Consumer medicine information

What is in this leaflet?

This leaflet answers some common questions about Primacor injections. It does not contain all the available information.

It does not take the place of talking to your doctor, pharmacist or nurse.

All medicines have benefits and risks. In deciding to give you Primacor your doctor has weighed the risks of taking Primacor against the benefits this medicine is expected to have for you.

If you have any concerns about this medicine ask your doctor.

What is Primacor used for?

Primacor is used for the short term treatment of severe congestive heart failure. This is a condition where the heart fails to pump enough blood around the body. The symptoms of this condition include weakness, breathlessness, fluid build-up in the tissues and a blue discolouration of the skin.

Primacor also helps to maintain the output of blood from the heart in patients following heart surgery.

Primacor helps improve the efficiency with which your heart pumps blood around your body.

Primacor works by increasing the force by which your heart muscles work and opening up your blood vessels to allow blood to flow more freely.

Before Primacor is Given

When Primacor should not be used:

You should not use Primacor if you are allergic to milrinone, similar medicines, or any of the ingredients listed at the end of this leaflet.

The symptoms of an allergic reaction may include a rash, asthma attack or hay fever.

You should not use Primacor if you have certain severe problems (obstructive aortic or pulmonary valvular disease).

Primacor should not be given if you are pregnant or breastfeeding, unless you and your doctor have discussed the risks and benefits involved.

It is not known whether Primacor can harm your baby or whether it is found in breast milk.

Before you are given it:

You must tell your doctor if:

• you suffer from kidney disease
• you already suffer from another heart condition
• you are allergic to other drugs used to treat congestive heart failure.

You should talk to your doctor if you are using any other medicines, including medicines that you buy without a prescription.

These medicines may be affected by Primacor or affect the way that Primacor works.

If you have not told your doctor about any of these things, tell him/her before Primacor is given to you.

How Primacor is given

Primacor is usually given to you in hospital. It is given to you as a series of injections as follows:

Adults:

Initial Dose

One injection given slowly over a 10 minute period.

Second Dose

The Primacor will be diluted with intravenous fluids and injected slowly into a vein. This "infusion" may last up to 48 hours. The dose used will depend upon the severity of your condition.

Primacor is not recommended for use in children.

If you take too much (Overdose)

Too high a dose of Primacor may cause low blood pressure. If this occurs, the dose of Primacor may be reduced or the infusion temporarily stopped.

Side Effects

Tell your doctor as soon as you do not feel well while Primacor is being given to you.

Primacor helps most people with severe congestive heart failure, but it may have unwanted effects in some people.

All medicines have side effects. Some times they are serious, most of the time they are not.

Effects you may feel during the Primacor injection include:

• An irregular heartbeat
• Low blood pressure
• Light headedness, dizziness
• Chest pain
• Headaches
• Skin rashes

Other side effects not listed above may also occur in some people.

Tell your doctor if you notice anything else that is making you feel unwell.

Storage

If you need to store Primacor make sure it is in a cool dry place where the temperature does not exceed 30°C.

Do not refrigerate.

This is not all the information available on Primacor. If you have any more questions or are not sure about anything ask your doctor, pharmacist or nurse.

Product Description

Primacor is a clear colourless to pale yellow solution.

A box contains 10 ampoules.

Each Primacor 10 mL ampoule contains:

Active Ingredient

Milrinone Lactate 1mg/mL

Other ingredients

Glucose monohydrate

Water for Injections

Lactic acid

Sodium hydroxide

Manufacturer

Primacor is supplied in Australia by:

sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park, NSW 2113
Freecall No: 1800 818 806

Primacor is supplied in New Zealand by:

sanofi-aventis new zealand limited
Level 8, James & Wells Tower
56 Cawley Street
Ellerslie, Auckland
Freecall No: 0800 283 684

This leaflet was last revised in April 2020.

Primacor-cmiv2-30apr20

* Trademark

Published by MIMS July 2020

1 Name of Medicine

Milrinone lactate.

2 Qualitative and Quantitative Composition

Sterile, single dose ampoules. Single-dose ampoules of 10 mL contain in each mL milrinone lactate equivalent to 1 mg milrinone, and 47 mg glucose monohydrate, in water for injections. The pH is adjusted to between 3.2 and 4.0 with lactic acid or sodium hydroxide. The total concentration of lactic acid can vary between 0.95 mg/mL and 1.29 mg/mL. These ampoules require preparation of dilutions prior to administration to patients intravenously.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Sterile aqueous solution of the lactate salt of milrinone for injection or infusion intravenously.
Colourless to pale yellow in solution.

4 Clinical Particulars

4.9 Overdose

Doses of Primacor injection may induce hypotension because of its vasodilator effect. If this occurs, administration of Primacor should be reduced or temporarily discontinued until the patient's condition stabilises. No specific antidote is known, but general measures for circulatory support should be taken.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Whereas the Chinese Hamster Ovary Chromosome Aberration Assay was positive in the presence of a metabolic activation system, results from the Ames Test, the Mouse Lymphoma Assay, the Micronucleus Test and the in vivo Rat Bone Marrow Metaphase Analysis indicated an absence of mutagenic potential.
Carcinogenicity. Twenty-four months of oral administration of Primacor to mice at doses up to 40 mg/kg/day was unassociated with evidence of carcinogenic potential. Neither was there evidence of carcinogenic potential when Primacor was orally administered to rats at doses up to 5 mg/kg/day for 24 months or at 25 mg/kg/day for up to 18 months in males and 20 months in females.
Animal toxicity. Oral and intravenous administration of toxic dosages of Primacor to rats and dogs resulted in myocardial degeneration/fibrosis and endocardial haemorrhage, principally affecting the left ventricular papillary muscles. Coronary vascular lesions characterised by periarterial oedema and inflammation have been observed in dogs only. The myocardial/endocardial changes are similar to those produced by β-adrenergic receptor agonists such as isoprenaline, while the vascular changes are similar to those produced by minoxidil and hydralazine.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Primacor Injection, brand of milrinone lactate, is a member of a new class of bipyridine inotropic/vasodilator agents with phosphodiesterase activity, distinct from digitalis glycosides or catecholamines. Primacor (milrinone lactate) is designated chemically as 1,6-dihydro-2-methyl-6-oxo-[3,4'- bipyridine]-5-carbonitrile lactate and has the structure below.
Milrinone is an off-white to tan crystalline compound with a molecular weight of 211.2 and an empirical formula of C₁₂H₉N₃O. It is stable and colourless to pale yellow in solution.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMILLAC.gifCAS number. Milrinone: 78415-72-2.
Milrinone lactate: 100286-97-3

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/PRIMCOST.gif