important to consider factors that affect digoxin blood levels (e.g., body weight, age, renal function, concomitant drugs) since toxic levels of digoxin are only slightly higher than therapeutic levels. Dosing can be either initiated with a loading dose followed by maintenance dosing if rapid titration is desired or initiated with maintenance dosing without a loading dose.

Consider interruption or reduction in digoxin dose prior to electrical cardioversion [see Warnings and Precautions ] . Use digoxin solution to obtain the appropriate dose in infants, young pediatric patients, or patients with very low body weight.