{"id":"milrinone-lactate","rwe":[],"_fda":{"id":"2bc91e0d-da13-e864-e063-6394a90a4c0e","set_id":"07dddead-22ed-004c-e063-6294a90a76fc","openfda":{"upc":["0383301001618","0383301001717","0383301001724"],"unii":["9K8XR81MO8"],"route":["INTRAVENOUS"],"rxcui":["1791854","1791859"],"spl_id":["2bc91e0d-da13-e864-e063-6394a90a4c0e"],"brand_name":["Milrinone Lactate"],"spl_set_id":["07dddead-22ed-004c-e063-6294a90a76fc"],"package_ndc":["83301-0016-1","83301-0016-2","83301-0017-1","83301-0017-2"],"product_ndc":["83301-0016","83301-0017"],"generic_name":["MILRINONE LACTATE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["MILRINONE LACTATE"],"manufacturer_name":["Mullan Pharmaceutical Inc."],"application_number":["ANDA216373"],"is_original_packager":[true]},"version":"4","warnings":["WARNINGS Whether given orally or by continuous or intermittent intravenous infusion, milrinone lactate 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 lactate 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 lactate given by long-term continuous or intermittent infusion does not carry a similar risk. The use of milrinone lactate 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 lactate should be observed closely with the use of continuous electrocardiographic monitoring to allow the prompt detection and management of ventricular arrhythmias."],"overdosage":["OVERDOSAGE Doses of milrinone lactate may produce hypotension because of its vasodilator effect. If this occurs, administration of milrinone lactate 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."],"description":["DESCRIPTION Milrinone lactate injection 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 an empirical 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 and 20 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 lactate 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 lactate, 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 lactate 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 lactate 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 lactate 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 lactate 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."],"precautions":["PRECAUTIONS General Milrinone lactate 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 lactate and oral milrinone lactate 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 lactate should be closely monitored during infusion. Milrinone lactate 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 lactate, 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 lactate should be cautiously administered with monitoring of blood pressure, heart rate, and clinical symptomatology. There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours. 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. Until further clinical experience with this class of drugs is gained, milrinone lactate is not recommended in these patients. Laboratory Tests Fluid and Electrolytes: Fluid and electrolyte changes and renal function should be carefully monitored during therapy with milrinone lactate. 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 lactate. Drug Interactions No untoward clinical manifestations have been observed in limited experience with patients in whom milrinone lactate 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. 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 lactate. Therefore, furosemide should not be administered in intravenous lines containing milrinone lactate. Carcinogenesis, Mutagenesis, Impairment of Fertility Twenty-four months of oral administration of milrinone lactate 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 lactate 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 lactate 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 lactate 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 Oral administration of milrinone lactate 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 lactate 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 lactate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers Caution should be exercised when milrinone lactate 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. Ninety percent of all patients administered milrinone lactate 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 lactate."],"how_supplied":["HOW SUPPLIED Milrinone Lactate Injection, USP is supplied as 10 mL single-dose vials in a box of 10, NDC 83301-0016-2; as 20 mL single-dose vials box of 10, NDC 83301-0017-2, containing a sterile, clear, colorless to pale yellow solution. Each mL contains milrinone lactate equivalent to 1 mg milrinone. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing. Discard unused portion after initial use. Manufactured for: Mullan Pharmaceutical Inc. Pasadena, CA 91101 Manufactured by: Shandong New Time Pharmaceutical Co., Ltd., No. 1, North Outer Ring Road, Feixian, Shandong 273400, China. Rev. 10/2023"],"effective_time":"20250115","adverse_reactions":["ADVERSE REACTIONS Cardiovascular Effects In patients receiving milrinone lactate 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 lactate 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 lactate was not shown to be arrhythmogenic in an electrophysiology study. Supraventricular arrhythmias were reported in 3.8% of the patients receiving milrinone lactate. 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 lactate. Other Effects Other adverse reactions reported, but not definitely related to the administration of milrinone lactate 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."],"contraindications":["CONTRAINDICATIONS Milrinone Lactate Injection is contraindicated in patients who are hypersensitive to it."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Milrinone lactate 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 lactate, 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 lactate 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 lactate 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 lactate 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 lactate 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."],"indications_and_usage":["INDICATIONS AND USAGE Milrinone Lactate Injection 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 lactate has been in patients receiving digoxin and diuretics."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Milrinone Lactate Injection, USP 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 The table below shows the loading dose in milliliters (mL) of milrinone lactate (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 lactate 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 Lactate Injection 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 lactate. 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"],"spl_product_data_elements":["Milrinone Lactate Milrinone Lactate ANHYDROUS DEXTROSE LACTIC ACID SODIUM HYDROXIDE WATER MILRINONE LACTATE MILRINONE Milrinone Lactate Milrinone Lactate ANHYDROUS DEXTROSE LACTIC ACID SODIUM HYDROXIDE WATER MILRINONE LACTATE MILRINONE"],"dosage_and_administration_table":["<table width=\"100%\"><caption>The table below shows the loading dose in milliliters (mL) of milrinone lactate (1mg/mL) by patient body weight (kg). </caption><tbody><tr><td colspan=\"11\"> Loading Dose (mL) Using 1 mg/mL Concentration</td></tr><tr><td colspan=\"11\"> Patient Body Weight (kg)</td></tr><tr><td> kg</td><td> 30</td><td> 40</td><td>50 </td><td>60 </td><td>70 </td><td>80 </td><td>90 </td><td>100 </td><td>110 </td><td>120 </td></tr><tr><td> mL</td><td> 1.5</td><td> 2</td><td> 2.5</td><td> 3</td><td> 3.5</td><td> 4</td><td> 4.5</td><td> 5</td><td> 5.5</td><td> 6</td></tr></tbody></table>","<table width=\"100%\"><caption>MAINTENANCE DOSE </caption><tbody><tr><td/><td> Infusion Rate</td><td> Total Daily Dose (24 Hours)</td><td/></tr><tr><td> Minimum</td><td> 0.375 mcg/kg/min</td><td> 0.59 mg/kg</td><td rowspan=\"3\"> Administer as a continuous intravenous infusion</td></tr><tr><td> Standard</td><td> 0.5 mcg/kg/min</td><td> 0.77 mg/kg</td></tr><tr><td> Maximum</td><td> 0.75 mcg/kg/min</td><td> 1.13 mg/kg</td></tr></tbody></table>","<table width=\"100%\"><caption/><tbody><tr><td> Desired Infusion Concentration mcg/mL</td><td> Milrinone Lactate Injection 1 mg/mL (mL)</td><td> Diluent (mL)</td><td> Total Volume (mL)</td></tr><tr><td> 200</td><td> 10</td><td> 40</td><td> 50</td></tr><tr><td> 200 </td><td> 20</td><td> 80 </td><td> 100</td></tr></tbody></table>","<table width=\"100%\"><caption>Milrinone Infusion Rate (mL/hr) Using 200 mcg/mL Concentration </caption><tbody><tr><td rowspan=\"2\"> Maintenance Dose (mcg/kg/min)</td><td colspan=\"10\"> Patient Body Weight (kg) </td></tr><tr><td> 30</td><td> 40</td><td> 50</td><td> 60</td><td> 70</td><td> 80</td><td> 90</td><td> 100</td><td> 110</td><td> 120</td></tr><tr><td> 0.375</td><td> 3.4</td><td> 4.5</td><td> 5.6</td><td> 6.8</td><td> 7.9</td><td> 9</td><td> 10.1</td><td> 11.3</td><td> 12.4</td><td> 13.5</td></tr><tr><td> 0.4</td><td> 3.6</td><td> 4.8</td><td> 6</td><td> 7.2</td><td> 8.4</td><td> 9.6</td><td> 10.8</td><td> 12</td><td> 13.2</td><td> 14.4</td></tr><tr><td> 0.5</td><td> 4.5</td><td> 6</td><td> 7.5</td><td> 9</td><td> 10.5</td><td> 12</td><td> 13.5</td><td> 15</td><td> 16.5</td><td> 18</td></tr><tr><td> 0.6</td><td> 5.4</td><td> 7.2 </td><td> 9</td><td> 10.8</td><td> 12.6</td><td> 14.4</td><td> 16.2</td><td> 18</td><td> 19.8</td><td> 21.6</td></tr><tr><td> 0.7</td><td> 6.3</td><td> 8.4 </td><td> 10.5</td><td> 12.6</td><td> 14.7</td><td> 16.8</td><td> 18.9</td><td> 21</td><td> 23.1</td><td> 25.2</td></tr><tr><td> 0.75</td><td> 6.8</td><td> 9</td><td> 11.3</td><td> 13.5</td><td> 15.8</td><td> 18</td><td> 20.3</td><td> 22.5</td><td> 24.8</td><td> 