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The product code(s) for this leaflet is: PL 31750/0177.
Dobutamine 5 mg/ml solution for infusion in pre-filled syringe
Dobutamine 5 mg/ml solution for infusion in pre-filled syringe
dobutamine
1. What Dobutamine is and what it is used for
2. What you need to know before you are given Dobutamine
3. How Dobutamine will be given
4. Possible side effects
5. How to store Dobutamine
6. Contents of the pack and other information
Dobutamine belongs to a group of medicines called catecholamines. It helps your heart to work more effectively. It works by strengthening the pumping action of the heart, increasing the amount of blood flow in the body and by expanding your veins and arteries.
Dobutamine is used in adults
Paediatric population
Dobutamine is indicated in all paediatric age groups (from neonates to 18 years of age) as inotropic support in low cardiac output hypoperfusion states resulting from decompensated heart failure, following cardiac surgery, cardiomyopathies and in cardiogenic or septic shock.
If you have certain heart or blood vessel disorders, Dobutamine should not be used to detect poor blood supply to your heart.
Tell your doctor, pharmacist or nurse before using Dobutamine if you have any of the following conditions
Increments in heart rate and blood pressure appear to be more frequent and intense in children than in adults. The new-born baby cardiovascular system has been reported to be less sensitive to dobutamine and hypotensive effect (low blood pressure) seems to be more often observed in adult patients than in small children. Accordingly, the use of dobutamine in children should be monitored closely.
Caution is advised in giving high doses of Dobutamine to children. Your doctor will adjust the required dose for your child carefully.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Dobutamine can interact with a number of medicines and supplements, which may either raise or lower the level of the medicine in your blood.
It may still be all right for you to receive Dobutamine and your doctor will be able to decide what is suitable for you.
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Dobutamine should not be given to pregnant women unless medicinally justified.
Breast-feeding
If you are breast-feeding ask your doctor or pharmacist for advice before taking this medicine.
It is recommended that you stop breast-feeding during your treatment with Dobutamine.
If you have any concerns ask your doctor or pharmacist.
This medicinal product contains 162 mg sodium (main component of cooking/table salt) in each pre-filled syringe. This is equivalent to 8.1% of the maximum daily dietary intake of sodium for an adult.
Dobutamine will be given to you by specifically trained health care professionals and emergency equipment will be available.
Dobutamine will be given as an infusion (drip) into your veins. The required rate of infusion depends on your response to therapy and any side effects. Your doctor will decide the dose of Dobutamine you will be given and will adjust the flow rate and duration of your infusion.
Dosage for stimulation of the heart
Adults and the elderly
Most patients respond to doses of 2.5-10 micrograms of Dobutamine per kg body weight per minute. Doses up to 40 micrograms of Dobutamine per kg body weight per minute have been given.
Dosage for stress testing of the heart
Adults and the elderly
The recommended dosage is an incremental increase from 5 to maximum 40 μg/kg/minute.
In the elderly, another dosage scheme may also be considered.
Dosage in children
For all paediatric age groups (neonates to 18 years) an initial dose of 5 micrograms/kg/minute, adjusted according to clinical response to 2-20 micrograms/kg/minute is recommended.
Occasionally, a dose as low as 0.5-1.0 micrograms/kg/minute will produce a response.
The required dose for children should be titrated in order to allow for the supposedly smaller “therapeutic width” in children.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Your doctor will discuss these side effects with you and explain the risks and benefits of your treatment.
Very common side effects (may affect more than 1 in 10 people)
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Very rare (may affect up to 1 in 10,000 people, including isolated cases)
Not known (frequency cannot be estimated from the available data)
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 via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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 label, pouch and carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
After opening the syringe, the product should be used immediately in order to avoid microbial contamination. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C unless preparation has taken place in controlled and validated aseptic conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Dobutamine is a clear, colourless to slightly yellow solution for infusion.
Dobutamine is available in packs containing 1 or 5 pouches with one pre-filled syringe containing 50 ml solution for infusion, one plunger rod and one scavenger.
This medicinal product is authorised in the Member States of the EEA under the following names
Germany: Dobutamin SUN
France: Dobutamine SUN
Italy: Dobutamina SUN
The Netherlands: Dobutamine SUN
United Kingdom: Dobutamine
This leaflet was last revised in February 2022
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