Lanoxin 0.25mg/ml, 2ml

Manufacturer COVIS PHARMA 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
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Pharmacologic Class
Na+/K+-ATPase inhibitor
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Pregnancy Category
Category C
FDA Approved
Jan 1954
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Digoxin is a medication used to strengthen the heart's pumping ability and to help control an irregular or fast heartbeat. It works by affecting the electrical activity and muscle contractions of your heart.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all the information provided. Adhere to the dosage instructions and administration guidelines. This medication is administered via injection into a muscle or vein.

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

If you miss a dose, contact your doctor promptly to receive guidance on the next steps to take.
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Lifestyle & Tips

  • Take exactly as prescribed; do not skip doses or take extra doses.
  • Report any new medications, supplements, or herbal products to your doctor, as many can interact with digoxin.
  • Maintain a balanced diet and adequate fluid intake to prevent electrolyte imbalances, especially potassium. Avoid excessive licorice consumption.
  • Regularly monitor your pulse as instructed by your doctor. Do not take if your pulse is below a certain rate (e.g., 60 beats per minute) without consulting your doctor.
  • Attend all scheduled doctor appointments and laboratory tests (blood tests) to monitor drug levels and kidney function.

Dosing & Administration

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Adult Dosing

Standard Dose: Loading dose: 0.5-1 mg IV in divided doses over 24 hours. Maintenance dose: 0.125-0.25 mg IV daily.
Dose Range: 0.125 - 1 mg

Condition-Specific Dosing:

rapidDigitalization: 0.4-0.6 mg IV initially, then 0.1-0.3 mg IV every 6-8 hours until desired effect or total dose of 0.8-1.2 mg. Maintenance dose then initiated.
slowDigitalization: 0.125-0.25 mg IV daily for 7 days to reach steady state.
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Pediatric Dosing

Neonatal: Highly individualized based on age, weight, and renal function. Consult specialized pediatric cardiology guidelines. Typical total digitalizing dose (TDD) 20-30 mcg/kg IV.
Infant: Highly individualized based on age, weight, and renal function. Consult specialized pediatric cardiology guidelines. Typical TDD 30-50 mcg/kg IV.
Child: Highly individualized based on age, weight, and renal function. Consult specialized pediatric cardiology guidelines. Typical TDD 30-50 mcg/kg IV.
Adolescent: Dosing approaches adult dosing, but still individualized based on weight and renal function. Typical TDD 8-12 mcg/kg IV.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-79 mL/min: Reduce maintenance dose by 25-50% or extend dosing interval.
Moderate: CrCl 30-49 mL/min: Reduce maintenance dose by 50-75% or extend dosing interval.
Severe: CrCl <30 mL/min: Reduce maintenance dose by 75-80% or extend dosing interval significantly (e.g., every 3-5 days).
Dialysis: Digoxin is not significantly removed by hemodialysis. Dose adjustments based on residual renal function. Administer after dialysis.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Digoxin inhibits the Na+/K+-ATPase pump in myocardial cells. This leads to an increase in intracellular sodium, which in turn promotes calcium influx via the Na+/Ca2+ exchanger. The increased intracellular calcium enhances myocardial contractility (positive inotropic effect). It also directly stimulates the vagus nerve, leading to decreased heart rate and slowed conduction through the AV node (negative chronotropic and dromotropic effects).
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV)
Tmax: Immediate (IV)
FoodEffect: Not applicable for IV administration.

Distribution:

Vd: 6.2-7.4 L/kg (large, due to extensive tissue binding)
ProteinBinding: 20-30%
CnssPenetration: Limited

Elimination:

HalfLife: 36-48 hours (normal renal function); significantly prolonged in renal impairment (up to 4-5 days)
Clearance: Approximately 50-70 mL/min/1.73m² (primarily renal)
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: 50-70% (renal excretion)
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Pharmacodynamics

OnsetOfAction: 5-30 minutes (IV)
PeakEffect: 1.5-6 hours (IV)
DurationOfAction: Several days (due to long half-life and tissue binding)

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 immediately or seek emergency 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
Persistent upset stomach or vomiting
Diarrhea that does not subside
Changes in vision
Seeing halos or bright colors around lights
Unexplained weight loss
Decreased appetite
Feeling extremely tired or weak
Abnormal heart rhythms, including fast or slow heartbeat
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 is 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 (early signs of toxicity)
  • Unusual tiredness, weakness, or confusion
  • Blurred vision, seeing halos around lights (especially yellow-green), or other visual disturbances
  • Slow or irregular heartbeat, palpitations, or fainting spells
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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, as this may affect your treatment.

