MILRINONE-BAXTER CONCENTRATED SOLUTION FOR INJECTION 10MG/10ML [SIN15249P]

Product Info

MILRINONE-BAXTER CONCENTRATED SOLUTION FOR INJECTION 10MG/10ML

[SIN15249P]

INDICATIONS AND USAGE
Milrinone-Baxter Concentrated Solution for Injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving Milrinone-Baxter Concentrated Solution for Injection 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 Concentrated Solution for Injection has been in patients receiving digoxin and diuretics. There is no experience in controlled trials with infusions of Milrinone Concentrated Solution for Infusion for periods exceeding 48 hours.

DOSAGE AND ADMINISTRATION
Infusion should be commenced as soon as practicable after preparation of the mixture in order to reduce microbiological hazards. Preparations not used within 24 hours should be discarded. Compatibility studies with the diluents were conducted in non-PVC (polypropylene) bags.
Milrinone Concentrated Solution for Injection should be administered with a loading dose followed by a continuous infusion (maintenance dose) according to the following guidelines:

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

Milrinone Concentrated Solution for Injection drawn from ampoules 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.

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.

When administering Milrinone-Baxter Concentrate Solution for Injection (milrinone lactate) by continuous infusion, it is advisable to use a calibrated electronic infusion device.

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 Concentrated Solution for Injection. 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:

CONTRAINDICATIONS
Milrinone-Baxter Concentrated Solution for Injection is contraindicated in patients who are hypersensitive to it.