Milrinone

Indications

INDICATIONS AND USAGE Milrinone Lactate in 5% Dextrose 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 and administration (summary)

DOSAGE AND ADMINISTRATION Milrinone Lactate in 5% Dextrose Injection 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 Note: Milrinone Lactate in 5% Dextrose Injection (200 mcg/mL) in Flexible Plastic Container is for intravenous infusion only. Dosage recommendations using a 1 mg/mL concentration of milrinone are included for informational purposes only. The table below shows the loading dose in milliliters (mL) of milrinone (1 mg/mL) by patient body weight (kg).

Contraindications

CONTRAINDICATIONS Milrinone is contraindicated in patients who are hypersensitive to it. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

Warnings and precautions

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.

Pregnancy

Pregnancy Category C Oral administration of milrinone to pregnant rats and rabbits during organogenesis produced no evidence of teratogenicity at dose levels up to 40 mg/kg/day and 12 mg/kg/day, respectively.

Storage and supply

HOW SUPPLIED Milrinone Lactate in 5% Dextrose Injection is a clear, colorless to pale yellow solution and is supplied in Flexible Plastic Containers as follows: 20 mg per 100 mL (200 mcg (0.2 mg)/mL) 100 mL Single-Dose Flexible Containers packaged in a Carton of 10 NDC 55150-287-10 40 mg per 200 mL (200 mcg (0.2 mg)/mL) 200 mL Single-Dose Flexible …

Source: Milrinone Lactate In 5% Dextrose (Milrinone Lactate) — US FDA prescribing information, 2023-02-01, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.