Milrinone Lactate in Dextrose 200 ug/mL
Milrinone Lactate in Dextrose · INJECTION, SOLUTION · Hikma Pharmaceuticals USA Inc.
Milrinone Lactate in Dextrose is a injection, solution containing milrinone lactate in dextrose at 200 ug/mL, taken intravenous. Manufactured by Hikma Pharmaceuticals USA Inc..
Key Facts
- Brand Name
- Milrinone Lactate in Dextrose
- Generic Name
- Milrinone Lactate in Dextrose
- NDC Code (Product)
0143-9719- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- 200 ug/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA090038
- Marketing Start
- 01/21/2010
Recall History
No Recall HistorySide 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 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION Milrinone Lactate in 5% Dextrose Injection should not be used for administering a loading dose. The information regarding loading doses for milrinone is for 1 mg/mL vial 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 Dose 50 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 6.0 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 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/kg Milrinone drawn from vials should be diluted prior to maintenance dose administratio…
Warnings
WARNINGS 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.
Contraindications
CONTRAINDICATIONS Milrinone lactate injection is contraindicated in patients who are hypersensitive to it.
Drug Interactions
Drug Interactions No untoward clinical manifestations have been observed in limited experience with patients in whom milrinone was used concurrently with the following drugs: digitalis glycosides; lidocaine, quinidine; hydralazine, prazosin; isosorbide dinitrate, nitroglycerin; chlorthalidone, furosemide, hydrochlorothiazide, spironolactone; captopril; heparin, warfarin, diazepam, insulin; and potassium supplements.
Adverse Reactions
ADVERSE REACTIONS Cardiovascular Effects In patients receiving milrinone 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 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 was not shown to be arrhythmogenic in an electrophysiology study. Supraventricular arrhythmias were reported in 3.8% of the patients receiving milrinone. 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-marketing experience, there ha…
Frequently Asked Questions
What is Milrinone Lactate in Dextrose used for?
Milrinone Lactate in Dextrose contains Milrinone Lactate in Dextrose. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Milrinone Lactate in Dextrose a controlled substance?
Milrinone Lactate in Dextrose is not classified as a controlled substance by the DEA.
What is the generic name for Milrinone Lactate in Dextrose?
The generic name for Milrinone Lactate in Dextrose is Milrinone Lactate in Dextrose. There are no other listed brand versions of Milrinone Lactate in Dextrose.
What is the NDC code for Milrinone Lactate in Dextrose 200 ug/mL?
The NDC (National Drug Code) for Milrinone Lactate in Dextrose 200 ug/mL is 0143-9719, listed by Hikma Pharmaceuticals USA Inc..
Other Milrinone Lactate in Dextrose Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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