Milrinone Lactate In Dextrose
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
Milrinone Lactate in 5% Dextrose Injection is a sterile, aqueous solution of milrinone in 5% dextrose. It is administered by the intravenous route. It is premixed and requires no further dilution.
Milrinone 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.
Milrinone is an off-white to tan crystalline compound with a molecular formula of C12H9N3O. 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.
The molecular structures of milrinone lactate and dextrose (hydrous) are as follows:
The PAB Container is Latex-free, PVC-free, and DEHP-free.
The PAB plastic container system provides a ready-to-use dilution of milrinone in a volume of 100 mL of 5% Dextrose Injection. Each mL contains milrinone lactate equivalent to 200 mcg milrinone. The nominal concentration of Lactic Acid USP is 0.282 mg/mL. Each mL also contains 49.4 mg Dextrose, Anhydrous, USP in Water for Injection, USP. The pH is adjusted to between 3.2 and 4.0 with lactic acid and/or sodium hydroxide.
The solution contains no preservative and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded.
The PAB plastic container system is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The safety of the plastic container has been confirmed by biological evaluation procedures.
The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests – Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. No overwrap is necessary.
Sources
Milrinone Lactate In Dextrose Manufacturers
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B. Braun Medical Inc.
![Milrinone Lactate In Dextrose (Milrinone Lactate And Dextrose Monohydrate) Injection [B. Braun Medical Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Milrinone Lactate In Dextrose | B. Braun Medical Inc.
CAUTION: DO NOT ADMIX WITH OTHER DRUGS.
MUST NOT BE USED IN SERIES CONNECTIONS.
Milrinone Lactate in 5% Dextrose Injection should not be used for administering a loading dose. The information regarding loading doses for milrinone shown below is for informational purposes only.
A loading dose of milrinone lactate injection (1 mg [base]/mL) should be administered followed by a continuous infusion (maintenance dose) according to the following guidelines:
LOADING DOSE50 mcg/kg: Administer slowly over 10 minutes
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 6.0The 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 0.50 mcg/kg/min 0.77 mg/kg Maximum 0.75 mcg/kg/min 1.13 mg/kgThe 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 Patient Body Weight (kg) (mcg/kg/min) 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 0.400 3.6 4.8 6.0 7.2 8.4 9.6 10.8 12.0 13.2 14.4 0.500 4.5 6.0 7.5 9.0 10.5 12.0 13.5 15.0 16.5 18.0 0.600 5.4 7.2 9.0 10.8 12.6 14.4 16.2 18.0 19.8 21.6 0.700 6.3 8.4 10.5 12.6 14.7 16.8 18.9 21.0 23.1 25.2 0.750 6.8 9.0 11.3 13.5 15.8 18.0 20.3 22.5 24.8 27.0When administering milrinone by continuous infusion, it is advisable to use a calibrated electronic infusion device.
Dosage Adjustment in Renally Impaired PatientsData 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 m2) Infusion Rate
(mcg/kg/min) 5 0.20 10 0.23 20 0.28 30 0.33 40 0.38 50 0.43The PAB® plastic container system contains milrinone equivalent to 200 mcg/mL milrinone in 5% Dextrose Injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if cloudy or precipitated or if the seals are not intact.
If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.
Use sterile equipment. It is recommended that the intravenous administration apparatus be replaced at least once every 24 hours.
Directions for Use of PAB® Plastic Container SystemCAUTION: DO NOT ADMIX WITH OTHER DRUGS.
MUST NOT BE USED IN SERIES CONNECTIONS.
For intravenous infusion only.
Store the individual container in the storage carton until ready to use.
Aseptic technique is required.
Caution – Before use, perform the following checks: (a) Read the label. Ensure solution is the one ordered and is within the expiration date. (b) Inspect the solution in good light for cloudiness, haze or particulate matter; check the container for leakage or damage. Any container which is suspect should not be used.Check for minute leaks by squeezing solution container firmly. Use only if solution is clear and container and seals are intact.
Single dose plastic container. Discard unused portion.
Consult Package Insert for complete product information.
2. Caution – IV admixtures containing this solution and other drugs should be avoided. Additives should not be introduced into this solution. If used with a primary intravenous fluid system, the primary solution should be discontinued during milrinone infusion. 3. To Attach Administration Set
Remove the set port closure. Hold the container below the set port and grasp cap between thumb and forefinger, then roll cap upward (see Figure A). Push the spike into and through the diaphragm of the port (see Figure B). Continue with Directions for Use for the administration set. Suspend the container using the hole in the lower flap. -
Baxter Healthcare Corporation
Milrinone Lactate In Dextrose | Baxter Healthcare Corporation
Milrinone should be administered with a loading dose followed by a continuous infusion (maintenance dose) according to the following guidelines:
Loading Dose50 mcg/kg: Administer slowly over 10 minutes
Note: Milrinone (200 mcg/mL) in INTRAVIA 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 (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 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0The 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 0.50 mcg/kg/min 0.77 mg/kg Maximum 0.75 mcg/kg/min 1.13 mg/kgThe 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 0.400 3.6 4.8 6.0 7.2 8.4 9.6 10.8 12.0 13.2 14.4 0.500 4.5 6.0 7.5 9.0 10.5 12.0 13.5 15.0 16.5 18.0 0.600 5.4 7.2 9.0 10.8 12.6 14.4 16.2 18.0 19.8 21.6 0.700 6.3 8.4 10.5 12.6 14.7 16.8 18.9 21.0 23.1 25.2 0.750 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 PatientsData 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 m2) Infusion Rate
(mcg/kg/min) 5 0.20 10 0.23 20 0.28 30 0.33 40 0.38 50 0.43Parenteral 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.
![Milrinone Lactate In Dextrose (Milrinone Lactate) Injection, Solution [Baxter Healthcare Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8fd0f93a-6150-4020-b7ee-4b95b520f6ce&name=78d8f819-f097-494d-9701-61ad3ae23e56-02.jpg)
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