Lanoxin Ped 0.1mg/ml Inj, 1ml

Manufacturer COVIS PHARMA Active Ingredient Digoxin Injection(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 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Digoxin is a medicine used to strengthen the heart's pumping ability and to help control an irregular heartbeat. It works by affecting certain chemicals in the heart muscle. It's often used for heart failure and certain types of irregular heart rhythms like atrial fibrillation.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and be sure to follow all instructions provided. This medication is administered via injection into a muscle or vein.

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.

If you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
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Lifestyle & Tips

  • Take medication exactly as prescribed, do not miss doses.
  • Report any signs of toxicity (nausea, vomiting, vision changes, extreme tiredness, slow or irregular heartbeat) immediately to your doctor.
  • Maintain a balanced diet and adequate fluid intake to prevent electrolyte imbalances, especially if also taking diuretics.
  • Avoid sudden changes in diet or use of herbal supplements without consulting your doctor, as some can interact with digoxin.
  • Regularly monitor your pulse as instructed by your healthcare provider.

Dosing & Administration

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Adult Dosing

Standard Dose: Rapid Digitalization (IV): 0.4-0.6 mg initially, then 0.1-0.3 mg every 6-8 hours until desired effect (total 0.8-1.2 mg). Maintenance (IV): 0.125-0.25 mg daily.
Dose Range: 0.125 - 1.2 mg

Condition-Specific Dosing:

heartFailure: Maintenance: 0.125-0.25 mg IV daily, target serum concentration 0.5-0.9 ng/mL.
atrialFibrillation: Maintenance: 0.125-0.25 mg IV daily, target serum concentration 1.0-2.0 ng/mL for rate control.
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Pediatric Dosing

Neonatal: Total Digitalizing Dose (IV): Premature: 15-25 mcg/kg; Full-term: 20-30 mcg/kg. Administer 50% initially, then 25% every 6-8 hours for 2 doses. Maintenance Dose (IV): Premature: 4-6 mcg/kg/day; Full-term: 5-8 mcg/kg/day (divided q12-24h).
Infant: Total Digitalizing Dose (IV, 1 month-2 years): 30-50 mcg/kg. Administer 50% initially, then 25% every 6-8 hours for 2 doses. Maintenance Dose (IV): 8-12 mcg/kg/day (divided q12-24h).
Child: Total Digitalizing Dose (IV, 2-5 years): 25-35 mcg/kg; (5-10 years): 15-30 mcg/kg. Administer 50% initially, then 25% every 6-8 hours for 2 doses. Maintenance Dose (IV): 2-5 years: 7-10 mcg/kg/day; 5-10 years: 4-8 mcg/kg/day (divided q12-24h).
Adolescent: Total Digitalizing Dose (IV, >10 years): 8-12 mcg/kg (max 0.8-1.2 mg). Administer 50% initially, then 25% every 6-8 hours for 2 doses. Maintenance Dose (IV): 2.5-5 mcg/kg/day (max 0.125-0.25 mg/day).
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-70 mL/min: Reduce dose by 25-50% or extend interval to 36 hours.
Moderate: CrCl 10-50 mL/min: Reduce dose by 50-75% or extend interval to 48 hours.
Severe: CrCl <10 mL/min: Reduce dose by 75-85% or extend interval to 72 hours or longer.
Dialysis: Not significantly removed by hemodialysis. Administer after dialysis if given on dialysis days. Dose adjustment based on CrCl is primary.

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 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 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: 100% (IV)
Tmax: 1-4 hours (for peak effect after IV administration, due to distribution phase)
FoodEffect: Not applicable for IV administration.

Distribution:

Vd: 4-7 L/kg (adults); higher in children (up to 10 L/kg in infants)
ProteinBinding: 20-30%
CnssPenetration: Limited

Elimination:

HalfLife: 36-48 hours (normal renal function); significantly prolonged in renal impairment (up to 4-5 days)
Clearance: Primarily renal clearance, proportional to creatinine clearance
ExcretionRoute: Renal (glomerular filtration and tubular secretion)
Unchanged: 50-70%
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Pharmacodynamics

OnsetOfAction: 5-30 minutes (IV)
PeakEffect: 1-4 hours (IV)
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

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

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
Upset stomach or vomiting
Diarrhea that persists
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. Although 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 unusual symptoms, contact your doctor for advice:

For all uses of this medication:
+ Dizziness or headache
+ Stomach pain
* If you receive this medication as an injection in the muscle:
+ Pain at the injection site

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact 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 pulse rate (bradycardia)
  • Irregular heartbeat 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 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 treatment.

