Milrinone Lactate
.2 mg/mL · Injection, Solution
- Prescription only
- Phosphodiesterase 3 Inhibitor
- Active substance
- Milrinone Lactate in 5% Dextrose
- Made by
- Eugia US LLC
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2023-02-01
Phosphodiesterase 3 Inhibitor
- Milrinone Lactate in 5% Dextrose Injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure.
Milrinone is contraindicated in patients who are hypersensitive to it. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- Milrinone Lactate in 5% Dextrose Injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure.
- Patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment.
- The facility for immediate treatment of potential cardiac events, which may include life-threatening ventricular arrhythmias, must be available.
- The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics.
- There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours.
From the official label · 2023-02-01 · DailyMed
How it works
From this product’s own US prescribing label.
Milrinone is a positive inotrope and vasodilator, with little chronotropic activity different in structure and mode of action from either the digitalis glycosides or catecholamines.
Milrinone, at relevant inotropic and vasorelaxant concentrations, is a selective inhibitor of peak III cAMP phosphodiesterase isozyme in cardiac and vascular muscle.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2023-02-01
Do not take it if
Milrinone is contraindicated in patients who are hypersensitive to it. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- Milrinone Lactate in 5% Dextrose Injection should be administered with a loading dose followed by a continuous infusion (maintenance dose) according to the following guidelines:
- Loading Dose 50 mcg/kg:
- Administer slowly over 10 minutes Note:
- Milrinone Lactate in 5% Dextrose Injection (200 mcg/mL) in Flexible Plastic Container is for intravenous infusion only.
- Dosage recommendations using a 1 mg/mL concentration of milrinone are included for informational purposes only.
- The table below shows the loading dose in milliliters (mL) of milrinone (1 mg/mL) by patient body weight (kg).
- Loading Dose (mL) Using 1 mg/mL Concentration Patient Body Weight (kg) kg 30 40 50 60 70 80 90 100 110 120 mL 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5
- 6.0 The loading dose may be given undiluted, but diluting to a rounded total volume of 10 or 20 mL (see appropriate package insert for diluents) may simplify the visualization of the injection rate.
- Maintenance Dose Infusion Rate Total Daily Dose (24 Hours) Minimum 0.375 mcg/kg/min 0.59 mg/kg Administer as a continuous intravenous infusion Standard 0.5 mcg/kg/min 0.77 mg/kg Maximum 0.75 mcg/kg/min 1.13 mg/kg The infusion rate should be adjusted according to hemodynamic and clinical response.
- Patients should be closely monitored.
- In controlled clinical studies, most patients showed an improvement in hemodynamic status as evidenced by increases in cardiac output and reductions in pulmonary capillary wedge pressure.
- Note:
- See " Dosage Adjustment in Renally Impaired Patients." Dosage may be titrated to the maximum hemodynamic effect and should not exceed 1.13 mg/kg/day.
- Duration of therapy should depend upon patient responsiveness.
- The maintenance dose in mL/hr by patient body weight (kg) may be determined by reference to the following table.
- Milrinone Infusion Rate (mL/hr) Using 200 mcg/mL Concentration Maintenance Dose (mcg/kg/min) Patient Body Weight (kg) 30 40 50 60 70 80 90 100 110 120 0.375 3.4 4.5 5.6 6.8 7.9 9.0 10.1 11.3 12.4 13.5 0.4 3.6 4.8 6.0 7.2 8.4 9.6 10.8 12.0 13.2 14.4 0.5 4.5 6.0 7.5 9.0 10.5 12.0 13.5 15.0 16.5 18.0 0.6 5.4 7.2 9.0 10.8 12.6 14.4 16.2 18.0 19.8 21.6 0.7 6.3 8.4 10.5 12.6 14.7 16.8 18.9 21.0 23.1 25.2 0.75 6.8 9.0 11.3 13.5 15.8 18.0 20.3 22.5 24.8
- 27.0 Dosage Adjustment in Renally Impaired Patients Data obtained from patients with severe renal impairment (creatinine clearance = 0 to 30 mL/min) but without congestive heart failure have demonstrated that the presence of renal impairment significantly increases the terminal elimination half-life of milrinone.
