Leaflet: information for the user

Corotrope 1 mg/ml injectable solution

Milrinone lactate

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Corotrope and for what it is used

2. What you need to know before starting to use Corotrope

3. How to use Corotrope

4. Possible side effects

5. Storage of Corotrope

6. Contents of the pack and additional information

Corotrope belongs to a group of medications known as cardiac stimulants (used to increase the force with which the heart contracts).

Corotrope is used in the short-term treatment of acute congestive heart failure (the heart cannot pump enough blood to the entire body).

Corotrope may be used in children for:

- short-term treatment (up to 35 hours) of severe congestive heart failure (the heart cannot pump enough blood to the rest of the body) when other medications have not worked.

- short-term treatment (up to 35 hours) of acute heart failure after heart surgery, that is, when the heart has difficulty pumping blood to the entire body.

No use Corotrope

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• If the total volume of your blood has decreased (hypovolemia).

Advertencias y precauciones

Consult with your doctor before starting to use Corotrope:

-If you are pregnant or breastfeeding (see section “Embarazo y lactancia”).

-If you have had a heart attack.

-If you have an abnormal heart rhythm.

-If you have severe heart problems.

-If you have low blood pressure (hypotension).

Inform your doctor if you have severe kidney disease.

When Corotrope is administered to you, your doctor will perform continuous monitoring of your blood pressure, heart rate, overall clinical condition, electrocardiogram, fluid levels in your body, and/or kidney function. Blood tests may also be performed to control your platelet levels (blood components that contribute to blood clotting) and hemoglobin levels (component of red blood cells).

Kids

The following information should be taken into account in addition to the warnings and precautions described above for adults.

Before administering the Corotrope infusion, your doctor will perform monitoring of several parameters such as heart rate and blood pressure. Blood tests will also be performed.

The infusion will not be initiated if heart rate and blood pressure are not stable.

Please inform your doctor if:

• Your child has kidney problems.
• Your child is premature or has low birth weight.
• Your child has a heart condition called persistent ductus arteriosus: a connection between two major blood vessels (aorta and pulmonary artery) that persists and should be closed.

Your doctor will decide whether your child will be treated with Corotrope in these cases.

Use of Corotrope with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

When furosemide (diuretic: medication used to eliminate fluid) is administered intravenously together with milrinone, a chemical interaction occurs immediately, forming a precipitate. Therefore, furosemide should not be administered together with milrinone intravenously. Lactate milrinone should not be diluted in intravenous infusion solutions containing sodium bicarbonate.

Embarazo y lactancia

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

No adequate controlled studies are available in pregnant women or breastfeeding women. Lactate milrinone may be used during these periods at the discretion of the doctor and only when the potential benefits justify the possible risks to the fetus. The conditions of use and the interest of milrinone in acute myocardial infarction in the child have not yet been determined, therefore, the use of milrinone is not recommended in these cases.

Corotrope contains glucose

This medication contains glucose. Patients with diabetes mellitus should note that this medication contains 0.47 g of glucose per 10 ml ampoule.

Corotrope contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per ml of injectable solution; this is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Corotrope treatment will only be performed in hospitalized patients in the intensive care unit and under continuous hemodynamic monitoring. The medication will be administered by a healthcare professional.

It can be administered directly, or diluted in sterile 5% glucose solution, 0.45% sodium chloride, or 0.9% sodium chloride. The infusion (form of medication administration) will be performed through a constant flow pump, connected to a needle or catheter located in a vein as thick as possible. Before administration, the solution must be examined under light and not used if discoloration is observed.

The diluted solution must be used within 24 hours after preparation.

Corotrope treatment should start with a loading dose, followed by a continuous infusion (maintenance dose), according to the following guidelines:

Loading dose: 50 micrograms/kg, administered slowly over 10 minutes.

Maintenance dose:0.375 to 0.75 micrograms/kg/minute. The infusion rate will be adjusted according to the patient's clinical and hemodynamic response.

Do not exceed the maximum dose of 1.13 mg/kg/day.

Doses adjusted in patients with renal insufficiency:results obtained in patients with severe renal insufficiency, but without heart failure, have shown that renal insufficiency significantly increases the terminal elimination half-life of milrinone, so it may be necessary to reduce the dose.

The duration of treatment will depend on the patient's response: the usual period is 48 to 72 hours.

If you estimate that Corotrope's action is too strong or too weak, inform your doctor or pharmacist.

