Consumer medicine information

Dopamine Juno

Dopamine hydrochloride

BRAND INFORMATION

Brand name

Dopamine Juno

Active ingredient

Dopamine hydrochloride

Schedule

SUMMARY CMI

DOPAMINE JUNO

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using DOPAMINE JUNO?

DOPAMINE JUNO contains the active ingredient dopamine hydrochloride. Dopamine may be used to increase low blood pressure in people who have a severe infection, experienced a heart attack, lost blood during an accident, kidney failure or problems after surgery. Dopamine may be used to help the heart pump better in some people with congestive heart failure. For more information, see Section 1. Why am I using DOPAMINE JUNO? in the full CMI.

2. What should I know before I use DOPAMINE JUNO?

Do not use if you have ever had an allergic reaction to dopamine or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use DOPAMINE JUNO? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with dopamine and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use DOPAMINE JUNO?

Your doctor will decide the appropriate dose for you.
A doctor or nurse will usually prepare and administer the injection or infusion.
Follow all instructions given to you by your doctor and pharmacist.

More instructions can be found in Section 4. How do I use DOPAMINE JUNO? in the full CMI.

5. What should I know while using DOPAMINE JUNO?

Things you should do	Remind any doctor, dentist or pharmacist you visit that you are receiving dopamine.
Driving or using machines	Be careful before you drive or use any machines or tools until you know how dopamine affects you. Dopamine may cause dizziness in some people.
Drinking alcohol	Tell your doctor if you drink alcohol. Alcohol may increase the side effects of some medicines.
Looking after your medicine	This medicine will be stored in the pharmacy or on the ward (stored below 25°C, protected from light).

For more information, see Section 5. What should I know while using DOPAMINE JUNO? in the full CMI.

6. Are there any side effects?

Dopamine may cause dizziness, nausea, vomiting, headache, anxiety, cold or tingling feet, chest pain, irregular or rapid heart beat, or difficulty breathing.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

DOPAMINE JUNO

Active ingredient(s): Dopamine (DO-pa-meen) hydrohcloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using dopamine. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using this medicine.

Where to find information in this leaflet:

1. Why am I using DOPAMINE JUNO?
2. What should I know before I use DOPAMINE JUNO?
3. What if I am taking other medicines?
4. How do I use DOPAMINE JUNO?
5. What should I know while using DOPAMINE JUNO?
6. Are there any side effects?
7. Product details

1. Why am I using DOPAMINE JUNO?

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.

2. What should I know before I use DOPAMINE JUNO?

Warnings

Do not use DOPAMINE JUNO if:

You are allergic to dopamine, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
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 are being given certain anaesthetics at the same time.
You are currently using ergotamine, a medicine used to treat migraines.

Check with your doctor if you:

Have allergies to any other medicines, sulfites, and other substance such as foods, preservatives or dyes.
Have 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.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

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

Some medicines and dopamine may 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, 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.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these could affect dopamine.

4. How do I use DOPAMINE JUNO?

How much to use

Your doctor will decide the appropriate dose for you.

When to use dopamine

You will be given dopamine infusions as directed by your doctor.

How to use dopamine

Dopamine JUNO 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 use too much dopamine

As Dopamine JUNO 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.

5. What should I know while using DOPAMINE JUNO?

Things you should do

Remind any doctor, dentist or pharmacist you visit that you have been given dopamine.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how dopamine affects you.

Dopamine may cause dizziness in some people.

Drinking alcohol

Tell your doctor if you drink alcohol.

Alcohol may increase the side effects of some medicines.

Looking after your medicine

Dopamine JUNO 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 25°C.

Getting rid of any unwanted medicine

Any unwanted medicine will be disposed of in a safe manner by your doctor, nurse or pharmacist.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects	What to do
dizziness nausea vomiting headache anxiety.	Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects	What to do
cold or tingling feet which may indicate problems with blood circulation chest pain irregular or rapid heart beat difficulty breathing.	Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What DOPAMINE JUNO contains

Active ingredient (main ingredient)	Dopamine hydrochloride.
Other ingredients (inactive ingredients)	Water for Injection Potassium metabisulfite Sodium chloride Hydrochloric acid/Sodium hydroxide
Allergen information	Contains sulfites

Do not take this medicine if you are allergic to any of the ingredients contained in this product.

