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Digoxin Uses, Dosage, Side Effects & Warnings | DrugsAtlas

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Therapeutic Class

Cardiac glycoside

Subclass

Digitalis alkaloid

Speciality

Cardiology

Schedule (India)

schedule H

Routes

Oral, Intravenous

Formulations

Tablets: 0.25 mg
Oral solution (paediatric): 0.05 mg/mL
Injection: 0.25 mg/mL (2 mL ampoule)

Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Congestive Heart Failure (HFrEF) — Symptomatic control, especially with concurrent atrial fibrillation

A. Oral Route

Parameter	Recommendation
Starting dose	0.125–0.25 mg once daily
Titration	Adjust based on clinical response, heart rate, and serum digoxin levels after 1 week
Usual maintenance dose	0.125–0.25 mg once daily
Maximum dose	0.25 mg/day (0.5 mg/day only in exceptional cases with close monitoring)

B. Intravenous Route (when oral not feasible or rapid control needed)

Parameter	Recommendation
Starting dose (Loading)	0.25–0.5 mg IV over 15–30 minutes
Titration	Additional 0.25 mg IV every 6 hours × 2 doses (total loading: 0.75–1 mg over 24 hours)
Usual maintenance dose	Convert to oral 0.125–0.25 mg once daily after stabilization
Maximum dose	1 mg total IV loading in 24 hours

Clinical Notes:

Does NOT reduce mortality; used for symptom relief and rate control
Target therapeutic trough level: 0.5–0.9 ng/mL for HFrEF
Use lower doses (0.125 mg daily or alternate days) for elderly, low body weight, or renal impairment

2. Atrial Fibrillation — Rate Control (particularly in patients with heart failure or sedentary individuals)

A. Oral Route

Parameter	Recommendation
Starting dose (Loading)	0.5 mg in divided doses over 24 hours (e.g., 0.25 mg × 2 doses, 6–8 hours apart)
Titration	Assess heart rate response after 24–48 hours
Usual maintenance dose	0.125–0.25 mg once daily
Maximum dose	0.25 mg/day for long-term use

B. Intravenous Route

Parameter	Recommendation
Starting dose (Loading)	0.25–0.5 mg IV over 15–30 minutes
Titration	Additional 0.25 mg IV every 6 hours × 2 doses if needed
Usual maintenance dose	Convert to oral therapy once rate controlled
Maximum dose	1 mg total IV loading in 24 hours

Clinical Notes:

Not first-line monotherapy in active/ambulatory patients or high sympathetic states (exercise, thyrotoxicosis)
Often combined with beta-blockers or diltiazem for optimal rate control
Target resting heart rate: <80–90 bpm

Secondary Indications — Adults (Off-label, if any)

Indication	Dose	Duration	Supervision	Label Status	Evidence Basis
Paroxysmal supraventricular tachycardia (PSVT) — when adenosine, beta-blockers, or CCBs ineffective/contraindicated	0.25–0.5 mg IV single dose; repeat 0.25 mg after 4–6 hours if needed	Single episode management	Specialist only	OFF-LABEL	Indian cardiology practice; limited RCT data

Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Congestive Heart Failure and Supraventricular Tachyarrhythmias

Digitalizing (Loading) Dose — Give in divided doses over 12–24 hours

Age Group	Oral Loading Dose	IV Loading Dose	Notes
Preterm neonates	20–30 mcg/kg total	15–25 mcg/kg total	Give 50% initially, then 25% × 2 at 8-hour intervals
Term neonates (0–1 month)	25–35 mcg/kg total	20–30 mcg/kg total	Same divided schedule
Infants (1–24 months)	35–60 mcg/kg total	30–50 mcg/kg total	Higher doses due to larger volume of distribution
Children (2–10 years)	30–40 mcg/kg total	25–35 mcg/kg total	Divide as above
Children (>10 years)	10–15 mcg/kg total OR 0.75–1.5 mg total	8–12 mcg/kg OR 0.5–1 mg total	Adult-like dosing

Maintenance Dose

Age Group	Oral Maintenance	IV Maintenance
Preterm neonates	5–8 mcg/kg/day in 2 divided doses	4–6 mcg/kg/day
Term neonates	8–10 mcg/kg/day in 2 divided doses	6–8 mcg/kg/day
Infants (1–24 months)	10–15 mcg/kg/day in 2 divided doses	8–12 mcg/kg/day
Children (2–10 years)	8–10 mcg/kg/day in 2 divided doses	6–8 mcg/kg/day
Children (>10 years)	2.5–5 mcg/kg/day OR 0.125–0.25 mg/day	Same as oral

Age Restrictions:

NOT recommended below 6 weeks of age except under paediatric cardiology supervision in tertiary care settings
Avoid IM administration due to severe local pain and erratic absorption

Safety Monitoring:

Baseline ECG (PR interval, rhythm) and serum electrolytes (K⁺, Mg²⁺, Ca²⁺)
Therapeutic drug level: 0.8–2.0 ng/mL (levels >2 ng/mL indicate toxicity risk)
IV administration: give slowly over ≥5 minutes with ECG monitoring
Monitor heart rate appropriate for age

Secondary Indications — Paediatric Doses (Off-label, if any)

Not applicable.

