Digoxin 0.25mg/ml Inj, 2ml

Manufacturer SANDOZ Active Ingredient Digoxin Injection(di JOKS in) Pronunciation di-JOKS-in
It is used to treat heart failure (weak heart).It is used to treat a certain type of abnormal heartbeat (atrial fibrillation).It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Cardiac Glycoside; Antiarrhythmic (Class IV); Inotropic Agent
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Pharmacologic Class
Na+/K+-ATPase Inhibitor
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Pregnancy Category
Category C
FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Digoxin is a medicine that helps your heart beat stronger and more regularly. It's used to treat certain heart conditions like heart failure and irregular heartbeats (atrial fibrillation).
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and adhere to all guidelines provided. This drug is administered via injection into a muscle or vein.

For storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to keep this medication at home.

If you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
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Lifestyle & Tips

  • Take your medication exactly as prescribed, do not skip doses or take extra.
  • Report any new or worsening symptoms to your doctor immediately.
  • Maintain a consistent diet and avoid sudden changes in potassium intake (e.g., excessive licorice, potassium-rich foods if advised by doctor).
  • Avoid over-the-counter medications, herbal supplements, or new prescriptions without consulting your doctor or pharmacist, as many can interact with digoxin.
  • Attend all scheduled blood tests and doctor appointments to monitor your heart and medication levels.

Dosing & Administration

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Adult Dosing

Standard Dose: Loading Dose (Rapid Digitalization): 0.5-1 mg IV given in divided doses (e.g., 0.25-0.5 mg initially, then 0.125-0.25 mg every 6-8 hours until desired effect or total loading dose reached). Maintenance Dose: 0.125-0.25 mg IV daily (adjust based on renal function, body weight, and serum levels).
Dose Range: 0.125 - 1.5 mg

Condition-Specific Dosing:

Heart Failure: Lower target serum concentrations (0.5-0.9 ng/mL) often preferred.
Atrial Fibrillation: Higher target serum concentrations (1-2 ng/mL) may be needed for rate control.
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Pediatric Dosing

Neonatal: Total Digitalizing Dose (TDD) IV: Premature: 15-25 mcg/kg; Full-term: 20-30 mcg/kg. Maintenance: 25-35% of TDD daily, divided every 12-24 hours.
Infant: TDD IV (1 month - 2 years): 30-50 mcg/kg. Maintenance: 25-35% of TDD daily, divided every 12-24 hours.
Child: TDD IV (2-10 years): 20-35 mcg/kg. Maintenance: 25-35% of TDD daily, divided every 12-24 hours.
Adolescent: TDD IV (>10 years): 8-12 mcg/kg (max 1-1.5 mg). Maintenance: 0.125-0.25 mg IV daily. Dosing should be individualized based on age, weight, renal function, and clinical response, with careful monitoring of serum levels.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-79 mL/min: Reduce maintenance dose by 25% or extend interval to 36 hours.
Moderate: CrCl 10-49 mL/min: Reduce maintenance dose by 50-75% or extend interval to 48 hours.
Severe: CrCl <10 mL/min: Reduce maintenance dose by 75% or extend interval to 72 hours or longer.
Dialysis: Not significantly removed by hemodialysis. Dose adjustment required based on residual renal function. Administer after dialysis if given on dialysis days.

Hepatic Impairment:

Mild: No significant adjustment needed.
Moderate: No significant adjustment needed.
Severe: No significant adjustment needed.

Pharmacology

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Mechanism of Action

Digoxin inhibits the Na+/K+-ATPase pump in myocardial cells, leading to an increase in intracellular sodium. This, in turn, reduces the activity of the Na+/Ca2+ exchanger, resulting in increased intracellular calcium concentration. The elevated intracellular calcium enhances the force of myocardial contraction (positive inotropic effect). It also increases vagal tone, leading to decreased heart rate and slowed conduction through the AV node (negative chronotropic and dromotropic effects), which is beneficial in atrial fibrillation.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV)
Tmax: 5-30 minutes (IV)
FoodEffect: Not applicable for IV administration.

Distribution:

Vd: 5-10 L/kg (large, distributes extensively into muscle and other tissues)
ProteinBinding: 20-30%
CnssPenetration: Limited

Elimination:

HalfLife: 36-48 hours (normal renal function); significantly prolonged in renal impairment
Clearance: Approximately 50-70 mL/min/1.73m² (primarily renal)
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: 50-70%
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Pharmacodynamics

OnsetOfAction: 5-30 minutes (IV)
PeakEffect: 1-4 hours (IV)
DurationOfAction: Several days (due to long half-life and tissue binding)
Confidence: High

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Upset stomach or vomiting
Persistent diarrhea
Changes in vision
Seeing halos or bright colors around lights
Unexplained weight loss
Decreased appetite
Feeling tired or weak
Abnormal heartbeat, including fast or slow heart rate
New or worsening irregular heartbeat
Hallucinations (seeing or hearing things that are not there)
Changes in behavior or mood
Confusion
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material
Enlarged breasts

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:

For all uses of this medication:
+ Dizziness or headache
+ Stomach pain
* If you receive this medication as an injection in the muscle:
+ Pain at the injection site

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Nausea, vomiting, loss of appetite, or diarrhea
  • Unusual tiredness, weakness, or confusion
  • Blurred vision, seeing yellow or green halos around lights, or other visual disturbances
  • Very slow heart rate (bradycardia) or an irregular heartbeat
  • Dizziness or fainting
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have a history of heart problems or have recently had a heart attack.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other medications and health issues.

Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

To ensure safe use, follow your doctor's instructions for monitoring your blood pressure and heart rate. Additionally, have your blood work and other laboratory tests done as directed by your doctor. This includes regular blood tests to measure the level of digoxin in your body. It is crucial to have your blood drawn before taking your daily dose of digoxin (take the medication after the lab test). If you have any questions or concerns, discuss them with your doctor.

This medication may interfere with certain laboratory tests, so it is vital to notify all your healthcare providers and laboratory personnel that you are taking this drug.

If you are scheduled to undergo a cardioversion procedure to restore a normal heart rhythm, inform your doctor that you are taking this medication. Your doctor needs to be aware of your medication regimen to ensure your safety.

Keep this medication out of the reach of children, as accidental ingestion can be fatal. If a child accidentally takes this medication, seek immediate medical attention.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

When administering this medication to children, use it with caution, as the risk of certain side effects may be higher in this age group.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe nausea, vomiting, and abdominal pain
  • Profound bradycardia or other life-threatening arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, severe AV block)
  • Hyperkalemia (high potassium levels)
  • Profound weakness, lethargy, confusion, or seizures

What to Do:

If you suspect an overdose, seek immediate medical attention. Call emergency services (e.g., 911 in the US) or a poison control center (1-800-222-1222). Treatment may include activated charcoal (if oral ingestion), correction of electrolyte imbalances, and administration of Digoxin Immune Fab (DigiFab) for severe toxicity.

Drug Interactions

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Major Interactions

  • Amiodarone (significantly increases digoxin levels, reduce digoxin dose by 30-50%)
  • Verapamil (increases digoxin levels, reduce digoxin dose by 25-50%)
  • Diltiazem (increases digoxin levels, reduce digoxin dose by 25-50%)
  • Quinidine (increases digoxin levels, reduce digoxin dose by 30-50%)
  • Propafenone (increases digoxin levels)
  • Macrolide antibiotics (e.g., clarithromycin, erythromycin - increase digoxin levels by altering gut flora)
  • Itraconazole (increases digoxin levels)
  • Cyclosporine (increases digoxin levels)
  • Diuretics (thiazide and loop diuretics - can cause hypokalemia, increasing risk of digoxin toxicity)
  • Amphotericin B (can cause hypokalemia, increasing risk of digoxin toxicity)
  • Sympathomimetics (e.g., dopamine, dobutamine - increased risk of arrhythmias)
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Moderate Interactions

  • Beta-blockers (additive bradycardia and AV block)
  • Calcium supplements (hypercalcemia can precipitate digoxin toxicity)
  • NSAIDs (may impair renal function, affecting digoxin clearance)
  • Rifampin (decreases digoxin levels)
  • Phenytoin (decreases digoxin levels)
  • St. John's Wort (decreases digoxin levels)
  • Antacids, Cholestyramine, Sucralfate (if oral, can decrease absorption, but less relevant for IV)
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Minor Interactions

  • Metoclopramide (may decrease digoxin absorption if oral, not relevant for IV)

Monitoring

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Baseline Monitoring

Electrocardiogram (ECG)

Rationale: To assess baseline cardiac rhythm, conduction, and identify any pre-existing abnormalities that may influence digoxin therapy or toxicity risk.

Timing: Prior to initiation of therapy.

Serum Electrolytes (Potassium, Magnesium, Calcium)

Rationale: Electrolyte imbalances, particularly hypokalemia, hypomagnesemia, and hypercalcemia, can predispose to digoxin toxicity.

Timing: Prior to initiation of therapy.

Renal Function (BUN, Serum Creatinine, eGFR/CrCl)

Rationale: Digoxin is primarily renally eliminated; impaired renal function necessitates dose adjustment and increases toxicity risk.

Timing: Prior to initiation of therapy.

Left Ventricular Ejection Fraction (LVEF)

Rationale: For patients with heart failure, to assess cardiac function and guide therapy.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Digoxin Serum Concentration

Frequency: At steady state (typically 5-7 days after initiation or dose change), then periodically (e.g., every 6-12 months) or if toxicity is suspected.

