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STERILE DOBUTAMINE HYDROCHLORIDE SOLUTION 250MG IN 20ML

Active substance(s): DOBUTAMINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Sterile Dobutamine Hydrochloride Solution 250mg in 20ml
(Dobutamine hydrochloride)
Read all of 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 or nurse.
! This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same
as yours.
! If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section
4.
What is in this leaflet:
1. What Dobutamine Hydrochloride Solution is
and what it is used for
2. What you need to know before you are
given Dobutamine Hydrochloride Solution
3. How to use Dobutamine Hydrochloride
Solution
4. Possible Side Effects
5. How to store Dobutamine Hydrochloride
Solution
6. Contents of the pack and other information
1. WHAT DOBUTAMINE HYDROCHLORIDE
SOLUTION IS AND WHAT IT IS USED FOR
Dobutamine Hydrochloride Solution belongs to a
group of medicines known as inotropes.
Dobutamine Hydrochloride Solution is a heart
stimulant and is used to increase the strength of
the heart beat.
Dobutamine Hydrochloride Solution is used to
increase the output of the heart in some conditions
of heart failure caused by disease of the heart
muscle or shock, after a heart attack or after heart
surgery. It may also be used to improve the
performance of the heart during artificial
ventilation. Sometimes dobutamine hydrochloride
may be used to stimulate the heart instead of
exercise during special stress testing of the heart.
2. WHAT YOU NEED TO KNOW BEFORE YOU
ARE GIVEN DOBUTAMINE
HYDROCHLORIDE SOLUTION
Do not use Dobutamine Hydrochloride Solution
if you:
! Are hypersensitive (allergic) to dobutamine,
sodium metabisulphate (E223) or any other
ingredients contained in the injection (listed in
section 6)
! Suffer from high blood pressure due to a
tumour near the kidney (phaeocromocytoma)
! Have certain heart or blood vessel disorders.
Dobutamine Hydrochloride Solution should not
be used to detect poor blood supply to your
heart (a cardiac stress test known as
Dobutamine Stress Echocardiography).
Warnings and precautions
Talk to your doctor or pharmacist or nurse before
using this medicine if you:
! Have recently had a heart attack
! Have had a heart transplant
! Are asthmatic
! Have unstable angina
! Have heart disease
! Have high blood pressure
! Have any condition that would make exercise
dangerous for you.

You will be closely monitored during your
treatment with Dobutamine Hydrochloride
Solution.
Other medicines and Dobutamine
Hydrochloride Solution:
Please tell your doctor or nurse if you are taking or
have recently taken any other medicines, including
medicines obtained without prescription. This is
especially important with the following medicines
as they may interact with Dobutamine
Hydrochloride Solution:
! Beta blockers (medicines used to relieve
certain heart conditions, anxiety and migraine
e.g carvedilol)
! Anaesthetics in particular cyclopropane,
halothane
! Entacapone (a medicine used to treat
Parkinson's Disease).
Pregnancy and breast-feeding:
Please tell your doctor or nurse before being given
this medicine if you are pregnant or breast-feeding.
The doctor will then decide if this medicine is
suitable for you.
Driving and using machines:
You should not drive or use any machinery if you
think you are affected after receiving this medicine.
Dobutamine Hydrochloride Solution contains
sodium metabisulpite (E223):
This may rarely cause severe hypersensitivity
reactions and bronchospasm.
3. HOW TO USE DOBUTAMINE
HYDROCHLORIDE SOLUTION
Dobutamine Hydrochloride Solution is diluted prior
to being administered by intravenous infusion.
Your nurse or doctor will administer the infusion.
Your doctor will decide the correct dosage for you
and how and when the infusion will be given. They
can give you more information if you need it.
Adults and the elderly:
The solution must be diluted to at least 50ml before
being administered but it must not be added to any
solution which is alkaline. Because it has a very
short duration of action, dobutamine is given by
continuous infusion into a vein. If your blood
volume is low for any reason, you may be given an
infusion of blood or plasma before treatment with
dobutamine starts.
Dobutamine Hydrochloride Solution must be
diluted to at least 50ml with one of the following
intravenous solutions before use:
! Sodium chloride intravenous infusion BP 0.9%
w/v
! Dextrose intravenous infusion BP 5% w/v
! 5% dextrose and 0.9% sodium chloride
intravenous infusion BP
! 5% dextrose and 0.45% sodium chloride
intravenous infusion BP
! Sodium lactate intravenous infusion BP.
Heart Failure
When dobutamine is used for the treatment of
heart failure, the rate of administration will be
adjusted according to the effect but the usual dose
is between 2.5 and 10 micrograms per kilogram
body weight per minute. The dose can be as low
as 0.5 micrograms/kg/minute or as high as 40
micrograms/kg/minute. It is better to reduce the
dose gradually than stop it suddenly.

Stress testing
When dobutamine is being used instead of
exercise during stress testing, the starting dose is
5 micrograms/kg/minute and increased at 8 minute
intervals by 5 micrograms/kg/minute to a maximum
of 20 micrograms/kg/min.
During this time, continuous electrocardiogram
(ECG) monitoring should be done and the infusion
stopped if the heart rate or blood pressure rises too
high, or there are abnormalities on the ECG trace.

!

Use in children:
This medicine is not for use in children.

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If you are given too much Dobutamine
Hydrochloride solution
Your dose will be carefully calculated by the
doctors so overdose is unlikely.
However, if too much is given, you may feel sick, or
be sick, lose your appetite, feel shaky, anxious,
have palpitations, have a headache, feel short of
breath and have chest pain. You should tell the
doctor or nurse straight away.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Your doctor will examine your heart before giving
you this medicine to decide if you are suitable to
receive the drug.
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 (petechail 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)
! 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
HYDROCHLORIDE SOLUTION
The solution will be stored below 21oC and
protected from light. The nurse or doctor will check
that the solution is not past its expiry date before
administering the infusion. After dilution the
solution should be administered immediately or it
may be stored at 2-8°C for a maximum of 24 hours.
Keep out of the sight and reach of children.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Dobutamine Hydrochloride Solution
contains:
The solution contains the active ingredient
dobutamine hydrochloride. Each 20 ml of solution
contains dobutamine hydrochloride equivalent to
250 mg dobutamine in a sterile solution for
infusion.
The solution contains the following inactive
ingredients:
Sodium metabisulphate (E223)
Sodium hydroxide
Hydrochloric acid
Water for injection.
What Dobutamine Hydrochloride Solution
looks like and the contents of the pack:
Dobutamine Hydrochloride Solution is supplied in
20ml clear glass ampoules.
Dobutamine Hydrochloride Solution is available in
cartons containing 1, 5 or 10 ampoules.
Marketing Authorisation Holder and
Manufacturer:
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
Manufacturer
EGIS Pharmaceutical Works
RTLACTAT Apszergy Ara, 9900 Kormend
Ma Ty As Kiral Y Uta
Hungary
This leaflet was revised in December 2014.

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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.

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