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DOPAMINE 40 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): DOPAMINE HYDROCHLORIDE / DOPAMINE HYDROCHLORIDE / DOPAMINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Dopamine 40 mg/ml

Concentrate for solution for infusion
dopamine 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
nurse.
• If you get any side effects talk to your doctor or nurse.
This includes any possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Dopamine is and what it is used for
What you need to know before you take Dopamine
How to take Dopamine
Possible side effects
How to store Dopamine
Contents of the pack and other information

1. WHAT DOPAMINE IS AND WHAT IT IS USED FOR
Dopamine is a medicine that stimulates the heart and has
effects on the blood vessels.
Dopamine can be used:
• to treat low blood pressure or shock (reduction of blood
flow through the body tissues) after a heart attack,
blood poisoning, trauma (injury).
• in combination with other treatments where low blood
pressure occurs after open heart surgery.
• in congestive heart failure (heart failure due to a
build-up of fluid/blood).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DOPAMINE
Do not take Dopamine:
• if you are allergic to dopamine hydrochloride or any of
the other ingredients of this medicine (listed in
section 6).
• if you have a tumour that causes an increase in blood
pressure.
• if you have irregular or rapid heartbeats.
If possible, tell your doctor if any of the above applies to
you before this medicine is used.
Warnings and Precautions
Talk to your doctoror nurse before using Dopamine.
Special care needs to be taken with Dopamine :
• if you have diabetes.
• if you have kidney or liver problems.
• if you have a history of blood circulation problems
(you will be monitored for any changes in colour or
temperature of your fingers or toes).
• if you have narrow angle glaucoma.
• if you have benign prostatic hyperplasia with urinary
retention.
• if you have an overactive thyroid gland.
If possible, tell your doctor if any of the above applies to
you before this medicine is used.

&

Other medicines and Dopamine
Special care is needed if you are using other medicines
as some could interact with dopamine, for example:
• anaesthetics (dopamine should not be used with
cyclopropane and halogenated hydrocarbon
anaesthetics).
• alpha- and beta-blockers, e.g. propranolol (medicines
which are often used for treating blood pressure and
heart disorders).
• monoamine oxidase inhibitors (anti-depressant
medicines).
• phenytoin (a medicine used to treat epilepsy).
• reserpin, cardiac glucosides, metoclopramide.
• thyroid hormones.
• antiarrhythmics.
Tell your doctor if you are using, have recently used or
might use any other medicines.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
for advice before using this medicine.
Your doctor will only use this medicine if the expected
benefits outweigh any potential risk to your baby.
Driving and using machines
Not applicable, as the drug product is to be administered
at the hospital.
Dopamine contains sodium metabisulphite
This excipient may rarely cause severe hypersensitivity
(severe allergy) reactions and bronchospasm (breathing
difficulties).
This medicinal product contains less than 1 mmol sodium
(23 mg) per ampoule, i.e. essentially ‘sodium-free’.

3. HOW TO TAKE DOPAMINE
This medicine will be diluted before it is given to you. It
will be given as an infusion (drip) into a vein.
Dose
If your blood volume is low, you may be given a
transfusion of blood or a plasma expander before
dopamine is given.
Your doctor will work out the correct dose of dopamine for
you and how often it must be given. The dose will depend
upon your medical condition and your size.
The rate of administration will be carefully controlled and
adjusted according to your response. During treatment
your heart rate, blood pressure and urine output will be
measured to check how you are responding.
If you use more Dopamine than you should
This medicine will be given to you in a hospital, under the
supervision of a doctor. It is unlikely that you will be given
too much or too little, however, tell your doctor or nurse if
you have any concerns.

The following information is intended for healthcare professionals only:

Dopamine 40 mg/ml concentrate for solution for infusion
Dopamine hydrochloride
Incompatibilities
Dopamine , concentrate for solution for infusion, should not be added to any alkaline intravenous solutions, i.e. sodium
bicarbonate. Any solution which exhibits physical or chemical incompatibility through a colour change or precipitate
should not be administered.
It is suggested that admixtures containing gentamicin sulphate, cephalothin sodium, cephalothin sodium neutral or
oxacillin sodium should be avoided unless all other viable alternatives have been exhausted.
Admixtures of ampicillin and dopamine in 5% glucose solution are alkaline and incompatible and result in
decomposition of both drugs. They should not be admixed.
Admixtures of dopamine, amphotericin B in 5% glucose solution are incompatible as a precipitate forms immediately
on mixing.
Special precautions for disposal and other handling
For single use.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Parenteral drug products should be visually inspected for particulate matter and discolouration prior to administration.
Do not use if the injection is darker than slightly yellow or discoloured in any other way.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
More common reactions include
Cardiovascular: Ectopic heart beats, racing heart
(tachycardia), pain angina-related
(anginal pain), palpitation, low
blood pressure (hypotension) and
narrowing of the small arteries
(vasoconstriction).
Gastrointestinal: Feeling sick (nausea) and vomiting.
Nervous System: Headache, anxiety, tremor.
Respiratory:
Laboured breathing (dyspnoea).
Renal and
Urinary Disorders: Going to the toilet a lot (polyuria).
Investigations:
Serum glucose level increased, BUN
(Blood urea nitrogen) level increased.
Less common reactions include
Biochemical
Abnormalities:
Kidney failure (azotaemia).
Cardiovascular: Irregular transfer (aberrant
conduction), slow heartbeat
(bradycardia), widened QRS complex,
high blood pressure (hypertension),
gangrene, fatal ventricular
arrhythmias (irregular heartbeat) have
been reported on rare occasions.
Eye Disorders:
Great dilatation of the pupil
(mydriasis).
Nervous System: Hair standing on end (piloerection).
Serious or Life-threatening Reactions:
Gangrene of the extremities has occurred following higher
doses and in lower doses patients with pre-existing
vascular disease.
Dopamine may lead to changes in your blood chemistry.
Your doctor may take blood samples to monitor for these.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via Yellow
Card Scheme, Website: 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 DOPAMINE
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 and carton after EXP. The expiry date
refers to the last day of that month.
Do not store above 25°C.
Keep the ampoule in the outer carton in order to protect
from light.

Parenteral drug products should be visually inspected
for particulate matter and discolouration prior to
administration. Do not use if the injection is darker than
slightly yellow or discoloured in any other way.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Dopamine contains
• The active substance is dopamine hydrochloride.
• The other ingredients are sodium metabisulphite,
hydrochloric acid, sodium hydroxide and water for
injections.
What Dopamine looks like and contents of
the pack
Dopamine is a clear colourless to pale yellow solution
packed in 5 ml clear, type I glass one point-cut (OPC)
ampoules, packed in cardboard cartons.
Pack size: 10 ampoules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Hikma Farmacêutica (Portugal) S.A.
Estrada do Rio da Mó, nº8, 8A e 8B
Fervença
2705-906 Terrugem SNT
Portugal
Manufacturer
Hikma Italia S.P.A.
Viale Certosa, 10
27100 Pavia
Italy
Distributed by:
Consilient Health (UK) Ltd.
No. 1 Church Road, Richmond upon Thames, Surrey,
TW9 2QE
This medicinal product is authorised in the
Member States of the EEA under the
following names:
Austria:
Dopamin Hikma 40 mg/ml Konzentrat
zur Herstellung einer Infusionslösung
Germany:
Dopamine Hikma 40 mg/ml, Konzentrat
zur Herstellung einer Infusionslösung
Italy:
Dopamina Hikma
Portugal:
Dopamina Hikma
The Netherlands: Dopamine Hikma 40 mg/ml,
Concentraat voor oplossing voor infusie
United Kingdom: Dopamine 40 mg/ml, Concentrate for
solution for infusion
This leaflet was last revised in September 2016.

P0519

&
Preparation of Infusion Solutions
Suggested Dilution
Aseptically transfer the sterile concentrate for solution for infusion into the IV solution as shown in the following table:
Strength of Concentrate
(mg/ml)

Volume of concentrate
(ml)

Volume of IV Solution
(ml)

Final Concentration
(microgram/ml)

40
40

5
5

500
250

400
800

Dopamine hydrochloride can be diluted with:
- 0.9% Sodium Chloride Injection
- 5% Glucose Injection
- 5% Glucose and 0.9% Sodium Chloride Injection
- 0.45% Sodium Chloride Solution
- 5% Glucose and 0.45% Sodium Chloride Solution
- 5% Glucose in Ringer Lactate Solution
- Sodium Lactate 1/6 Molar Injection
- Lactated Ringer’s Injection

In-use stability:
Chemical and physical in-use stability has been
demonstrated for 24 hours at room temperature (< 25ºC).
From a microbiological point of view, the product should
be used immediately. 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 2º to 8ºC, unless dilution has taken place in
controlled and validated aseptic conditions.

Expand Transcript

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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