Skip to Content

DOBUTAMINE 12.5MG/ML STERILE CONCENTRATE

Active substance(s): DOBUTAMINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
• severe allergic reactions (anaphylactic reactions) and severe life-threatening asthmatic
episodes possibly due to sensitivity to sodium metabisulphite (see Section 2)
• muscle cramp (myoclonus) in patients with severe renal failure receiving dobutamine
• abnormal heart function test (electrocardiogram ST segment elevation)
• inflammation of heart muscle (eosinophilic myocarditis) in heart transplant patients
• heart block (left ventricular outflow tract obstruction)
• fatal heart rupture
• restlessness
• feeling sick (nausea)
• headache
• pins and needles (paraesthesia)
• tremor
• increased desire to urinate (at high doses)
• feelings of heat and anxiety
• muscle cramp (myoclonic spasm).
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 via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE DOBUTAMINE STERILE CONCENTRATE
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date printed on the ampoule and carton. The
expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the container in the outer carton in order to protect from light.
The prepared solution must be used within 24 hours.
If only part used, discard the remaining solution.
If the solution appears darker than slightly yellow or discoloured in any other way, it should
be returned unused to the pharmacist.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Dobutamine Sterile Concentrate contains
The active substance is Dobutamine Hydrochloride. The other ingredients are Sodium
Metabisulphite (E223) and hydrochloric acid or sodium hydroxide in Water for Injections.
What Dobutamine Sterile Concentrate looks like and contents of the pack
Dobutamine 12.5mg/ml Sterile Concentrate BP is a clear, colourless or almost colourless
sterile concentrate for solution for infusion presented in 20ml clear glass ampoules (small
glass bottles). Each 20ml ampoule contains Dobutamine Hydrochloride equivalent to
250mg dobutamine (each 1ml contains dobutamine hydrochloride equivalent to 12.5mg
dobutamine). There are five 20ml ampoules packed in to one cardboard box.
Marketing authorization holder
Mercury Pharmaceuticals (Ireland) Ltd,
4045, Kingswood Road, City West Business Park, Co Dublin, Ireland.
Manufacturer
B. Braun Melsungen AG, Mistelweg 2, 12357 Berlin, Germany.
This leaflet was last revised in January 2015.
100431/LF/021/03

4

Package leaflet: Information for the user

Dobutamine 12.5mg/ml Sterile Concentrate
Dobutamine Hydrochloride
Read all this leaflet carefully before you start using this medicine because it
contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
The name of this product is Dobutamine 12.5 mg/ml Sterile Concentrate (called
Dobutamine Sterile Concentrate from here on in this leaflet).
What is in this leaflet:
1. What Dobutamine Sterile Concentrate is and what it is used for
2. What you need to know before you use Dobutamine Sterile Concentrate
3. How to use Dobutamine Sterile Concentrate
4. Possible side effects
5. How to store Dobutamine Sterile Concentrate
6. Contents of the pack and other information
1. WHAT DOBUTAMINE STERILE CONCENTRATE IS AND WHAT IT IS USED FOR
The active ingredient in this product is Dobutamine which helps to increase the force of
contraction of the heart muscle, when the heart is unable to pump sufficient blood to meet
the demands of the body (low output heart failure).
It is used
• in the treatment of low output heart failure associated with myocardial infarction (a heart
attack); open heart surgery; cardiomyopathies (heart muscle disease of unknown cause);
septic shock or cardiogenic shock (shock due to heart disease)
• to increase or maintain the volume of blood pumped by the heart during mechanical
ventilation (a method used to assist or replace spontaneous breathing)
• as an alternative to exercise for stress testing the heart.
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DOBUTAMINE STERILE CONCENTRATE
Dobutamine Sterile Concentrate should not be used if:
• you know that you are allergic to Dobutamine or to any other ingredients (see section 6
of this leaflet)
• you have a reduced volume of blood in the circulation (for example due to haemorrhage,
dehydration or severe burns)
• you have tumor on your adrenal gland which is located near your kidney
• you have certain heart or blood vessel disorders. Dobutamine should not be used to
detect poor blood supply to your heart (a cardiac stress test known as Dobutamine
Stress Echocardiography).