This medication may interact with other medications or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your overall health status, including any existing medical conditions

Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. It is your responsibility to verify that it is safe to take this medication in combination with your other medications and health conditions.
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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 checks to measure the level of digoxin in your body. It is recommended 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 crucial 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.

To prevent accidental ingestion, keep this medication out of the reach of children, as it 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, planning to become pregnant, or 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 diarrhea
  • Profound bradycardia (very slow heart rate)
  • Various cardiac arrhythmias (e.g., heart block, ventricular tachycardia, ventricular fibrillation)
  • Severe confusion, delirium, or seizures
  • Hyperkalemia (especially in acute overdose)

What to Do:

Seek immediate medical attention or call 911. For suspected overdose, call Poison Control at 1-800-222-1222. Treatment may involve activated charcoal, correction of electrolyte imbalances, antiarrhythmics, and in severe cases, Digoxin Immune Fab (DigiFab) antibodies.

Drug Interactions

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Major Interactions

  • Amiodarone (increases digoxin levels significantly, requires dose reduction)
  • Verapamil (increases digoxin levels, requires dose reduction)
  • Diltiazem (increases digoxin levels, requires dose reduction)
  • Quinidine (increases digoxin levels, requires dose reduction)
  • Propafenone (increases digoxin levels)
  • Macrolide antibiotics (e.g., clarithromycin, erythromycin - can increase digoxin levels by altering gut flora)
  • Cyclosporine (increases digoxin levels)
  • Spironolactone (can interfere with digoxin assays and increase levels)
  • Diuretics (especially loop and thiazide diuretics - can cause hypokalemia, increasing risk of digoxin toxicity)
  • Amphotericin B (can cause hypokalemia, increasing risk of digoxin toxicity)
  • Beta-blockers (additive bradycardia/AV block risk)
  • Calcium channel blockers (non-dihydropyridine, e.g., verapamil, diltiazem - additive bradycardia/AV block risk)
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Moderate Interactions

  • Antacids (may decrease digoxin absorption if taken concurrently)
  • Cholestyramine (may decrease digoxin absorption)
  • Metoclopramide (may decrease digoxin absorption)
  • Rifampin (may decrease digoxin levels)
  • St. John's Wort (may decrease digoxin levels)
  • NSAIDs (may impair renal function, indirectly affecting digoxin clearance)
  • Captopril, Enalapril (may increase digoxin levels slightly)
  • Succinylcholine (may increase risk of arrhythmias)
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Minor Interactions

  • Psyllium (may decrease digoxin absorption)

Monitoring

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Baseline Monitoring

Serum electrolytes (Potassium, Magnesium, Calcium)

Rationale: Electrolyte imbalances, especially 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.

Timing: Prior to initiation of therapy.

Thyroid function tests (TSH)

Rationale: Hypothyroidism can decrease digoxin clearance, while hyperthyroidism can increase it, affecting therapeutic levels.

Timing: Prior to initiation of therapy.

Electrocardiogram (ECG)

Rationale: To assess baseline cardiac rhythm and identify pre-existing conduction abnormalities.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Serum Digoxin Concentration (SDC)

Frequency: At steady state (at least 6-8 hours after last dose, preferably just before next dose), then periodically (e.g., every 6-12 months or with clinical changes/suspected toxicity/drug interactions).

Target: 0.5-0.9 ng/mL for heart failure; 0.8-2.0 ng/mL for rate control in atrial fibrillation (individualized).

Action Threshold: Levels >2.0 ng/mL are 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)

Frequency: Periodically, especially if on diuretics or with changes in renal function.

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

Action Threshold: Hypokalemia (<3.5 mEq/L) or hypomagnesemia (<1.7 mg/dL) significantly increases risk of toxicity.

