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PRIMACOR is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving PRIMACOR 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 PRIMACOR has been in patients receiving digoxin and diuretics. There is no experience in controlled trials with infusions of PRIMACOR for periods exceeding 48 hours.
DOSAGE AND ADMINISTRATION
PRIMACOR (milrinone lactate) should be administered with a loading dose followed by a continuous infusion (maintenance dose) according to the following guidelines:
50 mcg/kg: Administer slowly over 10 minutes
Note: PRIMACOR Flexible Containers (200 mcg/mL in 5% Dextrose Injection) are for intravenous infusion only and should not be used for a loading dose. Dosage recommendations using a 1mg/mL concentration of milrinone are included for informational purposes only. The loading dose should be administered using a milrinone 1mg/mL vial.
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)|
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.
|Total Daily Dose|
|Infusion Rate||(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/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.
Note: PRIMACOR supplied in 100 mL and 200 mL Flexible Containers (200 mcg/mL in 5% Dextrose Injection) need not be diluted prior to use.
PRIMACOR Infusion Rate (mL/hr) Using 200 mcg/mL Concentration
|Maintenance Dose (mcg/kg/min)||Patient Body Weight (kg)|
When administering PRIMACOR (milrinone lactate) by continuous infusion, it is advisable to use a calibrated electronic infusion device.
The Flexible Container has a concentration of milrinone equivalent to 200 mcg/mL in 5% Dextrose Injection. To use the Flexible Container, tear the overwrap at the notch and remove the Pre-Mix solution container. Squeeze the container firmly to check for leaks. Discard the container if leaks are found since the sterility of the product could be affected. Do not add supplementary medication. To prepare the container for administration of PRIMACOR intravenously, use aseptic techniques.
- The flow control clamp of the administration set is closed.
- The cover of the outlet port at the bottom of the container is removed.
- Noting the full directions on the administration set carton, the piercing pin of the set is inserted into the port with a twisting motion until it is firmly seated.
- The container is suspended on the hanger.
- The drip chamber is squeezed and released to establish the fill level.
- The flow control clamp is opened to expel air from the set, and then closed.
- The set is attached to the venipuncture device, primed, and if not indwelling, the venipuncture is performed.
- The rate of administration is controlled with the flow control clamp. WARNING- DO NOT USE IN SERIES CONNECTIONS. Caution: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.
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 PRIMACOR. 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/1.73m2)||Infusion Rate (mcg/kg/min)|
PRIMACOR Flexible Containers (200 mcg/mL in 5% Dextrose Injection) are supplied:
100 mL (200 mcg/mL) NDC 0024-1203-11 in 5% Dextrose
Injection single units.
200 mL (200 mcg/mL) NDC 0024-1203-22 in 5% Dextrose Injection single units.
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the Flexible Containers be stored at room temperature, 25° C (77° F), however, brief exposure up to 40° C (104° F) does not adversely affect the product.
Manufactured by: Hospira Inc. Lake Forest, IL 60045. Manufactured for: sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Prescribing Information as of April 2007. Novation, the supply company of VHA and UHC, and NOVAPLUS are trademarks of Novation, LLC. FDA Rev date: 10/30/2007This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 7/2/2008
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