Milrinone 1mg/ml Inj, 20ml

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
Dec 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 more strongly and to relax your blood vessels. This helps your heart work more efficiently and improves blood flow throughout your body. It's typically used for a short time when your heart isn't pumping enough blood, 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 accompanying information. Take this medication exactly as directed, and adhere to all guidelines provided. This drug is administered as an intravenous infusion, which means it is given through a vein over a specified period of time.

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

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

Dosing & Administration

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Adult Dosing

Standard Dose: Loading dose: 50 mcg/kg IV over 10 minutes, followed by continuous 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 IV over 10 minutes, followed by continuous infusion: 0.375 to 0.75 mcg/kg/min. Adjust infusion rate based on hemodynamic response and tolerability.
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Pediatric Dosing

Neonatal: Loading dose: 50-75 mcg/kg IV over 30-60 minutes, followed by continuous infusion: 0.25-0.75 mcg/kg/min. Dosing varies significantly based on gestational age, postnatal age, and clinical condition.
Infant: Loading dose: 50-75 mcg/kg IV over 30-60 minutes, followed by continuous infusion: 0.25-0.75 mcg/kg/min. Dosing varies significantly based on clinical condition.
Child: Loading dose: 50-75 mcg/kg IV over 30-60 minutes, followed by continuous infusion: 0.25-0.75 mcg/kg/min. Dosing varies significantly based on clinical condition.
Adolescent: Loading dose: 50-75 mcg/kg IV over 30-60 minutes, followed by continuous infusion: 0.25-0.75 mcg/kg/min. Dosing varies significantly based on clinical condition.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-90 mL/min: No specific adjustment, monitor closely.
Moderate: CrCl 20-49 mL/min: Infusion rate 0.25 mcg/kg/min.
Severe: CrCl <20 mL/min: Infusion rate 0.2 mcg/kg/min.
Dialysis: Consider lower doses and close monitoring as milrinone is not significantly removed by hemodialysis. Dosage adjustments based on residual renal function.

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 smooth muscle. This inhibition leads to an increase in intracellular cyclic adenosine monophosphate (cAMP). In the myocardium, increased cAMP results in enhanced calcium influx, leading to increased contractility (positive inotropic effect). In vascular smooth muscle, increased cAMP leads to relaxation, resulting in vasodilation (decreased preload and afterload).
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV administration)
Tmax: Not applicable (IV infusion, rapid onset)
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 hours (adults); 1.4-4.5 hours (pediatrics, varies with age)
Clearance: 0.13 L/kg/hr (adults)
ExcretionRoute: Renal (primarily unchanged)
Unchanged: Approximately 85% (within 24 hours)
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Pharmacodynamics

OnsetOfAction: Within 5-10 minutes (after loading dose)
PeakEffect: Within 10-60 minutes (after initiation of infusion)
DurationOfAction: Varies with infusion duration and renal function; effects dissipate within 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. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious reaction:

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. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any side effects that bother you or persist, 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:

  • Dizziness or lightheadedness (signs of low blood pressure)
  • Palpitations or a racing heart (signs of irregular heart rhythm)
  • Chest pain
  • 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 symptoms you experienced as a result of the allergy.
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 issues with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions.

Remember, do not start, stop, or adjust 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.
Regularly undergo blood work and other laboratory tests as directed by your doctor to monitor your condition.
Also, check your blood pressure and heart rate as instructed by your doctor to ensure your safety while taking this medication.
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. Discontinue or reduce milrinone infusion. Administer fluids and vasopressors (e.g., norepinephrine) to support blood pressure. Correct electrolyte imbalances. Continuous ECG monitoring. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Furosemide (precipitation when mixed directly in IV line)
  • Other inotropes/vasodilators (potential for additive hemodynamic effects, requiring close monitoring)
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Moderate Interactions

  • Digoxin (potential for additive effects on cardiac contractility, monitor for arrhythmias)
  • Antiarrhythmics (potential for increased risk of arrhythmias, especially ventricular)

Monitoring

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Baseline Monitoring

Electrolytes (especially potassium)

Rationale: Hypokalemia can increase the risk of arrhythmias; correct before or during milrinone therapy.

