Lanoxin 0.25mg Tablets (white)

Manufacturer CONCORDIA PHARMACEUTICALS Active Ingredient Digoxin Tablets(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.
đŸˇī¸
Drug Class
Cardiac Glycoside; Antiarrhythmic (Class IV); Inotropic Agent
đŸ§Ŧ
Pharmacologic Class
Na+/K+-ATPase Inhibitor
🤰
Pregnancy Category
Category C
✅
FDA Approved
Jan 1954
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Digoxin is a medication used to help your heart beat stronger and more regularly. It can help improve symptoms of heart failure and control a fast or irregular heartbeat (like atrial fibrillation). It works by affecting how certain minerals move in and out of your heart cells.
📋

How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, it's essential to take it as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. Take your medication at the same time every day to establish a routine. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling better.

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a secure location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to check if there are any drug take-back programs available in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
💡

Lifestyle & Tips

  • Take digoxin exactly as prescribed, at the same time each day.
  • Do not stop taking digoxin without consulting your doctor.
  • Monitor your pulse daily and report if it is unusually slow or irregular.
  • Maintain a balanced diet and avoid sudden changes in potassium intake (e.g., excessive licorice, potassium-rich foods if not advised by doctor).
  • Stay hydrated, especially if you experience vomiting or diarrhea, as dehydration can affect electrolyte balance and digoxin levels.
  • Be aware of symptoms of toxicity and report them immediately.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Maintenance: 0.125 mg to 0.25 mg orally once daily. Loading (rapid): 0.25 mg every 6-8 hours for 2-3 doses, then maintenance. Loading (slow): 0.125 mg to 0.25 mg orally once daily for 7 days.
Dose Range: 0.0625 - 0.5 mg

Condition-Specific Dosing:

heartFailure: Maintenance: 0.125 mg to 0.25 mg orally once daily, adjusted based on clinical response and serum levels.
atrialFibrillation: Maintenance: 0.125 mg to 0.25 mg orally once daily, adjusted to achieve desired ventricular rate control.
đŸ‘ļ

Pediatric Dosing

Neonatal: Highly individualized, typically 10-30 mcg/kg total digitalizing dose (TDD) orally, divided over 24 hours, then 25-30% of TDD daily maintenance. Consult specific pediatric dosing guidelines.
Infant: Highly individualized, typically 30-50 mcg/kg TDD orally, divided over 24 hours, then 25-30% of TDD daily maintenance. Consult specific pediatric dosing guidelines.
Child: Highly individualized, typically 20-40 mcg/kg TDD orally, divided over 24 hours, then 25-30% of TDD daily maintenance. Consult specific pediatric dosing guidelines.
Adolescent: Similar to adult dosing, but may require lower doses based on weight and renal function. Consult specific pediatric dosing guidelines.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: CrCl 50-79 mL/min: Reduce dose by 25-50% or extend dosing interval.
Moderate: CrCl 30-49 mL/min: Reduce dose by 50-75% or extend dosing interval.
Severe: CrCl <30 mL/min: Reduce dose by 75-80% or extend dosing interval significantly (e.g., 0.0625 mg every other day or three times weekly).
Dialysis: Digoxin is minimally removed by hemodialysis. Dose adjustments are based on residual renal function. Administer after dialysis if given on dialysis days.

Hepatic Impairment:

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

Pharmacology

đŸ”Ŧ

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 the exchange of intracellular sodium for extracellular calcium via the Na+/Ca2+ exchanger. The increased intracellular calcium enhances the contractility of the cardiac muscle (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), useful in atrial fibrillation.
📊

Pharmacokinetics

Absorption:

Bioavailability: Tablets: 60-80%; Elixir/Capsules: 90-100%
Tmax: Oral: 1-2 hours (onset of action 0.5-2 hours)
FoodEffect: Food may delay absorption but does not significantly affect the extent of absorption. High-fiber meals may decrease absorption.

