Digoxin 50 Mcg/ml (0.05 Mg/ml) Drp

Manufacturer VISTAPHARM Active Ingredient Digoxin Oral Solution(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
Antiarrhythmic; Inotropic agent
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Pharmacologic Class
Cardiac glycoside
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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 medicine 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 these steps:

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.

When taking a liquid dose, make sure to:

Measure the dose carefully using the measuring device provided with the medication.
If a measuring device is not included, ask your pharmacist for one to ensure accurate dosing.

Storing and Disposing of Your Medication

To keep your medication safe and effective:

Store it at room temperature, away from direct light.
Keep it in a dry place, avoiding bathrooms and other areas with high humidity.
Store all medications in a secure location, out of reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in local drug take-back programs.

What to Do If You Miss a Dose

If you miss a dose, follow these steps:

Take the missed dose as soon as you remember.
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 medicine at the same time each day.
  • Do not stop taking digoxin without talking to 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 sudden changes in diet, especially those high in fiber, as they can affect absorption.
  • 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: Loading dose: 0.5-1.5 mg total, given in divided doses over 24 hours. Maintenance dose: 0.125-0.25 mg once daily.
Dose Range: 0.0625 - 0.5 mg

Condition-Specific Dosing:

heartFailure: Maintenance dose typically 0.125 mg daily, adjusted based on renal function and serum levels.
atrialFibrillation: Maintenance dose typically 0.125-0.25 mg daily, adjusted to achieve desired ventricular rate control and serum levels.
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Pediatric Dosing

Neonatal: Premature: Loading 15-25 mcg/kg PO/IV. Full-term: Loading 20-30 mcg/kg PO/IV. Maintenance: 20-30% of loading dose daily in 2 divided doses.
Infant: 1-24 months: Loading 30-50 mcg/kg PO/IV. Maintenance: 25-35% of loading dose daily in 2 divided doses.
Child: 2-5 years: Loading 25-35 mcg/kg PO/IV. Maintenance: 25-35% of loading dose daily in 2 divided doses. 5-10 years: Loading 15-30 mcg/kg PO/IV. Maintenance: 25-35% of loading dose daily in 2 divided doses.
Adolescent: Over 10 years: Loading 10-15 mcg/kg PO/IV (max 1 mg). Maintenance: 0.125-0.25 mg daily.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-79 mL/min: Reduce maintenance dose by 25-50% or extend dosing interval.
Moderate: CrCl 30-49 mL/min: Reduce maintenance dose by 50-75% or extend dosing interval.
Severe: CrCl <30 mL/min: Reduce maintenance dose by 75-87.5% or extend dosing interval (e.g., every 48-72 hours).
Dialysis: Digoxin is not significantly removed by hemodialysis. Dose adjustment needed based on residual renal function. Administer after dialysis.

Hepatic Impairment:

Mild: No specific adjustment typically needed as hepatic metabolism is minor.
Moderate: No specific adjustment typically needed.
Severe: No specific adjustment typically 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 the contractility of the cardiac muscle (positive inotropic effect). It also increases vagal tone, leading to decreased heart rate (negative chronotropic effect) and decreased conduction velocity through the AV node (negative dromotropic effect).
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Pharmacokinetics

Absorption:

Bioavailability: Oral solution: 70-85%
Tmax: Oral solution: 0.5-2 hours
FoodEffect: Food may delay absorption but does not significantly affect the extent of absorption. High-fiber meals may decrease absorption.

Distribution:

Vd: Adults: 5-7 L/kg; Children: 7-16 L/kg (higher in infants)
ProteinBinding: 20-30%
CnssPenetration: Limited

Elimination:

HalfLife: Adults (normal renal function): 36-48 hours; Anuric patients: 4-5 days
Clearance: Primarily renal clearance, proportional to creatinine clearance.
ExcretionRoute: Renal (unchanged drug)
Unchanged: 50-70%
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Pharmacodynamics

OnsetOfAction: Oral solution: 15-30 minutes
PeakEffect: Oral solution: 2-6 hours
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 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 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 (common early signs of toxicity)
  • Unusual tiredness, weakness, or confusion
  • Blurred vision, seeing yellow or green halos around lights, or other visual disturbances
  • Slow or irregular heartbeat, palpitations, or fainting spells
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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 list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you 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 dose 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 your safety while taking this drug, 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 crucial 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 vital 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 prevent accidental exposure, keep this medication out of the reach of children, as ingestion can be fatal. If a child accidentally takes this drug, 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. It is necessary to discuss the potential benefits and risks of taking 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., AV block, ventricular tachycardia, ventricular fibrillation)
  • Lethargy, confusion, disorientation, seizures
  • Hyperkalemia (especially in acute overdose)

What to Do:

Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Treatment may include activated charcoal (if acute ingestion), correction of electrolyte imbalances, antiarrhythmics, and in severe cases, Digoxin Immune Fab (DigiFab) fragments.

