Consumer medicine information

DBL Sterile Dopamine Concentrate

Dopamine hydrochloride

BRAND INFORMATION

Brand name

DBL Sterile Dopamine Concentrate

Active ingredient

Dopamine hydrochloride

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using DBL Sterile Dopamine Concentrate.

What is in this leaflet

This leaflet answers some common questions about DBL Sterile Dopamine Concentrate.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given DBL Sterile Dopamine Concentrate against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor or pharmacist.

Keep this leaflet in a safe place. You may need to read it again.

What DBL Sterile Dopamine Concentrate is used for

Dopamine acts in different ways, depending on the dose given. At low doses, dopamine increases blood flow to the kidneys. At higher doses, it increases the blood flow to the muscles and can increase the heart’s pumping efficiency.

Dopamine may be used to increase low blood pressure in people who have:

  • experienced a heart attack
  • a severe infection
  • lost blood during an accident
  • kidney failure
  • problems after surgery.

Dopamine may be used to help the heart pump better in some people with congestive heart failure.

Your doctor may have prescribed DBL Sterile Dopamine Concentrate for another reason.

Ask your doctor if you have any questions about why DBL Sterile Dopamine Concentrate has been prescribed for you.

There is no evidence that dopamine is addictive.

This medicine is available only with a doctor’s prescription.

Before you are given DBL Sterile Dopamine Concentrate

When you must not be given it

You must not be given DBL Sterile Dopamine Concentrate if you have an allergy to dopamine or any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include:

  • shortness of breath, wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

You should not be given dopamine if you have any of the following medical conditions:

  • adrenal gland tumour (phaeochromocytoma)
  • fast or irregular heart beat (arrhythmia, ventricular fibrillation)
  • overactive thyroid gland (hyperthyroidism).
  • liver disease
  • kidney disease

You should not be given dopamine if:

  • you are being given certain anaesthetics at the same time
  • you are currently using ergotamine, a medicine used to treat migraines.

If you are not sure whether you should be given dopamine, talk to your doctor or pharmacist.

Before you are given it

Tell your doctor or pharmacist if you have allergies to:

  • any other medicines
  • sulfites
  • any other substances, such as foods, preservatives or dyes.

Tell your doctor if you are pregnant or intend to become pregnant. If it is necessary for you to be given dopamine, your doctor will discuss the risks and benefits of using it during pregnancy.

Tell your doctor if you are breast-feeding or plan to breast-feed. Your doctor will discuss the possible risks and benefits of you being given dopamine during breast-feeding.

Tell your doctor if you have or have had any medical conditions, especially the following:

  • hardening of the blood vessels
  • Raynaud’s disease, where the fingers become white and very painful when cold
  • diabetes
  • frostbite
  • high blood pressure.

If you have not told your doctor about any of the above, tell them before you are given dopamine.

Taking other medicines

Tell your doctor or pharmacist if you are using any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and dopamine may interfere with each other. These include:

  • some anaesthetic agents
  • ergotamine, methysergide and dihydroergotamine (medicines used to prevent or treat migraines)
  • some heart and blood pressure tablets, including digoxin, prazosin, beta-blockers such as propranolol and metoprolol, calcium channel blockers and glyceryl trinitrate
  • antidepressants (MAO inhibitors, tricyclic antidepressants)
  • haloperidol or droperidol (medicines used to treat some mental illnesses)
  • medicines used to control seizures (fits), such as phenytoin.

These medicines may be affected by dopamine, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist will advise you.

Your doctor and pharmacist may have more information on medicines to be careful with or avoid while being given dopamine.

How DBL Sterile Dopamine Concentrate is given

How much is given

Your doctor will decide what dose you will receive. This depends on your condition and other factors, such as your weight.

How it is given

DBL Sterile Dopamine Concentrate is diluted and given slowly as an infusion (a drip) into a vein. This medicine should only be given by a doctor, nurse or other trained person.

If you take too much (overdose)

As DBL Sterile Dopamine Concentrate is given to you in hospital under the supervision of your doctor, it is very unlikely that you will receive an overdose. Symptoms of a dopamine overdose include the effects listed below in the ‘Side Effects’ section but are usually of a more severe nature.

While you are being given DBL Sterile Dopamine Concentrate

Things you must do

Tell any other doctors, dentists and pharmacists who treat you that you have been given dopamine.

