Lanoxin 0.0625mg Tablets (peach)

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.
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Drug Class
Cardiac Glycoside; Antiarrhythmic
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Pharmacologic Class
Na+/K+-ATPase Inhibitor
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Pregnancy Category
Category C
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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 help your heart beat stronger and more regularly. It's often prescribed for heart failure to improve the heart's pumping ability, or for certain irregular heart rhythms (like atrial fibrillation) to slow down a fast heartbeat. It's very important to take this medicine exactly as prescribed because too much can be harmful.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions 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 directed by your doctor or healthcare provider, even if you start to feel better.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Keep all medications out of the reach of children and pets to prevent accidental ingestion. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist or healthcare provider. If you have questions about disposing of your medication, consult with your pharmacist, who can also inform you about potential drug take-back programs 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 is 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.
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Lifestyle & Tips

  • Take your medication exactly as prescribed, at the same time each day.
  • Do not stop taking digoxin without consulting your doctor.
  • Learn how to check your pulse and report if it's unusually slow (e.g., below 60 beats per minute) or irregular.
  • Maintain a balanced diet and adequate fluid intake to prevent electrolyte imbalances, especially potassium. Avoid sudden changes in potassium intake.
  • Inform all healthcare providers, including dentists, that you are taking digoxin.
  • Avoid taking antacids or laxatives within 2 hours of your digoxin dose unless directed by your doctor.
  • Be aware of symptoms of toxicity and report them immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: 0.125 mg to 0.25 mg orally once daily (maintenance dose) after digitalization
Dose Range: 0.0625 - 0.5 mg

Condition-Specific Dosing:

heartFailure: Initial loading dose (digitalization) typically 0.5-1.5 mg total in divided doses over 24 hours, followed by maintenance.
atrialFibrillation: Initial loading dose (digitalization) typically 0.5-1.5 mg total in divided doses over 24 hours, followed by maintenance to achieve target heart rate.
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Pediatric Dosing

Neonatal: Highly individualized based on age, weight, and renal function. Requires careful titration and monitoring.
Infant: Highly individualized based on age, weight, and renal function. Requires careful titration and monitoring.
Child: Highly individualized based on age, weight, and renal function. Requires careful titration and monitoring.
Adolescent: Highly individualized based on age, weight, and renal function. Requires careful titration and monitoring.
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Dose Adjustments

Renal Impairment:

Mild: Reduce maintenance dose by 25-50% or extend dosing interval.
Moderate: Reduce maintenance dose by 50-75% or extend dosing interval significantly.
Severe: Reduce maintenance dose by 75% or more, or administer every 3-5 days. Monitor levels closely.
Dialysis: Digoxin is not significantly removed by hemodialysis. Dose adjustments based on residual renal function.

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+/Ca++ exchanger. The increased intracellular calcium enhances myocardial contractility (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.
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Pharmacokinetics

Absorption:

Bioavailability: 60-80% (tablets)
Tmax: 0.5-2 hours (oral)
FoodEffect: Food may delay absorption but does not significantly affect the extent of absorption. High-fiber meals may decrease absorption.

Distribution:

Vd: 5-8 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: Primarily renal clearance, proportional to creatinine clearance
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: 50-70%
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Pharmacodynamics

OnsetOfAction: 0.5-2 hours (oral)
PeakEffect: 2-6 hours (oral)
DurationOfAction: 3-4 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 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.
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Seek Immediate Medical Attention If You Experience:

  • Nausea, vomiting, loss of appetite
  • Diarrhea
  • Unusual tiredness or weakness
  • Blurred vision, seeing halos around lights (yellow/green tint)
  • Changes in color perception
  • Headache, confusion, dizziness
  • Slow or irregular heartbeat
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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 symptoms you experienced.
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 treatments and health issues.

Remember, do not start, stop, or adjust 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 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.

Please note that this medication may interfere with certain laboratory tests. Be sure to inform all your healthcare providers and laboratory personnel that you are taking this drug.

If you consume a diet high in bran or fiber, notify 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, inform your doctor that you are taking this medication.

To avoid accidental exposure, keep this medication out of the reach of children, as 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, use this medication with caution, as the risk of certain side effects may be higher in this population.

