Milrinone Dw5 Inj, 200ml

Manufacturer BAXTER MEDICATION DELIVERY 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 medication given by IV infusion in the hospital 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, especially when your heart is very weak.
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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 follow all instructions provided. This drug is administered as an intravenous infusion, which means it is given into a vein over a 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 what to do next.
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Lifestyle & Tips

  • This medication is administered in a hospital setting, typically in an intensive care unit. Lifestyle modifications are not directly applicable during treatment.
  • Patients should follow all instructions from their healthcare team regarding activity, diet, and fluid restrictions.

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:

Acute Decompensated Heart Failure: 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. Max total daily dose: 1.13 mg/kg.
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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. Titrate to effect.
Infant: Loading dose: 50-75 mcg/kg IV over 30-60 minutes. Maintenance infusion: 0.2-0.75 mcg/kg/min IV. Titrate to effect.
Child: Loading dose: 50-75 mcg/kg IV over 30-60 minutes. Maintenance infusion: 0.2-0.75 mcg/kg/min IV. Titrate to effect.
Adolescent: Loading dose: 50 mcg/kg IV over 10 minutes. Maintenance infusion: 0.375 to 0.75 mcg/kg/min IV. Titrate to effect.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-80 mL/min: Maintenance infusion 0.375 mcg/kg/min.
Moderate: CrCl 20-49 mL/min: Maintenance infusion 0.25 mcg/kg/min.
Severe: CrCl <20 mL/min: Maintenance infusion 0.2 mcg/kg/min.
Dialysis: Not well studied, but significant dose reduction likely required. 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. Use with caution due to potential for altered drug metabolism and excretion.

Pharmacology

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Mechanism of Action

Milrinone is a selective phosphodiesterase-3 (PDE3) inhibitor. By inhibiting PDE3, it prevents the breakdown of cyclic adenosine monophosphate (cAMP) in cardiac and vascular smooth muscle cells. This leads to increased intracellular cAMP levels, resulting in: 1) Positive inotropy: Increased calcium influx into myocardial cells, enhancing myocardial contractility. 2) Vasodilation: Relaxation of vascular smooth muscle, leading to decreased preload (pulmonary capillary wedge pressure) and afterload (systemic vascular resistance).
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV administration)
Tmax: Not applicable (IV infusion, immediate effect)
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 with normal renal function); significantly prolonged in renal impairment (up to 4.8 hours in severe renal impairment)
Clearance: 0.13 L/kg/hr (adults)
ExcretionRoute: Renal (approximately 85% as unchanged drug or its O-glucuronide metabolite)
Unchanged: Approximately 83% (in urine)
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Pharmacodynamics

OnsetOfAction: 5-15 minutes (after loading dose)
PeakEffect: 10-60 minutes
DurationOfAction: Variable, dependent on infusion rate and renal function (typically 3-6 hours after discontinuation of infusion in patients with normal renal function)

Safety & Warnings

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Side Effects

WHAT ARE SOME SIDE EFFECTS THAT I NEED TO CALL MY DOCTOR ABOUT RIGHT AWAY? WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:Signs of an allergic reaction, like 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; or swelling of the mouth, face, lips, tongue, or throat.Severe dizziness or passing out. Fast or abnormal heartbeat. WHAT ARE SOME OTHER SIDE EFFECTS OF THIS DRUG? All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.You may report side effects to the FDA at 1- 800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Feeling dizzy or lightheaded
  • Feeling like your heart is racing or skipping beats (palpitations)
  • Chest pain or discomfort
  • Headache
  • Nausea or vomiting
  • Any new or worsening symptoms
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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 and its symptoms.
If you have a history of heart valve problems or have recently experienced 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 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. 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.
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Overdose Information

Overdose Symptoms:

  • Severe hypotension (very low blood pressure)
  • Ventricular arrhythmias (abnormal heart rhythms, potentially life-threatening)

What to Do:

Treatment is supportive. If hypotension occurs, milrinone administration should be reduced or discontinued. General measures to support circulation should be taken, such as fluid replacement and vasopressors if necessary. Close monitoring of cardiac rhythm is essential. Call 1-800-222-1222 (Poison Control) for further guidance.

Drug Interactions

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Major Interactions

  • Disopyramide (risk of severe hypotension and arrhythmias)
  • Furosemide (physical incompatibility, precipitate formation if mixed directly)
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Moderate Interactions

  • Other vasodilators (e.g., nitrates, ACE inhibitors, ARBs): May cause additive hypotensive effects.
  • Other inotropes (e.g., dobutamine, dopamine): May cause additive effects on heart rate and contractility, increasing risk of arrhythmias.
  • Antiarrhythmics (e.g., amiodarone, sotalol): Increased risk of ventricular arrhythmias, especially in patients with underlying cardiac disease.
  • Digoxin: No direct interaction, but monitor for additive effects on cardiac contractility and potential for arrhythmias if hypokalemia occurs.

Monitoring

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Baseline Monitoring

Electrocardiogram (ECG)

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

Timing: Prior to initiation

Blood Pressure (BP)

Rationale: To establish baseline hemodynamic status and guide initial dosing.