- Reductions in infusion rate may be necessary in patients with renal impairment.
- For patients with clinical evidence of renal impairment, the recommended infusion rate can be obtained from the following table:
- Creatinine Clearance (mL/min/1.73 m 2 ) Infusion Rate (mcg/kg/min) 5 0.2 10 0.23 20 0.28 30 0.33 40 0.38 50
- 0.43 Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
- Milrinone Lactate in 5% Dextrose Injection is a clear, colorless to pale yellow solution.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- Whether given orally or by continuous or intermittent intravenous infusion, milrinone has not been shown to be safe or effective in the longer (greater than 48 hours) treatment of patients with heart failure.
- In a multicenter trial of 1088 patients with Class III and IV heart failure, long-term oral treatment with milrinone was associated with no improvement in symptoms and an increased risk of hospitalization and death.
- In this study, patients with Class IV symptoms appeared to be at particular risk of life-threatening cardiovascular reactions.
- There is no evidence that milrinone given by long-term continuous or intermittent infusion does not carry a similar risk.
- The use of milrinone both intravenously and orally has been associated with increased frequency of ventricular arrhythmias, including nonsustained ventricular tachycardia.
- Long-term oral use has been associated with an increased risk of sudden death.
- Hence, patients receiving milrinone should be observed closely with the use of continuous electrocardiographic monitoring to allow the prompt detection and management of ventricular arrhythmias.
- General Milrinone should not be used in patients with severe obstructive aortic or pulmonic valvular disease in lieu of surgical relief of the obstruction.
- Like other inotropic agents, it may aggravate outflow tract obstruction in hypertrophic subaortic stenosis.
- Supraventricular and ventricular arrhythmias have been observed in the high-risk population treated.
- In some patients, injections of milrinone and oral milrinone have been shown to increase ventricular ectopy, including nonsustained ventricular tachycardia.
- The potential for arrhythmia, present in congestive heart failure itself, may be increased by many drugs or combinations of drugs.
- Patients receiving milrinone should be closely monitored during infusion.
- Milrinone produces a slight shortening of AV node conduction time, indicating a potential for an increased ventricular response rate in patients with atrial flutter/fibrillation which is not controlled with digitalis therapy.
- During therapy with milrinone, blood pressure and heart rate should be monitored and the rate of infusion slowed or stopped in patients showing excessive decreases in blood pressure.
- If prior vigorous diuretic therapy is suspected to have caused significant decreases in cardiac filling pressure, milrinone should be cautiously administered with monitoring of blood pressure, heart rate, and clinical symptomatology.
- Cases of infusion site reaction have been reported with intravenous milrinone therapy (see ADVERSE REACTIONS ).
- Consequently, careful monitoring of the infusion site should be maintained to
- avoid possible extravasation.
- Use in Acute Myocardial Infarction No clinical studies have been conducted in patients in the acute phase of post myocardial infarction.
- Laboratory Tests Fluid and electrolytes:
- Fluid and electrolyte changes and renal function should be carefully monitored during therapy with milrinone.
- Improvement in cardiac output with resultant diuresis may necessitate a reduction in the dose of diuretic.
- Potassium loss due to excessive diuresis may predispose digitalized patients to arrhythmias.
- Therefore, hypokalemia should be corrected by potassium supplementation in advance of or during use of milrinone.
- Drug Interactions No untoward clinical manifestations have been observed in limited experience with patients in whom milrinone was used concurrently with the following drugs:
- Chemical Interactions There is an immediate chemical interaction which is evidenced by the formation of a precipitate when furosemide is injected into an intravenous line of an infusion of milrinone.
- Therefore, furosemide should not be administered in intravenous lines containing milrinone.
- Carcinogenesis, Mutagenesis, Impairment of Fertility Twenty-four months of oral administration of milrinone to mice at doses up to 40 mg/kg/day (about 50 times the human oral therapeutic dose in a 50 kg patient) was unassociated with evidence of carcinogenic potential.
- Neither was there evidence of carcinogenic potential when milrinone was orally administered to rats at doses up to 5 mg/kg/day (about 6 times the human oral therapeutic dose) for twenty-four months or at 25 mg/kg/day (about 30 times the human oral therapeutic dose) for up to 18 months in males and 20 months in females.
- Whereas the Chinese Hamster Ovary Chromosome Aberration Assay was positive in the presence of a metabolic activation system, results from the Ames Test, the Mouse Lymphoma Assay, the Micronucleus Test, and the in vivo Rat Bone Marrow Metaphase Analysis indicated an absence of mutagenic potential.
- In reproductive performance studies in rats, milrinone had no effect on male or female fertility at oral doses up to 32 mg/kg/day.
- Animal Toxicity Oral and intravenous administration of toxic dosages of milrinone to rats and dogs resulted in myocardial degeneration/fibrosis and endocardial hemorrhage, principally affecting the left ventricular papillary muscles.
- Coronary vascular lesions characterized by periarterial edema and inflammation have been observed in dogs only.
- The myocardial/endocardial changes are similar to those produced by beta-adrenergic receptor agonists such as isoproterenol, while the vascular changes are similar to those produced by minoxidil and hydralazine.
- Doses within the recommended clinical dose range (up to 1.13 mg/kg/day) for congestive heart failure patients have not produced significant adverse effects in animals.
- Pregnancy Category C Oral administration of milrinone to pregnant rats and rabbits during organogenesis produced no evidence of teratogenicity at dose levels up to 40 mg/kg/day and 12 mg/kg/day, respectively.
- Nursing Mothers Caution should be exercised when milrinone is administered to nursing women, since it is not known whether it is excreted in human milk.
- Pediatric Use Safety and effectiveness in pediatric patients have not been established.
- Use in Elderly Patients There are no special dosage recommendations for the elderly patient.
- General Milrinone should not be used in patients with severe obstructive aortic or pulmonic valvular disease in lieu of surgical relief of the obstruction.
- Like other inotropic agents, it may aggravate outflow tract obstruction in hypertrophic subaortic stenosis.
- Supraventricular and ventricular arrhythmias have been observed in the high-risk population treated.
- In some patients, injections of milrinone and oral milrinone have been shown to increase ventricular ectopy, including nonsustained ventricular tachycardia.
- The potential for arrhythmia, present in congestive heart failure itself, may be increased by many drugs or combinations of drugs.
- Patients receiving milrinone should be closely monitored during infusion.
- Milrinone produces a slight shortening of AV node conduction time, indicating a potential for an increased ventricular response rate in patients with atrial flutter/fibrillation which is not controlled with digitalis therapy.
- During therapy with milrinone, blood pressure and heart rate should be monitored and the rate of infusion slowed or stopped in patients showing excessive decreases in blood pressure.
- If prior vigorous diuretic therapy is suspected to have caused significant decreases in cardiac filling pressure, milrinone should be cautiously administered with monitoring of blood pressure, heart rate, and clinical symptomatology.
- Cases of infusion site reaction have been reported with intravenous milrinone therapy (see ADVERSE REACTIONS ).
- Consequently, careful monitoring of the infusion site should be maintained to
- avoid possible extravasation.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- Category C Oral administration of milrinone to pregnant rats and rabbits during organogenesis produced no evidence of teratogenicity at dose levels up to 40 mg/kg/day and 12 mg/kg/day, respectively.
- Milrinone did not appear to be teratogenic when administered intravenously to pregnant rats at doses up to 3 mg/kg/day (about 2.5 times the maximum recommended clinical intravenous dose) or pregnant rabbits at doses up to 12 mg/kg/day, although an increased resorption rate was apparent at both 8 mg/kg/day and 12 mg/kg/day (intravenous) in the latter species.
- 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.
- Caution should be exercised when milrinone is administered to nursing women, since it is not known whether it is excreted in human milk.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Other medicines
- No untoward clinical manifestations have been observed in limited experience with patients in whom milrinone was used concurrently with the following drugs:
- digitalis glycosides; lidocaine, quinidine; hydralazine, prazosin; isosorbide dinitrate, nitroglycerin; chlorthalidone, furosemide, hydrochlorothiazide, spironolactone; captopril; heparin, warfarin, diazepam, insulin; and potassium supplements.
Quoted from the official label, section “Drug Interactions”.
If you take too much
In an emergency, call your local emergency number or a poison control centre.
- Doses of milrinone may produce hypotension because of its vasodilator effect.
- If this occurs, administration of milrinone should be reduced or temporarily discontinued until the patient’s condition stabilizes.
- No specific antidote is known, but general measures for circulatory support should be taken.
Quoted from the official label, section “Overdosage”.
Use in children
Safety and effectiveness in pediatric patients have not been established.
Quoted from the official label, section “Pediatric Use”.
Use in older people
- in Elderly Patients There are no special dosage recommendations for the elderly patient.
- Ninety percent of all patients administered milrinone in clinical studies were within the age range of 45 to 70 years, with a mean age of 61 years.
- Patients in all age groups demonstrated clinically and statistically significant responses.
- No age-related effects on the incidence of adverse reactions have been observed.
- Controlled pharmacokinetic studies have not disclosed any age-related effects on the distribution and elimination of milrinone.
Quoted from the official label, section “Geriatric Use”.
Side effects
- Cardiovascular Effects In patients receiving milrinone in Phase II and III clinical trials, ventricular arrhythmias were reported in 12.1%:
- Ventricular ectopic activity, 8.5%; nonsustained ventricular tachycardia, 2.8%; sustained ventricular tachycardia, 1% and ventricular fibrillation, 0.2% (2 patients experienced more than one type of arrhythmia).
- Holter recordings demonstrated that in some patients injection of milrinone increased ventricular ectopy, including nonsustained ventricular tachycardia.
- Life-threatening arrhythmias were infrequent and when present have been associated with certain underlying factors such as preexisting arrhythmias, metabolic abnormalities (e.g. hypokalemia), abnormal digoxin levels and catheter insertion.
- Milrinone was not shown to be arrhythmogenic in an electrophysiology study.
- Supraventricular arrhythmias were reported in 3.8% of the patients receiving milrinone.
- The incidence of both supraventricular and ventricular arrhythmias has not been related to the dose or plasma milrinone concentration.
- Other cardiovascular adverse reactions include hypotension, 2.9% and angina/chest pain, 1.2%.
- In the post-marketing experience, there have been rare cases of “torsades de pointes” reported.
- CNS Effects Headaches, usually mild to moderate in severity, have been reported in 2.9% of patients receiving milrinone.
- Other Effects Other adverse reactions reported, but not definitely related to the administration of milrinone include hypokalemia, 0.6%; tremor, 0.4%; and thrombocytopenia, 0.4%.
- Post-Marketing Adverse Event Reports In addition to adverse events reported from clinical trials, the following events have been reported from worldwide post-marketing experience with Milrinone:
- Isolated spontaneous reports of bronchospasm and anaphylactic shock.
- Liver function test abnormalities and skin reactions such as rash.
- Administration site conditions: Infusion site reaction.
Quoted from the official label, section “Adverse Reactions”.
What to discuss with your doctor
in Acute Myocardial Infarction No clinical studies have been conducted in patients in the acute phase of post myocardial infarction. Until further clinical experience with this class of drugs is gained, milrinone is not recommended in these patients.
Quoted from the official label, section “Patient Counseling Information”.
