Milrinone Dw5 Inj, 100ml

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 medicine given through an IV (into your vein) to help your heart pump stronger and to relax your blood vessels. This helps your heart work more efficiently and improves blood flow throughout your body. It's typically used in the hospital for serious heart conditions.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the instructions carefully. This medication is administered as an infusion into a vein over a specified period.

Storing and Disposing of Your Medication

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

Missing a Dose

If you miss a dose, contact your doctor to receive guidance on the next steps to take.
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Lifestyle & Tips

  • Not applicable as this is an acute, inpatient IV medication.

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 continuous infusion.
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 continuous infusion, adjusted based on hemodynamic response and tolerance.
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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 continuous infusion. (Often used off-label for cardiac dysfunction post-surgery or in shock)
Infant: Loading dose: 50-75 mcg/kg IV over 30-60 minutes. Maintenance infusion: 0.2-0.75 mcg/kg/min IV continuous infusion.
Child: Loading dose: 50-75 mcg/kg IV over 30-60 minutes. Maintenance infusion: 0.2-0.75 mcg/kg/min IV continuous infusion.
Adolescent: Loading dose: 50 mcg/kg IV over 10 minutes. Maintenance infusion: 0.375 to 0.75 mcg/kg/min IV continuous infusion (similar to adult dosing, but consider weight).
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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 0.28-0.43 mcg/kg/min.
Severe: CrCl <20 mL/min: Maintenance infusion 0.2-0.28 mcg/kg/min.
Dialysis: Not available (Milrinone is not significantly removed by hemodialysis; dose adjustment based on residual renal function is key).

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 metabolism/excretion.

Pharmacology

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Mechanism of Action

Milrinone is a bipyridine inotropic/vasodilator agent with phosphodiesterase-3 (PDE3) inhibitor activity. It inhibits cyclic AMP (cAMP) phosphodiesterase in cardiac and vascular muscle, leading to an increase in intracellular cAMP. In the myocardium, this results in increased calcium influx, enhancing myocardial contractility (positive inotropy). In vascular smooth muscle, increased cAMP leads to vasodilation, reducing both preload and afterload.
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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); higher in neonates/children (0.9-1.5 L/kg)
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 impairment)
Clearance: 0.13 L/kg/hr (adults)
ExcretionRoute: Renal (primarily as unchanged drug)
Unchanged: Approximately 85% (in urine)
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Pharmacodynamics

OnsetOfAction: 5-15 minutes (after loading dose)
PeakEffect: 10-60 minutes (after loading dose)
DurationOfAction: Variable, dependent on infusion rate and renal function; effects cease rapidly after discontinuation due to short half-life.

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. 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 side effects that bother you or persist, contact your doctor for guidance.

Reporting Side Effects

This list is not exhaustive, and you may have questions about other potential side effects. If you do, don't hesitate to reach out 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. Your doctor is available to provide medical advice about side effects, so don't hesitate to contact them if you have any concerns.
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Seek Immediate Medical Attention If You Experience:

  • Feeling dizzy or lightheaded (especially when standing up)
  • Chest pain or discomfort
  • Feeling your heart race or beat irregularly (palpitations)
  • Severe 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.
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. 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. 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, potentially life-threatening)

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. Monitor ECG continuously. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Furosemide (precipitation if mixed directly in IV line)
  • Other inotropic agents (e.g., dobutamine, dopamine) - potential for additive effects leading to excessive hypotension or arrhythmias. Use with caution and close monitoring.
  • Vasodilators (e.g., nitrates, hydralazine) - potential for additive hypotensive effects.
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Moderate Interactions

  • Digoxin (may be used concomitantly, but monitor for additive inotropic effects and potential for arrhythmias)
  • Antihypertensives (additive hypotensive effects)

Monitoring

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Baseline Monitoring

Hemodynamic parameters (BP, HR, CVP, PAWP, CO/CI)

Rationale: To assess baseline cardiac function and guide initial dosing.

Timing: Prior to initiation of therapy

Electrocardiogram (ECG)

Rationale: To assess for pre-existing arrhythmias and monitor for new ones.

Timing: Prior to initiation of therapy

Renal function (BUN, creatinine, CrCl)

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

Timing: Prior to initiation of therapy

Electrolytes (Potassium, Magnesium)

Rationale: Hypokalemia or hypomagnesemia can predispose to arrhythmias.