Renal function (BUN, Serum Creatinine)

Frequency: Periodically, especially in elderly or those with comorbidities affecting renal function.

Target: Within normal limits for age/baseline.

Action Threshold: Deterioration in renal function requires digoxin dose adjustment.

Heart Rate and Rhythm

Frequency: Daily (in acute setting), then regularly during follow-up visits.

Target: Individualized, typically 60-100 bpm for heart rate control.

Action Threshold: Bradycardia (<60 bpm), new arrhythmias (e.g., AV block, ventricular ectopy) may indicate toxicity.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Anorexia
  • Diarrhea
  • Fatigue
  • Weakness
  • Headache
  • Dizziness
  • Confusion
  • Visual disturbances (blurred vision, yellow-green halos, scotomas)
  • Cardiac arrhythmias (bradycardia, AV block, premature ventricular contractions, ventricular tachycardia/fibrillation)

Special Patient Groups

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Pregnancy

Category C. Digoxin crosses the placenta. Used in pregnancy for maternal cardiac conditions (e.g., heart failure, supraventricular arrhythmias) and for fetal supraventricular tachycardia. Benefits must outweigh potential risks. Fetal monitoring is recommended.

Trimester-Specific Risks:

First Trimester: Limited data, but generally not associated with major congenital malformations.
Second Trimester: Used for maternal cardiac conditions and fetal arrhythmias. Close monitoring of maternal digoxin levels and fetal heart rate/rhythm.
Third Trimester: Used for maternal cardiac conditions and fetal arrhythmias. Close monitoring of maternal digoxin levels and fetal heart rate/rhythm.
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Lactation

L3 (Moderately Safe). Digoxin is excreted into breast milk in small amounts, generally considered clinically insignificant. Monitor breastfed infant for signs of toxicity (e.g., bradycardia, vomiting, lethargy).

Infant Risk: Low risk of adverse effects in healthy, full-term infants. Higher risk in premature or renally impaired infants.
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Pediatric Use

Dosing is highly individualized based on age, weight, and renal function. Narrow therapeutic index requires careful titration and frequent monitoring of serum levels and clinical response. Higher risk of toxicity in neonates and infants due to immature renal function and different volume of distribution. Consult pediatric cardiology guidelines.

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Geriatric Use

Elderly patients are more susceptible to digoxin toxicity due to age-related decline in renal function, lower muscle mass (affecting volume of distribution), and increased likelihood of polypharmacy and electrolyte imbalances. Lower initial doses and careful titration are recommended. Frequent monitoring of renal function 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 can occur even within the 'therapeutic' range, especially with electrolyte disturbances (hypokalemia, hypomagnesemia, hypercalcemia).
  • Clinical signs of toxicity often precede elevated serum levels.
  • Visual disturbances (yellow-green halos) are classic but late signs of toxicity.
  • Digoxin Immune Fab (DigiFab) is the antidote for severe, life-threatening digoxin toxicity.
  • Avoid abrupt discontinuation in patients with atrial fibrillation, as it may lead to rapid ventricular rate.
  • Not a first-line agent for heart failure with reduced ejection fraction (HFrEF) but can be used for symptom control in patients who remain symptomatic despite optimal guideline-directed medical therapy (GDMT), especially if also in atrial fibrillation.
  • Not effective for rate control in exercise-induced atrial fibrillation due to its vagal-mediated effects being less pronounced during sympathetic activation.
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Alternative Therapies

  • Beta-blockers (for rate control in atrial fibrillation, HFrEF)
  • Calcium channel blockers (non-dihydropyridine, e.g., verapamil, diltiazem - for rate control in atrial fibrillation)
  • ACE inhibitors/ARBs/ARNI (for HFrEF)
  • Mineralocorticoid receptor antagonists (MRAs, e.g., spironolactone, eplerenone - for HFrEF)
  • SGLT2 inhibitors (for HFrEF)
  • Diuretics (for symptom management in heart failure)
  • Ivabradine (for HFrEF with elevated heart rate)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 10 x 2ml vials (0.25mg/ml)
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. Properly dispose of unused or expired medications by checking with your pharmacist for the recommended disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist. If you have any questions or concerns about your medication, consult with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will aid in providing appropriate treatment.