What DOPAMINE JUNO looks like

A clear, colourless to pale yellow solution in a coloured glass ampoule.

Australian registration numbers:

AUST R 332320

Who distributes DOPAMINE JUNO

Juno Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121

www.junopharm.com.au

This leaflet was updated in January 2025.

Published by MIMS February 2025

BRAND INFORMATION

Brand name

Dopamine Juno

Active ingredient

Dopamine hydrochloride

Schedule

1 Name of Medicine

Dopamine hydrochloride.

2 Qualitative and Quantitative Composition

Dopamine Juno is a sterile solution containing dopamine hydrochloride 200 milligram/5 mL.
The pH of the solution is between 2.5 and 5. It must be diluted before use.

Excipient with known effect.

Potassium metabisulfite.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Concentrated injection for infusion.
Ampoules containing a clear colourless or pale yellow solution.

4 Clinical Particulars

4.1 Therapeutic Indications

For the correction of haemodynamic imbalance present in:
Acute hypotension or shock associated with myocardial infarction, endotoxic septicaemia, trauma and renal failure.
As an adjunct after open heart surgery, where there is persistent hypotension after correction of hypovolaemia.
In chronic cardiac decompensation as in congestive failure.

4.2 Dose and Method of Administration

Warning.

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.
In appropriate cases, restoration of blood volume with plasma, whole blood, or a suitable plasma expander, should be instituted prior to administration: central venous pressure should be 10 to 15 cm H₂O, or pulmonary wedge pressure 14 to 18 mmHg.
Product is for single use in one patient only. Discard any residue.

Dosage.

Adult.

When appropriate, increase blood volume with a suitable plasma expander, whole blood or plasma until central venous pressure is 10 to 15 cm H₂O or pulmonary wedge pressure is 14 to 18 mmHg. Begin administration of diluted solution at doses of 2 to 5 microgram/kg/min in patients who are likely to respond to modest increments of heart force and renal perfusion (see Section 5 Pharmacological Properties, Table 3 for physiological effects at various doses).
In more seriously ill patients, begin administration of diluted solution at doses of 5 microgram/kg/min and increase gradually using 5 to 10 microgram/kg/min increments up to 20 to 50 microgram/kg/min as needed. In patients who do not respond to these doses with adequate arterial pressures or urine flow, additional increments may be employed in an effort to produce an appropriate arterial pressure and central perfusion. If doses of dopamine in excess of 50 microgram/kg/min are required, it is suggested that urine output be checked frequently. Should urine flow begin to decrease in the absence of hypotension, reduction of dosage should be considered. Once optimal haemodynamic effects have been achieved, the lowest dose that maintains these effects should be used. Multiclinic trials have shown that more than 50% of the patients were satisfactorily maintained on doses of dopamine less than 20 microgram/kg/min.
Treatment of all patients requires constant evaluation of therapy in terms of the blood volume, augmentation of myocardial contractility, distribution of peripheral perfusion and urinary output. Dosage should be adjusted according to the patient's response with particular attention to diminution of established urine flow rate, increasing tachycardia or development of new dysrhythmias as indices for decreasing or temporarily suspending the dosage.
Care must be taken in patients with cardiac decompensation to avoid alpha-adrenoceptor induced vasoconstriction and increased afterload. These patients should be started on a dose of 1 to 2 microgram/kg/minute and the rate of infusion increased with caution. Patients with occlusive vascular disease should also be commenced on a similar low dose.
For patients with severe, refractory, chronic congestive heart failure who are to be treated for a short period of time with dopamine, it is recommended that the infusion rate be commenced at a rate of 0.5 to 2 microgram/kg/min, increasing the dose as the urine flow increases to a usual maintenance dose of 1 to 3 microgram/kg/min. The infusion rate should be reduced if the diastolic blood pressure or heart rate increases.