Renal Adjustments

Mandatory dose adjustment — digoxin is primarily renally excreted (70–80%)

eGFR (mL/min/1.73 m²)	Dose Adjustment
>50	Usual dose; monitor levels periodically
30–50	0.125 mg once daily OR 0.0625 mg twice daily
10–30	0.125 mg every alternate day OR 0.0625 mg once daily
<10 or Dialysis	0.125 mg every 48–72 hours; guide by serum levels

Haemodialysis: Digoxin is NOT efficiently removed (large volume of distribution); no supplemental dose required. Adjust based on pre-dialysis serum levels.

Peritoneal dialysis: Minimal removal; same dosing as eGFR <10.

Hepatic adjustment

Contraindications

Ventricular fibrillation
Ventricular tachycardia (unless heart failure-related and under specialist care)
Hypersensitivity to digoxin or other digitalis glycosides
Second-degree or third-degree AV block (without functioning pacemaker)
Sick sinus syndrome (without functioning pacemaker)
Hypertrophic obstructive cardiomyopathy (HOCM) with outflow tract obstruction
Wolff-Parkinson-White (WPW) syndrome with atrial fibrillation
Known digitalis toxicity
Severe hypokalaemia or hypercalcaemia (correct before initiating)

Cautions

Renal impairment — requires dose reduction and level monitoring
Electrolyte disturbances (hypokalaemia, hypomagnesaemia, hypercalcaemia) — predispose to toxicity
Elderly patients — reduced renal clearance and increased sensitivity
Acute myocardial infarction — may increase oxygen demand and arrhythmia risk
Thyroid disorders — hypothyroidism increases sensitivity; hyperthyroidism increases resistance
Cor pulmonale or severe pulmonary disease
Recent cardioversion — increased sensitivity post-procedure
Restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis
Concomitant use of drugs that increase digoxin levels or cause hypokalaemia

Pregnancy

Parameter	Details
Overall safety	Generally considered safe; used when clearly indicated
Placental transfer	Yes — crosses placenta; fetal serum levels approximately equal to maternal
Teratogenicity	No documented teratogenic risk in humans
When to use	Maternal heart failure, atrial fibrillation, or treatment of fetal supraventricular tachycardia
Preferred alternative	Digoxin is often the preferred agent for fetal arrhythmias
Monitoring	Maternal serum digoxin levels, serum potassium, renal function; fetal heart rate monitoring

Lactation

Parameter	Details
Compatibility	Compatible with breastfeeding
Milk levels	Low; milk-to-plasma ratio approximately 0.6–0.9
Infant exposure	Estimated infant dose <2% of maternal dose — clinically insignificant
Preferred alternative	Not required; digoxin is acceptable during lactation
Infant monitoring	Observe for unusual drowsiness, feeding difficulties, or poor weight gain (rare)

Elderly

Starting dose: 0.125 mg once daily or alternate days
Titration: Slow; reassess after 1–2 weeks
Special considerations:
- Age-related decline in renal function increases toxicity risk
- Increased myocardial sensitivity to digitalis effects
- Higher incidence of drug interactions (polypharmacy)
- Lean body mass should guide dosing
- Serum level monitoring strongly recommended
- Watch for neurological toxicity: confusion, visual disturbances, delirium

Major drug interactions

Interacting Drug	Effect	Management
Amiodarone	Increases digoxin levels by 50–100% (P-gp inhibition, reduced renal clearance)	Reduce digoxin dose by 50%; monitor serum levels
Quinidine	Increases digoxin levels by 50–100%	Reduce digoxin dose by 50%; monitor serum levels
Verapamil	Increases digoxin levels by 40–80%; additive AV nodal blockade	Reduce digoxin dose by 25–50%; ECG monitoring
Diltiazem	Increases digoxin levels by 20–40%; additive AV nodal effects	Monitor digoxin levels; ECG surveillance
Dronedarone	Increases digoxin levels significantly	Reduce digoxin dose by 50%; limit digoxin to ≤0.125 mg/day
Macrolides (erythromycin, clarithromycin)	Increase digoxin via P-glycoprotein inhibition and altered gut flora	Monitor digoxin levels; consider dose reduction
Potassium-wasting diuretics (furosemide, thiazides)	Hypokalaemia potentiates digoxin toxicity	Maintain serum K⁺ >4 mEq/L; consider K⁺ supplementation or K⁺-sparing diuretics
Spironolactone	Can increase digoxin levels; may interfere with digoxin assay	Monitor clinically; use digoxin-specific assay if available
Cyclosporine	Increases digoxin levels	Monitor digoxin levels closely
Itraconazole/Ketoconazole	P-gp inhibition increases digoxin levels	Monitor and reduce dose if needed