Be sure to keep all of your doctor’s appointments so that your progress can be checked. Your doctor will check your progress and may want to take some tests from time to time. This helps to prevent unwanted side effects.

Things to be careful of

Be careful driving or operating machinery until you know how this medicine affects you.

If you are feeling dizzy or drowsy do not drive, operate machinery, or do anything else that could be dangerous.

Side effects

Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well while you are being given dopamine or soon after the injection. Dopamine may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor, nurse or pharmacist if you notice any of the following and they worry you:

  • dizziness
  • nausea
  • vomiting
  • headache
  • anxiety.

These are the more common side effects of dopamine and are usually mild.

Tell your doctor or nurse immediately if you notice any of the following:

  • cold or tingling feet which may indicate problems with blood circulation
  • chest pain
  • irregular or rapid heart beat
  • difficulty breathing.

These may be serious side effects. You may need urgent medical attention. Serious side effects are rare.

Other side effects not listed above may occur in some patients. Tell your doctor, pharmacist or nurse if you notice anything that is making you feel unwell.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After you are given DBL Sterile Dopamine Concentrate

Storage

DBL Sterile Dopamine Injection Concentrate will be stored in the pharmacy or on the ward. The injection is kept in a cool dry place, protected from light, where the temperature stays below 30C.

Product description

What it looks like

DBL Sterile Dopamine Concentrate is a sterile, clear colourless to pale yellow liquid in a glass ampoule.

Each 5 mL ampoule contains 200 milligrams of dopamine hydrochloride.

It is available in packs of 5 ampoules.

Ingredients

Active ingredients:

  • Dopamine hydrochloride.

Other ingredients

  • Water for Injection
  • Sodium metabisulfite.

DBL Sterile Dopamine Concentrate does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Supplier

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizer.com.au

Australian Registration Number:

AUST R 16378

This leaflet was updated in:
August 2021.

™ Trademark

© Pfizer Australia Pty Ltd 2021

Published by MIMS October 2021

BRAND INFORMATION

Brand name

DBL Sterile Dopamine Concentrate

Active ingredient

Dopamine hydrochloride

Schedule

S4

 

Boxed Warnings

Dopamine is a potent drug. It must be diluted before administration. Do not add to alkaline solutions such as sodium bicarbonate, as these inactivate dopamine.

1 Name of Medicine

Dopamine hydrochloride.

2 Qualitative and Quantitative Composition

Dopamine hydrochloride is a naturally occurring biochemical catecholamine precursor of noradrenaline and adrenaline. The chemical name of dopamine hydrochloride is 4-(2-aminoethyl) benzene-1,2-diol hydrochloride and has the chemical formula C8H11NO2.HCl.
DBL Sterile Dopamine Concentrate is a sterile solution of Dopamine Hydrochloride BP in water for injection, containing 1% sodium metabisulfite. The strength supplied is 200 mg/5 mL in a clear glass ampoule.
Excipient with known effect. Sodium metabisulfite.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Dopamine hydrochloride is a white, odourless powder, freely soluble in water and soluble in alcohol. It is sensitive to light, alkalis, iron salts and oxidising agents. The pH of the solution is approximately 4. It must be diluted before use.

4 Clinical Particulars

4.9 Overdose

Symptoms. Excessive elevation of blood pressure and vasoconstriction could be expected to occur due to the alpha-adrenergic actions of dopamine, especially in patients with a history of occlusive vascular disease (see Section 4.8 Adverse Effects (Undesirable Effects)).
Treatment. In case of accidental overdose the rate of administration should be reduced or the infusion discontinued temporarily until the patient's condition stabilises. Since the duration of action of dopamine is quite short, no additional measures are usually necessary. If these measures fail to stabilise the patient's condition in a relatively short time, use of the short acting alpha-adrenergic blocking agent, phentolamine, should be considered.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. The genotoxic potential of dopamine has not been evaluated.
Carcinogenicity. Long-term studies in animals have not been performed to evaluate the carcinogenic potential of dopamine.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. The chemical structure is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSDOPHYD.gif MW: 189.6.
CAS number. CAS 51-61-6.

7 Medicine Schedule (Poisons Standard)

Schedule 4.

Summary Table of Changes

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