What it looks like and how it is packed
- Milrinone Lactate in 5% Dextrose Injection is a clear, colorless to pale yellow solution and is supplied in Flexible Plastic Containers as follows:
- 20 mg per 100 mL (200 mcg (0.2 mg)/mL) 100 mL Single-Dose Flexible Containers packaged in a Carton of 10 NDC 55150-287-10 40 mg per 200 mL (200 mcg (0.2 mg)/mL) 200 mL Single-Dose Flexible Containers packaged in a Carton of 10 NDC 55150-288-10 Exposure of pharmaceutical products to heat should be minimized.
- Avoid excessive heat.
- Protect from freezing.
- It is recommended that the product be stored at room temperature, 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product.
- Discard unused portion.
- The container closure is not made with natural rubber latex.
- Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd.
- E.
- Windsor, NJ 08520 Manufactured by:
- Eugia Pharma Specialities Limited Hyderabad - 500032 India Revised:
- February 2023
Quoted from the official label, section “How Supplied”.
What is in it
- Milrinone lactate is a member of a new class of bipyridine inotropic/vasodilator agents with phosphodiesterase inhibitor activity, distinct from digitalis glycosides or catecholamines.
- Milrinone lactate is designated chemically as 1,6-dihydro-2-methyl-6-oxo-[3,4’-bipyridine]-5-carbonitrile lactate and has the following structure:
- Milrinone, USP is a white to tan crystalline powder with a molecular weight of 211.2 and a molecular formula of C 12 H 9 N 3 O.
- It is slightly soluble in methanol, and very slightly soluble in chloroform and in water.
- As the lactate salt, it is stable and clear, colorless to pale yellow solution.
- Milrinone is available as sterile aqueous solutions of the lactate salt of milrinone for infusion intravenously.
- The flexible containers provide two ready-to-use dilutions of milrinone in volumes of 100 mL and 200 mL of 5% Dextrose Injection.
- Each mL contains 285 mcg milrinone lactate equivalent to 200 mcg milrinone USP.
- The nominal concentration of lactic acid is 0.282 mg/mL.
- Each mL also contains 54.3 mg Dextrose Hydrous, USP.
- The pH is adjusted with lactic acid and/or sodium hydroxide pH 3.5 (3.2 to 4.0).
- The flexible plastic container is made up of multilayer polypropylene with a foil overwrap.
- Solutions in contact with the plastic container leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.
- The flexible container has a foil overwrap.
- Water can permeate the plastic into the overwrap, but the amount is insufficient to significantly affect the premixed solution.
- Milrinone Lactate Chemical Structure
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (7)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 7 of 7
- Milrinone LactateThis onePrescription onlyEugia US LLCNo ingredient list on the stored label
- Milrinone Lactate in DextrosePrescription onlyBaxter Healthcare CorporationNo ingredient list on the stored label
- Milrinone Lactate in 5% DextrosePrescription onlyCaplin Steriles LimitedNo ingredient list on the stored label
- Milrinone Lactate in DextrosePrescription onlyGland Pharma LimitedNo ingredient list on the stored label
- Milrinone Lactate in DextrosePrescription onlyHospira, Inc.No ingredient list on the stored label
- Milrinone Lactate in DextrosePrescription onlySagent PharmaceuticalsNo ingredient list on the stored label
- Milrinone Lactate in 5% DextrosePrescription onlySomerset Therapeutics, LLCNo ingredient list on the stored label
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
FranceNo exact match for this strength and form
Details
| Made by | Eugia US LLC |
|---|---|
| Active substance | Milrinone Lactate in 5% Dextrose |
| Strength | .2 mg/mL |
| Form | Injection, Solution |
| Route | Intravenous |
| Packs | 10 POUCH in 1 CARTON / 1 BAG in 1 POUCH / 100 mL in 1 BAG · 10 POUCH in 1 CARTON / 1 BAG in 1 POUCH / 200 mL in 1 BAG |
| NDC | 55150-287 |
| NDC | 55150-288 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
10 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Injection, Solution10 products
- .2 mg/mL
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.