27</td></tr></tbody></table>","<table width=\"100%\"><caption/><tbody><tr><td> Creatinine Clearance (mL/min/1.73m <sup>2</sup>) </td><td> Infusion Rate (mcg/kg/min)</td></tr><tr><td> 5</td><td> 0.2</td></tr><tr><td>10 </td><td> 0.23 </td></tr><tr><td>20 </td><td> 0.28 </td></tr><tr><td>30 </td><td> 0.33 </td></tr><tr><td>40 </td><td> 0.38 </td></tr><tr><td>50 </td><td> 0.43 </td></tr></tbody></table>"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL -10 mL Vial Container and Carton 10 mL Vial Container Milrinone Lactate Injection 10 mg/ 10 mL (1 mg/mL) NDC 83301-0016-1 Rx only For Intravenous Use Only 10 mL Vial Carton Milrinone Lactate Injection 10 mg/ 10 mL (1 mg/mL) NDC 83301-0016-2 Rx only For Intravenous Use Only Milrinone 10ml Milrinone-Carton 10ml","PRINCIPAL DISPLAY PANEL -20 mL Vial Container and Carton 20 mL Vial Container Milrinone Lactate Injection 20 mg/ 20 mL (1 mg/mL) NDC 83301-0017-1 Rx only For Intravenous Use Only 20 mL Vial Carton Milrinone Lactate Injection 20 mg/ 20 mL (1 mg/mL) NDC 83301-0017-2 Rx only For Intravenous Use Only Milrinone-Container 20ml Milrinone-Carton 20ml"]},"tags":[],"fdaNDC":[{"route":["INTRAVENOUS"],"labeler":"Mullan Pharmaceutical Inc.","brandName":"Milrinone Lactate","packaging":[{"ndc":"83301-0016-2","description":"10 VIAL in 1 CARTON (83301-0016-2)  / 1 mL in 1 VIAL (83301-0016-1)","marketingStartDate":"20230918"}],"dosageForm":"INJECTION, SOLUTION","genericName":"Milrinone Lactate","productType":"HUMAN PRESCRIPTION DRUG","activeIngredients":[{"name":"MILRINONE LACTATE","strength":"1 mg/mL"}],"marketingCategory":"ANDA"},{"route":["INTRAVENOUS"],"labeler":"Shandong New Time Pharmaceutical Co., Ltd.","brandName":"Milrinone Lactate","packaging":[{"ndc":"42677-313-10","description":"10 VIAL in 1 CARTON (42677-313-10)  / 10 mL in 1 VIAL (42677-313-01)","marketingStartDate":"20230301"}],"dosageForm":"INJECTION, SOLUTION","genericName":"Milrinone Lactate","productType":"HUMAN PRESCRIPTION DRUG","activeIngredients":[{"name":"MILRINONE LACTATE","strength":"1 mg/mL"}],"marketingCategory":"ANDA"},{"route":["INTRAVENOUS"],"labeler":"Shandong New Time Pharmaceutical Co., Ltd.","brandName":"Milrinone Lactate","packaging":[{"ndc":"42677-314-10","description":"10 VIAL in 1 CARTON (42677-314-10)  / 20 mL in 1 VIAL (42677-314-01)","marketingStartDate":"20230301"}],"dosageForm":"INJECTION, SOLUTION","genericName":"Milrinone Lactate","productType":"HUMAN PRESCRIPTION DRUG","activeIngredients":[{"name":"MILRINONE LACTATE","strength":"1 mg/mL"}],"marketingCategory":"ANDA"},{"route":["INTRAVENOUS"],"labeler":"Caplin Steriles Limited","brandName":"Milrinone Lactate","packaging":[{"ndc":"65145-120-10","description":"10 VIAL in 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reports"}],"commonSideEffects":[{"effect":"Junctional ectopic tachycardia","drugRate":"18.4%","severity":"common","organSystem":""},{"effect":"Shock","drugRate":"12.1%","severity":"common","organSystem":""},{"effect":"Inotropic score > 20","drugRate":"10.5%","severity":"common","organSystem":""},{"effect":"Third-degree atrioventricular block","drugRate":"6.2%","severity":"common","organSystem":""},{"effect":"Haemorrhage intracranial","drugRate":"3%","severity":"common","organSystem":""},{"effect":"Neonatal respiratory failure","drugRate":"3%","severity":"common","organSystem":""}],"contraindications":["Hypersensitivity to milrinone lactate"],"specialPopulations":{"Pregnancy":"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. Milrinone lactate did not appear to be teratogenic when administered intravenously to pregnant rats at doses up to 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 increase in stillbirths was observed in one study at a dose of 40 mg/kg/day.","Geriatric use":"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 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.","Paediatric use":"Safety and effectiveness in pediatric patients have not been established."},"seriousAdverseEvents":[{"effect":"Neonatal respiratory failure","drugRate":"12.1%","severity":"serious"},{"effect":"Acute Kidney Injury Stage I or greater","drugRate":"8.5%","severity":"serious"},{"effect":"Readmission","drugRate":"3.1%","severity":"serious"},{"effect":"Re-operation and dialysis post re-operation","drugRate":"3.1%","severity":"serious"},{"effect":"Enalapril caused prolonged hospitalisation","drugRate":"3.1%","severity":"serious"},{"effect":"Fever and diarrea","drugRate":"3.1%","severity":"serious"},{"effect":"Upper respiratory tract infection","drugRate":"3.1%","severity":"serious"},{"effect":"AV block III","drugRate":"3.1%","severity":"serious"},{"effect":"Blood culture verified S. aureus sepsis","drugRate":"3.1%","severity":"serious"},{"effect":"Postoperative AV-block","drugRate":"3.1%","severity":"serious"}]},"trials":[],"_chembl":{"hba":3,"hbd":1,"psa":"69.54","alogp":"1.62","source":"ChEMBL","chemblId":"CHEMBL1200977","maxPhase":"4.0","moleculeType":"Small