Lanoxin 0.125mg Tablets (yellow)

Manufacturer CONCORDIA 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, inotropic agent
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Pharmacologic Class
Cardiac glycoside
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Pregnancy Category
C
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FDA Approved
Jan 1970
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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 can be used to treat heart failure, where your heart isn't pumping blood as effectively as it should, or to control a fast and irregular heartbeat called atrial fibrillation.
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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. Establish a routine by taking your medication at the same time every day. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing your medication 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 specifically instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to inquire about 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.
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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.
  • Monitor your pulse daily and report if it is unusually slow (e.g., below 60 beats per minute) or irregular.
  • Maintain a consistent diet and avoid sudden changes in potassium intake (e.g., excessive consumption of potassium-rich foods or potassium supplements) unless advised by your doctor.
  • Stay well-hydrated, especially if you are also taking diuretics, to prevent electrolyte imbalances.
  • Report any new medications, over-the-counter drugs, or herbal supplements to your doctor or pharmacist, as many can interact with digoxin.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized based on indication, renal function, and patient response. Typical maintenance dose: 0.125 mg to 0.25 mg once daily. Loading dose (rapid digitalization): 0.75 mg to 1.5 mg orally in divided doses over 24 hours.
Dose Range: 0.0625 - 0.5 mg

Condition-Specific Dosing:

heartFailure: Maintenance: 0.125 mg daily (may range from 0.0625 mg to 0.25 mg daily based on clinical response and serum levels).
atrialFibrillation: Maintenance: 0.125 mg to 0.25 mg daily to achieve target heart rate control and/or serum levels.
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Pediatric Dosing

Neonatal: Highly individualized based on gestational age, postnatal age, weight, and renal function. Typical total digitalizing dose (TDD) for full-term neonates: 20-30 mcg/kg orally, given in divided doses. Maintenance: 5-8 mcg/kg/day orally.
Infant: Highly individualized. Typical TDD for 1-24 months: 30-50 mcg/kg orally. Maintenance: 8-12 mcg/kg/day orally.
Child: Highly individualized. Typical TDD for 2-5 years: 25-35 mcg/kg orally. Maintenance: 6-9 mcg/kg/day orally. For >5 years: 10-15 mcg/kg orally. Maintenance: 2.5-4 mcg/kg/day orally.
Adolescent: Similar to adult dosing, but individualized based on weight and renal function. Often 0.125 mg daily.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-80 mL/min: Reduce dose by 25-50% or extend dosing interval. Monitor serum levels closely.
Moderate: CrCl 10-50 mL/min: Reduce dose by 50-75% or extend dosing interval. Monitor serum levels closely.
Severe: CrCl <10 mL/min: Reduce dose by 75-80% or extend dosing interval (e.g., 0.0625 mg every other day or three times weekly). Monitor serum levels closely.
Dialysis: Digoxin is minimally dialyzable. Dosing should be based on residual renal function. Administer after dialysis if possible. Monitor serum levels closely.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed (minimal hepatic metabolism).

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 the exchange of intracellular sodium for extracellular calcium via the Na+/Ca2+ exchanger. The increased 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), useful in atrial fibrillation.
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Pharmacokinetics

Absorption:

Bioavailability: 60-80% (for tablets)
Tmax: 0.5-2 hours (oral solution), 2-6 hours (tablets)
FoodEffect: Food may delay absorption but generally does not affect the extent of absorption. High-fiber meals may decrease absorption.

Distribution:

Vd: 5-8 L/kg (large volume of distribution, indicating extensive tissue binding)
ProteinBinding: 20-30%
CnssPenetration: Limited (but can cause CNS side effects at toxic levels)

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 total body clearance)
ExcretionRoute: Renal (primarily unchanged drug)
Unchanged: 50-70%
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Pharmacodynamics

OnsetOfAction: 0.5-2 hours (IV), 1-6 hours (oral)
PeakEffect: 2-6 hours (IV), 4-8 hours (oral)
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

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 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 not mentioned here. 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, or loss of appetite
  • Diarrhea
  • Unusual tiredness or weakness
  • Headache or dizziness
  • Confusion or changes in mental state
  • Blurred vision, seeing halos around lights (especially yellow or green), or other visual disturbances
  • 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 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 ability to take this medication safely.

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 currently 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 with all 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.

Please note that this medication may interfere with certain laboratory tests. Therefore, it is crucial 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, be sure to 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, this medication should be used 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. It is necessary 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 and vomiting
  • Profound bradycardia (very slow heart rate)
  • Various cardiac arrhythmias (e.g., heart block, ventricular tachycardia, ventricular fibrillation)
  • Hyperkalemia (especially in acute overdose)
  • Lethargy, confusion, seizures

What to Do:

If you suspect an overdose, 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, antiarrhythmic drugs, and in severe cases, Digoxin Immune Fab (DigiFab).