Distribution:

Vd: 4-7 L/kg (large, due to extensive tissue binding, especially to skeletal muscle)
ProteinBinding: 20-30%
CnssPenetration: Limited (approximately 1% of plasma concentration)

Elimination:

HalfLife: 36-48 hours (normal renal function); significantly prolonged in renal impairment (up to 4-5 days)
Clearance: Primarily renal clearance (60-80% of dose)
ExcretionRoute: Renal (unchanged drug)
Unchanged: 60-80%
âąī¸

Pharmacodynamics

OnsetOfAction: Oral: 0.5-2 hours; IV: 5-30 minutes
PeakEffect: Oral: 2-6 hours; IV: 1-4 hours
DurationOfAction: 3-4 days (due to long half-life and tissue binding)

Safety & Warnings

âš ī¸

Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while 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
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. While 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 symptoms that bother you or do not go away, contact your doctor:

Dizziness or headache
* Stomach pain

Reporting Side Effects

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

Seek Immediate Medical Attention If You Experience:

  • Nausea, vomiting, loss of appetite, abdominal pain
  • Unusual tiredness, weakness, dizziness, confusion
  • Blurred vision, seeing yellow-green halos around lights
  • Slow or irregular heartbeat, palpitations
  • New or worsening shortness of breath or swelling
📋

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 health conditions or medications. 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 complete medical history, including any health problems you have

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.
âš ī¸

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 (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 consume a diet high in bran or fiber, inform your doctor, as this may affect the medication's absorption. Also, if you are scheduled to undergo a cardioversion procedure to restore a normal heart rhythm, be sure to tell your doctor that you are taking this medication.

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. Similarly, if the patient is a child, this medication should be used with caution, as the risk of certain side effects may be higher in children.

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.
🆘

Overdose Information

Overdose Symptoms:

  • Severe nausea, vomiting, diarrhea
  • Profound bradycardia (very slow heart rate)
  • Life-threatening arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, severe AV block)
  • Severe confusion, delirium, seizures
  • Hyperkalemia (especially in acute overdose)

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment may involve activated charcoal, correction of electrolyte imbalances, antiarrhythmics, and in severe cases, Digoxin Immune Fab (DigiFab).

Drug Interactions

🔴

Major Interactions

  • Amiodarone (increases digoxin levels significantly, requires 50% digoxin dose reduction)
  • Verapamil (increases digoxin levels, requires 25-50% digoxin dose reduction)
  • Quinidine (increases digoxin levels, requires 50% digoxin dose reduction)
  • Propafenone (increases digoxin levels)
  • Dronedarone (increases digoxin levels)
  • Macrolide antibiotics (e.g., Clarithromycin, Erythromycin - may increase digoxin levels by altering gut flora)
  • Tetracycline antibiotics (may increase digoxin levels by altering gut flora)
  • Cyclosporine (increases digoxin levels)
  • Spironolactone (may interfere with digoxin assay, also increases digoxin levels)
  • Loop and Thiazide Diuretics (increase risk of hypokalemia, predisposing to digoxin toxicity)
  • Amphotericin B (increases risk of hypokalemia, predisposing to digoxin toxicity)
  • Calcium (IV) (may precipitate arrhythmias in digitalized patients)
🟡

Moderate Interactions

  • Beta-blockers (additive bradycardia)
  • Calcium Channel Blockers (e.g., Diltiazem - additive bradycardia, also may increase digoxin levels)
  • Antacids, Kaolin-pectin, Cholestyramine, Colestipol (decrease digoxin absorption)
  • Metoclopramide (decreases digoxin absorption)
  • Rifampin, Phenytoin, St. John's Wort (may decrease digoxin levels)
  • Succinylcholine (may enhance arrhythmogenic effects of digoxin)
đŸŸĸ

Minor Interactions

  • Not available

Monitoring

đŸ”Ŧ

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, CrCl)

Rationale: Digoxin is primarily renally excreted; impaired renal function necessitates dose adjustment.

Timing: Prior to initiation of therapy.

Electrocardiogram (ECG)

Rationale: To assess baseline cardiac rhythm, PR interval, QRS duration, and QT interval. Digoxin can cause various ECG changes.

Timing: Prior to initiation of therapy.

Liver Function Tests (LFTs)

Rationale: Although digoxin is minimally metabolized by the liver, baseline assessment is prudent.

Timing: Prior to initiation of therapy.

📊

Routine Monitoring

Serum Digoxin Concentration

Frequency: At least 7-14 days after initiation or dose change, then every 6-12 months, or whenever toxicity is suspected or clinical status changes.

Target: Heart Failure: 0.5-0.9 ng/mL; Atrial Fibrillation: 0.8-2.0 ng/mL (to achieve rate control). Note: Toxicity can occur at any level, especially with electrolyte imbalances.

Action Threshold: Levels >2.0 ng/mL are generally considered toxic, but clinical signs and symptoms are paramount. Levels within therapeutic range do not rule out toxicity.

