Milrinone 1mg/ml Inj, 10ml

Manufacturer FRESENIUS KABI Active Ingredient Milrinone(MIL ri none) Pronunciation MIL ri none
It is used to treat heart failure (weak heart).
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Drug Class
Inotropic agent
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Pharmacologic Class
Phosphodiesterase-3 (PDE3) inhibitor
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Pregnancy Category
Category C
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FDA Approved
Sep 1987
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Milrinone is a medication given intravenously (into a vein) to help your heart pump more strongly and to relax your blood vessels. It is used for a short time when your heart is very weak and needs extra help, often in a hospital setting.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all the information provided. Administration of this drug involves an infusion into a vein over a specified period of time.

For proper storage and disposal, consult with your doctor, nurse, or pharmacist if you need to keep this medication at home, as they can provide guidance on the correct storage procedures.

If you miss a dose, contact your doctor promptly to determine the best course of action.
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Lifestyle & Tips

  • This medication is administered in a hospital setting under close medical supervision.
  • Report any unusual symptoms immediately to your healthcare team.

Dosing & Administration

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Adult Dosing

Standard Dose: Loading dose: 50 mcg/kg IV over 10 minutes. Maintenance infusion: 0.375 to 0.75 mcg/kg/min IV.
Dose Range: 0.375 - 0.75 mg

Condition-Specific Dosing:

acuteDecompensatedHeartFailure: Loading dose: 50 mcg/kg IV over 10 minutes. Maintenance infusion: 0.375 to 0.75 mcg/kg/min IV, adjusted based on hemodynamic response and tolerance. Duration of therapy should be as short as possible.
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Pediatric Dosing

Neonatal: Loading dose: 50-75 mcg/kg IV over 30-60 minutes. Maintenance infusion: 0.2-0.75 mcg/kg/min IV. (Use with caution, limited data)
Infant: Loading dose: 50-75 mcg/kg IV over 30-60 minutes. Maintenance infusion: 0.2-0.75 mcg/kg/min IV. (Use with caution, limited data)
Child: Loading dose: 50-75 mcg/kg IV over 30-60 minutes. Maintenance infusion: 0.2-0.75 mcg/kg/min IV. (Use with caution, limited data)
Adolescent: Loading dose: 50-75 mcg/kg IV over 30-60 minutes. Maintenance infusion: 0.2-0.75 mcg/kg/min IV. (Use with caution, limited data)
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-90 mL/min: Maintenance infusion 0.43 mcg/kg/min.
Moderate: CrCl 20-49 mL/min: Maintenance infusion 0.28 mcg/kg/min.
Severe: CrCl <20 mL/min: Maintenance infusion 0.2 mcg/kg/min.
Dialysis: No specific recommendations for dialysis patients; dose adjustment based on CrCl is critical. Monitor closely.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: No specific adjustment recommended.

Pharmacology

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Mechanism of Action

Milrinone is a positive inotrope and vasodilator, with little chronotropic activity. It exerts its effects by inhibiting phosphodiesterase III (PDE3) in cardiac and vascular muscle. This inhibition leads to an increase in intracellular cyclic AMP (cAMP), which results in increased calcium influx into myocardial cells (enhancing contractility) and relaxation of vascular smooth muscle (vasodilation).
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV administration)
Tmax: Not applicable (IV infusion, peak effect reached rapidly after steady state)
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: 0.38 L/kg
ProteinBinding: Approximately 70%
CnssPenetration: Limited

Elimination:

HalfLife: 1.3 to 2.4 hours (prolonged in renal impairment)
Clearance: 0.13 L/kg/hr
ExcretionRoute: Renal (primarily)
Unchanged: Approximately 85% (in urine)
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Pharmacodynamics

OnsetOfAction: Within 5-15 minutes (after loading dose)
PeakEffect: Within 10-60 minutes (after loading dose)
DurationOfAction: Variable, dependent on infusion rate and renal function (typically hours after discontinuation)

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 immediate 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
* Fast or abnormal heartbeat

Other Possible Side Effects

Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have any side effects that bother you or do not go away, contact your doctor for advice.

Reporting Side Effects

This list does not include all possible side effects. If you have questions or concerns about side effects, talk to 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:

  • Feeling dizzy or lightheaded
  • Feeling your heart race or skip beats (palpitations)
  • Chest pain
  • Severe headache
  • Numbness or tingling in your hands or feet
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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 valve 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 conjunction with your other treatments and health issues.

Remember, do not start, stop, or modify 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. As directed by your doctor, regularly undergo blood tests and other laboratory assessments to monitor your condition. Additionally, check your blood pressure and heart rate as instructed by your doctor. If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor immediately. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Profound hypotension (very low blood pressure)
  • Cardiac arrhythmias (irregular heartbeats)

What to Do:

Treatment is supportive. If hypotension occurs, administer fluids and vasopressors. Continuous ECG and hemodynamic monitoring are essential. Call 1-800-222-1222 (Poison Control) for further guidance.

Drug Interactions

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Major Interactions

  • Disopyramide (risk of severe hypotension)
  • Furosemide (physical incompatibility, precipitate formation)
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Moderate Interactions

  • Other vasodilators (additive hypotensive effects)
  • Diuretics (may exacerbate hypokalemia, increasing arrhythmia risk)
  • Digoxin (may increase risk of arrhythmias, though often used together with careful monitoring)

Monitoring

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Baseline Monitoring

Fluid and Electrolyte Status (especially potassium)

Rationale: Hypokalemia should be corrected prior to or during milrinone administration to reduce the risk of arrhythmias.

Timing: Prior to initiation

Renal Function (serum creatinine, BUN, CrCl)

Rationale: Milrinone is primarily renally excreted; dose adjustments are necessary in renal impairment.

Timing: Prior to initiation

Hemodynamic Parameters (BP, HR, CVP, PCWP, CO)

Rationale: To establish baseline and guide initial dosing.

Timing: Prior to initiation

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Routine Monitoring

Electrocardiogram (ECG) monitoring

Frequency: Continuous

Target: Normal sinus rhythm, absence of significant arrhythmias

Action Threshold: Development of new or worsening ventricular arrhythmias (e.g., PVCs, VT, VF) requires immediate assessment and potential dose reduction or discontinuation.

Blood Pressure (BP)

Frequency: Continuous

Target: Maintain adequate perfusion pressure, avoid symptomatic hypotension

Action Threshold: Symptomatic hypotension or significant drop in BP requires dose reduction or discontinuation.

Heart Rate (HR)

Frequency: Continuous

Target: Maintain within acceptable limits

Action Threshold: Significant tachycardia or bradycardia.

Fluid and Electrolyte Status (especially potassium)

Frequency: Daily or more frequently as clinically indicated

Target: Potassium 3.5-5.0 mEq/L

Action Threshold: Hypokalemia requires correction.

Renal Function (serum creatinine, BUN)

Frequency: Daily or every other day, as clinically indicated

Target: Stable or improving renal function

Action Threshold: Worsening renal function may necessitate dose adjustment.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Palpitations
  • Chest pain
  • Shortness of breath
  • Headache
  • Nausea
  • Vomiting
  • Fever
  • Tremor

Special Patient Groups

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Pregnancy

Milrinone is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects at doses higher than human therapeutic doses.

Trimester-Specific Risks:

First Trimester: Potential for adverse developmental effects, though human data are limited.
Second Trimester: Potential for adverse developmental effects, though human data are limited.
Third Trimester: Potential for adverse developmental effects, though human data are limited. May affect fetal hemodynamics.
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Lactation

It is not known whether milrinone is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from milrinone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: Not available, potential for serious adverse reactions.
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Pediatric Use

Use in pediatric patients is off-label and based on limited data. Dosing is weight-based and requires careful titration. Neonates and infants may have different pharmacokinetic profiles. Close monitoring of hemodynamics, fluid balance, and electrolytes is crucial due to increased risk of hypotension and arrhythmias.

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Geriatric Use

No specific dose adjustment is required based solely on age, but elderly patients are more likely to have decreased renal function, which necessitates dose adjustment. They may also be more sensitive to the hypotensive and arrhythmogenic effects of milrinone. Close monitoring is essential.

Clinical Information

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Clinical Pearls

  • Milrinone is for short-term use in acute decompensated heart failure; long-term use is associated with increased mortality.
  • Correct hypokalemia and hypovolemia prior to and during milrinone administration to minimize arrhythmia risk and optimize hemodynamic response.
  • Monitor ECG continuously for arrhythmias, especially ventricular arrhythmias.
  • Monitor blood pressure closely; milrinone can cause significant hypotension.
  • Dose must be adjusted in patients with renal impairment.
  • Do not mix milrinone with furosemide in the same IV line due to physical incompatibility and precipitate formation.
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Alternative Therapies

  • Dobutamine (beta-1 adrenergic agonist, positive inotrope)
  • Dopamine (dose-dependent effects, inotropic and vasopressor)
  • Levosimendan (calcium sensitizer, K-ATP channel opener - not FDA approved in US)
  • Norepinephrine (vasopressor, some inotropic effect)
  • Epinephrine (inotropic and vasopressor)
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Cost & Coverage

Average Cost: Varies widely, typically $50-$200 per 10ml vial (1mg/ml)
Generic Available: Yes
Insurance Coverage: Tier 3 or 4 (Specialty/Non-preferred Brand, if applicable, but usually covered in hospital setting)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others or take someone else's medication.

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 to do so by a healthcare professional or pharmacist, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs, which can be an alternative disposal option.

Some medications may come with an additional patient information leaflet. Check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to 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, as this will aid in providing appropriate treatment.