Timing: Prior to initiation

Renal function (BUN, creatinine, CrCl)

Rationale: Milrinone is primarily renally eliminated; dose adjustment required for impairment.

Timing: Prior to initiation

Blood pressure (BP)

Rationale: To establish baseline and monitor for hypotension.

Timing: Prior to initiation

Heart rate (HR) and ECG

Rationale: To establish baseline and monitor for arrhythmias.

Timing: Prior to initiation

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Routine Monitoring

Hemodynamic parameters (BP, HR, CVP, PAWP, Cardiac Output)

Frequency: Continuously or frequently (e.g., every 15-60 minutes initially, then as clinically indicated)

Target: Individualized based on patient's condition and therapeutic goals (e.g., MAP >65 mmHg, CI >2.2 L/min/m2)

Action Threshold: Significant hypotension (e.g., SBP <90 mmHg or symptomatic hypotension), tachycardia, or arrhythmias; adjust dose or discontinue.

ECG (continuous monitoring)

Frequency: Continuously

Target: Normal sinus rhythm, absence of significant arrhythmias

Action Threshold: Development of new or worsening arrhythmias (e.g., ventricular tachycardia, fibrillation); consider dose reduction or discontinuation.

Electrolytes (especially potassium and magnesium)

Frequency: Daily or more frequently if abnormalities detected

Target: Potassium 4.0-5.0 mEq/L, Magnesium 1.8-2.5 mg/dL

Action Threshold: Hypokalemia or hypomagnesemia; replete electrolytes promptly.

Fluid balance (urine output, daily weights)

Frequency: Every 4-8 hours for urine output, daily for weights

Target: Adequate urine output (>0.5 mL/kg/hr), stable or decreasing weight (if fluid overloaded)

Action Threshold: Oliguria, anuria, or significant fluid retention; assess renal function and fluid status.

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Symptom Monitoring

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

Special Patient Groups

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Pregnancy

Category C. Milrinone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects at high doses.

Trimester-Specific Risks:

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

L3 (Moderately safe). Milrinone is excreted into breast milk in animals. It is unknown if it is excreted in human milk. Caution should be exercised when milrinone is administered to a nursing mother. Consider the benefits of breastfeeding versus the potential risks to the infant.

Infant Risk: Potential for adverse effects on infant cardiovascular system. Monitor infant for signs of hypotension or arrhythmias.
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Pediatric Use

Milrinone has been used in pediatric patients for acute heart failure, including neonates, infants, and children. Dosing is weight-based and often requires careful titration. Pharmacokinetics can vary significantly with age, especially in neonates, leading to longer half-lives and requiring lower doses or longer dosing intervals. Close hemodynamic and ECG monitoring is essential.

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Geriatric Use

No specific dose adjustment is required based solely on age, but elderly patients are more likely to have impaired renal function. Dosage adjustments should be made based on renal function (CrCl) in elderly patients. They may also be more sensitive to the hypotensive effects.

Clinical Information

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Clinical Pearls

  • Milrinone is a potent inodilator; monitor blood pressure and heart rate closely, especially during the loading dose.
  • Correct hypokalemia prior to or during milrinone administration to minimize the risk of arrhythmias.
  • Dose must be adjusted for renal impairment; calculate creatinine clearance before initiating therapy.
  • Do not mix milrinone directly with furosemide in the same IV line due to precipitation.
  • Long-term oral use of milrinone in chronic heart failure is associated with increased mortality and is contraindicated.
  • Often used as a bridge to transplant or mechanical circulatory support in severe heart failure.
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Alternative Therapies

  • Dobutamine (beta-1 adrenergic agonist, positive inotrope)
  • Dopamine (dose-dependent effects, inotropic at moderate doses)
  • Norepinephrine (vasopressor, some inotropic effect)
  • Levosimendan (calcium sensitizer, inodilator - not FDA approved in US)
  • Digoxin (cardiac glycoside, positive inotrope)
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Cost & Coverage

Average Cost: Not available Not available
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 the reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed otherwise, do not flush medications down the toilet or drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. 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 medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion.