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Hospira UK Ltd

Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK
Fax: +44 (0)800 098 8653
Medical Information Direct Line: 1 800 633 363


Summary of Product Characteristics last updated on medicines.ie: 20/06/2017
SPC Dopamine Hydrochloride 40 mg/ml Sterile Concentrate


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1. NAME OF THE MEDICINAL PRODUCT

Dopamine Hydrochloride 40 mg/ml Sterile Concentrate


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml of concentrate contains 40 mg dopamine hydrochloride

Each 5 ml ampoule contains 200 mg dopamine hydrochloride

Excipients: Each ampoule contains 50 mg sodium metabisulphate (E223) equivalent to 10 mg per ml.

For a full list of excipients, see section 6.1.


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3. PHARMACEUTICAL FORM

Concentrate for solution for infusion (Sterile concentrate)

Ampoules containing a clear colourless or pale yellow solution


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Dopamine is indicated for the correction of haemodynamic imbalance present in:

1) Acute hypotension or shock associated with myocardial infarction, endotoxic septicaemia, trauma and renal failure.

2) As an adjunct after open heart surgery where there is persistent hypotension after correction of hypovolamia.

3) In chronic cardiac decompensation as in congestive failure.


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4.2 Posology and method of administration

To be administered by intravenous infusion only after dilution with the appropriate diluents.

ADULTS

Where appropriate, the circulating blood volume must be restored with a suitable plasma expander or whole blood, prior to administration of dopamine hydrochloride.

Begin infusion of dopamine hydrochloride solution at doses of 2.5 mcg/kg/min in patients who are likely to respond to modest increments of heart force and renal perfusion.

In more severe cases, administration may be initiated at a rate of 5 mcg/kg/min and increased gradually in 5 to 10 mcg/kg/min increments up to 20 to 50 mcg/kg/min as needed. If doses in excess of 50 mcg/kg/min are required, it is advisable to check urine output frequently.

Should urinary flow begin to decrease in the absence of hypotension, reduction of dopamine dosage should be considered. It has been found that more than 50% of patients have been satisfactorily maintained on doses less than 20 mcg/kg/min.

In patients who do not respond to these doses, additional increments of dopamine may be given in an effort to achieve adequate blood pressure, urine flow and perfusion generally.

Treatment of all patients requires constant evaluation of therapy in terms of blood volume, augmentation of cardiac contractility, and distribution of peripheral perfusion and urinary output.

Dosage of dopamine 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 indications for decreasing or temporarily suspending the dosage.

CHILDREN

The safety and efficacy of dopamine in paediatric patients has not been established.

GERIATRIC

No variation in dosage is suggested for geriatric patients. However, close monitoring is suggested for blood pressure, urine flow and peripheral tissue perfusion.


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4.3 Contraindications

Hypersensitivity to dopamine or to any of the excipients listed in section 6.1.

Dopamine should not be used in patients with phaeochromocytoma or hyperthyroidism.

Dopamine should not be used in the presence of uncorrected atrial or ventricular tachyarrhythmias or ventricular fibrillation.

Cyclopropane and halogenated hydrocarbon anaesthetics should be avoided.


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4.4 Special warnings and precautions for use

Dopamine should not be used in the presence of uncorrected tachyarrhythmias or ventricular fibrillation. Nor should be used in patients with phaeochromocytoma or hyperthroidism. Cyclopropane and halogenated hydrocarbon anaesthetics should be avoided.

Patients who have been treated with MAO inhibitors prior to dopamine should be given reduced doses; the starting dose should be one tenth (1/10th) of the usual dose.

Excess administration of potassium-free solutions may result in significant hypokalaemia.

The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary oedema.

Precautions:

Hypovolaemia should be corrected where necessary prior to dopamine infusion. Low doses should be used in shock due to acute myocardial infarction.

If a disproportionate rise in diastolic pressure (i.e. a marked decrease in pulse pressure) is observed, the infusion rate should be decreased and the patients observed carefully for further evidence of predominant vasoconstriction activity, unless such an effect is desired.

Patients with a history of peripheral vascular disease should be closely monitored for any changes in colour or temperature of the skin of the extremities. If change of skin colour or temperature occurs and is thought to be the result of compromised circulation to the extremities, the benefits of continued dopamine infusion should be weighed against the risk of possible necrosis. These changes may be reversed by decreasing the rate or discontinuing the infusion. IV administration of phentolamine mesylate 5-10 mg may reverse the ischaemia.

Dopamine hydrochloride in 5% dextrose injection should be infused into a large vein whenever possible to prevent the possibility of infiltration of perivascular tissue adjacent to the infusion site. Extravasation may cause necrosis and sloughing of the surrounding tissue. Ischaemia can be reversed by infiltration of the affected area with 10-15 ml of saline containing 5 to 10 mg phentolamine mesylate. A syringe with a fine hypodermic needle should be used to liberally infiltrate the ischaemic area as soon as extravasation is noted

Dopamine should be used with extreme caution in patients inhaling cyclopropane or halogenated hydrocarbon anaesthetics due to the arterial arrhythmogenic potential.

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

As the effect of dopamine on impaired renal and hepatic function is not known, close monitoring is advised.

Dopamine infusion should be withdrawn gradually, to avoid unnecessary hypotension.


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4.5 Interaction with other medicinal products and other forms of interaction

i) Anaesthetics:

The myocardium is sensitised by the effect of dopamine, cyclopropane or halogenated hydrocarbon anaesthetics, and these should be avoided. This interaction applies both to pressor activity and cardiac beta adrenergic stimulation.

ii) Alpha and Beta Blockers:

The cardiac effects of dopamine are antagonised by β-adrenergic blocking agents such as propanolol and metoprolol, and the peripheral vasoconstriction caused by high doses of dopamine is antagonised by α-adrenergic blocking agents.

Dopamine-induced renal and mesenteric vasodilation is not antagonised by either α or β-adrenergic blocking agents, but, in animals, is antagonised by haloperidol or other butyrophenones, phenothiazines, and opiates.

iii) Monoamine Oxidase (MAO) Inhibitors:

MAO inhibitors potentiate the effect of dopamine and its duration of action. Patients who have been treated with MAO inhibitors prior to administration of dopamine will therefore require a substantially reduced dosage. (The starting dose should be one tenth (1/10th) of the usual dose).

(iv) Phenytoin:

Administration of IV phenytoin to patients receiving dopamine has resulted in hypotension and bradycardia; some clinicians recommend that phenytoin be used with extreme caution, if at all, in patients receiving dopamine.

Dopamine may increase the effects of diuretic agents.

The ergot alkaloids should be avoided because of the possibility of excessive vasoconstriction. Tricyclic antidepressants and guanethidine may potentiate the pressor response to dopamine.


4.6 Fertility, pregnancy and lactation

Use in Pregnancy:

Animal studies have shown no evidence of teratogenic effects with dopamine. However, the effect of dopamine on the human foetus is unknown. Therefore the drug should be used in pregnant women only when the expected benefits outweigh the potential risk to the foetus.

Use in Lactation:

It is not known if dopamine is excreted in breast milk, nor is the effect on the infant known.


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4.7 Effects on ability to drive and use machines

Not applicable.


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4.8 Undesirable effects

Adverse reactions to dopamine are related to its pharmacological action.

More common reactions include:-

Cardiac disorders

Ectopic heart beats, tachycardia, anginal pain, palpitation,

Vascular disorders:

Hypotension, vasoconstriction.

Gastrointestinal disorders:

Nausea, vomiting.

Nervous system disorders:

Headache.

Respiratory, thoracic and mediastinal disorders:

Dyspnoea.

Less common reactions include:-

Renal and urinary disorders:

Azotaemia.

Cardiac disorders:

Conduction disorders, bradycardia, electrocardiogram QRS complex prolonged, cardiac arrhythmias have been reported on rare occasions.

Vascular disorders:

Hypertension.

Eye disorders:

Mydriasis.

Skin and subcutaneous tissue disorders:

Piloerection.

Serious or Life-threatening Reactions:

Infections and infestations:

Gangrene of the feet has occurred following doses of 10-14 mcg/kg/min and higher in a few patients with pre-existing vascular disease.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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 via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.


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4.9 Overdose

Excessive elevation of blood pressure and vasoconstriction can occur due to the alpha adrenergic actions of dopamine, especially in patients with a history of occlusive vascular disease. If desired, this condition can be rapidly reversed by dose reduction or discontinuing the infusion, since dopamine has a half-life of less than 2 minutes in the body.

Should these measures fail, an infusion of an alpha adrenergic blocking agent, e.g., phentolamine mesylate, should be considered.

Dopamine at the infusion site can cause local vasoconstriction, hence the desirability of infusing into a large vein. The resulting ischaemia can be reversed by infiltration of the affected area with 10-15 ml of saline containing 5 mg to 10 mg phentolamine mesylate. A syringe with a fine hypodermic needle should be used to liberally infiltrate the ischaemic area as soon as extravasation is noted.

Accidental Overdosage:

Accidental overdosage as evidenced by excessive blood pressure elevation can be controlled by dose reduction or discontinuing the dopamine infusion for a short period, since the duration of action of dopamine is short.

Should these measures fail, an infusion of phentolamine mesylate should be considered.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Dopamine stimulates adrenergic receptors of the sympathetic nervous system. The drug has principally a direct stimulatory effect on β1-adrenergic receptors, but also appears to have an indirect effect by releasing norepinephrine from its storage sites. Dopamine also appears to act on specific dopaminergic receptors in the renal, mesenteric, coronary, and intracerebral vascular beds to cause vasodilation. The drug has little or no effect on β2-adrenergic receptors.

In IV doses of 0.5-2 microgram/kg per minute, the drug acts predominantly on dopaminergic receptors; in IV doses of 2-10 microgram/kg per minute, the drug also stimulates β1-adrenergic receptors. In higher therapeutic doses, α-adrenergic receptors are stimulated and the net effect of the drug is the result of α-adrenergic, β1-adrenergic, and dopaminergic stimulation. The main effects of dopamine depend on the dose administered. In low doses, cardiac stimulation and renal vascular dilation occur and in larger doses vasoconstriction occurs. It is believed that α-adrenergic effects result from inhibition of the production of cyclic adenosine -31, 51-monophosphate (cAMP) by inhibition of the enzyme adenyl cyclase, whereas β-adrenergic effects result from stimulation of adenyl cyclase activity.


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5.2 Pharmacokinetic properties

Absorption:

Orally administered dopamine is rapidly metabolised in the G.I. tract. Following IV administration, the onset of action of dopamine occurs within 5 minutes, and the drug has a duration of action of less than 10 minutes.

Distribution:

The drug is widely distributed in the body but does not cross the blood-brain barrier to a substantial extent. It is not known if dopamine crosses the placenta.

Elimination:

Dopamine has a plasma half-life of about 2 minutes. Dopamine is metabolised in the liver, kidneys, and plasma by monoamine oxidase (MAO) and catechol-0-methyltransferase to the inactive compounds homovanillic acid (HVA) and 3,4-dihydroxyphenylacetic acid. In patients receiving MAO inhibitors, the duration of action of dopamine may be as long as 1 hour. About 25% of a dose of dopamine is metabolised to norepinephrine within the adrenergic nerve terminals.

Dopamine is excreted in urine principally as HVA and its sulphate and glucuronide conjugates and as 3,4-dihydroxyphenylacetic acid. A very small fraction of a dose is excreted unchanged. Following administration of radio labelled dopamine, approximately 80% of the radioactivity reportedly is excreted in urine within 24 hours.


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5.3 Preclinical safety data

There is no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Sodium Metabisulphite (E223)

Sodium Hydroxide

Hydrochloric Acid

Water for Injections


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6.2 Incompatibilities

Dopamine Hydrochloride Sterile Concentrate 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.


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6.3 Shelf life

As packaged for sale: 3 years.

In-use: Following dilution in the recommended diluents (see Section 6.6), chemical and physical in-use stability has been demonstrated for 48 hours at a temperature not above 25°C.

However, 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 2-8°C unless dilution has taken place in controlled and validated aseptic conditions.


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6.4 Special precautions for storage

As packaged for sale: Do not store above 30°C. Keep the ampoules in the outer carton.

In use: See section 6.3, Shelf life.


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6.5 Nature and contents of container

Clear, type I, glass ampoules. Pack Size : 5's and 50's ampoules. Not all pack sizes may be marketed.


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6.6 Special precautions for disposal and other handling

For single use. Discard any unused contents.

Do not use if the solution is discoloured.

Preparation of Infusion Solutions

Suggested Dilution

Aseptically transfer Dopamine Hydrochloride Sterile Concentrate into the IV solution as shown in the following table :-

Strength of Concentrate

Volume of concentrate

ml

IV Solution

Volume

ml

Final Concentration

microgram/ml

200 mg/5 ml

5

500

400

200 mg/5 ml

5

250

800

200 mg/5 ml

10

250

1600

200 mg/5 ml

20

500

1600

Dopamine hydrochloride can be diluted with:-

Sodium Chloride (0.9%) Intravenous Infusion

Dextrose (5%), sodium chloride (0.45%) solution

Sodium Lactate Intravenous Infusion, Compound (Hartmann's Solution for Injection)


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7. MARKETING AUTHORISATION HOLDER

Hospira UK Limited

Horizon

Honey Lane

Hurley

Maidenhead

SL6 6RJ

United Kingdom


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8. MARKETING AUTHORISATION NUMBER(S)

PA 0437/003/001


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 21 May 1986

Date of last renewal: 21 May 2006


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10. DATE OF REVISION OF THE TEXT

November 2015



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Active Ingredients

 
   Dopamine Hydrochloride