This leaflet contains important information about your medicine; read it carefully.
Keep this leaflet; you may want to read it again.
If you have any questions or are not sure about anything, ask your doctor or pharmacist.
DOPAMINE 40 mg/ml and 160 mg/ml STERILE CONCENTRATE
- The active substance is dopamine hydrochloride
- The other ingredients are sodium metabisulphite and Water for Injections.
The marketing authorisation holder and company responsible for batch release in the European Union is
The manufacturer is
What Dopamine Sterile Concentrate is and what it is used for
Dopamine is a medicine that stimulates the heart and acts on the blood vessels, in the form of a concentrate for solution for infusion (a concentrated solution which is diluted to make a solution which can be given as a slow injection via a drip).
The medicine is presented in glass containers called ampoules. The solution in each 5 ml (millilitre) ampoule contains either 200 mg (milligrams) or 800 mg of dopamine hydrochloride.
For the ampoule containing 200 mg of dopamine, each ml of solution contains 40 mg of dopamine hydrochloride. It is available in packs containing 5 x 5 ml or 50 x 5 ml ampoules.
For the ampoule containing 800 mg of dopamine, each ml of solution contains 160 mg of dopamine hydrochloride. It is available in packs containing 5 x 5 ml ampoules.
Dopamine can be used:
- for low blood pressure or shock (reduction of blood flow through the body tissues) after a heart attack, blood poisoning, trauma (injury) or kidney failure
- 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)
Before Dopamine Sterile Concentrate is used
Dopamine Sterile Concentrate should not be used:
- if you have a tumour that causes an increase in blood pressure
- if you have an overactive thyroid gland
- if you have irregular or rapid heartbeats
- if you are being given certain anaesthetics, such as halothane
- if you have shown signs of hypersensitivity (severe allergy) to dopamine or sodium metabisulphite on previous occasions
Special care will be taken:
- if you have diabetes
- 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 are taking certain other medicines, such as:
- anaesthetics
- alpha & 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)
Please tell your doctor if you are taking, or have recently taken, any other medicines, including ones that are not prescribed for you.
Pregnancy and Breastfeeding
If you are pregnant or breastfeeding you will only be given dopamine if it is absolutely essential.
Important information about one of the ingredients of Dopamine Sterile Concentrate
This medicine contains sodium metabisulphite, which can cause an allergic type reaction (skin rash, swelling of eyelids, face or lips, or difficulty in breathing). This is rare but you may be more at risk if you suffer from allergies or asthma.
How Dopamine Sterile Concentrate is used
The dose of medicine given to you will depend upon your medical condition, body weight and your response.
If the volume of your blood is low, before you are given dopamine hydrochloride you may be given a transfusion of blood or a plasma expander.
The medicine will be diluted e.g. with 5% dextrose before it is given to you. It will be given as a slow injection via a drip into a vein.
As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much, however tell your doctor or pharmacist if you have any concerns.
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.
Possible side effects
Like all medicines, dopamine hydrochloride can have side effects.
If any the following happen, tell the doctor immediately:
- pain in your fingers or toes (at higher doses, especially in people who have had problems with their circulation, gangrene can occur)
- pain at the injection site immediately or soon after injection
- abnormal heart beats
- severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint.
These are very serious side effects. You may need urgent medical attention. All of these very serious side effects are rare.
Other possible side effects include:
- quick or slow heart beats
- chest pain
- low blood pressure (you may feel dizzy or faint, particularly when standing up or getting out of bed)
- feeling or being sick
- headache
- dilation of the pupil of the eye (mydriasis) which may cause difficulty with bright lights
- shortness of breath
- goose pimples
If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
Storing Dopamine Sterile Concentrate
Keep out of the reach of children.
The ampoules should not be stored above 30°C.
The ampoules should be stored in the outer carton (in order to protect from light).
This medicine should not be used after the expiry date printed on the ampoule.
This medicine should not be used if the solution is discoloured.
Date of preparation
November 2005
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