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DOPACARD

Active substance(s): DOPEXAMINE HYDROCHLORIDE

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Benign arrhythmias such as ventricular premature beats and, more rarely, serious arrhythmias have
been reported in some patients. If excessive tachycardia occurs during DOPACARD administration,
then a reduction or temporary discontinuation of the infusion should be considered.

Name of the Medicinal Product
DOPACARD® 50mg/5ml Concentrate for Solution for Infusion
Qualitative and Quantitative Composition
Dopexamine hydrochloride as a 1% solution (w/v). Each 5 ml ampoule contains 50 mg of
dopexamine hydrochloride.
For a full list of excipients, see List of Excipients.
Pharmaceutical Form
Concentrate for solution for infusion.
The solution is clear and colourless, with pH 2.2 – 2.8.
Clinical Particulars
Therapeutic Indications
DOPACARD is indicated for short-term intravenous administration to patients in whom afterload
reduction, (through peripheral vasodilatation, and/or renal and mesenteric vasodilatation), combined
with a mild positive inotropic effect is required for the treatment of exacerbations of chronic heart
failure, or heart failure associated with cardiac surgery.
Posology and Method of Administration
For intravenous use only.
DOPACARD must be diluted before use. For instructions on dilution of the product before
administration, see Special precautions for disposal and other handling.
Dosage
Adults and the elderly:
Infusion should begin at a dose of 0.5 microgram/kg/min and may be increased to 1 microgram/
kg/min and then in increments (0.5-1 microgram/kg/min) up to 6 micrograms/kg/min at not less
than 15 minute intervals according to the patient’s haemodynamic and clinical response. Smaller
increments (0.5 microgram/kg/min) may be justified in certain patients according to haemodynamic
and clinical response.
Children:
The safety and efficacy of DOPACARD for use in children have not been established.
Administration
DOPACARD should only be administered intravenously by infusion through a cannula or catheter in
a central or large peripheral vein. Contact with metal parts in infusion apparatus should be
minimised. A device which provides accurate control of the rate of flow is essential.
Central administration: DOPACARD can be administered via a cannula or catheter sited in a central
vein. The concentration of the infusion solution for administration via this route must not exceed
4mg/ml.
Peripheral administration: DOPACARD can be administered via a cannula in a large peripheral vein.
The concentration of the infusion solution for administration via this route must not exceed 1mg/ml.
Thrombophlebitis has been reported with peripheral administration using concentrations of
DOPACARD exceeding 1mg/ml.
During the administration of DOPACARD, as with any parenteral catecholamine, the rate of
administration and duration of therapy should be adjusted according to the patient’s response as
determined by heart rate and rhythm (ECG), blood pressure, urine flow and, whenever possible,
measurement of cardiac output.
It is recommended that the infusion of DOPACARD is reduced gradually rather than withdrawn
abruptly.
The duration of therapy is dependent upon the patient’s overall response to treatment. Extended
therapy beyond 48 hours has not been fully evaluated.
Contra-indications
Known hypersensitivity to dopexamine hydrochloride or excipients (disodium edetate).
Patients who are receiving monoamine oxidase inhibitors (MAOIs).
Phaeochromocytoma.
Thrombocytopenia.
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Special Warnings and Precautions For Use
DOPACARD should not be administered to patients with severe hypotension or a markedly reduced
systemic vascular resistance until specific resuscitative measures have been taken to restore blood
pressure to a clinically acceptable level.

In patients with a marked reduction in systemic vascular resistance, DOPACARD should not be used
as a direct substitute for pressor agents or other inotropes.
As with other catecholamines, DOPACARD should be administered with caution to patients with a
clinical history of ischaemic heart disease especially following acute myocardial infarction or recent
episodes of angina pectoris as a tachycardia may increase myocardial oxygen demand and further
exacerbate myocardial ischaemia.
Correction of hypovolaemia must be achieved prior to administration of DOPACARD. Hypovolaemia
should also be corrected during therapy as vasodilatation occurs due to treatment.
Care should be exercised so as to restrict the sodium and fluid load during administration of DOPACARD.
Care must be exercised when administering DOPACARD in the presence of hypokalaemia or
hyperglycaemia. In common with other ß2-agonists, DOPACARD depresses plasma potassium and
raises plasma glucose. These effects are minor and reversible.
Monitoring of potassium and glucose is advisable in patients likely to be at risk from such changes,
e.g. diabetics, patients with myocardial infarction or patients being treated with diuretics or cardiac
glycosides.
As has been observed with other ß2-adrenergic agonists, a small reversible fall in circulating platelet
numbers has been observed in some patients. No adverse effects attributable to alterations in
platelet count have been seen in clinical studies.
As with other parenteral catecholamines, there have been occasional reports of partial tolerance,
with some attenuation of the haemodynamic response developing during long-term infusions of
DOPACARD.
The risk of thrombophlebitis and local necrosis may be increased if the concentration of DOPACARD
administered via a peripheral vein exceeds 1 mg/ml. Thrombophlebitis is rare when the
concentration of drug used for peripheral administration is less than 1 mg/ml.
Interaction with Other Medicinal Products and Other Forms of Interaction
As DOPACARD inhibits the Uptake-1 mechanism, it may potentiate the effects of exogenous
catecholamines such as noradrenaline. Caution is recommended when these agents are
administered concomitantly with DOPACARD or soon after its discontinuation.
There is no evidence of an interaction with dopamine, other than possible attenuation of the indirect
sympathomimetic inotropic effects of higher doses of dopamine due to Uptake-1 blockade by
DOPACARD.
Concomitant use with ß2-adrenergic and dopamine receptor antagonists requires caution since
possible attenuation of the pharmacological effects of DOPACARD may occur.
Pregnancy and Lactation
There is no experience of the use of DOPACARD in pregnant or lactating women and therefore its
safety in these situations has not been established. There is insufficient evidence from animal studies
to indicate it is free from hazard.
Therefore DOPACARD is not recommended for use in pregnant or lactating women.
Effects on Ability to Drive and Use Machines
No studies on the effects on the ability to drive and use machines have been performed.
Undesirable Effects
Careful titration of the dose may minimise the incidence of adverse events.
Tachycardia is the most common undesirable effect reported with DOPACARD administration in
studies of use in heart failure. The increases in heart rate are dose-related and, in most cases, not
clinically significant.
Hypertension and transient hypotension have been reported after cardiac surgery with a common
frequency. These events, however, are not uncommon as compensatory mechanisms following
cardiac surgery.
A full list of adverse reactions reported with DOPACARD during clinical studies and post marketing
experience is shown in the tables below. Adverse reactions are listed below as MedDRA preferred
term by system organ class and frequency (frequencies are defined as: very common ≥1/10,
common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to <1/100, not known (cannot be estimated
from the available data):

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Patients with left ventricular outlet obstruction such as hypertrophic obstructive cardiomyopathy or
aortic stenosis. In such patients, positive inotropic activity may increase left ventricular outflow
obstruction and sudden vasodilatation may cause hypotension.

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DOPACARD® 50 mg/5 ml
Concentrate for Solution for Infusion
Dopexamine hydrochloride

DOPACARD® 50 mg/5 ml
Concentrate for Solution for Infusion
(Dopexamine hydrochloride as a 1% solution w/v)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
In this leaflet:
1.
What DOPACARD is and what it is used for.
2.
Before you use DOPACARD.
3.
How to use DOPACARD.
4.
Possible side effects.
5.
How to store DOPACARD.
6.
Further information.
1. WHAT DOPACARD IS AND WHAT IT IS USED FOR
The name of this medicine is DOPACARD 50 mg/5 ml Concentrate for Solution for Infusion. The active
ingredient in this medicine is dopexamine hydrochloride which belongs to a group of medicines called
sympathomimetics.
DOPACARD is used to widen your blood vessels and allow your heart to pump blood easily to your vital
organs, such as kidneys or liver.
It is also used as a supportive treatment during times when your heart is not pumping blood around your
body properly.
2. BEFORE YOU ARE GIVEN DOPACARD
You should not be given DOPACARD if you:

Are allergic (hypersensitive) to dopexamine hydrochloride or any of the other ingredients
of DOPACARD.

Are taking, or have recently taken, medicines for depression called monoamine oxidase
inhibitors (MAOI).
Have a disorder of the adrenal glands which causes you to have high blood pressure
(phaeochromocytoma).

Have a blood disorder that affects the number of platelets in your blood (thrombocytopenia).

Have any heart problems (for example, a partially blocked artery).
DOPACARD is not suitable for use in children.
Take special care with DOPACARD if you:

Have very low blood pressure.

Have been told by your doctor you have poor blood circulation.

Have recently had any chest pains or if you have a history of chest pain.

Have ever had a heart attack.