Serum Electrolytes (Potassium, Magnesium, Calcium)

Frequency: Periodically, especially if on diuretics or other medications affecting electrolytes, 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, particularly hypokalemia, requires immediate correction.

Renal Function (BUN, Serum Creatinine)

Frequency: Periodically (e.g., every 3-6 months) or more frequently in patients with unstable renal function or those on nephrotoxic drugs.

Target: Within normal limits for age/sex.

Action Threshold: Increasing creatinine indicates need for digoxin dose adjustment.

Heart Rate and Rhythm

Frequency: Daily by patient (pulse check) and regularly by clinician.

Target: Typically 60-90 bpm for heart failure, or target rate for AFib.

Action Threshold: Bradycardia (<60 bpm), new arrhythmias (e.g., PVCs, AV block, atrial tachycardia with block) may indicate toxicity.

đŸ‘ī¸

Symptom Monitoring

  • Gastrointestinal: Nausea, vomiting, anorexia, abdominal pain, diarrhea.
  • Neurological: Fatigue, lethargy, headache, dizziness, confusion, delirium, hallucinations.
  • Visual: Blurred vision, yellow-green halos (xanthopsia), photophobia.
  • Cardiac: Bradycardia, irregular pulse, palpitations, syncope, new or worsening arrhythmias (e.g., premature ventricular contractions, AV block, atrial tachycardia with block, ventricular tachycardia/fibrillation).

Special Patient Groups

🤰

Pregnancy

Digoxin crosses the placenta. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It has been used for fetal supraventricular tachycardia.

Trimester-Specific Risks:

First Trimester: Limited data, but no clear evidence of teratogenicity.
Second Trimester: Generally considered relatively safe for use if indicated.
Third Trimester: Generally considered relatively safe for use if indicated. Monitor maternal and fetal heart rate.
🤱

Lactation

Digoxin is excreted into breast milk in small amounts. Levels in breast milk are generally low and infant exposure is minimal. Considered compatible with breastfeeding by most experts.

Infant Risk: Low risk of adverse effects to the breastfed infant. Monitor infant for signs of digoxin toxicity (e.g., bradycardia, vomiting, lethargy).
đŸ‘ļ

Pediatric Use

Dosing is complex and highly individualized based on age, weight, and indication. Neonates and infants require careful monitoring due to immature renal function and varying sensitivity. Narrow therapeutic index requires precise dosing and frequent monitoring of serum levels and clinical status.

👴

Geriatric Use

Elderly patients are more susceptible to digoxin toxicity due to age-related decline in renal function, lower muscle mass (affecting Vd), and increased likelihood of polypharmacy and electrolyte imbalances. Lower initial doses and careful monitoring of renal function and serum digoxin levels are essential.

Clinical Information

💎

Clinical Pearls

  • Digoxin has a narrow therapeutic index; careful dosing and monitoring are crucial.
  • Electrolyte imbalances, particularly hypokalemia, hypomagnesemia, and hypercalcemia, significantly increase the risk of digoxin toxicity, even at therapeutic serum levels.
  • Clinical signs and symptoms of toxicity often precede elevated serum digoxin levels.
  • Always check renal function before initiating and periodically during digoxin therapy.
  • Many common medications (e.g., amiodarone, verapamil, quinidine, macrolides) can significantly increase digoxin levels, necessitating dose reduction.
  • Digoxin is not a first-line agent for rate control in acute atrial fibrillation in patients without heart failure due to its delayed onset and narrow therapeutic window.
  • In acute digoxin toxicity with life-threatening arrhythmias or hyperkalemia, Digoxin Immune Fab (DigiFab) is the antidote.
🔄

Alternative Therapies

  • For Heart Failure with Reduced Ejection Fraction (HFrEF): ACE inhibitors/ARBs/ARNI, Beta-blockers, Mineralocorticoid Receptor Antagonists (MRAs), SGLT2 inhibitors.
  • For Rate Control in Atrial Fibrillation: Beta-blockers (e.g., Metoprolol, Carvedilol), Non-dihydropyridine Calcium Channel Blockers (e.g., Verapamil, Diltiazem).
  • For Rhythm Control in Atrial Fibrillation: Antiarrhythmic drugs (e.g., Amiodarone, Flecainide, Sotalol), Catheter ablation.
💰

Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (0.25mg generic)
Generic Available: Yes
Insurance Coverage: Tier 1 (preferred generic)
📚

General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them 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. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.