LANOXIN PEDIATRIC
Clinical safety rating: caution
Comprehensive clinical and safety monograph for LANOXIN PEDIATRIC (LANOXIN PEDIATRIC).
Inhibition of Na+/K+ ATPase leading to increased intracellular calcium and positive inotropy.
| Metabolism | Hepatic via glucuronidation; substrate of P-glycoprotein; renal excretion of unchanged drug. |
| Excretion | Renal excretion of unchanged drug accounts for 60-80% of elimination; nonrenal clearance is 20-40% (biliary/fecal). |
| Half-life | Terminal elimination half-life is 36-48 hours in adults with normal renal function; prolonged to 3.5-5 days in anephric patients due to reduced renal clearance. |
| Protein binding | 20-30% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Vd is 5-10 L/kg in adults, indicating extensive tissue binding; higher in infants (up to 16 L/kg) with reduced protein binding. |
| Bioavailability | Oral: 60-80% (Lanoxin Pediatric elixir 70-85%); variable due to first-pass metabolism and P-glycoprotein effects. |
| Onset of Action | IV: 5-30 minutes; Oral: 0.5-2 hours. |
| Duration of Action | Duration of clinical effect is 3-6 days, correlating with tissue (myocardial) binding; cardiac effects persist after serum levels decline. |
Adult: Oral loading dose 0.75-1.5 mg in divided doses over 24-48 hours. Maintenance: 0.125-0.5 mg once daily. Intravenous: Loading dose 0.5-1 mg over 10-20 minutes, then maintenance 0.125-0.5 mg once daily.
| Dosage form | INJECTABLE |
| Renal impairment | GFR >50 mL/min: no adjustment; GFR 10-50 mL/min: reduce dose by 25-50%; GFR <10 mL/min: reduce dose by 50-75% or consider alternative. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 25-50%; Child-Pugh C: avoid use or reduce dose by 50-75% with monitoring. |
| Pediatric use | Oral loading: 10-20 mcg/kg in divided doses over 24 hours; maintenance: 5-10 mcg/kg once daily. IV loading: 10-15 mcg/kg; maintenance: 4-8 mcg/kg once daily. Monitor levels. |
| Geriatric use | Reduced dose: initial maintenance 0.0625-0.125 mg once daily due to age-related renal impairment and increased sensitivity. Monitor renal function and serum digoxin levels. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for LANOXIN PEDIATRIC (LANOXIN PEDIATRIC).
| Breastfeeding | Digoxin is excreted into breast milk with an M/P ratio of approximately 0.6–0.9. Levels are low (typically <1 ng/mL) and considered compatible with breastfeeding; however, monitor infant for signs of toxicity including bradycardia and feeding difficulties. |
| Teratogenic Risk | First trimester: No evidence of increased risk of major malformations. Second/third trimester: Potential for fetal bradycardia, cardiac arrhythmias, and intrauterine growth restriction due to transplacental transfer and maternal hemodynamic changes. |
■ FDA Black Box Warning
Digitalis toxicity can cause severe arrhythmias; monitoring of serum digoxin levels required.
| Common Effects | Visual impairment Skin rash Nausea Vomiting Diarrhea Dizziness Arrhythmia irregular heartbeats |
| Serious Effects |
Hypersensitivity to digoxin, ventricular fibrillation, digitalis toxicity.
| Precautions | Risk of toxicity in renal impairment, electrolyte disturbances, and drug interactions; monitor digoxin levels and ECG. |
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| Fetal Monitoring |
| Monitor maternal serum digoxin levels, renal function, electrolytes (especially potassium, magnesium, calcium), and ECG for signs of toxicity. Assess fetal heart rate and rhythm via ultrasound or non-stress test, as well as fetal growth and amniotic fluid volume. |
| Fertility Effects | No known adverse effects on fertility from digoxin. Underlying cardiac disease may impact pregnancy outcomes. |