Primacor

Primacor is a prescription medication used for short-term treatment of acute decompensated heart failure (a specific type of heart problem).  

• Sanofi-Aventis U.S. LLC

Tell your doctor if you are pregnant or plan to become pregnant.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Take Primacor exactly as prescribed.

Primacor comes in injectable form to be given directly into the vein (IV) by a healthcare professional.

Milrinone is a vasodilator that works by relaxing the muscles in your blood vessels to help them dilate (widen). This lowers blood pressure and allows blood to flow more easily through your veins and arteries.

Milrinone is used as a short-term treatment for life-threatening heart failure.

Milrinone may also be used for purposes not listed in this medication guide.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have:

• chest pain;

• a light-headed feeling, like you might pass out;

• bronchospasm (wheezing, chest tightness, trouble breathing); or

• low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, extreme thirst, increased urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

• headache;

• tremors; or

• easy bruising or bleeding.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

200 MCG/ML IN 5% DEXTROSE INJECTION

Cardiovascular Effects

In patients receiving Primacor 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 Primacor 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. Primacor was not shown to be arrhythmogenic in an electrophysiology study. Supraventricular arrhythmias were reported in 3.8% of the patients receiving Primacor. 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 have been rare cases of "torsades de pointes" reported.

CNS Effects

Headaches, usually mild to moderate in severity, have been reported in 2.9% of patients receiving Primacor.

Other Effects

Other adverse reactions reported, but not definitely related to the administration of Primacor include hypokalemia, 0.6%; tremor, 0.4%; and thrombocytopenia, 0.4%.

Post-Marketing Adverse Event Reports

In addition to adverse events reported from clinical trials, the following events have been reported from worldwide post-marketing experience with Primacor:

Isolated spontaneous reports of bronchospasm and anaphylactic shock.

Liver function test abnormalities and skin reactions such as rash.

Administration site conditions: Infusion site reaction.

Primacor Flexible Containers (200 mcg/mL in 5% Dextrose Injection) are supplied:

100 mL (200 mcg/mL) NDC 0024-1203-11 in 5% Dextrose Injection single units.

200 mL (200 mcg/mL) NDC 0024-1203-22 in 5% Dextrose Injection single units.

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the Flexible Containers be stored at room temperature, 25 C (77 F), however, brief exposure up to 40 C (104 F) does not adversely affect the product.

Manufactured by:
Hospira Inc.
Lake Forest, IL 60045

Manufactured for:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807

Revised March 2007B

©2007 sanofi-aventis U.S. LLC