Use in children

• Your doctor should administer a first dose of 50-75 micrograms per kilogram of body weight over 30 to 60 minutes.
• Then, a dose of 0.25-0.75 micrograms per kilogram of body weight per minute will be administered according to the child's response to treatment and the appearance of adverse effects. Corotrope can be administered for up to 35 hours.

During infusion, your child will be continuously monitored: your doctor will perform controls of various parameters such as heart rate and blood pressure, and blood tests will be performed to evaluate the response to treatment and the appearance of adverse effects.

Use in elderly patients

If the patient does not have renal insufficiency, no dose adjustment is necessary.

If you use more Corotrope than you should

High doses of milrinone can cause hypotension (abnormal decrease in blood pressure) and cardiac arrhythmias (change in heart rhythm). In case of overdose, the administration of Corotrope will be reduced or temporarily suspended. No antidote is known, and general measures will be taken to stabilize the patient.

In case of overdose or accidental ingestion, consult the Toxicological Information Service at phone 91 562 04 20, indicating the medication and the amount taken.

If you forgot to use Corotrope

Do not use a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects observed, according to their frequency of presentation: very frequent (may affect more than one in 10 patients); frequent (may affect up to one in 10 patients); infrequent (may affect up to one in 100 patients); rare (may affect up to one in 1,000 patients); very rare (may affect up to one in 10,000 patients); unknown frequency (cannot be estimated from available data), have been:

Cardiovascular side effects:

• Frequent:

• ventricular ectopy (abnormal heartbeats).
• sustained or nonsustained ventricular tachycardia (abnormally fast heart rate).
• supraventricular arrhythmia (change in heart rhythm).
• hypotension (abnormal decrease in blood pressure).

• Infrequent:

• ventricular fibrillation (very rapid, uncontrolled irregular heartbeats).
• angina/ chest pain.
• Very rare:“Torsades de pointes” (a form of ventricular tachycardia: abnormally fast heart rate).

The occurrence of ventricular and supraventricular arrhythmias has not been related to the dose or plasma levels (in the blood) of milrinone. Severe arrhythmias that may threaten the patient's life are often associated with certain factors such as: a history of arrhythmias, metabolic alterations (e.g. hypokalemia: low potassium levels), abnormal levels of digoxin (a medication used for heart problems) and catheter insertion.

Hematologic side effects:

• Infrequent: thrombocytopenia (reduction in the number of platelets).

General and local side effects:

•Unknown frequency: Local reactions.

• Very rare: anaphylactic shock (severe allergic reaction that may put your life at risk).

Respiratory side effects:

• Very rare: bronchospasm (contraction of the bronchial muscles).

Hepatic side effects:

• Infrequent: alterations in liver function tests.

Nervous system side effects:

• Frequent: headaches.
• Infrequent: tremor.

Dermatological side effects:

• Very rare: skin reactions such as rash.

Renal and urinary side effects:

• Unknown frequency: renal failure, resulting from simultaneous hypotension.

Metabolic side effects:

• Infrequent: hypokalemia (decrease in potassium levels).

Other side effects in children

In addition to the side effects observed in adults, the following have been reported in children:

Unknown frequency:

• intraventricular hemorrhage (bleeding in areas surrounding the brain).
• a heart problem known as persistent ductus arteriosus: a connection between two major blood vessels (aorta and pulmonary artery) that persists when it should be closed. This can cause fluid buildup in the lungs, bleeding, intestinal destruction or part of the intestine that could cause death.

Furthermore, compared to adults, it appears that a decrease in the number of platelets in the blood occurs more frequently in children and the risk of this side effect increases with the duration of Corotrope infusion. The problems with heart rhythm seem to occur less frequently in children than in adults.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store below 25°C.

Do not use this medication after the expiration date that appears on the packaging and on the ampoules after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Corotrope

• The active principle is lactate of milrinone. Each milliliter of solution contains 1 mg of milrinone.
• The other components (excipients) are: lactic acid, anhydrous glucose, and water for injectable preparations.

Appearance of the product and contents of the packaging

The injectable solution is a transparent, colorless to pale yellow liquid.

Each package contains 10 colorless glass ampoules.

Standard package with 10 ampoules of 10 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

sanofi-aventis, S.A.

C/ Roselló i Porcel, 21

08016 Barcelona

Spain

Responsible for manufacturing:

Delpharm Dijon

6, Boulevard L’Europe

F-21800 Quétigny (France)

Last review date of this leaflet: October 2022

The detailed information of this medicine is available on the webpage of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/