LANOXICAPS

Clinical safety rating: caution

Comprehensive clinical and safety monograph for LANOXICAPS (LANOXICAPS).

How it works

Inhibition of Na+/K+-ATPase pump, leading to increased intracellular sodium and calcium, positive inotropy, and increased vagal tone.

What the body does with it

Metabolism	Primarily renal excretion as unchanged drug; minor hepatic metabolism via CYP3A4 and glucuronidation.
Excretion	Digitoxin is primarily excreted via the kidneys (approx. 70-80%) as unchanged drug and metabolites; the remainder undergoes biliary/fecal elimination (approx. 20-30%).
Half-life	Terminal elimination half-life is approximately 5-7 days (120-168 hours) in patients with normal renal function; prolonged in renal impairment, necessitating dose adjustment.
Protein binding	Digitoxin is approximately 90-97% bound to serum proteins, primarily albumin.
Volume of Distribution	Volume of distribution is approximately 0.6 L/kg, indicating extensive tissue binding and distribution; the large Vd reflects accumulation in tissues like myocardium and skeletal muscle.
Bioavailability	Oral bioavailability is virtually 100% (90-100%) for Lanoxicaps (digitoxin), with consistent absorption from the gastrointestinal tract.
Onset of Action	Oral: Onset of action occurs within 0.5-2 hours; peak effect is achieved in 2-6 hours. Intravenous: Onset within 15-30 minutes; peak effect in 1-4 hours.
Duration of Action	Duration of action is 3-7 days after oral administration due to slow elimination; clinical effects may persist for several days after discontinuation.

Classification & Brands

Dosing & administration

0.125-0.25 mg orally daily, initially 0.25 mg daily in divided doses 3-4 times daily, maintenance 0.125-0.25 mg daily.

Dosage form	CAPSULE
Renal impairment	For eGFR <50 mL/min, reduce dose by 50% or extend dosing interval: eGFR 35-50 mL/min: 0.125 mg every 24-48 hours; eGFR 10-34 mL/min: 0.125 mg every 48-72 hours; eGFR <10 mL/min: 0.125 mg every 72-96 hours.
Liver impairment	Severe hepatic impairment (Child-Pugh class C) requires dose reduction by 50-75%; monitor digoxin levels. Avoid in fulminant hepatitis.
Pediatric use	Neonates: 4-6 mcg/kg/day; Infants: 6-10 mcg/kg/day; Children 1-5 years: 10-15 mcg/kg/day; Children 6-12 years: 8-10 mcg/kg/day; Adolescents: 3-5 mcg/kg/day. All doses given orally.
Geriatric use	Start at lower dose (0.0625-0.125 mg daily) due to reduced renal function and lean body mass; monitor serum creatinine and digoxin levels.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for LANOXICAPS (LANOXICAPS).

Breastfeeding	Digoxin is excreted into breast milk at low levels (M/P ratio ~0.6–0.9); infant exposure is subtherapeutic. Considered compatible with breastfeeding, but monitor infant for signs of digoxin toxicity (e.g., arrhythmias, nausea).
Teratogenic Risk	FDA Pregnancy Category C. First trimester: digitalis glycosides cross placenta; animal studies show fetotoxicity, but no adequate human data. Second/third trimester: risk of fetal bradycardia, low birth weight; therapeutic levels near toxic for fetus. Use only if maternal benefit outweighs risk.

Warnings & precautions

■ FDA Black Box Warning

Toxicity: Narrow therapeutic index; monitor serum levels; avoid in patients with ventricular fibrillation or outflow obstruction.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Ventricular fibrillation","Hypersensitivity to digitalis glycosides","Wolff-Parkinson-White syndrome with atrial fibrillation","Second- or third-degree AV block (without pacemaker)","Hypertrophic obstructive cardiomyopathy"]

Clinical Precautions

Precautions

Monitor for digitalis toxicity (anorexia, nausea, visual disturbances, arrhythmias). Adjust dose in renal impairment, hypokalemia, hypomagnesemia, hypercalcemia, and hypothyroidism.