Paediatric.

It is not recommended for use in children as safety and efficacy in this age group has not been established.

Geriatric.

No variation in dosage is suggested for geriatric patients.

Method of administration.

The rate of administration should be controlled in order to prevent inadvertent bolus administration: constant evaluation of therapy should be undertaken (i.e. blood volume, ECG, arterial blood pressure, urine output, augmentation of myocardial contractility and distribution of peripheral perfusion. Measurement of central venous pressure and pulmonary wedge pressure and cardiac output are also helpful). Dopamine should be administered into a large vein (preferably of the antecubital fossa) to reduce the risk of extravasation into surrounding tissue which may cause necrosis.

Antidote for peripheral ischaemia following extravasation.

To prevent sloughing and necrosis in ischaemic areas, the area should be infiltrated as soon as possible with 10 to 15 mL of sodium chloride intravenous infusion 0.9% containing from 5 to 10 milligram of phentolamine, an adrenergic blocking agent. A syringe with a fine hypodermic needle should be used, and the solution liberally infiltrated throughout the ischaemic area. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperaemic changes if the area is infiltrated within 12 hours. Therefore, phentolamine should be given as soon as possible after the extravasation is noted.

Suggested dilution.

Aseptically transfer Dopamine Juno into the intravenous solution as shown in Table 1:

In patients in whom greater fluid load is undesirable, an alternative regimen is suggested (see Table 2):

Rate of administration.

Dopamine, after dilution, is administered intravenously through a suitable intravenous catheter or needle. An intravenous drip chamber or other suitable metering device is essential for controlling the rate of flow in drops per minute. Each patient must be individually titrated to the desired haemodynamic and/or renal response with dopamine. In titrating to the desired increase in systolic blood pressure, the optimum dosage rate for renal response may be exceeded, thus, necessitating a reduction in rate after the haemodynamic condition is stabilised.
Administration at rates greater than 50 microgram/kg/minute has safely been used in advanced circulatory decompensation states. If unnecessary fluid expansion is of concern, adjustment of drug concentration may be preferred over increasing the flow rate of a less concentrated dilution.

Compatibilities.

Dopamine has been reported to be compatible with the following: sodium chloride 0.9%, glucose 5%, glucose 5% and sodium chloride 0.9%, glucose 5% in sodium chloride 0.45%, glucose 5% in lactated Ringer's solution, sodium lactate 1/6 M injection, lactated Ringer's injection.
It is recommended that, if dopamine is administered with other drugs, a "piggyback" administration set or administration into a second injection site is used to avoid mixing of potent drugs with dopamine. Admixtures of dopamine with other medicines should not be prepared.

Note.

Dopamine should not be added to sodium bicarbonate and other alkaline solutions (see Section 4.4 Special Warnings and Precautions for Use) as they will inactivate dopamine. If sodium bicarbonate is simultaneously indicated to treat acidosis, it should be given through a separate infusion line from a separate container.

IV fluids.

Dopamine injection has been shown to be stable for 24 hours when 200 milligram is diluted in 250 mL or 500 mL of the following intravenous fluids: sodium chloride infusion 0.9%, glucose 5% injection, glucose 5% and sodium chloride infusion 0.9%, 5% glucose in lactated Ringer's solution, 1/6 M sodium lactate injection, lactated Ringer's injection.
However, to reduce microbiological hazard, use as soon as practicable after reconstitution/preparation. If storage of an infusion solution is necessary, hold at 2-8°C for not more than 24 hours.