Moderate drug interactions

Interacting Drug	Effect	Management
Beta-blockers	Additive bradycardia and AV nodal block	Can be used together; monitor heart rate and ECG
Rifampicin	Induces P-gp; reduces digoxin levels by 30–50%	Monitor efficacy; may need dose increase
Phenytoin, Carbamazepine	May reduce digoxin absorption and increase metabolism	Monitor digoxin levels
St John's Wort	Reduces digoxin levels (P-gp induction)	Avoid concomitant use or monitor closely
Antacids (aluminium/magnesium)	May reduce digoxin absorption	Separate administration by at least 2 hours
Sucralfate	May reduce digoxin absorption	Administer digoxin 2 hours before sucralfate
Metoclopramide	Increases GI motility; may reduce digoxin absorption	Monitor clinical response
NSAIDs	May reduce renal clearance of digoxin	Monitor renal function and digoxin levels
Propafenone	Increases digoxin levels by 30–40%	Monitor levels; may need dose reduction

Common Adverse effects

Nausea, vomiting, anorexia
Diarrhoea, abdominal discomfort
Fatigue, weakness
Headache, dizziness
Bradycardia (sinus)
Visual disturbances (blurred vision, yellow-green halos, altered colour perception)

Serious Adverse effects

Adverse Effect	Clinical Notes
Digoxin toxicity syndrome	Nausea, vomiting, confusion, visual changes, cardiac arrhythmias — requires immediate discontinuation and hospitalisation
Ventricular arrhythmias	Premature ventricular contractions, bigeminy, ventricular tachycardia, ventricular fibrillation
High-grade AV block	Second- or third-degree heart block; may require temporary pacing
Atrial tachycardia with block	Pathognomonic of digoxin toxicity
Severe hyperkalaemia	In acute massive overdose; life-threatening
Neuropsychiatric effects	Confusion, disorientation, hallucinations, psychosis (especially in elderly)

Management of severe toxicity:

Discontinue digoxin immediately
Correct electrolyte abnormalities (especially potassium)
Continuous ECG monitoring
Digoxin-specific antibody fragments (Fab) — indicated for life-threatening arrhythmias or ingestion >10 mg in adults (availability in India is limited; contact tertiary centre)

Monitoring requirements

Baseline (before initiation):

Serum creatinine and eGFR
Serum electrolytes: potassium, magnesium, calcium
12-lead ECG
Body weight (use ideal body weight for dosing in obesity)
Thyroid function (if clinically indicated)

After initiation or dose change:

Serum digoxin level: Obtain at least 6–8 hours post-dose (trough preferred); measure after 5–7 days of stable dosing
Target: 0.5–0.9 ng/mL for heart failure; 0.8–2 ng/mL for AF rate control
Heart rate and rhythm assessment
Repeat electrolytes within 1 week if unstable or diuretics co-prescribed
Clinical assessment for toxicity symptoms

Long-term:

Serum digoxin levels every 3–6 months, or sooner if:
- Change in renal function
- New interacting drug added
- Clinical features suggestive of toxicity
- Dose adjustment made
Renal function every 3–6 months (more frequently in elderly)
Periodic electrolyte monitoring

Brands in India

Brand Name	Manufacturer
Lanoxin	GSK/Aspen
Cardioxin	Cadila
Toloxin	Torrent
Digoxin (generic)	Multiple manufacturers

Digoxin is included in AIIMS and JIPMER hospital formularies.

Price range (INR)

Formulation	Approximate Price
Tablet 0.25 mg	₹1–4 per tablet
Injection 0.25 mg/mL (2 mL)	₹10–20 per ampoule
Oral solution 0.05 mg/mL	₹25–40 per 10 mL

Regulatory status: Included in National List of Essential Medicines (NLEM) 2022; price under NPPA regulatory control.

Clinical pearls

Narrow therapeutic index — Small margin between therapeutic and toxic doses; always maintain high vigilance for toxicity signs.
Electrolyte correction is mandatory — Never initiate or continue digoxin without ensuring adequate serum potassium and magnesium levels.
Lower doses are usually sufficient — Target serum level of 0.5–0.9 ng/mL in heart failure provides benefit without increased mortality; avoid levels >1.2 ng/mL.
Avoid routine use in HFpEF — Digoxin has no proven benefit in heart failure with preserved ejection fraction.
Toxicity can occur even with "normal" levels — Clinical assessment remains paramount; serum levels do not always correlate with toxicity.
Watch for sudden renal decline — Any acute kidney injury can unmask digoxin toxicity; reassess dosing immediately.
Drug interaction vigilance — When adding amiodarone, quinidine, or verapamil, pre-emptively reduce digoxin dose by 50%.

Version

RxIndia v1.0 — 10 May 2025

Reference

- CDSCO drug database and approved product inserts
- National List of Essential Medicines (NLEM) 2022
- Indian Pharmacopoeia
- API Textbook of Medicine
- AIIMS Formulary
- Cardiological Society of India — Consensus documents on Atrial Fibrillation (2021)
- IAP Drug Formulary (paediatric dosing reference)
- WHO Model Formulary (supportive paediatric reference)
- Harrison's Principles of Internal Medicine (supportive reference)
- Goodman & Gilman's The Pharmacological Basis of Therapeutics (pharmacology reference)

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Clinical Responsibility

This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.

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