Target: 0.5-0.9 ng/mL for heart failure; 1-2 ng/mL for rate control in atrial fibrillation (individualized). Levels should be drawn at least 6-8 hours (preferably 12-24 hours) after the last dose.

Action Threshold: >2 ng/mL generally considered toxic, but toxicity can occur at lower levels, especially with electrolyte imbalances. Levels <0.5 ng/mL may indicate subtherapeutic dosing.

Serum Electrolytes (Potassium, Magnesium, Calcium)

Frequency: Periodically (e.g., every 3-6 months) or more frequently if on diuretics or other interacting drugs, or if toxicity is suspected.

Target: Potassium: 3.5-5.0 mEq/L; Magnesium: 1.7-2.2 mg/dL; Calcium: 8.5-10.2 mg/dL.

Action Threshold: Any significant deviation, especially hypokalemia, requires immediate correction.

Renal Function (BUN, Serum Creatinine)

Frequency: Periodically (e.g., every 3-6 months) or more frequently if renal function is unstable or if on nephrotoxic drugs.

Target: Within normal limits for patient's age/baseline.

Action Threshold: Significant increase in creatinine or decrease in eGFR warrants digoxin dose adjustment.

Electrocardiogram (ECG)

Frequency: Periodically or if signs/symptoms of toxicity or new arrhythmias develop.

Target: Normal sinus rhythm or controlled atrial fibrillation/flutter.

Action Threshold: New arrhythmias (e.g., bradycardia, AV block, ventricular ectopy, non-paroxysmal junctional tachycardia) or changes suggestive of digoxin effect (e.g., PR prolongation, ST depression, T wave flattening) may indicate toxicity.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Anorexia
  • Diarrhea
  • Fatigue
  • Weakness
  • Headache
  • Dizziness
  • Confusion
  • Visual disturbances (e.g., blurred vision, yellow/green halos, scotomas)
  • Bradycardia (slow heart rate)
  • Palpitations or irregular heartbeat

Special Patient Groups

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Pregnancy

Digoxin is classified as Pregnancy Category C. It crosses the placenta. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Fetal monitoring for signs of toxicity (e.g., bradycardia) may be considered.

Trimester-Specific Risks:

First Trimester: Limited data, but generally not associated with major congenital malformations.
Second Trimester: Generally considered safe for use if clinically indicated.
Third Trimester: Generally considered safe for use if clinically indicated. Fetal monitoring may be appropriate.
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Lactation

Digoxin is excreted in breast milk in small amounts. The amount ingested by the infant is typically well below therapeutic levels. Generally considered compatible with breastfeeding (Lactation Risk L2).

Infant Risk: Low risk. Monitor breastfed infant for signs of digoxin toxicity (e.g., bradycardia, vomiting, poor feeding) but these are rare.
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Pediatric Use

Pediatric patients, especially neonates and infants, have a narrower therapeutic index and require highly individualized, weight-based dosing with careful monitoring of serum concentrations, renal function, and electrolytes. They may be more susceptible to toxicity.

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Geriatric Use

Elderly patients are at increased risk of digoxin toxicity due to age-related decline in renal function, decreased muscle mass (affecting Vd), and polypharmacy. Start with lower doses and titrate slowly. Close monitoring of renal function, electrolytes, and serum digoxin levels is crucial.

Clinical Information

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Clinical Pearls

  • Digoxin has a narrow therapeutic index; careful dosing and monitoring are essential.
  • Toxicity is often precipitated by hypokalemia, hypomagnesemia, or hypercalcemia. Always correct electrolyte imbalances before or during digoxin therapy.
  • Digoxin serum levels should be drawn at least 6-8 hours (preferably 12-24 hours) after the last dose to allow for complete distribution into tissues and avoid falsely elevated levels.
  • Clinical signs and symptoms of toxicity often precede elevated serum levels. Always treat the patient, not just the level.
  • Digoxin is not a first-line agent for rate control in acute atrial fibrillation in hemodynamically stable patients due to its slow onset of action compared to beta-blockers or calcium channel blockers.
  • In heart failure with reduced ejection fraction (HFrEF), digoxin is used to reduce hospitalizations and improve symptoms, but it does not improve survival.
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Alternative Therapies

  • For Heart Failure (HFrEF): ACE inhibitors/ARBs/ARNIs, Beta-blockers, Mineralocorticoid Receptor Antagonists (MRAs), SGLT2 inhibitors, Ivabradine.
  • For Atrial Fibrillation (Rate Control): Beta-blockers (e.g., metoprolol, carvedilol), Calcium Channel Blockers (non-dihydropyridine, e.g., verapamil, diltiazem).
  • For Atrial Fibrillation (Rhythm Control): Antiarrhythmic drugs (e.g., amiodarone, flecainide, sotalol, dofetilide), Catheter ablation.
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Cost & Coverage

Average Cost: Price varies widely by supplier and contract per 2ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may have additional patient information leaflets; check with your pharmacist for more details. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion.