Milrinone Lactate 1 mg/mL Injection, Solution, 10 vials
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Phosphodiesterase 3 Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Milrinone injection is used to treat heart failure. Milrinone is in a class of medications called cardiotonic agents. It works by helping the heart to pump better.
Read the full MedlinePlus article ↗- Milrinone is helping your heart pump more effectively during this acute episode. It works two ways: it makes your heart muscle contract with more force, and it relaxes your blood v...
- Why am I getting milrinone — what is it actually doing for my heart?
- Milrinone is only for short-term use — typically up to 48 hours based on controlled trial experience. Your care team will keep watching how your heart and blood pressure respond an...
- The most important ones to flag immediately are a racing, pounding, or irregular heartbeat — milrinone can trigger serious heart rhythm problems in some patients. Also tell your te...
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Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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47 mg / 1 mL
UNII 5SL0G7R0OK
A simple sugar made from corn or other plants, used in medicines as a filler and sweetener. It helps create the right texture and taste in tablets, powders, and liquid formulations.
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UNII 33X04XA5AT
Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Milrinone Lactate 1 mg/mL 00143-9373-10 | Hikma | 10 vials | — | AP | FDA listed | — |
| Milrinone Lactate 1 mg/mL 00143-9710-25 | Hikma | 25 vials | — | AP | FDA listed | — |
| Milrinone Lactate 1 mg/mL 00409-0212-01 | Hospira, | 10 vials | — | AP | FDA listed | — |
| Milrinone Lactate 1 mg/mL 42677-0313-10 | Shandong | 10 vials | — | AP | FDA listed | — |
| Milrinone Lactate 1 mg/mL 63323-0617-10 | Fresenius | 10 vials | — | AP | FDA listed | — |
| Milrinone Lactate 1 mg/mL 65145-0120-10 | Caplin | 10 vials | — | AP | FDA listed | — |
| Milrinone Lactate 1 mg/mL 70069-0807-10 | Somerset | 10 vials | — | AP | FDA listed | — |
| Milrinone Lactate 1 mg/mL 71288-0200-11 | Meitheal | 10 vials | — | AP | FDA listed | — |
| Milrinone Lactate 1 mg/mL 72485-0501-10 | Armas | 10 vials | — | AP | FDA listed | — |
| Milrinone Lactate 1 mg/mLthis 83301-0016-02 | Mullan | 10 vials | — | AP | FDA listed | — |
| Milrinone Lactate 1 mg/mL 00143-9326-10 | Hikma | 10 vials | — | AP | FDA listed | — |
| Milrinone Lactate 1 mg/mL 70069-0808-10 | Somerset | 10 vials | — | AP | FDA listed | — |
| Milrinone Lactate 1 mg/mL 70069-0809-01 | Somerset | 1 vial | — | AP | FDA listed | — |
| Milrinone Lactate 1 mg/mL 00143-9374-10 | Hikma | 10 vials | — | AP | FDA listed | — |
| Milrinone Lactate 1 mg/mL 72485-0502-10 | Armas | 10 vials | — | AP | FDA listed | — |
| Milrinone Lactate 1 mg/mL 72485-0503-01 | Armas | 1 vial | — | AP | FDA listed | — |
| Milrinone Lactate 1 mg/mL 00143-9708-10 | Hikma | 10 vials | — | AP | FDA listed | — |
| Milrinone Lactate 1 mg/mL 65145-0121-10 | Caplin | 10 vials | — | AP | FDA listed | — |
| Milrinone Lactate 1 mg/mL 65145-0122-01 | Caplin | 1 vial | — | AP | FDA listed | — |
| Milrinone Lactate 1 mg/mL 83301-0017-02 | Mullan | 10 vials | — | AP | FDA listed | — |
| Milrinone Lactate 1 mg/mL 42677-0314-10 | Shandong | 10 vials | — | AP | FDA listed | — |
| Milrinone Lactate 1 mg/mL 42677-0338-01 | Shandong | 1 vial | — | AP | FDA listed | — |
| Milrinone Lactate 1 mg/mL 00143-9709-10 | Hikma | 20 ml | — | AP | FDA listed | — |
| Milrinone Lactate 1 mg/mL 83301-0018-01 | Mullan | 1 vial | — | AP | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 83301-0016-02 You're viewing this | 10 VIAL in 1 CARTON (83301-0016-2) / 1 mL in 1 VIAL (83301-0016-1) | 2023-09-18 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Milrinone Lactate Injection, USP is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone lactate 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.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION A loading dose of Milrinone Lactate Injection ( 1mg [base]/mL ) should be administered followed by a continuous infusion (maintenance dose) according to the following guidelines: LOADING DOSE 50 mcg/kg: Administer slowly over 10 minutes The table below shows the loading dose in milliliters (mL) of milrinone (1mg/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 2.5 3 3.5 4 4.5 5 5.5 6 The loading dose may be given undiluted, but diluting to a rounded total volume of 10 or 20 mL (see Maintenance Dose 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 Milrinone drawn from vials should be diluted prior to maintenance dose administration. The diluents that may be used are 0.45% Sodium Chloride Injection USP, 0.9% Sodium Chloride Injection USP, or 5% Dextrose Injection USP. The table below shows the volume of diluent in milliliters (mL) that must be used to achieve 200 mcg/mL concentration for infusion, and the resultant total volumes.
Desired Infusion Concentration mcg/mL Milrinone 1 mg/mL (mL) Diluent (mL) Total Volume (mL) 200 10 40 50 200 20 80 100 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 10.1 11.3 12.4 13.5 0.4 3.6 4.8 6 7.2 8.4 9.6 10.8 12 13.2 14.4 0.5 4.5 6 7.5 9 10.5 12 13.5 15 16.5 18 0.6 5.4 7.2 9 10.8 12.6 14.4 16.2 18 19.8 21.6 0.7 6.3 8.4 10.5 12.6 14.7 16.8 18.9 21 23.1 25.2 0.75 6.8 9 11.3 13.5 15.8 18 20.3 22.5 24.8 27 When administering milrinone lactate by continuous infusion, it is advisable to use a calibrated electronic infusion device.
Intravenous drug products should be inspected visually and should not be used if particulate matter or discoloration is present. 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/1.73m 2 ) Infusion Rate (mcg/kg/min) 5 0.2 10 0.23 20 0.28 30 0.33 40 0.38 50 0.43
⛔ Contraindications ▾
CONTRAINDICATIONS Milrinone Lactate Injection, USP is contraindicated in patients who are hypersensitive to it.
⚠️ Warnings ▾
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.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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%. Isolated spontaneous reports of bronchospasm and anaphylactic shock have been received; and in the post-marketing experience, liver function test abnormalities and skin reactions such as rash have been reported.
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.
To report SUSPECTED ADVERSE REACTIONS, contact Mullan Pharmaceutical Inc., at 1-800-673-9839 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🆘 Overdosage ▾
OVERDOSAGE 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.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY 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. This inhibitory action is consistent with cAMP mediated increases in intracellular ionized calcium and contractile force in cardiac muscle, as well as with cAMP dependent contractile protein phosphorylation and relaxation in vascular muscle.
Additional experimental evidence also indicates that milrinone is not a beta-adrenergic agonist nor does it inhibit sodium-potassium adenosine triphosphatase activity as do the digitalis glycosides. Clinical studies in patients with congestive heart failure have shown that milrinone produces dose-related and plasma drug concentration-related increases in the maximum rate of increase of left ventricular pressure. Studies in normal subjects have shown that milrinone produces increases in the slope of the left ventricular pressure-dimension relationship, indicating a direct inotropic effect of the drug.
Milrinone lactate also produces dose-related and plasma concentration-related increases in forearm blood flow in patients with congestive heart failure, indicating a direct arterial vasodilator activity of the drug. Both the inotropic and vasodilatory effects have been observed over the therapeutic range of plasma milrinone concentrations of 100 ng/mL to 300 ng/mL. In addition to increasing myocardial contractility, milrinone improves diastolic function as evidenced by improvements in left ventricular diastolic relaxation.
The acute administration of intravenous milrinone has also been evaluated in clinical trials in excess of 1600 patients, with chronic heart failure, heart failure associated with cardiac surgery, and heart failure associated with myocardial infarction. The total number of deaths, either on therapy or shortly thereafter (24 hours) was 15, less than 0.9%, few of which were thought to be drug-related.
Pharmacokinetics Following intravenous injections of 12.5 mcg/kg to 125 mcg/kg to congestive heart failure patients, milrinone had a volume of distribution of 0.38 liters/kg, a mean terminal elimination half-life of 2.3 hours, and a clearance of 0.13 liters/kg/hr. Following intravenous infusions of 0.2 mcg/kg/min to 0.7 mcg/kg/min to congestive heart failure patients, the drug had a volume of distribution of about 0.45 liters/kg, a mean terminal elimination half-life of 2.4 hours, and a clearance of 0.14 liters/kg/hr.
These pharmacokinetic parameters were not dose-dependent, and the area under the plasma concentration versus time curve following injections was significantly dose-dependent. Milrinone has been shown (by equilibrium dialysis) to be approximately 70% bound to human plasma protein. The primary route of excretion of milrinone in man is via the urine.
The major urinary excretions of orally administered milrinone in man are milrinone (83%) and its 0-glucuronide metabolite (12%). Elimination in normal subjects via the urine is rapid, with approximately 60% recovered within the first two hours following dosing and approximately 90% recovered within the first eight hours following dosing. The mean renal clearance of milrinone is approximately 0.3 liters/min, indicative of active secretion.
Pharmacodynamics In patients with heart failure due to depressed myocardial function, milrinone produced a prompt dose and plasma concentration related increase in cardiac output and decreases in pulmonary capillary wedge pressure and vascular resistance, which were accompanied by mild-to-moderate increases in heart rate. Additionally, there is no increased effect on myocardial oxygen consumption. In uncontrolled studies, hemodynamic improvement during intravenous therapy with milrinone was accompanied by clinical symptomati…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Milrinone Lactate Injection, USP is supplied a sterile, clear, colorless to pale yellow solution. Each mL contains milrinone lactate equivalent to 1 mg milrinone. Strength and Volume Carton NDC Packing Configuration 10 mL ( 10 mg/10 mL) 83301-0016-2 10 Single-Dose Vials (NDC 83301-0016-1) in a carton 20 mL ( 20 mg/20 mL) 83301-0017-2 10 Single-Dose Vials (NDC 83301-0017-1) in a carton 50 mL ( 50 mg/50 mL) 83301-0018-1 1 Single-Dose Vial in a carton Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Avoid freezing. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.
Manufactured by: Shandong New Time Pharmaceutical Co., Ltd., Feixian, Linyi, Shandong 273499, China. Manufactured for: Mullan Pharmaceutical Inc. Pasadena, CA 91101, USA Revised: 07/2026
📋 Description ▾
DESCRIPTION Milrinone lactate is a member of a 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 is an off-white to tan crystalline compound 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 colorless to pale yellow in solution. Milrinone lactate is available as sterile aqueous solutions of the lactate salt of milrinone for injection or infusion intravenously. Sterile, single-dose vials: Single-dose vials of 10, 20 and 50 mL contain in each mL milrinone lactate equivalent to 1 mg milrinone and 47 mg Dextrose, Anhydrous, USP, in Water for Injection, USP.
The pH is adjusted to between 3.2 and 4.0 with lactic acid or sodium hydroxide. The total concentration of lactic acid can vary between 0.95 mg/mL and 1.29 mg/mL. These vials require preparation of dilutions prior to administration to patients intravenously. structure CLINICAL PHARMACOLOGY 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. This inhibitory action is consistent with cAMP mediated increases in intracellular ionized calcium and contractile force in cardiac muscle, as well as with cAMP dependent contractile protein phosphorylation and relaxation in vascular muscle. Additional experimental evidence also indicates that milrinone is not a beta-adrenergic agonist nor does it inhibit sodium-potassium adenosine triphosphatase activity as do the digitalis glycosides.
Clinical studies in patients with congestive heart failure have shown that milrinone produces dose-related and plasma drug concentration-related increases in the maximum rate of increase of left ventricular pressure. Studies in normal subjects have shown that milrinone produces increases in the slope of the left ventricular pressure-dimension relationship, indicating a direct inotropic effect of the drug. Milrinone lactate also produces dose-related and plasma concentration-related increases in forearm blood flow in patients with congestive heart failure, indicating a direct arterial vasodilator activity of the drug.
Both the inotropic and vasodilatory effects have been observed over the therapeutic range of plasma milrinone concentrations of 100 ng/mL to 300 ng/mL. In addition to increasing myocardial contractility, milrinone improves diastolic function as evidenced by improvements in left ventricular diastolic relaxation. The acute administration of intravenous milrinone has also been evaluated in clinical trials in excess of 1600 patients, with chronic heart failure, heart failure associated with cardiac surgery, and heart failure associated with myocardial infarction.
The total number of deaths, either on therapy or shortly thereafter (24 hours) was 15, less than 0.9%, few of which were thought to be drug-related. Pharmacokinetics Following intravenous injections of 12.5 mcg/kg to 125 mcg/kg to congestive heart failure patients, milrinone had a volume of distribution of 0.38 liters/kg, a mean terminal elimination half-life of 2.3 hours, and a clearance of 0.13 liters/kg/hr. Following intravenous infusions of 0.2 mcg/kg/min to 0.7 mcg/kg/min to congestive heart failure patients, the drug had a volume of distribution of about 0.45 liters/kg, a mean terminal elimination half-life of 2.4 hours, and a clearance of 0.14 liters/kg/hr.
These pharmacokinetic parameters were not dose-dependent, and the area under the plasma c…