Timing: Prior to initiation of therapy

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Routine Monitoring

Hemodynamic parameters (BP, HR, CVP, PAWP, CO/CI)

Frequency: Continuously (invasive monitoring) or frequently (non-invasive BP, HR)

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

Action Threshold: Significant hypotension (e.g., MAP <60 mmHg or symptomatic drop), tachycardia, or arrhythmias; adjust infusion rate or administer vasopressors.

ECG (continuous monitoring)

Frequency: Continuous

Target: Normal sinus rhythm, absence of significant arrhythmias

Action Threshold: Development of new or worsening arrhythmias (e.g., ventricular ectopy, non-sustained VT, atrial fibrillation with rapid ventricular response); consider dose reduction or antiarrhythmics.

Fluid balance (I&O)

Frequency: Every 1-4 hours

Target: Appropriate for patient's fluid status (e.g., euvolemic, negative balance if overloaded)

Action Threshold: Significant fluid overload or dehydration; adjust fluid administration or diuretic therapy.

Renal function (BUN, creatinine)

Frequency: Daily or as clinically indicated

Target: Stable or improving renal function

Action Threshold: Worsening renal function; consider milrinone dose reduction.

Electrolytes (Potassium, Magnesium)

Frequency: Daily or as clinically indicated

Target: Within normal limits (e.g., K 3.5-5.0 mEq/L, Mg 1.8-2.5 mg/dL)

Action Threshold: Hypokalemia or hypomagnesemia; replete electrolytes promptly.

Platelet count

Frequency: Periodically (e.g., every few days if prolonged use)

Target: Normal platelet count (>150,000/mm3)

Action Threshold: Thrombocytopenia (<100,000/mm3 or significant drop); consider discontinuation if drug-induced.

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Symptom Monitoring

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

Special Patient Groups

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Pregnancy

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. Animal studies have shown adverse effects at high doses.

Trimester-Specific Risks:

First Trimester: Potential for developmental toxicity based on animal data, but human data lacking.
Second Trimester: Potential for developmental toxicity based on animal data, but human data lacking.
Third Trimester: Potential for developmental toxicity based on animal data, but human data lacking. Consider effects on fetal circulation and potential for premature labor.
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Lactation

Lactation Risk 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 cardiac effects (e.g., hypotension, arrhythmias) in the infant. Monitor infant for signs of adverse effects.
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Pediatric Use

Milrinone is used in pediatric patients, including neonates, for conditions like low cardiac output syndrome after cardiac surgery or in septic shock. Dosing is weight-based and often requires careful titration. Pharmacokinetics can vary significantly with age, especially in neonates and infants, requiring close monitoring and dose adjustment. Renal function is a key determinant of clearance in this population.

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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. They may also be more sensitive to the hypotensive effects of milrinone. Close hemodynamic monitoring is essential.

Clinical Information

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Clinical Pearls

  • Milrinone is a potent inodilator; continuous hemodynamic monitoring (arterial line, CVP, PAWP if available) is crucial during administration.
  • Always adjust the maintenance infusion rate based on the patient's hemodynamic response, renal function, and tolerance.
  • Correct hypokalemia and hypomagnesemia prior to or during milrinone therapy to minimize the risk of arrhythmias.
  • Avoid direct mixing of milrinone with furosemide in the same IV line due to physical incompatibility and precipitation.
  • Milrinone is not recommended for long-term outpatient use in chronic heart failure due to increased mortality observed in some studies (e.g., PROMISE trial). It is primarily for acute, short-term management of decompensated heart failure or cardiogenic shock.
  • Platelet count should be monitored, especially with prolonged infusions, as thrombocytopenia can occur.
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Alternative Therapies

  • Dobutamine (beta-1 adrenergic agonist, positive inotrope)
  • Dopamine (dose-dependent effects: renal, inotropic, vasopressor)
  • Norepinephrine (primarily vasopressor, some inotropic effect)
  • Levosimendan (calcium sensitizer, K-ATP channel opener; not FDA approved in US, but used in Europe)
  • Intra-aortic balloon pump (IABP) or other mechanical circulatory support devices (for severe cases)
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Cost & Coverage

Average Cost: Varies widely by hospital contract and formulation (e.g., 1 mg/mL in 10 mL vial, or premixed bags) per vial or per 100mL bag
Generic Available: Yes
Insurance Coverage: Typically covered by hospital formularies and medical insurance as an inpatient medication.
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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; do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider. For guidance on the best disposal method, consult your pharmacist, who may also be aware of local drug take-back programs. 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 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.