Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 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; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg per 100 mL (200 mcg (0.2 mg) / mL) - Infusion Bag Label 100 mL Single Dose Flexible Container NDC 55150-287-01 Sterile Rx only Milrinone Lactate in 5% Dextrose Injection 20 mg per 100 mL (200 mcg (0.2 mg) / mL)* For Intravenous Infusion Only *Each mL contains 0.285 mg milrinone lactate equivalent to 0.2 mg milrinone USP, 0.282 mg lactic acid, 54.3 mg dextrose, hydrous, USP in water for injection, USP. The pH is adjusted with lactic acid and/or sodium hydroxide pH 3.5 (3.2 to 4.0). No preservative is added. Sterile, nonpyrogenic, single dose. Usual Dosage: Intravenously as directed by a physician. See package insert. Cautions: Check for minute leaks by squeezing bag firmly. If leaks are found, discard bag as sterility may be impaired. MUST NOT BE USED IN SERIES CONNECTIONS. Do not administer simultaneously with blood. Use only if solution is clear, colorless to pale yellow. Recommended storage: Store at room temperature 25°C (77°F); however brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing. Avoid excessive heat. Distributed by: Eugia US LLC Made in India E. Windsor, NJ 08520 Code: TS/DRUGS/01/2013/LVP P1431886 PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg per 100 mL (200 mcg (0.2 mg) / mL) - Infusion Bag Label; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg per 100 mL (200 mcg (0.2 mg) / mL) - Pouch (Overwrap) Label TO OPEN - TEAR AT NOTCH 100 mL Single Dose Flexible Container NDC 55150-287-01 Sterile Rx only Milrinone Lactate in 5% Dextrose Injection 20 mg per 100 mL (200 mcg (0.2 mg) / mL)* For Intravenous Infusion Only *Each mL contains 0.285 mg milrinone lactate equivalent to 0.2 mg milrinone USP, 0.282 mg lactic acid, 54.3 mg dextrose, hydrous, USP in water for injection, USP. The pH is adjusted with lactic acid and/or sodium hydroxide pH 3.5 (3.2 to 4.0). Sterile, nonpyrogenic, single dose container. No preservative is added. Use only if solution is clear, colorless to pale yellow. Discard unused portion. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard bag as sterility may be impaired. MUST NOT BE USED IN SERIES CONNECTIONS. Do not administer simultaneously with blood. Usual Dosage: See package insert. Store at room temperature 25°C (77°F); however brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing. Avoid excessive heat. See insert. Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier. The inner bag maintains the sterility of the product. Distributed by: Code: TS/DRUGS/01/2013/LVP Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 P4000380 Made in India eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg per 100 mL (200 mcg (0.2 mg) / mL) - Pouch (Overwrap) Label; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg per 100 mL (200 mcg (0.2 mg) / mL) - Carton Label 10 x 100 mL Single Dose Flexible Containers NDC 55150-287-10 Sterile Rx only Milrinone Lactate in 5% Dextrose Injection 20 mg per 100 mL (200 mcg (0.2 mg) / mL)* For Intravenous Infusion Only *Each mL contains 0.285 mg milrinone lactate equivalent to 0.2 mg milrinone USP, 0.282 mg lactic acid, 54.3 mg dextrose, hydrous, USP in water for injection, USP. The pH is adjusted with lactic acid and/or sodium hydroxide pH 3.5 (3.2 to 4.0). Sterile, nonpyrogenic, single dose container. No preservative is added. Use only if solution is clear, colorless to pale yellow. Discard unused portion. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard bag as sterility may be impaired. MUST NOT BE USED IN SERIES CONNECTIONS. Do not administer simultaneously with blood. Usual Dosage: See package insert. Store at room temperature 25°C (77°F); however brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing. Avoid excessive heat. See insert. Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier. The inner bag maintains the sterility of the product. Distributed by: Code: TS/DRUGS/01/2013/LVP Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Made in India P1431887 PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg per 100 mL (200 mcg (0.2 mg) / mL) - Carton Label; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 40 mg per 200 mL (200 mcg (0.2 mg) / mL) - Infusion Bag Label 200 mL Single Dose Flexible Container NDC 55150-288-01 Sterile Rx only Milrinone Lactate in 5% Dextrose Injection 40 mg per 200 mL (200 mcg (0.2 mg) / mL)* For Intravenous Infusion Only *Each mL contains 0.285 mg milrinone lactate equivalent to 0.2 mg milrinone USP, 0.282 mg lactic acid, 54.3 mg dextrose, hydrous, USP in water for injection, USP. The pH is adjusted with lactic acid and/or sodium hydroxide pH 3.5 (3.2 to 4.0). Sterile, nonpyrogenic, single dose. No preservative is added. Usual Dosage: Intravenously as directed by a physician. See package insert. Cautions: Check for minute leaks by squeezing bag firmly. If leaks are found, discard bag as sterility may be impaired. MUST NOT BE USED IN SERIES CONNECTIONS. Do not administer simultaneously with blood. Use only if solution is clear, colorless to pale yellow. Recommended storage: Store at room temperature 25°C (77°F); however brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing. Avoid excessive heat. Distributed by: Made in India Eugia US LLC Code: TS/DRUGS/01/2013/LVP E. Windsor, NJ 08520 P1431888 PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 40 mg per 200 mL (200 mcg (0.2 mg) / mL) - Infusion Bag Label; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 40 mg per 200 mL (200 mcg (0.2 mg) / mL) - Pouch (Overwrap) Label TO OPEN - TEAR AT NOTCH 200 mL Single Dose Flexible Container NDC 55150-288-01 Sterile Rx only Milrinone Lactate in 5% Dextrose Injection 40 mg per 200 mL (200 mcg (0.2 mg) / mL)* For Intravenous Infusion Only *Each mL contains 0.285 mg milrinone lactate equivalent to 0.2 mg milrinone USP, 0.282 mg lactic acid, 54.3 mg dextrose, hydrous, USP in water for injection, USP. The pH is adjusted with lactic acid and/or sodium hydroxide pH 3.5 (3.2 to 4.0). Sterile, nonpyrogenic, single dose container. No preservative is added. Use only if solution is clear, colorless to pale yellow. Discard unused portion. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard bag as sterility may be impaired. MUST NOT BE USED IN SERIES CONNECTIONS. Do not administer simultaneously with blood. Usual Dosage: See package insert. Store at room temperature 25°C (77°F); however brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing. Avoid excessive heat. See insert. Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier. The inner bag maintains the sterility of the product. Distributed by: Code: TS/DRUGS/01/2013/LVP Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 P4000381 Made in India eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 40 mg per 200 mL (200 mcg (0.2 mg) / mL) - Pouch (Overwrap) Label; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 40 mg per 200 mL (200 mcg (0.2 mg) / mL) - Carton Label 10 x 200 mL Single Dose Flexible Containers NDC 55150-288-10 Sterile Rx only Milrinone Lactate in 5% Dextrose Injection 40 mg per 200 mL (200 mcg (0.2 mg) / mL)* For Intravenous Infusion Only *Each mL contains 0.285 mg milrinone lactate equivalent to 0.2 mg milrinone USP, 0.282 mg lactic acid, 54.3 mg dextrose, hydrous, USP in water for injection, USP. The pH is adjusted with lactic acid and/or sodium hydroxide pH 3.5 (3.2 to 4.0). Sterile, nonpyrogenic, single dose container. No preservative is added. Use only if solution is clear, colorless to pale yellow. Discard unused portion. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard bag as sterility may be impaired. MUST NOT BE USED IN SERIES CONNECTIONS. Do not administer simultaneously with blood. Usual Dosage: See package insert. Store at room temperature 25°C (77°F); however brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing. Avoid excessive heat. See insert. Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier. The inner bag maintains the sterility of the product. Distributed by: Code: TS/DRUGS/01/2013/LVP Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Made in India P1431889 eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 40 mg per 200 mL (200 mcg (0.2 mg) / mL) - Carton Label
- HOW SUPPLIED 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
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg per 100 mL (200 mcg (0.2 mg) / mL) - Infusion Bag Label 100 mL Single Dose Flexible Container NDC 55150-287-01 Sterile Rx only Milrinone Lactate in 5% Dextrose Injection 20 mg per 100 mL (200 mcg (0.2 mg) / mL)* For Intravenous Infusion Only *Each mL contains 0.285 mg milrinone lactate equivalent to 0.2 mg milrinone USP, 0.282 mg lactic acid, 54.3 mg dextrose, hydrous, USP in water for injection, USP. The pH is adjusted with lactic acid and/or sodium hydroxide pH 3.5 (3.2 to 4.0). No preservative is added. Sterile, nonpyrogenic, single dose. Usual Dosage: Intravenously as directed by a physician. See package insert. Cautions: Check for minute leaks by squeezing bag firmly. If leaks are found, discard bag as sterility may be impaired. MUST NOT BE USED IN SERIES CONNECTIONS. Do not administer simultaneously with blood. Use only if solution is clear, colorless to pale yellow. Recommended storage: Store at room temperature 25°C (77°F); however brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing. Avoid excessive heat. Distributed by: Eugia US LLC Made in India E. Windsor, NJ 08520 Code: TS/DRUGS/01/2013/LVP P1431886 PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg per 100 mL (200 mcg (0.2 mg) / mL) - Infusion Bag Label
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg per 100 mL (200 mcg (0.2 mg) / mL) - Pouch (Overwrap) Label TO OPEN - TEAR AT NOTCH 100 mL Single Dose Flexible Container NDC 55150-287-01 Sterile Rx only Milrinone Lactate in 5% Dextrose Injection 20 mg per 100 mL (200 mcg (0.2 mg) / mL)* For Intravenous Infusion Only *Each mL contains 0.285 mg milrinone lactate equivalent to 0.2 mg milrinone USP, 0.282 mg lactic acid, 54.3 mg dextrose, hydrous, USP in water for injection, USP. The pH is adjusted with lactic acid and/or sodium hydroxide pH 3.5 (3.2 to 4.0). Sterile, nonpyrogenic, single dose container. No preservative is added. Use only if solution is clear, colorless to pale yellow. Discard unused portion. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard bag as sterility may be impaired. MUST NOT BE USED IN SERIES CONNECTIONS. Do not administer simultaneously with blood. Usual Dosage: See package insert. Store at room temperature 25°C (77°F); however brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing. Avoid excessive heat. See insert. Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier. The inner bag maintains the sterility of the product. Distributed by: Code: TS/DRUGS/01/2013/LVP Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 P4000380 Made in India eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg per 100 mL (200 mcg (0.2 mg) / mL) - Pouch (Overwrap) Label
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg per 100 mL (200 mcg (0.2 mg) / mL) - Carton Label 10 x 100 mL Single Dose Flexible Containers NDC 55150-287-10 Sterile Rx only Milrinone Lactate in 5% Dextrose Injection 20 mg per 100 mL (200 mcg (0.2 mg) / mL)* For Intravenous Infusion Only *Each mL contains 0.285 mg milrinone lactate equivalent to 0.2 mg milrinone USP, 0.282 mg lactic acid, 54.3 mg dextrose, hydrous, USP in water for injection, USP. The pH is adjusted with lactic acid and/or sodium hydroxide pH 3.5 (3.2 to 4.0). Sterile, nonpyrogenic, single dose container. No preservative is added. Use only if solution is clear, colorless to pale yellow. Discard unused portion. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard bag as sterility may be impaired. MUST NOT BE USED IN SERIES CONNECTIONS. Do not administer simultaneously with blood. Usual Dosage: See package insert. Store at room temperature 25°C (77°F); however brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing. Avoid excessive heat. See insert. Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier. The inner bag maintains the sterility of the product. Distributed by: Code: TS/DRUGS/01/2013/LVP Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Made in India P1431887 PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg per 100 mL (200 mcg (0.2 mg) / mL) - Carton Label
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 40 mg per 200 mL (200 mcg (0.2 mg) / mL) - Infusion Bag Label 200 mL Single Dose Flexible Container NDC 55150-288-01 Sterile Rx only Milrinone Lactate in 5% Dextrose Injection 40 mg per 200 mL (200 mcg (0.2 mg) / mL)* For Intravenous Infusion Only *Each mL contains 0.285 mg milrinone lactate equivalent to 0.2 mg milrinone USP, 0.282 mg lactic acid, 54.3 mg dextrose, hydrous, USP in water for injection, USP. The pH is adjusted with lactic acid and/or sodium hydroxide pH 3.5 (3.2 to 4.0). Sterile, nonpyrogenic, single dose. No preservative is added. Usual Dosage: Intravenously as directed by a physician. See package insert. Cautions: Check for minute leaks by squeezing bag firmly. If leaks are found, discard bag as sterility may be impaired. MUST NOT BE USED IN SERIES CONNECTIONS. Do not administer simultaneously with blood. Use only if solution is clear, colorless to pale yellow. Recommended storage: Store at room temperature 25°C (77°F); however brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing. Avoid excessive heat. Distributed by: Made in India Eugia US LLC Code: TS/DRUGS/01/2013/LVP E. Windsor, NJ 08520 P1431888 PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 40 mg per 200 mL (200 mcg (0.2 mg) / mL) - Infusion Bag Label
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 40 mg per 200 mL (200 mcg (0.2 mg) / mL) - Pouch (Overwrap) Label TO OPEN - TEAR AT NOTCH 200 mL Single Dose Flexible Container NDC 55150-288-01 Sterile Rx only Milrinone Lactate in 5% Dextrose Injection 40 mg per 200 mL (200 mcg (0.2 mg) / mL)* For Intravenous Infusion Only *Each mL contains 0.285 mg milrinone lactate equivalent to 0.2 mg milrinone USP, 0.282 mg lactic acid, 54.3 mg dextrose, hydrous, USP in water for injection, USP. The pH is adjusted with lactic acid and/or sodium hydroxide pH 3.5 (3.2 to 4.0). Sterile, nonpyrogenic, single dose container. No preservative is added. Use only if solution is clear, colorless to pale yellow. Discard unused portion. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard bag as sterility may be impaired. MUST NOT BE USED IN SERIES CONNECTIONS. Do not administer simultaneously with blood. Usual Dosage: See package insert. Store at room temperature 25°C (77°F); however brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing. Avoid excessive heat. See insert. Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier. The inner bag maintains the sterility of the product. Distributed by: Code: TS/DRUGS/01/2013/LVP Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 P4000381 Made in India eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 40 mg per 200 mL (200 mcg (0.2 mg) / mL) - Pouch (Overwrap) Label
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 40 mg per 200 mL (200 mcg (0.2 mg) / mL) - Carton Label 10 x 200 mL Single Dose Flexible Containers NDC 55150-288-10 Sterile Rx only Milrinone Lactate in 5% Dextrose Injection 40 mg per 200 mL (200 mcg (0.2 mg) / mL)* For Intravenous Infusion Only *Each mL contains 0.285 mg milrinone lactate equivalent to 0.2 mg milrinone USP, 0.282 mg lactic acid, 54.3 mg dextrose, hydrous, USP in water for injection, USP. The pH is adjusted with lactic acid and/or sodium hydroxide pH 3.5 (3.2 to 4.0). Sterile, nonpyrogenic, single dose container. No preservative is added. Use only if solution is clear, colorless to pale yellow. Discard unused portion. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard bag as sterility may be impaired. MUST NOT BE USED IN SERIES CONNECTIONS. Do not administer simultaneously with blood. Usual Dosage: See package insert. Store at room temperature 25°C (77°F); however brief exposure up to 40°C (104°F) does not adversely affect the product. Protect from freezing. Avoid excessive heat. See insert. Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier. The inner bag maintains the sterility of the product. Distributed by: Code: TS/DRUGS/01/2013/LVP Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Made in India P1431889 eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 40 mg per 200 mL (200 mcg (0.2 mg) / mL) - Carton Label
Overview
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
Indications & Usage
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.
Dosage & Administration
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.
Warnings & Precautions
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.
Contraindications
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.
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%. 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.
Drug Interactions
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.
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