Lanoxin - Clinical Pharmacology

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The Cockcroft and Gault formula for estimation of creatinine clearance includes age, body weight, and gender. Table 5 that provides the usual daily maintenance dose requirements of LANOXIN Tablets based on creatinine clearance (per 70 kg) is presented in the DOSAGE AND ADMINISTRATION section. Plasma digoxin concentration profiles in patients with acute hepatitis generally fell within the range of profiles in a group of healthy subjects.

Pharmacodynamic and Clinical Effects

The times to onset of pharmacologic effect and to peak effect of preparations of LANOXIN are shown in Table 2.

LANOXIN (digoxin) Tablets, USP

Table 2: Times to Onset of Pharmacologic Effect and to Peak Effect of Preparations of LANOXIN

Product Time to Onset of Effect* Time to Peak Effect* LANOXIN Tablets 0.5 -2 hours 2 -6 hours

LANOXIN Elixir Pediatric 0.5 -2 hours 2 -6 hours LANOXICAPS 0.5 -2 hours 2 -6 hours

LANOXIN Injection/IV 5 -30 minutes † 1 -4 hours * Documented for ventricular response rate in atrial fibrillation, inotropic effects and electrocardiographic changes. † Depending upon rate of infusion.

Hemodynamic Effects

Digoxin produces hemodynamic improvement in patients with heart failure. Short-and long-term therapy with the drug increases cardiac output and lowers pulmonary artery pressure, pulmonary capillary wedge pressure, and systemic vascular resistance. These hemodynamic effects are accompanied by an increase in the left ventricular ejection fraction and a decrease in end-systolic and end-diastolic dimensions.

Chronic Heart Failure:

Two 12-week, double-blind, placebo-controlled studies enrolled (RADIANCE trial) and 88 (PROVED trial) patients with NYHA class II or III heart failure previously treated with digoxin, a diuretic, and an ACE inhibitor (RADIANCE only) and randomized them to placebo or treatment with LANOXIN. Both trials demonstrated better preservation of exercise capacity in patients randomized to LANOXIN. Continued treatment with LANOXIN reduced the risk of developing worsening heart failure, as evidenced by heart failure-related hospitalizations and emergency care and the need for concomitant heart failure therapy.