Digoxin 0.25mg Tablets (white)

Manufacturer WEST-WARD 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
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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 treat certain heart conditions, like heart failure and irregular heartbeats (atrial fibrillation). It works by helping your heart beat stronger and more regularly. Because it's a powerful medicine, it's very important to take it exactly as prescribed and to be aware of potential side effects.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow these guidelines:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
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 to feel better.

Storing and Disposing of Your Medication

To ensure the safety and effectiveness 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 in a secure location, out of the reach of children and pets.
Dispose of unused or expired medication 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. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a drug take-back program in your area.

What to Do If You Miss a Dose

If you miss a dose of your medication:

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 a missed dose.
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Lifestyle & Tips

  • Take your medication at the same time each day.
  • Do not stop taking digoxin without consulting your doctor.
  • Avoid sudden changes in diet, especially those high in fiber, as this can affect absorption.
  • Maintain adequate hydration and electrolyte balance, especially if taking diuretics.
  • Report any new medications, over-the-counter drugs, or herbal supplements to your doctor, as many can interact with digoxin.
  • Learn to take your pulse and report if it is unusually slow or irregular.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

heartFailure: 0.125 mg once daily, target serum concentration 0.5-0.9 ng/mL
atrialFibrillation: 0.125 mg to 0.25 mg once daily, target serum concentration 0.8-2.0 ng/mL for rate control
rapidDigitalization: Loading dose: 0.5-1.0 mg orally in divided doses over 24 hours, followed by maintenance
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Pediatric Dosing

Neonatal: Dosing highly individualized based on age, weight, and renal function. Typical oral loading dose: 20-30 mcg/kg, maintenance: 5-8 mcg/kg/day.
Infant: Dosing highly individualized based on age, weight, and renal function. Typical oral loading dose: 30-50 mcg/kg, maintenance: 8-12 mcg/kg/day.
Child: Dosing highly individualized based on age, weight, and renal function. Typical oral loading dose: 20-40 mcg/kg, maintenance: 5-10 mcg/kg/day.
Adolescent: Dosing highly individualized based on age, weight, and renal function. Similar to adult dosing, but often lower initial doses.
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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 (e.g., every 48 hours).
Severe: CrCl <30 mL/min: Reduce dose by 75-87.5% or extend dosing interval (e.g., every 72 hours or less).
Dialysis: Not significantly removed by hemodialysis. Administer after dialysis. Significant dose reduction required (e.g., 0.0625 mg every 3-5 days).

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 inhibition leads to an increase in intracellular sodium concentration, which in turn reduces the activity of the Na+/Ca2+ exchanger. The resulting increase in intracellular calcium concentration enhances the force of myocardial contraction (positive inotropy). Digoxin also increases vagal tone, leading to decreased heart rate (negative chronotropy) and decreased conduction velocity through the AV node (negative dromotropy).
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Pharmacokinetics

Absorption:

Bioavailability: 60-80% (tablet)
Tmax: 1-3 hours
FoodEffect: Food may delay absorption but generally does not affect the extent of absorption. High-fiber meals may decrease absorption.

Distribution:

Vd: 5-10 L/kg (large volume of distribution, indicating extensive tissue binding)
ProteinBinding: 20-30%
CnssPenetration: Limited

Elimination:

HalfLife: 36-48 hours (in patients with 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 (primarily unchanged drug)
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

Serious 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 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 go away
Changes in vision
Seeing halos or bright colors around lights
Unexplained weight loss
Decreased appetite
Feeling 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's 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.
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Seek Immediate Medical Attention If You Experience:

  • Unusual tiredness or weakness
  • Nausea, vomiting, or loss of appetite
  • Diarrhea
  • Blurred vision or seeing yellow/green halos around lights
  • Confusion or disorientation
  • Slow heart rate (pulse below 60 beats per minute, or as advised by your doctor)
  • Irregular heartbeats
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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 issues 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 conditions.

Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor.
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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 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.

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. 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.
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Overdose Information

Overdose Symptoms:

  • Severe nausea, vomiting, diarrhea
  • Profound bradycardia (very slow heart rate)
  • Various cardiac arrhythmias (e.g., AV block, ventricular tachycardia, ventricular fibrillation)
  • Severe confusion, delirium, hallucinations
  • Visual disturbances (more pronounced)
  • Weakness, lethargy

What to Do:

If you suspect an overdose, seek immediate medical attention. Call 911 or your local emergency number. In the U.S., you can also call Poison Control at 1-800-222-1222. Treatment may involve activated charcoal, correction of electrolyte imbalances (especially potassium), and in severe cases, administration of Digoxin Immune Fab (DigiFab).