Clinical Tips & Counseling

Drug interactions

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LANOXICAPS

Clinical safety rating: caution

Comprehensive clinical and safety monograph for LANOXICAPS (LANOXICAPS).

How it works

Inhibition of Na+/K+-ATPase pump, leading to increased intracellular sodium and calcium, positive inotropy, and increased vagal tone.

What the body does with it

Metabolism	Primarily renal excretion as unchanged drug; minor hepatic metabolism via CYP3A4 and glucuronidation.
Excretion	Digitoxin is primarily excreted via the kidneys (approx. 70-80%) as unchanged drug and metabolites; the remainder undergoes biliary/fecal elimination (approx. 20-30%).
Half-life	Terminal elimination half-life is approximately 5-7 days (120-168 hours) in patients with normal renal function; prolonged in renal impairment, necessitating dose adjustment.
Protein binding	Digitoxin is approximately 90-97% bound to serum proteins, primarily albumin.
Volume of Distribution	Volume of distribution is approximately 0.6 L/kg, indicating extensive tissue binding and distribution; the large Vd reflects accumulation in tissues like myocardium and skeletal muscle.
Bioavailability	Oral bioavailability is virtually 100% (90-100%) for Lanoxicaps (digitoxin), with consistent absorption from the gastrointestinal tract.
Onset of Action	Oral: Onset of action occurs within 0.5-2 hours; peak effect is achieved in 2-6 hours. Intravenous: Onset within 15-30 minutes; peak effect in 1-4 hours.
Duration of Action	Duration of action is 3-7 days after oral administration due to slow elimination; clinical effects may persist for several days after discontinuation.

Classification & Brands

Dosing & administration

0.125-0.25 mg orally daily, initially 0.25 mg daily in divided doses 3-4 times daily, maintenance 0.125-0.25 mg daily.

Dosage form	CAPSULE
Renal impairment	For eGFR <50 mL/min, reduce dose by 50% or extend dosing interval: eGFR 35-50 mL/min: 0.125 mg every 24-48 hours; eGFR 10-34 mL/min: 0.125 mg every 48-72 hours; eGFR <10 mL/min: 0.125 mg every 72-96 hours.
Liver impairment	Severe hepatic impairment (Child-Pugh class C) requires dose reduction by 50-75%; monitor digoxin levels. Avoid in fulminant hepatitis.
Pediatric use	Neonates: 4-6 mcg/kg/day; Infants: 6-10 mcg/kg/day; Children 1-5 years: 10-15 mcg/kg/day; Children 6-12 years: 8-10 mcg/kg/day; Adolescents: 3-5 mcg/kg/day. All doses given orally.
Geriatric use	Start at lower dose (0.0625-0.125 mg daily) due to reduced renal function and lean body mass; monitor serum creatinine and digoxin levels.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for LANOXICAPS (LANOXICAPS).

Breastfeeding	Digoxin is excreted into breast milk at low levels (M/P ratio ~0.6–0.9); infant exposure is subtherapeutic. Considered compatible with breastfeeding, but monitor infant for signs of digoxin toxicity (e.g., arrhythmias, nausea).
Teratogenic Risk	FDA Pregnancy Category C. First trimester: digitalis glycosides cross placenta; animal studies show fetotoxicity, but no adequate human data. Second/third trimester: risk of fetal bradycardia, low birth weight; therapeutic levels near toxic for fetus. Use only if maternal benefit outweighs risk.

Warnings & precautions

■ FDA Black Box Warning

Toxicity: Narrow therapeutic index; monitor serum levels; avoid in patients with ventricular fibrillation or outflow obstruction.

Side Effect Profile

Serious Effects

Absolute Contraindications

Clinical Precautions

Precautions

Monitor for digitalis toxicity (anorexia, nausea, visual disturbances, arrhythmias). Adjust dose in renal impairment, hypokalemia, hypomagnesemia, hypercalcemia, and hypothyroidism.

Clinical Tips & Counseling

Drug interactions

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