4.3 Contraindications

Administration of dopamine is contraindicated in the following cases:
Phaeochromocytoma: dopamine may release catecholamines into the circulation, producing an additive effect to an already abnormally high catecholamine level, and causing acute hypertension.
Atrial or ventricular tachyarrhythmias or ventricular fibrillation.
Concurrent use with cyclopropane and halogenated hydrocarbon anaesthetics (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Hyperthyroidism.
Concurrent use with ergotamine (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

4.4 Special Warnings and Precautions for Use

Patients who are taking monoamine oxidase (MAO) inhibitors or who have taken them within the last two to three weeks require a substantially reduced starting dose, i.e. about 1/10th the usual dose (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Dopamine should not be added to alkaline diluents (see Section 4.2 Dose and Method of Administration; Section 6.2 Incompatibilities).
Hypovolaemia should be fully corrected prior to treatment with dopamine with a suitable plasma expander or whole blood or plasma until the central venous pressure is 10 to 15 cm H₂O or the pulmonary wedge pressure is 14 to 18 mmHg.
Excessive dosage may be indicated by a disproportionate rise in diastolic pressure (i.e. a marked decrease in pulse pressure). The infusion rate should be decreased or ceased and the patients observed carefully for further evidence of predominant vasoconstriction activity, unless such an effect is desired.
Those patients with pre-existing peripheral vascular disease, such as that due to atherosclerosis, arterial embolism, Buerger's disease, Raynaud's disease, diabetic endarteritis or cold injury (e.g. frostbite), may be more susceptible to peripheral ischaemia and subsequent gangrene and should be observed carefully for any changes in colour or temperature of the skin in the extremities. If ischaemia occurs and is thought to be due to vasoconstriction, the benefits of the dopamine infusion should be weighed against the risks of possible necrosis. Ischaemia may be reversed by either decreasing the rate or discontinuing the infusion. Intravenous administration of phentolamine 5 to 10 milligram may also reverse the ischaemia.
As with any cardiac stimulant, care should be exercised when administering dopamine to patients with cardiac ischaemia.
Acidosis, hypercapnia or hypoxia may reduce the effectiveness and/or increase the incidence of adverse effects of dopamine. These conditions should be corrected prior to or concurrently with administration of dopamine.
Pulmonary hypertension may be exacerbated due to dopamine-induced pulmonary vasoconstriction. Where dopamine-induced pulmonary hypertension has occurred, isoprenaline may be considered as an alternative inotropic agent.
Routine monitoring of blood pressure, ECG, cardiac status and renal output, is necessary in all patients. Where possible, the cardiac output and pulmonary wedge pressure should also be measured.
If a disproportionate rise in the diastolic pressure (i.e. a marked decrease in the pulse pressure) is observed, the infusion rate should be decreased or suspended and the patient observed closely, unless such an effect is required.
Dopamine Juno contains potassium metabisulfite, which may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than non-asthmatic people.
Hypotension may occur when attempting to wean patients from dopamine and it may be necessary to substitute dopamine with another pressor agent or to expand blood volume whilst gradually reducing the infusion rate.
Dopamine should be infused into a large vein whenever possible to prevent the possibility of extravasation into tissue adjacent to the infusion site. The infusion site should be continuously monitored for free flow. Extravasation may cause necrosis and sloughing of the surrounding tissue. A syringe with a fine hypodermic needle should be used to liberally infiltrate the ischemic area as soon as extravasation is noted.

Diabetes.

Glucose solutions should be used with caution in patients with known subclinical or overt diabetes mellitus.

Use in hepatic impairment.

Dopamine is metabolised in the tissues and blood by MAO inhibitors and COMT. Since the effect of impaired liver function is not known, close monitoring is advisable.

Use in renal impairment.

Dopamine and its metabolites are almost completely excreted in the urine. Since the effect of impaired renal function is not known, close monitoring of such patients is advisable.

Use in the elderly.

Close monitoring is required for blood pressure, urine flow, and peripheral tissue perfusion.

Paediatric use.

It is not recommended for use in children as safety and efficacy in this age group has not been established.

Effects on laboratory tests.

Dopamine or its metabolites may interfere with urine tests for amino acids or catecholamines and also with tests for detecting uric acid or urobilinogen.
Infusion of dopamine suppresses pituitary secretion of thyroid stimulating hormone, and prolactin.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Alcohol.

No information available.

Food.

