Digoxin 0.125mg Tablets (yellow)

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
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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 certain types of heart failure or to control a fast, irregular heartbeat called atrial fibrillation. Because the dose needs to be very precise, it's 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, 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 instructed to do so by your doctor or pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or inquire 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'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 at the same time each day.
  • Do not stop taking digoxin suddenly without consulting your doctor.
  • Monitor your pulse rate daily as instructed by your doctor. Report if it's too slow or irregular.
  • Maintain a balanced diet and adequate fluid intake to prevent dehydration and electrolyte imbalances.
  • Avoid taking antacids or laxatives within 2 hours of your digoxin dose unless advised by your doctor.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, as many can interact with digoxin.

Dosing & Administration

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Adult Dosing

Standard Dose: Maintenance dose typically 0.125 mg to 0.25 mg once daily, individualized based on renal function, lean body weight, and therapeutic response. Loading dose (digitalization) may be used for rapid effect.
Dose Range: 0.0625 - 0.5 mg

Condition-Specific Dosing:

heartFailure: 0.125 mg daily (or 0.0625 mg daily in elderly/renal impairment) aiming for serum concentration 0.5-0.9 ng/mL.
atrialFibrillation: 0.125 mg to 0.25 mg daily, aiming for serum concentration 0.8-2.0 ng/mL for rate control.
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Pediatric Dosing

Neonatal: Highly individualized based on age, weight, and renal function. Initial loading dose (oral) 20-30 mcg/kg, maintenance 5-8 mcg/kg/day divided BID.
Infant: Highly individualized. Initial loading dose (oral) 30-50 mcg/kg, maintenance 8-12 mcg/kg/day divided BID.
Child: Highly individualized. Initial loading dose (oral) 30-50 mcg/kg, maintenance 8-12 mcg/kg/day divided BID.
Adolescent: Similar to adult dosing, but individualized based on weight and renal function.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-79 mL/min: Reduce dose by 25-50% or extend dosing interval. Monitor serum levels.
Moderate: CrCl 30-49 mL/min: Reduce dose by 50-75% or extend dosing interval. Monitor serum levels.
Severe: CrCl <30 mL/min: Reduce dose by 75-87.5% or extend dosing interval significantly (e.g., 0.0625 mg every 2-3 days). Monitor serum levels closely.
Dialysis: Digoxin is minimally dialyzable. Dosing adjustments are based on residual renal function. No supplemental dose needed after dialysis.

Hepatic Impairment:

Mild: No specific adjustment needed as hepatic metabolism is minimal.
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, resulting in increased intracellular calcium. The increased intracellular calcium enhances the force of myocardial contraction (positive inotropic effect). Digoxin also increases vagal tone, leading to decreased heart rate and slowed conduction through the AV node, which is beneficial for rate control in atrial fibrillation.
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Pharmacokinetics

Absorption:

Bioavailability: 60-80% (tablets), 90-100% (elixir/capsules)
Tmax: 1-3 hours (oral tablets)
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 volume of distribution, concentrates in heart, kidney, skeletal muscle)
ProteinBinding: 20-30%
CnssPenetration: Limited (but can cause CNS 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% unchanged)
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: 60-80%
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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

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 resolve
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. 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 yellow or green halos around lights
  • Confusion or unusual changes in behavior
  • Slow pulse rate (below your target range, usually <60 beats per minute)
  • Irregular heartbeats or palpitations
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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 and its symptoms.
Other heart conditions you may have, as this medication may interact with them.
* If you have recently experienced a heart attack, as this may affect your treatment plan.