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, requires dose reduction)
  • Macrolide antibiotics (e.g., clarithromycin, erythromycin - may increase digoxin levels by altering gut flora)
  • Cyclosporine (increases digoxin levels)
  • Spironolactone (may interfere with digoxin assays and increase levels)
  • Diuretics (thiazide and loop 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, kaolin-pectin, cholestyramine (may decrease digoxin absorption)
  • Metoclopramide (may decrease digoxin absorption)
  • Rifampin, phenytoin, St. John's Wort (may decrease digoxin levels)
  • Succinylcholine (may enhance arrhythmogenic effects)
  • Sympathomimetics (e.g., dopamine, dobutamine - increased risk of arrhythmias)
  • Captopril, enalapril (may increase digoxin levels slightly)
  • NSAIDs (may impair renal function, indirectly affecting digoxin clearance)
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Minor Interactions

  • Psyllium (may decrease absorption)

Monitoring

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Baseline Monitoring

Serum electrolytes (Potassium, Magnesium, Calcium)

Rationale: Electrolyte imbalances, especially hypokalemia, hypomagnesemia, and hypercalcemia, can precipitate digoxin toxicity.

Timing: Prior to initiation of therapy.

Renal function (Serum Creatinine, eGFR)

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

Timing: Prior to initiation of therapy.

Electrocardiogram (ECG)

Rationale: To assess baseline cardiac rhythm, PR interval, and QRS duration, and to identify pre-existing conduction abnormalities.

Timing: Prior to initiation of therapy.

Thyroid function tests (TSH)

Rationale: Hypothyroidism can decrease digoxin clearance, hyperthyroidism can increase it.

Timing: Prior to initiation of therapy, if clinically indicated.

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Routine Monitoring

Serum Digoxin Concentration (SDC)

Frequency: At least 7-14 days after initiation or dose change (to allow for steady state), then every 6-12 months, or more frequently if toxicity is suspected, renal function changes, or interacting drugs are added/removed.

Target: 0.5-0.9 ng/mL for heart failure; 0.8-2.0 ng/mL for rate control in atrial fibrillation (though lower ranges are 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 (e.g., every 3-6 months), or more frequently if on diuretics or other interacting drugs, 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, especially hypokalemia, requires immediate correction.

Renal function (Serum Creatinine, eGFR)

Frequency: Periodically (e.g., every 3-6 months), or more frequently in elderly patients or those with fluctuating renal function.

Target: Stable within patient's baseline.

Action Threshold: Significant decline in renal function necessitates digoxin dose adjustment.

Heart Rate and Rhythm

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

Target: Appropriate for indication (e.g., 60-90 bpm for AFib rate control, or as clinically indicated for HF).

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

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Anorexia
  • Diarrhea
  • Fatigue
  • Weakness
  • Headache
  • Dizziness
  • Confusion
  • Delirium
  • 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

Digoxin is classified as Pregnancy Category C. It crosses the placenta. While not associated with major congenital malformations, its use should be carefully weighed against the potential risks and benefits. It is often used for fetal supraventricular tachycardia.

Trimester-Specific Risks:

First Trimester: Limited data, but generally not associated with increased risk of major malformations.
Second Trimester: Can be used for maternal cardiac conditions or fetal arrhythmias.
Third Trimester: Can be used for maternal cardiac conditions or fetal arrhythmias. Monitor maternal and fetal heart rate and rhythm.
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Lactation

Digoxin is excreted into breast milk in small amounts. The amount ingested by the infant is generally considered to be clinically insignificant. It is rated L3 (Moderately Safe) by Hale's Lactation Risk Categories. Monitor the infant for signs of toxicity (e.g., bradycardia, vomiting).

Infant Risk: Low risk of adverse effects for the breastfed infant, but caution is advised, especially in premature infants or those with impaired renal function.
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Pediatric Use

Dosing is highly individualized and complex due to significant variability in pharmacokinetics based on age, weight, and renal function. Pediatric patients, especially neonates and infants, have a narrower therapeutic index and are more susceptible to toxicity. Close monitoring of serum levels, electrolytes, and cardiac rhythm is essential.

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Geriatric Use

Elderly patients are more susceptible to digoxin toxicity due to age-related decline in renal function, decreased muscle mass (affecting Vd), and increased likelihood of polypharmacy and electrolyte imbalances. Lower initial doses and careful titration are recommended. 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 to avoid toxicity.
  • Electrolyte imbalances, particularly hypokalemia, hypomagnesemia, and hypercalcemia, significantly increase the risk of digoxin toxicity, even at therapeutic serum levels.
  • Renal function is the primary determinant of digoxin clearance; dose adjustments are critical in patients with impaired kidney function.
  • Many common medications (e.g., amiodarone, verapamil, diltiazem, macrolides) can significantly increase digoxin levels, necessitating dose reduction.
  • Clinical signs and symptoms of toxicity (e.g., GI upset, visual disturbances, arrhythmias) are often more reliable indicators of toxicity than serum levels alone.
  • Digoxin Immune Fab (DigiFab) is the antidote for severe, life-threatening digoxin toxicity.
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Alternative Therapies

  • For Heart Failure (reduced ejection fraction): ACE inhibitors, ARBs, ARNI (sacubitril/valsartan), beta-blockers, MRAs (spironolactone, eplerenone), SGLT2 inhibitors (dapagliflozin, empagliflozin).
  • For Atrial Fibrillation (rate control): Beta-blockers (e.g., metoprolol, carvedilol), non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem).
  • For Atrial Fibrillation (rhythm control): Antiarrhythmic drugs (e.g., flecainide, propafenone, sotalol, amiodarone), catheter ablation.
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (0.125mg generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (preferred generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 be sure to check with your pharmacist for more details. If you have any questions or concerns about your medication, don't hesitate to reach out to 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 information about the medication taken, the amount, and the time it happened.