Have any condition which can affect your blood sugar level e.g. diabetes
If any of the above apply to you, you should speak to your doctor before taking this medicine.
Taking other medicines
Please tell your doctor if you are taking or have recently taken other medicines, including medicines obtained
without a prescription. This is especially important if you are taking any of the following:

Water tablets (diuretics)

Medicines for a heart condition e.g. digoxin

Beta-blockers e.g. atenolol

Medicines for nausea and sickness e.g. prochlorperazine

Noradrenaline or dopamine
Pregnancy and breast-feeding
DOPACARD is not recommended for use during pregnancy and breast-feeding. If you are pregnant, think you
might be pregnant, or are breast-feeding tell your doctor or pharmacist before being given DOPACARD.
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3. HOW DOPACARD WILL BE GIVEN
Your doctor will ensure you have sufficient fluid circulating in your body before giving DOPACARD.
The doctor or other health care professional will make up the correct dose of DOPACARD for you and it will
be given as a solution by a slow injection or by a drip into a vein (infusion), for a maximum of 48 hours.
Your doctor will monitor your response to DOPACARD.

4. POSSIBLE SIDE EFFECTS
Like all medicines, DOPACARD can cause sides effects, although not everybody gets them. The following side
effects have been reported:
Very common side effects (occurring in more than 1 in 10 patients treated):

Faster heart beat

Nausea (feeling sick)
Common side effects (occurring in less than 1 in 10, but in more than 1 in 100 patients treated):

Racing or irregular heart beat, slower heart beat

High or low blood pressure

Abnormal heart trace (ECG), worsening heart failure, heart attack, chest pain
(angina)

Vomiting (being sick)

Shortness of breath

Increased sweating

Headaches

Shaking

Kidney failure

Severe breathing difficulties

Fluid on the lungs

Blood poisoning

Bleeding
Rarely redness and soreness may occur at the site where the drip enters the vein.

5. HOW TO STORE DOPACARD
Keep all medicines out of the reach and sight of children.
Keep the ampoule in the outer carton.
DOPACARD must not be used after the expiry date printed on the ampoule.
6. FURTHER INFORMATION
What DOPACARD contains
DOPACARD contains 5 ml of 1% dopexamine hydrochloride as the active substance. It also contains
disodium edetate, hydrochloric acid and water for injections as the inactive ingredients.
What DOPACARD looks like and contents of the pack
DOPACARD comes in boxes of 10 clear glass ampoules each containing 5 ml 1% w/w solution of dopexamine
hydrochloride.
Marketing Authorisation Holder
Cephalon UK Limited,
Ridings Point,
Whistler Drive,
Castleford,
West Yorkshire,
WF10 5HX,
UK
Manufacturer
Hospira S.p.A., Via Fosse Ardeatine 2, 20060 Liscate (MI), Italy.
This leaflet was last revised in June 2015.
DOPACARD is a registered trademark of Cephalon, Inc., or its affiliates
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DETACH HERE AND GIVE INFORMATION TO PATIENT

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

System Organ Class
Nervous system disorders
Cardiac disorders

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If you are given too much DOPACARD
It is unlikely you will be given too much DOPACARD, but if this happens your doctor will treat any symptoms
that may occur.

Table 1: Adverse reactions experienced by patients receiving Dopexamine from all heart failure studies

Vascular disorders
Respiratory, thoracic and
mediastinal disorders
Gastrointestinal disorders
Skin and subcutaneous tissue
disorders

Frequency
Common
Very common
Common

Common
Common

Undesirable effects
Tremor, headache
Tachycardia
Premature ventricular contractions
(PVCs), atrial fibrillation and
ventricular tachycardia, asystole and
angina
Transient hypotension
Dyspnoea

Very common
Common
Common

Nausea
Vomiting
Hyperhidrosis

Table 2: Adverse reactions experienced by patients receiving Dopexamine in cardiac surgery studies
System Organ Class
Infections and infestations
Cardiac disorders

Vascular disorders
Respiratory, thoracic and
mediastinal disorders

Renal and urinary disorders

Frequency
Common
Common

Common
Common

Common

Undesirable effects
Sepsis
Sinus and nodal
bradycardia, cardiac
arrest, myocardial
infarction, cardiac enzyme
changes, non-specific ECG
changes
Hypertension, haemorrhage
Respiratory failure,
acute respiratory distress
syndrome (ARDS),
pulmonary oedema,
pulmonary hypertension
Renal failure