Drug Interactions

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Major Interactions

  • Amiodarone (increases digoxin levels significantly)
  • Verapamil (increases digoxin levels)
  • Diltiazem (increases digoxin levels)
  • Quinidine (increases digoxin levels)
  • Propafenone (increases digoxin levels)
  • Macrolide antibiotics (e.g., clarithromycin, erythromycin - may increase digoxin levels)
  • Azole antifungals (e.g., itraconazole - may increase digoxin levels)
  • Cyclosporine (increases digoxin levels)
  • Spironolactone (may interfere with digoxin assays, also affects potassium)
  • Diuretics (thiazide, loop - can cause hypokalemia, increasing digoxin toxicity risk)
  • Amphotericin B (can cause hypokalemia, increasing digoxin toxicity risk)
  • Beta-blockers (additive bradycardia/AV block)
  • Calcium channel blockers (non-dihydropyridine, e.g., verapamil, diltiazem - additive bradycardia/AV block)
  • Sympathomimetics (e.g., dopamine, dobutamine - may increase risk of arrhythmias)
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Moderate Interactions

  • Antacids (may decrease digoxin absorption)
  • Cholestyramine (may decrease digoxin absorption)
  • Metoclopramide (may decrease digoxin absorption)
  • Rifampin (may decrease digoxin levels)
  • St. John's Wort (may decrease digoxin levels)
  • ACE inhibitors/ARBs (may increase potassium, reducing digoxin toxicity risk, but monitor for bradycardia)
  • NSAIDs (may impair renal function, affecting digoxin clearance)
  • Succinylcholine (may increase risk of arrhythmias)
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Minor Interactions

  • High-fiber foods (may slightly decrease 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: Before initiating therapy

Renal Function (CrCl, SCr)

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

Timing: Before initiating therapy

ECG

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

Timing: Before initiating therapy

Thyroid Function Tests

Rationale: Hypothyroidism can increase digoxin levels; hyperthyroidism can decrease levels.

Timing: Before initiating therapy (if clinically indicated)

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Routine Monitoring

Digoxin Serum Concentration

Frequency: At least 7-10 days after initiation or dose change, then every 6-12 months or as clinically indicated (e.g., suspected toxicity, change in renal function, drug interaction)

Target: Heart Failure: 0.5-0.9 ng/mL; Atrial Fibrillation: 0.8-2.0 ng/mL (for rate control)

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 with diuretic use or changes in clinical status; more frequently if abnormalities are detected.

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

Action Threshold: Hypokalemia (<3.5 mEq/L), hypomagnesemia (<1.7 mg/dL), or hypercalcemia (>10.2 mg/dL) increase toxicity risk. Correct imbalances promptly.

Renal Function (SCr, CrCl)

Frequency: Periodically, especially in elderly patients or those with comorbidities affecting renal function; more frequently if changes are suspected.

Target: Stable CrCl

Action Threshold: Significant decline in CrCl necessitates digoxin dose adjustment.

Heart Rate and Rhythm

Frequency: Daily (patient self-monitoring) and at each clinical visit.

Target: Appropriate for condition (e.g., HR 60-100 bpm for AF 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
  • Blurred vision
  • Yellow-green halos around lights (xanthopsia)
  • Diplopia
  • Confusion
  • Disorientation
  • Depression
  • New or worsening arrhythmias (e.g., bradycardia, AV block, premature ventricular contractions, ventricular tachycardia)

Special Patient Groups

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Pregnancy

Digoxin crosses the placenta. While generally considered safe for use in pregnancy when indicated for maternal cardiac conditions, it should be used with caution and only if the potential benefit outweighs the risk. Fetal monitoring may be necessary.

Trimester-Specific Risks:

First Trimester: Limited data, but no clear evidence of teratogenicity.
Second Trimester: Generally considered safe for maternal indications.
Third Trimester: Generally considered safe for maternal indications; monitor for fetal bradycardia.
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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 subtherapeutic and unlikely to cause adverse effects. Monitor breastfed infants for signs of digoxin toxicity (e.g., bradycardia, vomiting).

Infant Risk: Low risk (L2)
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Pediatric Use

Dosing is complex and highly individualized based on age, weight, and renal function. Pediatric patients, especially neonates and infants, are more susceptible to toxicity due to differences in pharmacokinetics and pharmacodynamics. Close monitoring of serum levels and clinical status is essential.

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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 Vd), and polypharmacy leading to drug interactions. Lower initial doses and careful monitoring of renal function and serum levels are crucial.

Clinical Information

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Clinical Pearls

  • Digoxin has a narrow therapeutic index; careful dosing and monitoring are essential.
  • 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 levels.
  • Digoxin Immune Fab (DigiFab) is the antidote for life-threatening digoxin toxicity.
  • Always check renal function before initiating and periodically during digoxin therapy.
  • Be aware of common drug interactions, especially with P-glycoprotein inhibitors (e.g., amiodarone, verapamil) and diuretics.
  • Digoxin is less effective for rate control in atrial fibrillation during exercise compared to beta-blockers or calcium channel blockers.
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Alternative Therapies

  • Beta-blockers (e.g., metoprolol, carvedilol) for rate control in AF and heart failure.
  • Calcium channel blockers (non-dihydropyridine, e.g., verapamil, diltiazem) for rate control in AF.
  • ACE inhibitors/ARBs for heart failure.
  • Diuretics for heart failure.
  • Mineralocorticoid receptor antagonists (e.g., spironolactone, eplerenone) for heart failure.
  • SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin) for heart failure.
  • ARNI (e.g., sacubitril/valsartan) for heart failure.
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (0.25mg generic)
Generic Available: Yes
Insurance Coverage: Tier 1 (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 information. If you have any questions or concerns about this 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 medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.