1 mg / ml injection solution
milrinone
1. What Corotrop is and what it is used for
Corotropic is a drug used to increase cardiac output (the work of the heart). The active substance is called milrinone. It is a substance with properties that increase the power of the heart to contract and dilate the blood vessels.
Corotrop can be used in adults for:
- short-term treatment of pronounced left heart failure (when the heart can not pump enough blood to the rest of the body) when other drugs do not help.
Corotrop can be used in children for:
- short-term treatment (up to 35 hours) of severe heart failure (when the heart can not pump enough blood to the rest of the body) when other drugs do not help.
- short-term treatment (up to 35 hours) of acute heart failure after heart surgery (when your heart temporarily has difficulty pumping blood into the body).
When Corotrop is used, constant monitoring of heart function and blood pressure is required.
Milrinone contained in Corotrop may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before you use Corotrop
Do not use Corotrop
- if you are allergic to milrinone or any of the other ingredients of this medicine (listed in section 6).
- if you have severe narrowing of the heart valves (obstructive aortic or pulmonary valve disease)
Warnings and cautions
Talk to your doctor or pharmacist before using Corotrop:
- if you have or are expected to be diagnosed with, certain types of heart rhythm disturbances (such as atrial flutter, atrial fibrillation, or certain other types of heart rhythm disturbances emanating from the lower chamber (ventricle) of the heart), as Corotrop may promote certain heart rhythm disturbances. Low levels of potassium in the blood and/or high levels of the cardiac drug digitalis further increases the risk of heart rhythm disorders. Your doctor will therefore check if further treatment is necessary or if dose adjustment or ECG monitoring is required.
- if it is suspected that your heart has too low a filling pressure (eg due to previous treatment with diuretics). Your doctor will check your filling pressure before treatment and correct it if necessary.
- if you have kidney disease or low blood pressure. Your doctor will make appropriate checks before and during your treatment and take these checks into account during treatment and when determining the dose of a Corotrop and other medicines.
- if you have a decreased platelet count ( platelets ) or red blood cells ( erythrocytes) or a low hemoglobin value, Corotrop can only be used under close monitoring of platelet count as treatment may further reduce blood counts.
Children and young people
In addition to what is mentioned under Warnings and precautions for adults, the following should be considered: Before giving Corotrop injection, your doctor will check several parameters such as heart rate and blood pressure. He/she will also prescribe blood sampling.
Injection one should not be started if your child’s heart rate or blood pressure is not stable.
Tell your doctor about:
- your child has kidney problems
- your baby is born prematurely or had a low birth weight.
- your child has a special heart problem called the open ductus arteriosus (a connection between two large blood vessels (the carotid artery and the pulmonary artery) that remains even though it should be closed).
Elderly patients
There are no special dosing recommendations for the elderly. Controlled pharmacokinetic studies to date have not shown any age-dependent effect on the distribution and/or secretion of milrinone, the active substance in Corotrop.
Other medicines and Corotrop
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
When Corotrop is given at the same time as heart-strengthening medicines (ie which increase the power of the heart’s contractions, eg dobutamine ), Corotrop can increase heart-strengthening (positive inotropic) effect of these medicines and vice versa.
Pregnancy and breastfeeding
There are no clinical data on the use of milrinone in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, prenatal development (ie before birth), childbirth, or postnatal development (ie after birth).
Use during pregnancy should be done with caution.
As it is unknown whether milrinone is excreted in human milk, breast-feeding must be discontinued during treatment.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
There is no experience available regarding adverse effects on the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. How to use Corotrop
Corotropic injection is used in hospitals as an intravenous injection/infusion. Dosage one is determined and adjusted individually by the doctor.
If you use more Corotrop than you should
Drops in blood pressure and rapid heartbeat can occur.
In case of overdose, your doctor will stop the infusion or reduce the infusion rate and possibly start other appropriate treatments. There is no known specific antidote.
If you forget to use Corotrop
Your doctor or nurse has instructions on when to get your medicine. It is unlikely that you will not receive the medicine listed. However, if you think you have missed a dose, tell your doctor or nurse.
If you have any further questions on the use of this product, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people): Headache, fainting ( syncope ). Palpitations, arrhythmias, low blood pressure ( hypotension ), heart failure.
Uncommon (may affect up to 1 in 100 people): Decreased platelet count. Low potassium levels. Tremors. Heart fibrillation. Severe chest pain, often with tightness over the chest and difficulty breathing. Nausea, vomiting. Impaired liver values as a result of impaired liver function.
Very rare (may affect up to 1 in 10,000 people): Allergic (anaphylactic) shock. A particularly dangerous form of palpitations ( torsade de points ). Spasmodic contractions in the trachea. Rash.
Has been reported (occurs in an unknown number of users): Reduction of red blood cells and/or hemoglobin concentration (blood pigment). Bleeding in fluid-filled areas (ventricles) surrounded by the brain ( intraventricular hemorrhage). Renal failure at simultaneously low blood pressure ( hypotension ). Reactions at the infusion site.
Life-threatening cardiac arrhythmias have occurred in patients with previously irregular heartbeat and/or metabolic disorders (low potassium levels) and/or high levels of digitalis (a heart drug).
Additional side effects are in children
In addition to the side effects reported in adults, the following have been reported in children:
Has been reported ( occurs in an unknown number of users ): A heart problem called open ductus arteriosus: a connection between two large blood vessels (the carotid artery and the pulmonary artery) that remain but should be closed. This can cause excess fluid in the lungs, bleeding, destruction of the intestine or parts of the intestine and can be fatal.
In addition to adults, a decrease in the number of platelets in the blood seems to occur more often in children, and the risk of this side effect increases with the infusion time.
Cardiac arrhythmias appear to occur less frequently in children than in adults.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address
5. How to store Corotrop
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C. Store in a cold place.
After dilution, the solution should be used within 12 hours.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is milrinone.
Each ml of solution for injection contains 1 mg milrinone. Each ampoule of 10 ml solution for injection contains 10 mg milrinone. - The other ingredients are glucose, lactic acid, sodium hydroxide, water for injections.
What the medicine looks like and the contents of the pack
Clear, pale yellow solution.
Corotrop is available in the following pack sizes:
The ampoule is 10×10 ml.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sanofi AB
Box 30052
104 25 Stockholm