Milrinone

Milrinone
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi

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Overview

Milrinone is a inotropic agent and vasodilator that is FDA approved for the {{{indicationType}}} of acute decompensated heart failure. Common adverse reactions include hypotension, ventricular arrhythmia, and headache.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Acute Decompensate Heart Failure

• Milrinone should be administered with a loading dose followed by a continuous infusion (maintenance dose) according to the following guidelines:

• Dosing Information

• Loading Dose

This image is provided by the National Library of Medicine.

• The loading dose may be given undiluted, but diluting to a rounded total volume of 10 or 20 mL may simplify the visualization of the injection rate.

This image is provided by the National Library of Medicine.

• Milrinone drawn from vials should be diluted prior to maintenance dose administration. The diluents that may be used are 0.45% Sodium Chloride Injection, 0.9% Sodium Chloride Injection, or 5% Dextrose Injection. 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.

This image is provided by the National Library of Medicine.

• 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.

• Maintenance Dose

• The maintenance dose in mL/hr by patient body weight (kg) may be determined by reference to the following table.

This image is provided by the National Library of Medicine.

• When administering 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. 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:

This image is provided by the National Library of Medicine.

• Intravenous drug products should be inspected visually and should not be used if particulate matter or discoloration is present.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Milrinone in adult patients.

Non–Guideline-Supported Use

Low Cardiac Output Syndrome, Pre-Transplantation

• Bridging therapy in patients with severe heart failure

• Dosing Information

• Loading dose of 50mcg/kg; mean maintenance dose was 0.43 mcg/kg/minute for a mean of 12 days.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• Safety and effectiveness in pediatric patients have not been established.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Milrinone in pediatric patients.

Non–Guideline-Supported Use

Adjunctive Therapy in Septic Shock

• In pediatric patients with nonhyperdynamic septic shock, intravenous milrinone (loading dose of 50 mg/kg followed by a continuous infusion of 0.5 mg/kg/min) improves cardiovascular function when administered with catecholamines.

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Milrinone in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Milrinone in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Milrinone in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Milrinone during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Milrinone with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Milrinone with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Milrinone with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Milrinone with respect to specific gender populations.

Race

There is no FDA guidance on the use of Milrinone with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Milrinone in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Milrinone in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Milrinone in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Milrinone in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Milrinone in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Milrinone in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Milrinone in the drug label.

Pharmacology

Milrinone
Systematic (IUPAC) name
6-methyl-2-oxo-5-pyridin-4-yl-1H-pyridine-3-carbonitrile
Identifiers
CAS number	78415-72-2
ATC code	C01CE02
PubChem	4197
DrugBank	APRD00010
Chemical data
Formula	Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox
Mol. mass	211.219 g/mol
Pharmacokinetic data
Bioavailability	100% (as IV bolus, infusion)
Protein binding	70 to 80%
Metabolism	Hepatic (12%)
Half life	2.3 hours
Excretion	Urine (85% as unchanged drug) within 24 hours
Therapeutic considerations
Pregnancy cat.	C(US)
Legal status	Rx Only
Routes	IV only

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Milrinone in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Milrinone in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Milrinone in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Milrinone in the drug label.

How Supplied

• Milrinone Lactate Injection is supplied as 10 mL (1 mg/mL) NDC 55390-019-10, box of 10; 20 mL (1 mg/mL) NDC 55390-020-10, box of 10; and 50 mL (1 mg/mL) NDC 55390-021-01, individually-boxed, single-dose vials containing a sterile, clear, colorless to pale yellow solution. Each mL contains milrinone lactate equivalent to 1 mg milrinone.

• Discard unused portion after initial use. Store at controlled room temperature 15° to 30°C (59° to 86°F) (see USP). Avoid freezing.

• Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing.

Storage

There is limited information regarding Milrinone Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Milrinone in the drug label.

Precautions with Alcohol

• Alcohol-Milrinone interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• Primacor®

Look-Alike Drug Names

• N/A

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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