1

continued over

Warnings and precautions
Talk to your doctor or nurse if you have any of the following conditions:
• You have any kidney disease or kidney failure
• You are pregnant or breast feeding
• You have diabetes
• You suffer from any type of heart disease
• You suffer from asthma
• You have low blood pressure along with heart problems
• You have any condition that would make exercise dangerous for you.
Speak to your doctor before you are given this injection if this applies to you. Your doctor will
monitor you for any side effects affecting the heart or kidneys while you are receiving Dobutamine.
Children
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.
Other medicines and Dobutamine Sterile Concentrate
Tell your doctor before you are given this medicine if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
Some drugs can interact with Dobutamine Sterile Concentrate, which can significantly alter
their effects. If you are already taking one of the following medicines, speak to your doctor
before you receive Dobutamine Sterile Concentrate.
• Anaesthetic (Medicine used for the temporary loss of sensation) drugs such as halothane
or other halogenated anaesthetics, isoflurane or cyclopropane
• Medicines which are often used for treating blood pressure and heart disorders (alpha
and beta blockers, e.g. propranolol)
• Medicines to treat depression, called monoamine oxidase inhibitors (MAOIs), in particular
moclobemide
• Medicines to treat Parkinson’s disease (a disease of nerve and brain) such as rasagiline,
entacapone etc.
Pregnancy and breast feeding
Tell your doctor before you are given this medicine if you are or think you may be pregnant
or are planning to become pregnant, or are breastfeeding or you are planning to breastfeed. As with all drugs, this medicine should only be given in pregnancy and when breast
feeding if absolutely necessary. Your doctor will be able to advise you.
Driving and using machines
You should not drive or use machinery if you are affected by the administration of
Dobutamine Concentrate.
Important information about some of the ingredients of Dobutamine Sterile
Concentrate
This medicinal product contains the preservative sodium metabisulphite, which may rarely
cause severe hypersensitivity (allergic) reactions and breathing difficulties (bronchospasm).
This medicinal product contains less than 1mmol sodium (23mg) per dose, i.e. essentially
“sodium free”.
3. HOW TO USE DOBUTAMINE STERILE CONCENTRATE
This injection will be administered under the supervision of a doctor. The exact dose will be
calculated according to your body weight.
The solution to be injected will then be diluted to the appropriate dose and given by
infusion (i.e. as a drip through a needle or tube) into a vein.
The rate of administration and the length of treatment will depend on your response to the
drug and will be adjusted according to factors such as your heart rate, blood pressure and
flow of urine. The dosage will be gradually reduced towards the end of treatment.

2

Use 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.
If you think you have been given more Dobutamine Sterile Concentrate than you
should have
As the injection will be administered under the supervision of a doctor, it is unlikely that you
will be given more than is necessary. However, if you have any concerns about the dose
of your medicine discuss them with your doctor.
If you develop symptoms due to over use of this product your doctor will stop giving you
this medicine and give you other medications for treatment.
If you have any further questions on the use of this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Dobutamine Sterile Concentrate can sometimes cause side-effects,
although not everybody gets them. These effects are generally dose related.
All medicines can cause allergic reactions although serious allergic reactions are
very rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids,
face or lips, rash, fever or itching (especially affecting your whole body) should be
reported to a doctor immediately.
The following side-effects have been reported:
Very common (more than 1 in 10 patients)
• increased heart rate
• chest pain
• heartbeat disturbances.
Common (in less than 1 in 10, but more than 1 in 100 patients)
• blood pressure increase or decrease
• narrowing of the blood vessels (vasoconstriction)
• irregular heartbeat (palpitations)
• asthma-like symptoms (bronchospasm)
• shortness of breath
• increase in white blood cells (eosinophilia)
• inhibition of blood clot formation
• rash (exanthema)
• fever
• inflammation of the vein at the injection site (phlebitis).
Uncommon (in less than 1 in 100, but more than 1 in 1000 patients)
• fast contractions of the ventricles of the heart (ventricular tachycardia)
• uncontrolled contractions of the ventricles of the heart (ventricular fibrillation)
• heart attack (myocardial infarction).
Very rare (in less than 1 in 10 000, including isolated cases)
• slow heartbeat (bradycardia)
• not enough blood supplied to the heart (myocardial ischaemia)
• low potassium (hypokalaemia)
• spots on the skin (petechial bleeding)
• heart block
• narrowing of the blood vessels supplying the heart (coronary vasospasm).
Not known (cannot be estimated from the available data)
• chest pain caused by stress (stress cardiomyopathy)
• allergic reactions (hypersensitivity reactions) including symptoms of rash, fever, increase
in white blood cells (eosinophilia) and asthma-like symptoms (bronchospasm)
3
continued over

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide