Digoxin 0.0625mg Tablets (peach)

Manufacturer NOVITIUM PHARMA /ANI 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
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 help your heart beat stronger and more regularly. It can be used to treat heart failure, where your heart isn't pumping blood as efficiently as it should, or to control your heart rate if you have an 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, take it exactly 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 to feel better.

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 it in a bathroom. Keep all medications in a secure location, out of the reach of children and pets. 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 the best way to dispose of your medication, consult with your pharmacist, who may be aware of 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 digoxin exactly as prescribed, usually once a day, at the same time each day.
  • Do not skip doses or take extra doses.
  • If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. Do not double dose.
  • Learn to take your pulse (heart rate) and report if it's unusually slow (e.g., below 60 beats per minute) or irregular.
  • Maintain a balanced diet and adequate fluid intake, especially if taking diuretics, to prevent electrolyte imbalances (like low potassium) which can increase the risk of side effects.
  • Avoid taking antacids or certain laxatives within 2 hours of your digoxin dose, as they can interfere with absorption.
  • Inform all healthcare providers, including dentists, that you are taking digoxin.
  • Do not stop taking digoxin suddenly without consulting your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Maintenance dose typically 0.125 mg to 0.25 mg once daily for heart failure or atrial fibrillation, adjusted based on renal function and therapeutic drug monitoring. Loading doses (digitalization) vary.
Dose Range: 0.0625 - 0.5 mg

Condition-Specific Dosing:

heartFailure: 0.125 mg to 0.25 mg daily (maintenance), after loading dose of 0.5-1.5 mg total over 24 hours.
atrialFibrillation: 0.125 mg to 0.25 mg daily (maintenance), after loading dose of 0.5-1.5 mg total over 24 hours.
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Pediatric Dosing

Neonatal: Dosing highly individualized based on age, weight, and renal function. Typically 10-30 mcg/kg total digitalizing dose (TDD) orally, given in divided doses over 24 hours, followed by maintenance.
Infant: Dosing highly individualized based on age, weight, and renal function. Typically 30-50 mcg/kg TDD orally, given in divided doses over 24 hours, followed by maintenance.
Child: Dosing highly individualized based on age, weight, and renal function. Typically 20-40 mcg/kg TDD orally, given in divided doses over 24 hours, followed by maintenance.
Adolescent: Dosing highly individualized based on age, weight, and renal function. Typically 10-15 mcg/kg TDD orally, given in divided doses over 24 hours, followed by maintenance (often adult doses).
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-80 mL/min: Reduce dose by 25-50% or extend dosing interval.
Moderate: CrCl 10-50 mL/min: Reduce dose by 50-75% or extend dosing interval.
Severe: CrCl <10 mL/min: Reduce dose by 75-87.5% or extend dosing interval (e.g., 0.0625 mg every 48-72 hours).
Dialysis: Digoxin is not significantly 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

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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+/Ca2+ exchanger. The increased intracellular calcium enhances myocardial contractility (positive inotropy). In the heart's electrical system, it increases vagal tone, leading to decreased heart rate and prolonged AV nodal conduction (negative chronotropy and dromotropy), useful in atrial fibrillation.
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Pharmacokinetics

Absorption:

Bioavailability: 60-80% (oral tablets)
Tmax: 0.5-2 hours (onset of action), 4-6 hours (peak effect)
FoodEffect: Food may delay absorption but does not significantly affect the extent of absorption. High-fiber meals may decrease absorption.

Distribution:

Vd: 5-10 L/kg (large volume of distribution due to tissue binding, especially to skeletal muscle)
ProteinBinding: 20-30%
CnssPenetration: Limited

Elimination:

HalfLife: 36-48 hours (normal renal function); significantly prolonged in renal impairment (up to 3.5-5 days in anuric patients)
Clearance: Approximately 50-70 mL/min/1.73m² (primarily renal)
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: 50-70%
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Pharmacodynamics

OnsetOfAction: 0.5-2 hours (oral)
PeakEffect: 4-6 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 Immediately

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 medical attention right away:

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
  • Loss of appetite
  • Diarrhea
  • Unusual tiredness or weakness
  • Blurred vision or seeing yellow/green halos around lights
  • Confusion or unusual thoughts
  • Slow or irregular heartbeat
  • Dizziness or lightheadedness
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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 other 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 combination with your other medications and health conditions.

Remember, do not start, stop, or change 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 blood tests 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 absorption of the medication. 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.