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 you determine if it is safe to take this medication in combination with your other treatments. Never 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 of digoxin levels in your blood. It is recommended to have your blood drawn before taking your daily dose of digoxin. 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 regulate your heart rhythm, make sure your doctor is aware 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 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, disorientation, delirium
  • Visual disturbances (more pronounced)
  • Hyperkalemia (especially in acute overdose)

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For suspected overdose, call Poison Control at 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)
  • Diltiazem (increases digoxin levels)
  • Quinidine (increases digoxin levels)
  • Propafenone (increases digoxin levels)
  • Macrolide antibiotics (e.g., clarithromycin, erythromycin - may increase digoxin levels by altering gut flora)
  • Cyclosporine (increases digoxin levels)
  • Spironolactone (may interfere with digoxin assay, also affects potassium)
  • Diuretics (especially loop and thiazide 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)
  • 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)
  • Cholestyramine (may decrease digoxin absorption)
  • Metoclopramide (may decrease digoxin absorption)
  • Rifampin (may decrease digoxin levels)
  • St. John's Wort (may decrease digoxin levels)
  • Thyroid hormones (may decrease digoxin effect)
  • Succinylcholine (may increase risk of arrhythmias)
  • Sympathomimetics (may increase risk of arrhythmias)
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Minor Interactions

  • Not available

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, CrCl)

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. Digoxin can cause various arrhythmias and conduction abnormalities.

Timing: Prior to initiation of therapy.

Thyroid Function Tests

Rationale: Hypothyroidism can increase digoxin levels, hyperthyroidism can decrease digoxin effect.

Timing: Consider if clinically indicated.

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Routine Monitoring

Serum Digoxin Concentration

Frequency: At least 7-14 days after initiation or dose change, then periodically (e.g., every 6-12 months) or if toxicity is suspected.

Target: 0.5-0.9 ng/mL for heart failure; 0.8-2.0 ng/mL for atrial fibrillation (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)

Frequency: Periodically, especially if on diuretics or if symptoms of toxicity arise.

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 toxicity risk; correct promptly.

Renal Function (BUN, Serum Creatinine)

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

Target: Within normal limits for age/baseline.

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

Heart Rate and Rhythm

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

Target: Individualized, typically 60-100 bpm for HF, or target rate for AF.

Action Threshold: Bradycardia (<60 bpm), irregular pulse, or new arrhythmias warrant investigation.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Anorexia
  • Diarrhea
  • Fatigue
  • Weakness
  • Headache
  • Dizziness
  • Confusion
  • Visual disturbances (blurred vision, yellow/green halos, scotomas)
  • Bradycardia
  • Palpitations
  • Irregular heart rhythm

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 or fetal tachyarrhythmias, it should be used with caution and close monitoring. Risk of fetal toxicity is low at therapeutic maternal levels.

Trimester-Specific Risks:

First Trimester: No clear evidence of teratogenicity.
Second Trimester: Generally considered safe for continued use if indicated.
Third Trimester: Generally considered safe for continued use if indicated. May be used for fetal tachyarrhythmias.
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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 (L3 - Moderately safe)
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Pediatric Use

Dosing is 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, electrolytes, and ECG is crucial.

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Geriatric Use

Elderly patients are more susceptible to digoxin toxicity due to age-related decline in renal function, lower lean body mass, and increased likelihood of polypharmacy and electrolyte imbalances. Lower initial doses and careful titration with frequent monitoring of serum levels and renal function are recommended.

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.
  • Clinical signs and symptoms of toxicity often precede elevated serum digoxin levels.
  • Digoxin Immune Fab (DigiFab) is the antidote for severe, life-threatening digoxin toxicity.
  • Always check renal function before initiating and periodically during digoxin therapy.
  • Be aware of numerous drug interactions, especially with P-glycoprotein inhibitors (e.g., amiodarone, verapamil, quinidine) which can significantly increase digoxin levels.
  • For chronic heart failure, digoxin is primarily used to reduce hospitalizations, not mortality. Its role is adjunctive to guideline-directed medical therapy (GDMT).
  • For atrial fibrillation, digoxin is effective for rate control, especially in patients with concomitant heart failure or sedentary lifestyle.
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Alternative Therapies

  • For heart failure with reduced ejection fraction (HFrEF): ACE inhibitors/ARBs/ARNI, beta-blockers, MRAs, SGLT2 inhibitors.
  • For rate control in atrial fibrillation: Beta-blockers (e.g., metoprolol, carvedilol), Calcium Channel Blockers (non-dihydropyridine, e.g., diltiazem, verapamil), Amiodarone (for rhythm control or refractory rate control).
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (0.125mg 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 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.