molecule","molecularWeight":"301.30","oralBioavailable":false},"_pubmed":{"count":12,"papers":[{"date":"2022","pmid":"36225556","title":"Drug-induced kidney injury in Chinese critically ill pediatric patients.","authors":"Hu B","journal":"Frontiers in pharmacology"},{"date":"2021 Jul 19","pmid":"34358122","title":"Albumin Nanoparticle Formulation for Heart-Targeted Drug Delivery: In Vivo Assessment of Congestive Heart Failure.","authors":"Lomis N","journal":"Pharmaceuticals (Basel, Switzerland)"},{"date":"2021 Apr 9","pmid":"33832123","title":"De Novo mutation of FOXF1 causes alveolar capillary dysplasia with misalignment of pulmonary veins: A case report.","authors":"Deng L","journal":"Medicine"},{"date":"2017 Jul","pmid":"28099979","title":"Milrinone Pharmacokinetics and Pharmacodynamics in Neonates with Persistent Pulmonary Hypertension of the Newborn.","authors":"Giaccone A","journal":"American journal of perinatology"},{"date":"2002 Mar 1","pmid":"11887412","title":"Physical compatibility of milrinone lactate injection with intravenous drugs commonly used in the pediatric intensive care unit.","authors":"Veltri MA","journal":"American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists"}]},"_rxnorm":{"forms":[{"tty":"SCD","name":"100 ML milrinone lactate 0.2 MG/ML Injection","rxcui":"1791840"},{"tty":"SCD","name":"200 ML milrinone lactate 0.2 MG/ML Injection","rxcui":"1791842"},{"tty":"SCD","name":"10 ML milrinone lactate 1 MG/ML Injection","rxcui":"1791854"},{"tty":"SCD","name":"20 ML milrinone lactate 1 MG/ML Injection","rxcui":"1791859"},{"tty":"SCD","name":"50 ML milrinone lactate 1 MG/ML Injection","rxcui":"1791861"}]},"aliases":[],"patents":[],"pricing":[],"_fixedAt":"2026-03-30T11:28:37.073289","_recalls":[{"date":"20190724","reason":"Lack of Assurance of Sterility: Bags have the potential to leak.","status":"Terminated","classification":"Class II"},{"date":"20170524","reason":"Lack of assurance of sterility: customer complaints received for the presence of leaks.","status":"Terminated","classification":"Class II"},{"date":"20230913","reason":"Failed Impurities/Degradation Specifications","status":"Terminated","classification":"Class III"},{"date":"20190724","reason":"Lack of Assurance of Sterility: Bags have the potential to leak.","status":"Terminated","classification":"Class II"}],"_sources":{"fdaNDC":{"url":"","method":"api_direct","source":"FDA NDC Directory","rawText":"","confidence":1,"sourceType":"fda_ndc","retrievedAt":"2026-04-19T19:01:26.491127+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T19:01:40.146003+00:00"},"dailyMed":{"url":"","method":"api_direct","source":"DailyMed (NIH/NLM)","rawText":"","confidence":1,"sourceType":"dailymed","retrievedAt":"2026-04-19T19:01:27.278416+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"Haiku strategic summary","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T07:54:23.286751+00:00"},"chemblData":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200977/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T19:01:33.654683+00:00"},"fdaRecalls":{"url":"","method":"api_direct","source":"FDA Enforcement/Recalls","rawText":"","confidence":1,"sourceType":"fda_enforcement","retrievedAt":"2026-04-19T19:01:32.142460+00:00"},"overdosage":{"url":"","method":"deterministic","source":"FDA Label (overdosage)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T19:01:23.318133+00:00"},"howSupplied":{"url":"","method":"deterministic","source":"FDA Label (how_supplied)","rawText":"HOW SUPPLIED Milrinone Lactate Injection, USP is supplied as 10 mL single-dose vials in a box of 10, NDC 83301-0016-2; as 20 mL single-dose vials box of 10, NDC 83301-0017-2, containing a sterile, clear, colorless to pale yellow solution. Each mL contains milrinone lactate equivalent to 1 mg milrinone. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing. Discard unused portion after initial use. Manufactured for: Mullan Pharmaceutical Inc. Pasadena, CA 91101 ","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T19:01:10.637423+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:02:15.935737+00:00"},"drugDescription":{"url":"","method":"ai_extraction","source":"FDA Label (description)","aiModel":"featherless","rawText":"DESCRIPTION Milrinone lactate injection 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 an empirical formula of C 12 H 9 N 3 O. It is slightly solu","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-19T19:01:23.318066+00:00"},"pharmacokinetics":{"url":"","method":"ai_extraction","source":"FDA Label (pharmacokinetics)","aiModel":"featherless","rawText":"CLINICAL PHARMACOLOGY Milrinone lactate 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 lactate, 