Keep this medication out of 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, use this medication 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 and vomiting
  • Profound bradycardia (very slow heart rate)
  • Various cardiac arrhythmias (e.g., heart block, ventricular tachycardia, ventricular fibrillation)
  • Severe confusion or disorientation
  • Seizures
  • Coma

What to Do:

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

Drug Interactions

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Major Interactions

  • Amiodarone (increases digoxin levels significantly, requires digoxin dose reduction by 50%)
  • Verapamil (increases digoxin levels, requires digoxin dose reduction by 50%)
  • Quinidine (increases digoxin levels, requires digoxin dose reduction by 50%)
  • Dronedarone (increases digoxin levels, requires digoxin dose reduction by 50%)
  • Macrolide antibiotics (e.g., Clarithromycin, Erythromycin - may increase digoxin levels by altering gut flora)
  • Propafenone (increases digoxin levels)
  • Ritonavir (may increase digoxin levels)
  • Spironolactone (may increase or decrease digoxin levels, also interferes with digoxin assays)
  • Diuretics (especially loop and thiazide diuretics - can cause hypokalemia, increasing risk of digoxin toxicity)
  • Amphotericin B (can cause hypokalemia, increasing risk of digoxin toxicity)
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Moderate Interactions

  • Beta-blockers (additive bradycardia/AV block)
  • Calcium channel blockers (e.g., Diltiazem - additive bradycardia/AV block, also may increase digoxin levels)
  • Antacids, Kaolin-pectin, Cholestyramine, Metoclopramide (may decrease digoxin absorption)
  • Rifampin, Phenytoin, St. John's Wort (may decrease digoxin levels via P-gp induction)
  • NSAIDs (may impair renal function, indirectly increasing digoxin levels)
  • Corticosteroids (may cause hypokalemia)
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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 precipitate digoxin toxicity.

Timing: Prior to initiation of therapy.

Renal function (BUN, Serum Creatinine, eGFR/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 and conduction, and to identify pre-existing arrhythmias or conduction abnormalities.

Timing: Prior to initiation of therapy.

Digoxin serum concentration

Rationale: To establish a baseline level if a loading dose is given, or to guide maintenance dosing. Not always required at baseline if standard dosing is used.

Timing: At least 6-8 hours after the last dose (preferably 12-24 hours after) or after steady-state is achieved (approx. 1 week).

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Routine Monitoring

Digoxin serum concentration

Frequency: Periodically (e.g., every 6-12 months, or more frequently if dose changes, renal function changes, or drug interactions occur, or toxicity is suspected).

Target: Heart Failure: 0.5-0.9 ng/mL; Atrial Fibrillation: 0.8-2.0 ng/mL (some sources suggest lower for AFib too, e.g., <1.2 ng/mL).

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

Serum electrolytes (Potassium, Magnesium, Calcium)

Frequency: Periodically (e.g., every 3-6 months, or more frequently if on diuretics or with changes in renal function).

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 (BUN, Serum Creatinine, eGFR/CrCl)

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

Target: Normal ranges for age and sex.

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

Heart rate and rhythm

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

Target: Heart rate typically 60-100 bpm (or target for AFib rate control).

Action Threshold: Bradycardia (<60 bpm), irregular pulse, or new arrhythmias (e.g., PVCs, AV block) 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 (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. While it crosses the placenta, it has been used safely in pregnant women for decades to treat maternal heart failure, arrhythmias, and fetal supraventricular tachycardia. Risks to the fetus are generally low, but close monitoring is recommended.

Trimester-Specific Risks:

First Trimester: No evidence of increased risk of congenital malformations.
Second Trimester: Generally considered safe and effective for maternal and fetal indications.
Third Trimester: Generally considered safe and effective. Maternal digoxin levels may decrease in late pregnancy due to increased renal clearance, requiring dose adjustment.
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Lactation

Digoxin is considered compatible with breastfeeding (Lactation Risk Category L2). It is excreted into breast milk in small amounts, but infant exposure is typically well below therapeutic levels and adverse effects are rare. Monitor breastfed infants for signs of digoxin toxicity (e.g., bradycardia, vomiting).

Infant Risk: Low risk.
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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, have different pharmacokinetic parameters (e.g., larger volume of distribution, variable renal clearance) and are more susceptible to toxicity. Close monitoring of serum levels and clinical status is essential. Digoxin is used for heart failure and supraventricular tachyarrhythmias in children.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Digoxin has a narrow therapeutic index, meaning the difference between an effective dose and a toxic dose is small. Close monitoring is essential.
  • 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 (e.g., GI upset, visual disturbances, arrhythmias) are often more reliable indicators of toxicity than serum levels alone.
  • Digoxin serum levels should be drawn at least 6-8 hours (preferably 12-24 hours) after the last dose to allow for distribution into tissues and avoid falsely elevated levels.
  • Many common medications (e.g., amiodarone, verapamil, quinidine, macrolides) can significantly increase digoxin levels, necessitating dose reduction.
  • Digoxin is primarily renally eliminated; dose adjustments are critical in patients with impaired renal function.
  • While traditionally used for heart failure, its role has diminished with the advent of other therapies (ACEIs, ARBs, beta-blockers, MRAs). It is now primarily reserved for symptom control in patients with HFrEF who remain symptomatic despite optimal guideline-directed medical therapy, or for rate control in chronic atrial fibrillation.
  • The 0.0625 mg tablet strength is particularly useful for patients requiring very low doses, such as those with significant renal impairment or elderly patients.
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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), Calcium Channel Blockers (e.g., Verapamil, Diltiazem).
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (0.0625mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (preferred generic) or Tier 2 (non-preferred generic) on most insurance formularies.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it's a good idea 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 medication, including the amount taken and the time it happened, to help healthcare professionals provide the best possible care.