Primacor
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Questions & Answers
Side Effects & Adverse Reactions
Whether given orally or by continuous or intermittent intravenous infusion, PRIMACOR 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 PRIMACOR 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 PRIMACOR given by long-term continuous or intermittent infusion does not carry a similar risk.
The use of PRIMACOR 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 PRIMACOR 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
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
PRIMACOR, brand of milrinone lactate injection, is a member of a class of bipyridine inotropic/vasodilator agents with phosphodiesterase inhibitor activity, distinct from digitalis glycosides or catecholamines. PRIMACOR (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 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. PRIMACOR is available as sterile aqueous solutions of the lactate salt of milrinone for infusion intravenously.
Pre-Mix Flexible Containers: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 milrinone lactate equivalent to 200 mcg milrinone. The nominal concentration of lactic acid is 0.282 mg/mL. Each mL also contains 49.4 mg dextrose, anhydrous, USP. The pH is adjusted to between 3.2 and 4.0 with lactic acid or sodium hydroxide. The flexible plastic container is comprised of polyvinyl chloride with a foil overwrap. Water can permeate the plastic into the overwrap, but the amount is insufficient to significantly affect the pre-mix solution.
Sources
Primacor Manufacturers
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Sanofi-aventis U.s. Llc
![Primacor (Milrinone Lactate) Injection, Solution [Sanofi-aventis U.s. Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Primacor | Sanofi-aventis U.s. Llc
PRIMACOR (milrinone lactate) 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: 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) 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 (seeMaintenance Dosefor 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 Standard 0.50 mcg/kg/min 0.77 mg/kg continuous Maximum 0.75 mcg/kg/min 1.13 mg/kg intravenous infusionThe 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 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 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.
1) The flow control clamp of the administration set is closed. 2) The cover of the outlet port at the bottom of the container is removed. 3) 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. 4) The container is suspended on the hanger. 5) The drip chamber is squeezed and released to establish the fill level. 6) The flow control clamp is opened to expel air from the set, and then closed. 7) The set is attached to the venipuncture device, primed, and if not indwelling, the venipuncture is performed. 8) 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 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 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) 5 0.20 10 0.23 20 0.28 30 0.33 40 0.38 50 0.43
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