"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is warning of several treatment-related serious adverse events in association with implantable left ventricular assist devices (LVADs) in heart-failure patients.
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Primacor IV Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Primacor (milrinone lactate) is a vasodilator used as a short-term treatment for treat life-threatening heart failure. Common side effects of Primacor include headache, tremors, or easy bruising or bleeding.
Primacor is given in a hospital setting under a physician's supervision. A loading (starting) dose of 50 mcg/kg is administered slowly over 10 minutes followed by a continuous infusion (maintenance dose) determined by the patient's weight. Primacor may interact with digoxin (digitalis, Lanoxin, Lanoxicaps), or diuretics (water pills). Other drugs may interact with Primacor. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Primacor should be used only if prescribed. It is not known whether this meidcation passes into breast milk or if it could harm a nursing baby. Consult your doctor before breast-feeding.
Our Primacor (milrinone lactate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Primacor IV in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Tell your caregivers at once if you have a serious side effect such as:
- chest pain;
- feeling like you might pass out;
- bronchospasm (wheezing, chest tightness, trouble breathing); or
- low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).
Less serious side effects may include:
- tremors; or
- easy bruising or bleeding.
Read the entire detailed patient monograph for Primacor IV (Milrinone)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Primacor IV FDA Prescribing Information: Side Effects
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.
In the post marketing experience, there have been rare cases of "torsades de pointes" reported.
Headaches, usually mild to moderate in severity, have been reported in 2.9% of patients receiving PRIMACOR.
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.
Read the entire FDA prescribing information for Primacor IV (Milrinone)
Additional Primacor IV Information
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