Timing: Prior to initiation

Heart Rate (HR)

Rationale: To establish baseline and monitor for tachycardia.

Timing: Prior to initiation

Renal Function (BUN, Creatinine, CrCl)

Rationale: Milrinone is primarily renally excreted; renal impairment necessitates dose adjustment.

Timing: Prior to initiation

Electrolytes (Potassium, Magnesium)

Rationale: Hypokalemia and hypomagnesemia can predispose to arrhythmias.

Timing: Prior to initiation

Fluid Status (CVP, PAWP if available)

Rationale: To assess volume status and guide fluid management, especially in heart failure.

Timing: Prior to initiation

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Routine Monitoring

Continuous ECG monitoring

Frequency: Continuously

Target: Normal sinus rhythm, absence of significant arrhythmias

Action Threshold: New onset or worsening ventricular arrhythmias (e.g., PVCs, VT, VF); significant bradycardia or tachycardia.

Continuous Blood Pressure monitoring (invasive preferred)

Frequency: Continuously

Target: Maintain systolic BP >90 mmHg or as clinically appropriate for patient's condition

Action Threshold: Significant hypotension (e.g., SBP <90 mmHg or >20% drop from baseline); requires dose reduction or discontinuation.

Heart Rate

Frequency: Continuously

Target: Maintain within physiological limits, avoid excessive tachycardia

Action Threshold: Persistent tachycardia (>120 bpm) or bradycardia (<50 bpm) not explained by other factors.

Fluid Intake and Output (I&O)

Frequency: Every 1-4 hours

Target: Maintain euvolemia or achieve negative fluid balance as indicated

Action Threshold: Significant fluid retention or excessive diuresis.

Electrolytes (Potassium, Magnesium)

Frequency: Daily or more frequently if abnormal

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

Action Threshold: Hypokalemia (<3.5 mEq/L) or hypomagnesemia (<1.8 mg/dL); requires prompt correction.

Renal Function (BUN, Creatinine)

Frequency: Daily

Target: Stable or improving renal function

Action Threshold: Worsening renal function (e.g., increasing creatinine); requires milrinone dose adjustment.

Hemodynamic Parameters (CVP, PAWP, Cardiac Index if available)

Frequency: As clinically indicated (e.g., every 4-8 hours or with dose changes)

Target: Improved cardiac index, decreased PAWP, decreased SVR

Action Threshold: Lack of hemodynamic improvement or worsening parameters.

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Symptom Monitoring

  • Hypotension (dizziness, lightheadedness, syncope)
  • Palpitations or irregular heartbeat
  • Chest pain or discomfort (angina)
  • Headache
  • Nausea/vomiting
  • Tremor
  • Fever

Special Patient Groups

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Pregnancy

Category C. Animal studies have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. Milrinone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for developmental abnormalities based on animal data; human data lacking.
Second Trimester: Potential for adverse effects on fetal cardiovascular system; human data lacking.
Third Trimester: Potential for adverse effects on fetal cardiovascular system; human data lacking.
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Lactation

L3 (Moderately Safe). It is not known whether milrinone is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants, 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 cardiovascular effects (e.g., hypotension, arrhythmias) in the infant. Monitor infant for signs of adverse effects.
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Pediatric Use

Milrinone has been used in pediatric patients, including neonates, infants, and children, for acute heart failure or low cardiac output states. Dosing is weight-based and requires careful titration. Pharmacokinetics can be variable in this population, especially in neonates and infants, necessitating close monitoring of hemodynamic response 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. Monitor closely for adverse effects, particularly hypotension and arrhythmias.

Clinical Information

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Clinical Pearls

  • Milrinone is typically used for short-term management of acute decompensated heart failure, particularly in patients with low cardiac output and elevated filling pressures.
  • It provides both inotropic support and vasodilation, making it useful in situations where both are desired (e.g., cardiogenic shock, bridge to transplant).
  • Close hemodynamic monitoring (e.g., arterial line, central venous pressure, pulmonary artery catheter) is crucial during milrinone infusion due to the risk of hypotension and arrhythmias.
  • Renal function must be assessed prior to and during therapy, as dose adjustments are critical in renal impairment to prevent drug accumulation and toxicity.
  • Correct hypokalemia and hypomagnesemia prior to and during milrinone therapy to minimize the risk of arrhythmias.
  • 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 (another inotropic agent, beta-1 agonist)
  • Dopamine (dose-dependent inotropic and vasopressor effects)
  • Norepinephrine (primarily vasopressor, some inotropic effect)
  • Levosimendan (calcium sensitizer, also has PDE3 inhibitory properties, not FDA approved in US)
  • Nitroglycerin (vasodilator, primarily venodilator)
  • Nitroprusside (balanced arterial and venous vasodilator)
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Cost & Coverage

Average Cost: Not readily available (hospital-administered IV drug) per vial
Generic Available: Yes
Insurance Coverage: Typically covered under hospital formulary and medical benefit for inpatient use.
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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 pour them down the 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 call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion.