Milrinone Lactate 1 mg/mL
Milrinone Lactate · INJECTION, SOLUTION · Mullan Pharmaceutical Inc.
Milrinone Lactate is an intravenous injection used to treat heart failure and improve heart function in critically ill patients. It works by helping the heart pump more effectively and relaxing blood vessels to reduce strain on the heart.
Key Facts
- Brand Name
- Milrinone Lactate
- Generic Name
- Milrinone Lactate
- NDC Code (Product)
83301-0016- Manufacturer
- Mullan Pharmaceutical Inc.
- Strength
- 1 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA216373
- Marketing Start
- 09/18/2023
Recall History
Pfizer Inc.
Lack of Assurance of Sterility: Bags have the potential to leak.
Baxter Healthcare Corporation
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Caplin Steriles Limited
Failed Impurities/Degradation Specifications
Pfizer Inc.
Lack of Assurance of Sterility: Bags have the potential to leak.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Milrinone Lactate Injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone lactate 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 lactate has been in patients receiving digoxin and diuretics.
Dosage & Administration
DOSAGE AND ADMINISTRATION Milrinone Lactate Injection, USP 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 The table below shows the loading dose in milliliters (mL) of milrinone lactate (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 2.5 3 3.5 4 4.5 5 5.5 6 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. 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 Milrinone lactate drawn from vials 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 (…
Warnings
WARNINGS Whether given orally or by continuous or intermittent intravenous infusion, milrinone lactate 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 lactate 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 lactate given by long-term continuous or intermittent infusion does not carry a similar risk. The use of milrinone lactate 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 lactate should be observed closely with the use of continuous electrocardiographic monitoring to allow the prompt detection and management of ventricular arrhythmias.
Contraindications
CONTRAINDICATIONS Milrinone Lactate Injection is contraindicated in patients who are hypersensitive to it.
Adverse Reactions
ADVERSE REACTIONS Cardiovascular Effects In patients receiving milrinone lactate 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 lactate 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 lactate was not shown to be arrhythmogenic in an electrophysiology study. Supraventricular arrhythmias were reported in 3.8% of the patients receiving milrinone lactate. 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…
Frequently Asked Questions
What is Milrinone Lactate used for?
Milrinone Lactate is an intravenous injection used to treat heart failure and improve heart function in critically ill patients. It works by helping the heart pump more effectively and relaxing blood vessels to reduce strain on the heart.
Is Milrinone Lactate a controlled substance?
Milrinone Lactate is not classified as a controlled substance by the DEA.
What is the generic name for Milrinone Lactate?
The generic name for Milrinone Lactate is Milrinone Lactate. There are 6 other brand versions of Milrinone Lactate.
What is the NDC code for Milrinone Lactate 1 mg/mL?
The NDC (National Drug Code) for Milrinone Lactate 1 mg/mL is 83301-0016, listed by Mullan Pharmaceutical Inc..