Drug Interactions

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Major Interactions

  • Amiodarone (increases digoxin levels significantly)
  • Dronedarone (increases digoxin levels)
  • Quinidine (increases digoxin levels)
  • Verapamil (increases digoxin levels)
  • Diltiazem (increases digoxin levels)
  • Propafenone (increases digoxin levels)
  • Macrolide antibiotics (e.g., Clarithromycin, Erythromycin - can increase digoxin levels by altering gut flora)
  • Tetracycline antibiotics (can increase digoxin levels by altering gut flora)
  • Cyclosporine (increases digoxin levels)
  • Spironolactone (can interfere with digoxin assays and increase levels)
  • Ritonavir (increases digoxin levels)
  • St. John's Wort (decreases digoxin levels)
  • Rifampin (decreases digoxin levels)
  • Cholestyramine (decreases digoxin absorption)
  • Antacids (decreases digoxin absorption)
  • Kaolin-pectin (decreases digoxin absorption)
  • Sucralfate (decreases digoxin absorption)
  • Diuretics (especially loop and thiazide diuretics - can cause hypokalemia, increasing digoxin toxicity risk)
  • Amphotericin B (can cause hypokalemia, increasing digoxin toxicity risk)
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Moderate Interactions

  • Beta-blockers (additive bradycardia)
  • Calcium supplements (hypercalcemia can potentiate digoxin toxicity)
  • ACE inhibitors/ARBs (may increase potassium, potentially reducing digoxin effect, but also reduce renal clearance of digoxin in some cases)
  • NSAIDs (may impair renal function, affecting digoxin clearance)
  • Metoclopramide (may decrease digoxin absorption)
  • Omeprazole (may increase digoxin levels)
  • Carvedilol (increases digoxin levels)
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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 or worsen digoxin toxicity.

Timing: Before initiation and periodically during therapy.

Renal function (BUN, Creatinine, eGFR/CrCl)

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

Timing: Before initiation and periodically during therapy.

Thyroid function tests (TSH)

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

Timing: Before initiation.

ECG

Rationale: To assess baseline cardiac rhythm, PR interval, and QTc interval. Digoxin can cause various arrhythmias and conduction abnormalities.

Timing: Before initiation.

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Routine Monitoring

Serum Digoxin Concentration (SDC)

Frequency: At least 7-14 days after initiation or dose change, then every 6-12 months, or more frequently if toxicity is suspected or renal function changes.

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 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 deviation, particularly hypokalemia, requires immediate correction.

Renal function (BUN, Creatinine)

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

Target: Normal ranges.

Action Threshold: Significant changes warrant digoxin dose adjustment.

Heart Rate and Rhythm

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

Target: Individualized, typically 60-100 bpm for adults (or target for AF rate control).

Action Threshold: Bradycardia (<60 bpm in adults), irregular pulse, or new arrhythmias should prompt evaluation.

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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 (bradycardia, AV block, premature ventricular contractions, ventricular tachycardia, ventricular fibrillation)

Special Patient Groups

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Pregnancy

Digoxin is Pregnancy Category C. While it crosses the placenta, it has been used safely in pregnant women for cardiac conditions. Fetal monitoring for heart rate and rhythm is recommended. Dosage may need adjustment due to increased renal clearance during pregnancy.

Trimester-Specific Risks:

First Trimester: No clear evidence of teratogenicity.
Second Trimester: Generally considered safe for use if indicated.
Third Trimester: Dosage may need to be increased due to increased volume of distribution and renal clearance. Monitor maternal serum levels and fetal heart rate.
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Lactation

Digoxin is excreted into breast milk in small amounts. The amount ingested by the infant is generally considered clinically insignificant. Monitor breastfed infants for signs of digoxin toxicity (e.g., bradycardia, vomiting).

Infant Risk: L3 (Moderately Safe) - Low risk of adverse effects to the infant. Monitor infant for signs of toxicity.
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Pediatric Use

Dosing is weight-based and varies significantly by age group (neonates, infants, children, adolescents). Neonates and infants have a higher volume of distribution and may require higher mg/kg doses. Close monitoring of serum levels, heart rate, and ECG is crucial due to narrow therapeutic index and variability in pharmacokinetics.

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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 creatinine clearance estimation), 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 essential.

Clinical Information

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Clinical Pearls

  • Digoxin has a narrow therapeutic index; careful dosing and monitoring are critical.
  • Toxicity can occur even within the 'therapeutic' range, especially with electrolyte disturbances (hypokalemia, hypomagnesemia, hypercalcemia).
  • Always check serum potassium, magnesium, and renal function before initiating and regularly during therapy.
  • Many drugs interact with digoxin, particularly those affecting P-glycoprotein or renal function. Review all concomitant medications.
  • The oral solution (0.05 mg/mL) is often preferred for pediatric patients or those requiring precise dose adjustments.
  • Symptoms of toxicity can be vague (GI upset, fatigue) or severe (cardiac arrhythmias, visual disturbances).
  • Digoxin Immune Fab (DigiFab) is the antidote for severe, life-threatening digoxin toxicity.
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Alternative Therapies

  • For Heart Failure: ACE inhibitors, ARBs, Beta-blockers, Mineralocorticoid Receptor Antagonists (MRAs), SGLT2 inhibitors, ARNI (Sacubitril/Valsartan), Ivabradine.
  • For Atrial Fibrillation (rate control): Beta-blockers (e.g., Metoprolol, Atenolol), Calcium Channel Blockers (e.g., Verapamil, Diltiazem), Amiodarone (for rhythm control or refractory rate control).
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Cost & Coverage

Average Cost: Varies widely per bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (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.