This medication can interact with other medications and 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 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 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.

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 are scheduled to undergo a cardioversion procedure to restore a normal heart rhythm, inform your doctor that you are taking this medication. Your doctor needs to be aware of this to provide appropriate care.

Keep this medication out of the 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.

When administering this medication to children, use it with caution, as the risk of certain side effects may be higher in this population.

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 bradycardia
  • Various cardiac arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, severe AV block, junctional tachycardia)
  • Profound nausea, vomiting, and abdominal pain
  • Lethargy, confusion, seizures
  • Hyperkalemia (especially in acute overdose)

What to Do:

Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Treatment may involve activated charcoal (if oral), atropine for bradycardia, temporary pacing, correction of electrolyte imbalances, and Digoxin Immune Fab (DigiFab) for severe or life-threatening toxicity.

Drug Interactions

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Contraindicated Interactions

  • Ventricular fibrillation
  • Known hypersensitivity to digoxin or other digitalis preparations
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Major Interactions

  • Amiodarone (increases digoxin levels significantly, reduce digoxin dose by 50%)
  • Verapamil, Diltiazem (increase digoxin levels, reduce digoxin dose by 25-50%)
  • Quinidine (increases digoxin levels, reduce digoxin dose by 50%)
  • Propafenone (increases digoxin levels)
  • Spironolactone (increases digoxin levels, interferes with digoxin assays)
  • Macrolide antibiotics (e.g., clarithromycin, erythromycin - increase digoxin levels via gut flora alteration or P-gp inhibition)
  • Cyclosporine (increases digoxin levels)
  • Itraconazole, Posaconazole (increase digoxin levels)
  • Ritonavir (increases digoxin levels)
  • Diuretics (loop and thiazide) causing hypokalemia/hypomagnesemia (increase risk of digoxin toxicity)
  • Amphotericin B (increases risk of hypokalemia and digoxin toxicity)
  • Succinylcholine (may cause arrhythmias with digoxin toxicity)
  • IV Calcium (rapid administration may precipitate arrhythmias in digitalized patients)
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Moderate Interactions

  • Beta-blockers (additive bradycardia/AV block)
  • ACE inhibitors/ARBs (may increase digoxin levels slightly, or reduce potassium, requiring monitoring)
  • NSAIDs (may impair renal function, indirectly affecting digoxin clearance)
  • Rifampin (decreases digoxin levels)
  • Metoclopramide (decreases digoxin absorption)
  • Cholestyramine, Colestipol (decrease digoxin absorption)
  • St. John's Wort (decreases digoxin levels)
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Minor Interactions

  • Antacids (may slightly decrease absorption if given orally, not relevant for IV)

Monitoring

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Baseline Monitoring

Serum Electrolytes (Potassium, Magnesium, Calcium)

Rationale: Electrolyte imbalances, particularly hypokalemia, hypomagnesemia, and hypercalcemia, can precipitate or worsen digoxin toxicity.

Timing: Prior to initiation of therapy.

Renal Function (BUN, Serum Creatinine, eGFR/CrCl)

Rationale: Digoxin is primarily renally cleared; impaired renal function necessitates dose adjustment and increases risk of accumulation.

Timing: Prior to initiation of therapy.

Electrocardiogram (ECG)

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

Timing: Prior to initiation of therapy.

Heart Rate and Rhythm

Rationale: To establish baseline and guide dosing, especially for rate control in atrial fibrillation.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Digoxin Serum Concentration

Frequency: At steady state (typically 5-7 days after initiation or dose change), then periodically (e.g., every 6-12 months) or if toxicity is suspected, or if renal function changes, or interacting drugs are added/removed.

Target: 0.5-0.9 ng/mL for heart failure; 1.0-2.0 ng/mL for rate control in atrial fibrillation (individualized based on clinical response and tolerability). Levels should be drawn at least 6-8 hours after the last dose (trough).

Action Threshold: Levels >2.0 ng/mL are often associated with toxicity; any level with signs/symptoms of toxicity warrants immediate evaluation and dose adjustment/cessation.

