Milrinone 1mg/ml Inj, 50ml

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; Vasodilator
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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 medicine given through a vein (IV) to help your heart pump blood more effectively and to relax your blood vessels. It's used for a short time when your heart is very weak and struggling to pump enough blood to your body, often in the hospital setting.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. This drug is administered as an intravenous infusion, which means it is given slowly into a vein over a period of time.

For proper storage and disposal, consult with your doctor, nurse, or pharmacist if you need to keep this medication at home. They will provide guidance on how to store it safely.

If you miss a dose, contact your doctor immediately 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.
  • Strict fluid intake and output monitoring will be performed.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

acuteDecompensatedHeartFailure: Loading dose: 50 mcg/kg over 10 min. Maintenance infusion: 0.375-0.75 mcg/kg/min, adjusted based on hemodynamic response and tolerability. Total daily dose should not exceed 1.13 mg/kg.
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Pediatric Dosing

Neonatal: Loading dose: 50-75 mcg/kg over 30-60 minutes. Maintenance infusion: 0.25-0.75 mcg/kg/min.
Infant: Loading dose: 50-75 mcg/kg over 30-60 minutes. Maintenance infusion: 0.25-0.75 mcg/kg/min.
Child: Loading dose: 50-75 mcg/kg over 30-60 minutes. Maintenance infusion: 0.25-0.75 mcg/kg/min.
Adolescent: Loading dose: 50 mcg/kg over 10 minutes. Maintenance infusion: 0.375-0.75 mcg/kg/min.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-90 mL/min: No specific adjustment, but monitor closely.
Moderate: CrCl 20-50 mL/min: Maintenance infusion 0.25-0.5 mcg/kg/min.
Severe: CrCl <20 mL/min: Maintenance infusion 0.2-0.25 mcg/kg/min.
Dialysis: Consider lower doses and monitor closely; milrinone is not significantly removed by hemodialysis.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: No specific adjustment recommended. Milrinone is primarily renally eliminated.

Pharmacology

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Mechanism of Action

Milrinone is a positive inotrope and vasodilator, with little chronotropic activity. It exerts its effects by selectively inhibiting phosphodiesterase 3 (PDE3) in cardiac and vascular muscle. This inhibition leads to an increase in intracellular cyclic adenosine monophosphate (cAMP), which results in increased calcium influx into myocardial cells (positive inotropy) and relaxation of vascular smooth muscle (vasodilation).
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV administration)
Tmax: Rapid (within minutes of IV administration)
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: 0.38 L/kg (adults); 0.45-0.9 L/kg (pediatrics)
ProteinBinding: Approximately 70%
CnssPenetration: Limited

Elimination:

HalfLife: 2.3-2.4 hours (adults); 1.4-4.5 hours (pediatrics, varies with age)
Clearance: 0.13 L/kg/hr (adults)
ExcretionRoute: Renal (primarily)
Unchanged: Approximately 85% excreted unchanged in urine within 24 hours
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Pharmacodynamics

OnsetOfAction: 5-15 minutes (after loading dose)
PeakEffect: Within 10-60 minutes
DurationOfAction: Varies with infusion rate and renal function; typically 3-6 hours after discontinuation of infusion.

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 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:

  • Severe dizziness or fainting (signs of low blood pressure)
  • Fast, pounding, or irregular heartbeat (signs of arrhythmia)
  • Chest pain or discomfort
  • Shortness of breath
  • Headache
  • Nausea or vomiting
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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 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 medications and health issues. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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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. Regularly undergo blood work and other laboratory tests as directed by your doctor. Additionally, monitor your blood pressure and heart rate according to your doctor's instructions. 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.
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Overdose Information

Overdose Symptoms:

  • Profound hypotension (low blood pressure)
  • Cardiac arrhythmias (e.g., ventricular tachycardia, fibrillation)

What to Do:

Treatment is supportive. If hypotension occurs, reduce or discontinue milrinone administration. Fluid replacement and vasopressors may be used to support blood pressure. Correct electrolyte imbalances. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Disopyramide (may cause severe hypotension)
  • Furosemide (physical incompatibility, do not mix directly)
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Moderate Interactions

  • Other vasodilators (additive hypotensive effects)
  • Diuretics (may exacerbate hypokalemia, increasing risk of arrhythmias)
  • Calcium channel blockers (additive effects on cardiac contractility and blood pressure)

Monitoring

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Baseline Monitoring

Electrocardiogram (ECG)

Rationale: To assess for pre-existing arrhythmias and establish baseline cardiac rhythm.