Not applicable.
Cyclopropane and halogenated anaesthetics sensitise the myocardium to the effects of dopamine. Dopamine should therefore be used with extreme caution with these drugs due to the potential for developing ventricular arrhythmias or hypertension.
MAO inhibitors potentiate the effect of dopamine and prolong its duration of action. Patients being treated, or who have been treated within the previous two to three weeks, with MAO inhibitors will, therefore, require a substantially reduced dosage of dopamine (the starting dose should be reduced to 1/10th of the usual dose or less).
Alpha and beta adrenergic receptor blocking drugs will interfere with the alpha and beta adrenergic responses induced by dopamine. The use of other pressor amines may be associated with complex interactions. The cardiac effects of dopamine are antagonized by β-adrenergic blocking agents such as propranolol and metoprolol, and the peripheral vasoconstriction caused by high doses of dopamine is antagonized by α-adrenergic blocking agents.
Hypotension may be observed with concurrent use of vasodilators such as glyceryl trinitrate, nitroprusside and calcium channel blockers.
In animal studies, large doses of butyrophenones blocked the dopaminergic mediated renal vasodilation. Whether this occurs in man is not known.
Tricyclic antidepressants may potentiate the cardiovascular effects of dopamine, possibly resulting in arrhythmias, tachycardia or severe hypertension or hyperpyrexia (see Section 4.4 Special Warnings and Precautions for Use).
Concurrent use of digitalis glycosides with dopamine may increase the risk of cardiac arrhythmias. Caution and close ECG monitoring are very important if concurrent use is necessary.
Concurrent use of methysergide or other ergot alkaloids with dopamine may result in excessive vasoconstriction and should be avoided. Ergot alkaloids or oxytocin may potentiate the pressor effect of dopamine and cause severe hypertension and rupture of cerebral blood vessels. Concurrent use of ergotamine with dopamine is not recommended as it may produce vascular ischaemia and gangrene.
Guanethidine may potentiate the pressor response to dopamine.
Concurrent use of intravenous phenytoin with dopamine may result in dose dependent, sudden hypotension and bradycardia and possibly cardiac arrest. If anticonvulsant therapy is necessary during administration of dopamine, an alternative to phenytoin should be considered. Caution is also advised with concurrent use of other hydantoins.
Also see Section 6.2 Incompatibilities.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Studies in animals have not been performed to assess the effects of dopamine on fertility.
(Category B3)
Category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals have shown evidence of increased foetal damage, the significance of which is considered uncertain in humans.
It is not known whether dopamine crosses the placental barrier. In one animal study, the administration of dopamine to pregnant rats resulted in a decreased survival rate of the newborn and cataract formation in the survivors. The benefits of using this product should be weighed against the possible risks to the foetus.
It is not known if dopamine is excreted in breast milk, nor is the effect on the infant known. Dopamine is inactive when ingested orally, nonetheless it is not recommended for breast-feeding mothers unless the expected benefits outweigh any potential risks.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration. Patients should refrain from driving or using machines until they know that the medicinal product does not negatively affect these abilities.

4.8 Adverse Effects (Undesirable Effects)

Common reactions.

Adverse reactions have been observed in 19% of patients during clinical evaluation; however, only half of these were attributed to dopamine. Treatment was terminated in 5% of all patients due to adverse reactions.

Cardiovascular.

Ectopic beats, tachycardia, anginal pain, palpitation, hypotension, vasoconstriction.

Gastrointestinal.

Nausea, vomiting.

Nervous system.

Headache.

Respiratory.

Dyspnoea.

Less common reactions.

Biochemical abnormalities.

Azotaemia.

Cardiovascular.

Atrial fibrillation, aberrant ventricular conduction, bradycardia, widened QRS complex, hypertension, ectopic heart beats. Gangrene of the feet has occurred in a few patients with pre-existing vascular disease. A few cases of peripheral cyanosis have been reported in patients receiving dopamine.

Nervous system.

Piloerection, anxiety.

Serious or life threatening reactions.