Serum Electrolytes (Potassium, Magnesium, Calcium)

Frequency: Periodically (e.g., every 1-3 months or as clinically indicated), especially 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 deviation from normal range, particularly hypokalemia or hypomagnesemia, requires prompt correction and re-evaluation of digoxin therapy.

Renal Function (BUN, Serum Creatinine, eGFR/CrCl)

Frequency: Periodically (e.g., every 3-6 months or as clinically indicated), especially in elderly patients or those with comorbidities affecting renal function.

Target: Stable renal function within normal limits or as expected for patient's baseline.

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

Heart Rate and Rhythm (ECG if indicated)

Frequency: Daily during digitalization, then regularly during maintenance. ECG if new arrhythmias or conduction disturbances are suspected.

Target: Heart rate appropriate for clinical condition (e.g., 60-90 bpm for AFib rate control).

Action Threshold: Bradycardia (<60 bpm in adults, or age-appropriate in children), new arrhythmias (e.g., PVCs, AV block, ventricular tachycardia), or worsening heart block.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Anorexia
  • Diarrhea
  • Fatigue
  • Weakness
  • Headache
  • Dizziness
  • Confusion
  • Delirium
  • Visual disturbances (e.g., blurred vision, yellow-green halos, scotomas)
  • Cardiac arrhythmias (e.g., bradycardia, AV block, premature ventricular contractions, ventricular tachycardia, junctional rhythm)

Special Patient Groups

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Pregnancy

Digoxin is classified as Pregnancy Category C. It crosses the placenta. Use during pregnancy is generally considered if the clinical benefit to the mother outweighs the potential risk to the fetus. It has been used to treat fetal tachyarrhythmias.

Trimester-Specific Risks:

First Trimester: Limited data, but no clear evidence of teratogenicity.
Second Trimester: Generally considered safe for use if indicated, with careful monitoring.
Third Trimester: Generally considered safe for use if indicated, with careful monitoring. Fetal heart rate and rhythm should be monitored.
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Lactation

Digoxin is excreted in breast milk in small amounts. The amount ingested by the infant is generally considered to be subtherapeutic and unlikely to cause adverse effects. It is generally considered compatible with breastfeeding (Lactation Risk L2).

Infant Risk: Low risk. Monitor breastfed infant for signs of digoxin toxicity (e.g., bradycardia, vomiting, lethargy), though unlikely.
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Pediatric Use

Pediatric patients, especially neonates and infants, have different pharmacokinetic parameters (e.g., higher volume of distribution, variable renal clearance) and a narrower therapeutic index compared to adults. Dosing must be carefully calculated based on age, weight, and renal function. Close monitoring of serum digoxin levels, electrolytes, and cardiac rhythm is crucial due to the high risk of toxicity.

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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 sensitivity to the drug's effects. Lower initial doses and careful titration are recommended. Close monitoring of renal function, electrolytes, and digoxin levels is essential.

Clinical Information

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Clinical Pearls

  • Digoxin has a narrow therapeutic index; careful dosing and monitoring are paramount.
  • Hypokalemia, hypomagnesemia, and hypercalcemia significantly increase the risk of digoxin toxicity. Always correct electrolyte imbalances before or during digoxin therapy.
  • Renal function is the primary determinant of digoxin clearance; dose adjustments are critical in renal impairment.
  • Many common medications (e.g., amiodarone, verapamil, quinidine) significantly increase digoxin levels, requiring substantial dose reductions.
  • Clinical signs and symptoms of toxicity (GI, visual, neurological, cardiac) often precede elevated serum levels.
  • In acute digoxin toxicity, hyperkalemia is common and can be life-threatening. In chronic toxicity, hypokalemia is more common.
  • 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, MRAs (e.g., spironolactone, eplerenone), SGLT2 inhibitors, ARNI (sacubitril/valsartan), Ivabradine.
  • For rate control in atrial fibrillation: Beta-blockers (e.g., metoprolol, carvedilol), Calcium channel blockers (e.g., verapamil, diltiazem), Amiodarone (for rhythm control or refractory rate control).
  • For supraventricular tachycardias: Adenosine, beta-blockers, calcium channel blockers, antiarrhythmics (e.g., flecainide, propafenone, sotalol, amiodarone).
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Cost & Coverage

Average Cost: Varies widely by pharmacy and dosage form per 1ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed otherwise, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper disposal method, consult your pharmacist for guidance. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.