Timing: Prior to initiation

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing.

Timing: Prior to initiation

Heart Rate (HR)

Rationale: To establish baseline and assess for tachycardia.

Timing: Prior to initiation

Renal Function (BUN, Creatinine, CrCl)

Rationale: Milrinone is primarily renally eliminated; renal impairment requires dose adjustment.

Timing: Prior to initiation

Electrolytes (Potassium, Magnesium)

Rationale: Hypokalemia and hypomagnesemia can increase the risk of arrhythmias; correct prior to infusion.

Timing: Prior to initiation

Fluid Status

Rationale: To optimize preload and prevent hypotension.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Continuously (invasive arterial line preferred)

Target: Maintain systolic BP >90 mmHg or as clinically indicated

Action Threshold: Hypotension (e.g., SBP <90 mmHg or significant drop from baseline); reduce infusion rate or discontinue.

Heart Rate (HR)

Frequency: Continuously (ECG monitor)

Target: Maintain within acceptable limits, avoid significant tachycardia

Action Threshold: Significant tachycardia or new onset arrhythmias; reduce infusion rate or discontinue.

Electrocardiogram (ECG)

Frequency: Continuous monitoring

Target: Normal sinus rhythm or stable baseline rhythm

Action Threshold: New onset or worsening arrhythmias (e.g., ventricular ectopy, non-sustained VT); reduce infusion rate or discontinue.

Fluid Balance (I&O, daily weights)

Frequency: Every 4-8 hours (I&O), daily (weights)

Target: Maintain euvolemia or achieve negative fluid balance as indicated

Action Threshold: Signs of fluid overload or dehydration; adjust fluid management.

Electrolytes (Potassium, Magnesium)

Frequency: Daily or more frequently if abnormal

Target: Potassium 4.0-5.0 mEq/L, Magnesium >2.0 mg/dL

Action Threshold: Hypokalemia or hypomagnesemia; replete electrolytes promptly.

Renal Function (BUN, Creatinine)

Frequency: Daily

Target: Stable or improving

Action Threshold: Worsening renal function; consider dose adjustment.

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Symptom Monitoring

  • Hypotension (dizziness, lightheadedness, syncope)
  • Arrhythmias (palpitations, chest discomfort, shortness of breath)
  • Headache
  • Tremor
  • Nausea/Vomiting
  • Chest pain (angina)

Special Patient Groups

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Pregnancy

Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for developmental toxicity based on animal studies.
Second Trimester: Potential for developmental toxicity based on animal studies.
Third Trimester: Potential for developmental toxicity based on animal studies.
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Lactation

L3 (Moderately Safe). 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: Potential for adverse effects on the infant, including cardiovascular effects. Monitor infant for signs of hypotension or arrhythmias.
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Pediatric Use

Milrinone has been used in pediatric patients with heart failure, including neonates, infants, and children. Dosing requires careful titration based on age, weight, and clinical response. Pharmacokinetics can vary significantly with age, especially in neonates and infants, requiring close monitoring of hemodynamic parameters and renal function.

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Geriatric Use

No specific dose adjustment is required based solely on age. However, elderly patients are more likely to have impaired renal function, which necessitates dose adjustment based on creatinine clearance. They may also be more susceptible to adverse effects like hypotension and arrhythmias, requiring careful monitoring.

Clinical Information

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Clinical Pearls

  • Milrinone is a potent vasodilator; monitor blood pressure continuously, preferably with an arterial line.
  • Correct hypokalemia and hypomagnesemia prior to and during milrinone infusion to minimize the risk of arrhythmias.
  • Dose adjustments are crucial in patients with renal impairment.
  • Do not mix milrinone with furosemide in the same IV line due to physical incompatibility (precipitation).
  • Milrinone is typically used for short-term therapy (e.g., 48-72 hours) in acute decompensated heart failure; long-term use is associated with increased mortality.
  • Monitor for signs of increased ventricular ectopy or other arrhythmias, especially in patients with pre-existing arrhythmias or electrolyte imbalances.
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Alternative Therapies

  • Dobutamine (beta-1 adrenergic agonist, positive inotrope)
  • Dopamine (dose-dependent effects, inotropic and vasopressor)
  • Levosimendan (calcium sensitizer, 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 50ml vial (1mg/ml)
Generic Available: Yes
Insurance Coverage: Tier 3 or Non-preferred Brand (if brand), Tier 1 or 2 (if 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 correct 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 quantity, and the time it was taken to ensure prompt and effective treatment.