Gangrene of feet has occurred following doses of 10 to 14 microgram/kg/min and higher and in a few patients with pre-existing vascular disease (see Section 4.4 Special Warnings and Precautions for Use).
Fatal ventricular arrhythmias have been reported on rare occasions. Extravasation of dopamine may cause necrosis and sloughing of surrounding tissue (see Section 4.2 Dose and Method of Administration).

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Symptoms.

Excessive elevation of blood pressure and vasoconstriction could be expected from accidental overdose (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). In New Zealand, call 0800 764 766.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Dopamine hydrochloride can stimulate alpha, beta and dopamine receptors. At infusion rates of 0.5 to 2 microgram/kg/min, dopamine receptors are selectively activated and blood pressure either does not change or decreases slightly. The most important effects are renal and mesenteric vasodilatation. Renal plasma flow, glomerular filtration rate and sodium excretion usually increase. At infusion rates of 2 to 10 microgram/kg/min, beta₁-receptors are activated and cardiac output and systolic blood pressure increase. The total peripheral resistance is relatively unchanged because of peripheral vasoconstriction (alpha effect) and muscle vasodilatation (beta effect). At infusion rates above 10 microgram/kg/min, alpha-receptors are activated, causing vasoconstriction, and both systolic and diastolic pressures increase. See Table 3.
Dopamine does not cross the blood-brain barrier and so does not activate dopamine receptors in the brain.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

The steady state blood levels following intravenous infusion have not been determined in any species, nor has the time for these to be achieved.

Distribution.

Dopamine is widely distributed in the body.

Protein binding.

No information is available for humans or animals (however, dopamine is rapidly metabolised and excreted).

Metabolism.

Dopamine is metabolised in the liver, kidneys and plasma and the metabolites are excreted by the kidneys. The major routes of metabolism are deamination by monoamine oxidase and formation of methylated and reduced derivatives by catechol-o-methyl transferase.
On infusion of ¹⁴C labelled dopamine into humans, it was found that approximately 75% of the infused dopamine was rapidly converted into metabolites of dopamine and 25% was synthesised into noradrenaline and its metabolic products. Only a trace of unlabelled adrenaline was detected. The principal metabolite of dopamine was 3-methoxy-4-hydroxy phenylethanol (18.6% of an infused dose) and the principal metabolites of noradrenaline were normetanephrine and 3-4-dihydroxy-mandelic acid.

Excretion.

97% of the infused dose of ¹⁴C labelled dopamine appeared in urine as metabolites. The metabolites of both dopamine and noradrenaline appear to be at least partially secreted (70% of an infused dose has been found to be secreted per 10 minutes infusion period). The degree of active excretion of dopamine is about the same as for adrenaline and noradrenaline and is inhibited by probenecid.

Onset of action.

5 minutes, with a duration of action of less than 10 minutes (in patients receiving monoamine oxidase inhibitors the duration of action may be as long as 1 hour).

Half-life.

Approximately 2 minutes after an intravenous bolus (due to rapid metabolism and excretion).

Clinical implication of pharmacokinetic data.

Dopamine should be given by continuous infusion because of the rapid metabolism and excretion of the drug.

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

6.1 List of Excipients

Potassium metabisulfate, sodium chloride, hydrochloric acid/sodium hydroxide, water for injections.

6.2 Incompatibilities

Dopamine is incompatible with ampicillin or amphotericin B, so should not be mixed with either of these drugs. Dopamine decomposes when mixed with ampicillin in 5% glucose solution, because the solution is alkaline. A precipitate forms immediately on mixing dopamine with amphotericin B in 5% glucose solution. Also see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light.

6.5 Nature and Contents of Container

Dopamine Juno is available in yellow glass ampoules in the following strength: 200 milligram dopamine hydrochloride/5 mL (cartons contain 5 ampoules).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

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.
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.

Chemical structure.

The chemical structure is:

MW 189.6.

CAS number.

CAS 51-61-6.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

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Dopamine Juno

Dopamine hydrochloride

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