If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor 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, abdominal pain
  • Profound bradycardia (very slow heart rate)
  • Various cardiac arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, severe AV block)
  • Confusion, disorientation, seizures
  • Hyperkalemia (especially in acute overdose)

What to Do:

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

Drug Interactions

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Major Interactions

  • Amiodarone (increases digoxin levels significantly)
  • Verapamil (increases digoxin levels significantly)
  • Quinidine (increases digoxin levels significantly)
  • Dronedarone (increases digoxin levels)
  • Propafenone (increases digoxin levels)
  • Macrolide antibiotics (e.g., clarithromycin, erythromycin - may increase digoxin levels by altering gut flora)
  • Tetracycline (may increase digoxin levels by altering gut flora)
  • Cyclosporine (increases digoxin levels)
  • Spironolactone (may interfere with digoxin assays, also 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)
  • Calcium (IV) (rapid administration can precipitate arrhythmias in digitalized patients)
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Moderate Interactions

  • Beta-blockers (additive bradycardia)
  • Calcium channel blockers (non-dihydropyridine, e.g., diltiazem - additive bradycardia, AV block)
  • Antacids, Kaolin-pectin, Cholestyramine, Colestipol (decrease digoxin absorption)
  • Rifampin, Phenytoin, St. John's Wort (may decrease digoxin levels)
  • Succinylcholine (may enhance arrhythmogenic effects)
  • Sympathomimetics (may increase risk of arrhythmias)
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Minor Interactions

  • Metoclopramide (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)

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

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 arrhythmias and conduction abnormalities.

Timing: Prior to initiation of therapy.

Liver Function Tests (LFTs)

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

Timing: Prior to initiation of therapy.

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Routine Monitoring

Serum Digoxin Concentration

Frequency: At least 7-14 days after initiation or dose change, then every 6-12 months or as clinically indicated (e.g., suspected toxicity, change in renal function, new interacting drug). Draw sample at least 6-8 hours after last dose.

Target: 0.5-0.9 ng/mL (for heart failure); 0.8-2.0 ng/mL (for rate control in AFib, though lower end of range often preferred to minimize toxicity)

Action Threshold: Levels >2.0 ng/mL are generally considered toxic, but toxicity can occur at lower levels, especially with electrolyte imbalances. Clinical status is paramount.

Serum Electrolytes (Potassium, Magnesium, Calcium)

Frequency: Periodically, especially if on diuretics or other drugs affecting electrolytes, or if symptoms of toxicity arise.

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, eGFR)

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

Target: Stable within patient's baseline

Action Threshold: Any decline in renal function necessitates re-evaluation of digoxin dose.

Heart Rate and Rhythm

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

Target: As per clinical goal (e.g., <100 bpm for AFib rate control)

Action Threshold: Bradycardia (<60 bpm), new arrhythmias, or worsening of existing arrhythmias may indicate toxicity.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Anorexia
  • Diarrhea
  • Fatigue
  • Weakness
  • Headache
  • Dizziness
  • Confusion
  • Depression
  • Visual disturbances (blurred vision, yellow/green halos, scotomas)
  • Cardiac arrhythmias (e.g., bradycardia, AV block, premature ventricular contractions, ventricular tachycardia, atrial tachycardia with block)

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Digoxin crosses the placenta. Fetal and maternal monitoring is recommended.

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. Maternal renal clearance may increase, requiring dose adjustments.
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Lactation

L2 - Likely compatible. Digoxin is excreted into breast milk in small amounts, but infant exposure is generally low and not expected to cause adverse effects. Monitor breastfed infant for signs of toxicity (e.g., bradycardia, vomiting).

Infant Risk: Low
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Pediatric Use

Dosing is complex and highly individualized based on age, weight, and renal function. Narrow therapeutic index requires careful titration and frequent monitoring of serum levels and clinical response. Infants and young children are 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, lower muscle mass (affecting creatinine clearance), and increased likelihood of polypharmacy and electrolyte imbalances. Lower initial doses and careful monitoring are essential.

Clinical Information

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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 levels.
  • Clinical signs and symptoms of toxicity often precede elevated serum digoxin levels.
  • Renal function is the primary determinant of digoxin clearance; dose adjustments are essential in renal impairment.
  • Digoxin Immune Fab (DigiFab) is the antidote for severe, life-threatening digoxin toxicity.
  • Always draw digoxin levels at least 6-8 hours after the last dose to allow for distribution into tissues and avoid falsely elevated levels.
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Alternative Therapies

  • For Heart Failure (reduced ejection fraction): ACE inhibitors, Angiotensin Receptor Blockers (ARBs), Beta-blockers, Mineralocorticoid Receptor Antagonists (MRAs), SGLT2 inhibitors, ARNI (Sacubitril/Valsartan).
  • 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: $15 - $50 per 30 tablets (0.0625mg or 0.125mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, 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.