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","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-19T19:01:10.637319+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T19:01:32.257273+00:00"},"faersTotalReports":{"url":"","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T19:01:31.774852+00:00"},"recentPublications":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T19:01:33.193786+00:00"},"rxnormFormulations":{"url":"https://rxnav.nlm.nih.gov/REST/drugs.json?name=Milrinone Lactate","method":"api_direct","source":"RxNorm (NIH)","rawText":"","confidence":1,"sourceType":"rxnorm","retrievedAt":"2026-04-19T19:01:25.971518+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:02:15.935682+00:00"},"safety.safetySignals":{"url":"","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T19:01:28.172691+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov resultsSection (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:02:15.935680+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with results)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:02:15.935640+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:54:23.286730+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T19:02:15.935664+00:00"}},"dailyMed":[{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8fd0f93a-6150-4020-b7ee-4b95b520f6ce","setid":"8fd0f93a-6150-4020-b7ee-4b95b520f6ce","title":"MILRINONE LACTATE IN DEXTROSE (MILRINONE LACTATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27a19fc1-5e18-44e1-957d-d90f18dedc54","setid":"27a19fc1-5e18-44e1-957d-d90f18dedc54","title":"MILRINONE LACTATE IN 5% DEXTROSE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fdaee3c-2144-4ca7-9868-54d251f468c0","setid":"0fdaee3c-2144-4ca7-9868-54d251f468c0","title":"MILRINONE LACTATE INJECTION, SOLUTION [SHANDONG NEW TIME PHARMACEUTICAL CO., LTD.]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=813e8ca2-de54-4a7c-a2d2-8bd44396c341","setid":"813e8ca2-de54-4a7c-a2d2-8bd44396c341","title":"MILRINONE LACTATE INJECTION, SOLUTION [HOSPIRA, INC.]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a2822b12-0560-49d6-ace5-2377c04425e8","setid":"a2822b12-0560-49d6-ace5-2377c04425e8","title":"MILRINONE LACTATE IN 5% DEXTROSE INJECTION, SOLUTION [CAPLIN STERILES LIMITED]"}],"offLabel":[],"timeline":[{"date":"20250902","type":"positive","milestone":"FDA approval — CAPLIN","regulator":"FDA","description":""},{"date":"20230123","type":"positive","milestone":"FDA approval — SHANDONG","regulator":"FDA","description":""},{"date":"20100121","type":"positive","milestone":"FDA approval — HIKMA FARMACEUTICA","regulator":"FDA","description":""},{"date":"20020528","type":"positive","milestone":"FDA approval — BAXTER HLTHCARE","regulator":"FDA","description":""},{"date":"20200324","type":"positive","milestone":"FDA approval — MEITHEAL","regulator":"FDA","description":""}],"variants":[{"slug":"milrinone-lactate-in-dextrose-5-in-plastic-container","route":"Intravenous","brandName":"Primacor","description":"Primacor","formulation":"Injection"}],"_dailymed":{"setId":"27a19fc1-5e18-44e1-957d-d90f18dedc54","title":"MILRINONE LACTATE IN 5% DEXTROSE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC]","labeler":"","products":[],"publishedDate":"Mar 26, 2026"},"_drugbank":{"source":"DrugBank","halfLife":"","metabolism":"","proteinBinding":"","bioavailability":""},"aiSummary":"Milrinone Lactate Injection is indicated for short-term intravenous treatment of acute decompensated heart failure. The drug carries significant cardiovascular risks including ventricular arrhythmias (12.1%), supraventricular arrhythmias (3.8%), and hypotension (2.9%), requiring close electrocardiographic monitoring. Post-marketing reports document rare but serious events including torsades de pointes, bronchospasm, anaphylactic shock, and liver function abnormalities. Clinical use requires immediate availability of cardiac event treatment facilities and careful patient selection, particularly in those with preexisting arrhythmias or metabolic abnormalities.","ecosystem":[],"mechanism":{"target":"Phosphodiesterase-3 (PDE-3) enzyme","novelty":"best-in-class","targets":[{"gene":"PDE3A","source":"DrugCentral","target":"Phosphodiesterase 3","protein":"cGMP-inhibited 3',5'-cyclic phosphodiesterase A"},{"gene":"PDE3B","source":"DrugCentral","target":"Phosphodiesterase 3","protein":"cGMP-inhibited 3',5'-cyclic phosphodiesterase B"},{"gene":"PDE5A","source":"DrugCentral","target":"cGMP-specific 3',5'-cyclic phosphodiesterase","protein":"cGMP-specific 3',5'-cyclic phosphodiesterase"},{"gene":"PDE4A","source":"DrugCentral","target":"Phosphodiesterase 4","protein":"cAMP-specific 3',5'-cyclic phosphodiesterase 4A"},{"gene":"PDE4B","source":"DrugCentral","target":"Phosphodiesterase 4","protein":"cAMP-specific 3',5'-cyclic phosphodiesterase 4B"},{"gene":"PDE4C","source":"DrugCentral","target":"Phosphodiesterase 4","protein":"cAMP-specific 3',5'-cyclic phosphodiesterase 4C"},{"gene":"PDE4D","source":"DrugCentral","target":"Phosphodiesterase 4","protein":"cAMP-specific 3',5'-cyclic phosphodiesterase 4D"}],"moaClass":"Phosphodiesterase 3 Inhibitors","modality":"small molecule","drugClass":"Inotropic agent; Phosphodiesterase-3 inhibitor; Vasodilator","explanation":"Milrinone works by inhibiting phosphodiesterase-3 (PDE-3), an enzyme responsible for breaking down cyclic adenosine monophosphate (cAMP) in cardiac and vascular smooth muscle cells. By preventing cAMP degradation, milrinone increases intracellular cAMP levels, leading to enhanced cardiac contractility (positive inotropic effect) and peripheral vasodilation (positive lusitropic effect). This dual mechanism improves cardiac output and reduces afterload, providing hemodynamic support in patients with acute decompensated heart failure.\n\nUnlike traditional beta-agonists, milrinone's mechanism is independent of beta-adrenergic receptors, making it effective in patients on concurrent beta-blocker therapy. The vasodilatory properties help reduce pulmonary and systemic congestion while improving coronary perfusion. However, the increased contractility and heart rate can increase myocardial oxygen demand, necessitating careful patient monitoring.","oneSentence":"Phosphodiesterase-3 inhibitor that increases cardiac contractility and promotes vasodilation through cAMP elevation.","technicalDetail":"Milrinone selectively inhibits PDE-3 isoenzyme, increasing myocardial and vascular cAMP concentrations. This enhances calcium sensitivity in cardiac myocytes and promotes smooth muscle relaxation in blood vessels. The drug exhibits a half-life of 2-3 hours and is primarily renally eliminated, requiring dose adjustment in renal impairment."},"_scrapedAt":"2026-03-27T23:28:07.642Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"chemblData":{"prodrug":0,"chemblId":"CHEMBL1200977","maxPhase":"4.0","chirality":2,"parenteral":true,"availability":1,"moleculeType":"Small molecule","withdrawnFlag":false,"naturalProduct":0,"blackBoxWarning":0,"oralBioavailable":false},"commercial":{"launchDate":"2002","annualCostUS":"$50-200/month","_launchSource":"DrugCentral (FDA 1987-12-31, SANOFI AVENTIS US)","currentRevenue":"Generic — no single company revenue","peakSalesEstimate":"$150M"},"fdaRecalls":[{"date":"20170515","reason":"Lack of assurance of sterility: customer complaints received for the presence of leaks.","status":"Terminated","distribution":"US and foreign countries: United Arab Emirates, Colombia, and Canada","classification":"Class II"},{"date":"20230814","reason":"Failed Impurities/Degradation Specifications","status":"Terminated","distribution":"Nationwide in Tennessee","classification":"Class III"}],"overdosage":"OVERDOSAGE Doses of milrinone lactate may produce hypotension because of its vasodilator effect. If this occurs, administration of milrinone lactate 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.","references":[],"_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T07:54:23.286954+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[{"name":"Dobutamine","company":"Various manufacturers","advantage":"Beta-1 adrenergic agonist with inotropic effects; longer clinical history; lower cost than milrinone"},{"name":"Levosimendan","company":"Orion Corporation","advantage":"Calcium sensitizer with inotropic and vasodilatory properties; available in Europe; potentially superior hemodynamic profile"},{"name":"Epinephrine","company":"Various manufacturers","advantage":"Combined alpha and beta-adrenergic effects; more potent vasoconstriction; widely available and cost-effective"},{"name":"Inhaled Nitric Oxide (iNO)","company":"Mallinckrodt, Ikaria","advantage":"Selective pulmonary vasodilator; reduces pulmonary vascular resistance without systemic hypotension; useful in right heart failure"},{"name":"Omecamtiv Mecarbil","company":"Amgen","advantage":"Cardiac myosin activator; novel mechanism improving cardiac contractility; oral formulation option for chronic use"}],"dataSources":[{"url":"https://tavily.com","name":"Tavily AI Search","fields":["latestUpdates"],"retrievedDate":"2026-04-07"},{"url":"https://jina.ai/reader","name":"Jina Reader","fields":["commercialAnalysis"],"retrievedDate":"2026-04-07"},{"url":"https://groq.com","name":"Groq (Llama 3.1 8B)","fields":["commercialAnalysis"],"retrievedDate":"2026-04-07"}],"howSupplied":"HOW SUPPLIED Milrinone Lactate Injection, USP is supplied as 10 mL single-dose vials in a box of 10, NDC 83301-0016-2; as 20 mL single-dose vials box of 10, NDC 83301-0017-2, containing a sterile, clear, colorless to pale yellow solution. Each mL contains milrinone lactate equivalent to 1 mg milrinone. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing. Discard unused portion after initial use. Manufactured for: Mullan Pharmaceutical Inc. Pasadena, CA 91101 Manufactured by: Shandong New Time Pharmaceutical Co., Ltd., No. 1, North Outer Ring Road, Feixian, Shandong 273400, China. Rev. 10/2023","indications":{"approved":[{"name":"Acute decompensated heart failure","regulator":"FDA"},{"name":"Acute decompensated heart failure in patients receiving digoxin","regulator":"FDA"},{"name":"Acute decompensated heart failure in patients receiving diuretics","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"isCanonical":true,"_fixedFields":["generics(16)","patents(0)"],"labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[],"trialDetails":[],"_emaApprovals":[{"date":"","name":"Milrinone Lactate","holder":"","status":"Authorised","rawText":"Skip to main content\nAn official website of the European Union\nHow do you know?\n\nWe use cookies on this website. Essential cookies allow it to work properly. Non-essential cookies allow us to collect anonymous data to improve our services. You can opt out of non-essential cookies at any time.\n\nMore information: Cookies and Europa Analytics (user behaviour data)\n\nAccept all cookies\nAccept only essential cookies\nSearch\nSelect how you want to search using keywords\nMedicines\nHuman regulatory\nVeterinary regulatory\nCommittees\nNews & events\nPartners & networks\nAbout us\nHome\nPage or document not found","regulator":"EMA","indication":""}],"_faersSignals":[{"count":93,"reaction":"DRUG INEFFECTIVE"},{"count":63,"reaction":"DEATH"},{"count":30,"reaction":"SUPRAVENTRICULAR TACHYCARDIA"},{"count":17,"reaction":"CARDIAC FAILURE"},{"count":17,"reaction":"HYPOTENSION"},{"count":16,"reaction":"ALLERGIC MYOCARDITIS"},{"count":14,"reaction":"RENAL FAILURE"},{"count":13,"reaction":"VENTRICULAR TACHYCARDIA"},{"count":11,"reaction":"DYSPNOEA"},{"count":11,"reaction":"OFF LABEL USE"}],"genericFilers":[],"latestUpdates":[{"url":"https://synapse.patsnap.com/drug/f29972e8755049e8932c905b41498376","date":"2026-04-07","type":"news","title":"Milrinone Lactate - Drug Targets, Indications, Patents - Synapse","source":"synapse.patsnap.com"},{"url":"https://www.drugpatentwatch.com/p/alphasignals/generic/milrinone+lactate","date":"2026-04-07","type":"news","title":"milrinone lactate - Profile - DrugPatentWatch","source":"www.drugpatentwatch.com"},{"url":"https://www.cognitivemarketresearch.com/milrinone-reagent-market-report","date":"2026-04-07","type":"news","title":"Milrinone Reagent Market Analysis 2026 - Cognitive Market Research","source":"www.cognitivemarketresearch.com"},{"url":"https://www.pfizerhospitalus.com/sites/default/files/news_announcements/milrinone_200ml_ndc_change_announcement_website_app_11_21_.pdf","date":"2026-04-07","type":"news","title":"[PDF] Milrinone Lactate in 5% Dextrose Injection 40 mg/200 mL (200 mcg ...","source":"www.pfizerhospitalus.com"},{"url":"https://www.federalregister.gov/documents/2025/12/12/2025-22683/pfizer-inc-us-agent-for-king-pharmaceuticals-llc-et-al-withdrawal-of-approval-of-20-abbreviated-new","date":"2026-04-07","type":"news","title":"Pfizer Inc., U.S. Agent for King Pharmaceuticals LLC, et al.","source":"www.federalregister.gov"}],"manufacturing":[],"_mhraApprovals":[{"name":"Milrinone Lactate","holder":"","status":"Licensed","licence":"PL 12345/0001","rawText":"MHRA does not collect any data that would identify you directly. We would like to use Google Analytics to help us improve our services. You can allow this by clicking accept all cookies or find out more first by visiting our cookie policy page.\n\nAccept all cookies\nProducts\nEnter a product, active substance, or PL number:\n\nor find by active substance:\n\nA\nB\nC\nD\nE\nF\nG\nH\nI\nJ\nK\nL\nM\nN\nO\nP\nQ\nR\nS\nT\nU\nV\nW\nX\nY\nZ\n0\n1\n2\n3\n4\n5\n6\n7\n8\n9\n\nReport a side effect with a medicine or medical device\n\nMake a report\nShowing results for Milrinone Lactate\n\n1 to 10 of 39\n\nIf the product information you are seeking does n","regulator":"MHRA"}],"_hyperScrapedAt":"2026-03-28T04:39:31.370017","_patentsChecked":true,"crossReferences":{"unii":"9K8XR81MO8","rxcui":"155120","splId":"2bc91e0d-da13-e864-e063-6394a90a4c0e","chemblId":"CHEMBL1200977","pubchemSID":"7849146"},"drugDescription":{"pH":"3.2 to 4.0","structure":"1,6-dihydro-2-methyl-6-oxo-[3,4'-bipyridine]-5-carbonitrile lactate","appearance":"Off-white to tan crystalline compound (as free base); stable and colorless to pale yellow in solution (as lactate salt)","composition":"Each mL contains 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.","molecularWeight":"211.2 g/mol","molecularFormula":"C12H9N3O"},"formularyStatus":[],"_approvalHistory":[{"sponsor":"CAPLIN","approvalDate":"20250902","submissionType":"ORIG","applicationNumber":"ANDA219170"},{"sponsor":"SHANDONG","approvalDate":"20230123","submissionType":"ORIG","applicationNumber":"ANDA216373"},{"sponsor":"SHANDONG","approvalDate":"20250605","submissionType":"SUPPL","applicationNumber":"ANDA216373"},{"sponsor":"HIKMA FARMACEUTICA","approvalDate":"20100121","submissionType":"ORIG","applicationNumber":"ANDA090038"},{"sponsor":"BAXTER HLTHCARE","approvalDate":"20080227","submissionType":"SUPPL","applicationNumber":"ANDA075834"},{"sponsor":"BAXTER HLTHCARE","approvalDate":"20040324","submissionType":"SUPPL","applicationNumber":"ANDA075834"},{"sponsor":"BAXTER HLTHCARE","approvalDate":"20020528","submissionType":"ORIG","applicationNumber":"ANDA075834"},{"sponsor":"MEITHEAL","approvalDate":"20200324","submissionType":"ORIG","applicationNumber":"ANDA211671"}],"chemblMechanisms":[{"actionType":"INHIBITOR","targetChemblId":"CHEMBL241","mechanismComment":null,"mechanismOfAction":"Phosphodiesterase 3A inhibitor"}],"developmentCodes":[],"ownershipHistory":[],"pharmacokinetics":{"tmax":"Not specified","halfLife":"Not specified","linearPK":"Not specified","clearance":"Not specified","excretion":"Not specified","metabolism":"Not specified","proteinBinding":"Not specified","bioavailability":"Not specified","specialPopulations":{"age":"Not specified","renal":"Not specified","weight":"Not specified","hepatic":"Not specified"},"volumeOfDistribution":"Not specified"},"publicationCount":12,"therapeuticAreas":["Cardiovascular"],"biosimilarFilings":[],"faersTotalReports":270,"commercialAnalysis":{"text":"Milrinone Lactate, a phosphodiesterase-3 inhibitor developed by Pfizer Inc., is a key player in the treatment of acute decompensated heart failure. According to the data from Cognitive Market Research, the global Milrinone Reagent market is expected to grow at a CAGR of 5.3% from 2026 to 2034 [1]. However, the current market position and revenue trajectory of Milrinone Lactate are not explicitly stated in the provided sources.\n\nThe competitive landscape of Milrinone Lactate is dominated by several generic drug sources, including Baxter Hlthcare Corp, Caplin, and Fresenius Kabi Usa [2]. These companies have filed for NDA approvals for their generic versions of Milrinone Lactate, which may pose a threat to Pfizer Inc.'s market share. Additionally, the patent expiration of Milrinone Lactate's US patents may lead to increased competition in the market [3].\n\nKey upcoming catalysts for Milrinone Lactate include the patent cliff, which is expected to occur in the near future, and the potential label expansions for the treatment of other cardiovascular diseases. However, the pipeline competitors for Milrinone Lactate are not explicitly stated in the provided sources. It is worth noting that the data on the market share and revenue of Milrinone Lactate is not available in the provided sources.\n\nIn conclusion, while Milrinone Lactate has a strong market position in the treatment of acute decompensated heart failure, the competitive landscape and upcoming catalysts may pose a threat to its market share. Further research is needed to determine the exact market position and revenue trajectory of Milrinone Lactate.\n\nReferences:\n[1] Cognitive Market Research, \"Milrinone Reagent Market Analysis 2026\" [2] DrugPatentWatch, \"milrinone lactate - Profile\" [3] Synapse, \"Milrinone Lactate - Drug Targets, Indications, Patents - Synapse\"","model":"llama-3.1-8b (Groq)","sources":[{"url":"https://synapse.patsnap.com/drug/f29972e8755049e8932c905b41498376","date":"","title":"Milrinone Lactate - Drug Targets, Indications, Patents - Synapse","source":"synapse.patsnap.com"},{"url":"https://www.drugpatentwatch.com/p/alphasignals/generic/milrinone+lactate","date":"","title":"milrinone lactate - Profile - DrugPatentWatch","source":"www.drugpatentwatch.com"},{"url":"https://www.cognitivemarketresearch.com/milrinone-reagent-market-report","date":"","title":"Milrinone Reagent Market Analysis 2026 - Cognitive Market Research","source":"www.cognitivemarketresearch.com"}],"disclaimer":"AI-generated analysis based on public sources. 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compatibility of milrinone lactate injection with intravenous drugs commonly used in the pediatric intensive care unit.","authors":"Veltri MA, Conner KG","journal":"Am J Health Syst Pharm","pubDate":"2002 Mar 1"},{"pmid":"10488574","title":"Assessment of inotropic and vasodilating effects of milrinone lactate in patients with dilated cardiomyopathy and severe heart failure.","authors":"Bregagnollo EA, Fortes AH, Cicogna AC","journal":"Arq Bras Cardiol","pubDate":"1999 Feb"},{"pmid":"10048881","title":"Stability of milrinone lactate in the presence of 29 critical care drugs and 4 i.v. solutions.","authors":"Akkerman SR, Zhang H, Mullins RE, Yaughn K","journal":"Am J Health Syst Pharm","pubDate":"1999 Jan 1"},{"pmid":"23989550","title":"Stability of Milrinone Lactate in 5% Dextrose Injection and 0.9% Sodium Chloride Injection at Concentrations of 400, 600, and 800 micrograms/mL.","authors":"Nguyen D, Gill MA, Wong F","journal":"Int J Pharm Compd","pubDate":"1998 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