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 the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
Overdose
The half-life of DOPACARD in blood is short (see Pharmacokinetic Properties). Consequently, the
effects of overdosage are likely to be short-lived provided that administration is discontinued.
However, in some cases, it may be necessary to initiate prompt supportive measures.
Effects of overdosage are likely to be related to the pharmacological actions and include tachycardia,
bradycardia, myocardial infarction, arrhythmias, tremulousness and tremor, nausea and vomiting,
headache, sweating, shortness of breath and anginal pain.
Management should be symptomatic and supportive. Stop the dopexamine infusion until symptoms
settle and heart rate and blood pressure return to normal. In asymptomatic patients monitor heart
rate and blood pressure for at least 30 minutes. Consider esmolol, metoprolol, or other
beta-adrenergic blocking agents for cardiac dysrhythmias.
Pharmacological Properties
Pharmacodynamic Properties
Pharmacotherapeutic group: Adrenergic and dopaminergic agents; ATC code: C01CA14
The primary actions of DOPACARD (dopexamine hydrochloride) are the stimulation of adrenergic
ß2-receptors and peripheral dopamine receptors of DA1 and DA2 subtypes. In addition, DOPACARD
is an inhibitor of neuronal re-uptake of noradrenaline (Uptake-1). These pharmacological actions
result in an increase in cardiac output mediated by afterload reduction (ß2, DA1) and mild positive
inotropism (ß2, Uptake-1 inhibition) together with an increase in blood flow to vascular beds (DA1)
such as the renal and mesenteric beds. DOPACARD therefore provides an increase in systemic
and regional oxygen delivery. DOPACARD is not an α-adrenergic agonist and does not cause
vasoconstriction and is not a pressor agent.
Pharmacokinetic Properties
DOPACARD is rapidly eliminated from blood with a half-life of approximately 6-7 minutes in healthy
volunteers and around 11 minutes in patients with cardiac failure. Subsequent elimination of the
metabolites is by urinary and biliary excretion. The response to DOPACARD is rapid in onset and
effects subside rapidly on discontinuation of the infusion.
Pre-clinical Safety Data
There is no information relevant to the prescriber, which has not been included in other sections of
this Summary of Product Characteristics.

Pharmaceutical Particulars
List of Excipients
Disodium edetate
Hydrochloric acid
Water for Injections.
Incompatibilities
DOPACARD should not be added to sodium bicarbonate or any other strongly alkaline solutions as
inactivation will occur.
DOPACARD should not be mixed with any other medicinal products before administration except
those mentioned in Special precautions for disposal and other handling.
Contact with metal parts, in infusion apparatus for example, should be minimised.
Shelf Life
The shelf life of unopened ampoules is 3 years.
Prepared intravenous solutions in 0.9% Sodium Chloride Injection or 5% Dextrose Injection are
stable for 24 hours at room temperature.
From a microbiological point of view, the product should be diluted and used immediately after
opening. 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 to 8°C, unless dilution
has taken place in controlled and validated aseptic conditions.
Special Precautions for Storage
Store below 25°C.
Keep the ampoule in the outer carton in order to protect from light and moisture.
For storage of sterile products that have been opened, diluted or reconstituted see Shelf Life.
Nature and Contents of Container
Box of 10 clear glass ampoules each containing 5ml of 1% (w/v) solution of dopexamine
hydrochloride (50mg per ampoule).
Special precautions for disposal and other handling
DOPACARD should only be diluted with 0.9% Sodium Chloride Injection, 5% Dextrose Injection,
Hartmann’s Solution (Compound Sodium Lactate Intravenous Infusion) or Dextrose 4%/Saline
0.18% Injection.
The appropriate volume of diluent solution should be aseptically extracted from the infusion bag, or
the metering chamber of the administration set, before adding the contents of the DOPACARD
ampoule(s) to arrive at the final concentration - see table below.
Care should be exercised in heart failure to restrict the sodium load and volume being administered.
Volume of diluent
Volume to be
No. of 5 ml DOPACARD Final Concentration
solution (ml)
extracted (ml)
ampoules to be added
µg/ml)
100
5
1
500
250
10
2
400
500
20
4
400
250
20
4
800
DOPACARD, in common with other catecholamines, may turn slightly pink in prepared solutions.
There is no significant loss of potency associated with this change.
Marketing Authorisation Holder
Cephalon UK Limited
Ridings Point,
Whistler Drive,
Castleford,
West Yorkshire,
WF10 5HX,
UK
Marketing Authorisation Number
PL 16260/0023
Date of First Authorisation / Renewal of Authorisation
22 March 2010
Date of Revision of the Text: June 2015
DOPACARD is a registered trademark of Cephalon, Inc., or its affiliates

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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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