Dopamine Hydrochloride 40mg/ml Sterile Concentrate

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DOPAMINE HYDROCHLORIDE

Available from:

Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece

ATC code:

C01CA04

INN (International Name):

DOPAMINE HYDROCHLORIDE 40 mg/ml

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

DOPAMINE HYDROCHLORIDE 40 mg/ml

Prescription type:

POM

Therapeutic area:

CARDIAC THERAPY

Authorization status:

Authorised

Authorization date:

2006-12-28

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DOPAMINE HYDROCHLORIDE
40 MG/ML STERILE CONCENTRATE
dopamine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
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.
WHAT IS IN THIS LEAFLET
1. What Dopamine Hydrochloride 40 mg/ml Sterile Concentrate is and
what it is used for
2. What you need to know before you use Dopamine Hydrochloride 40
mg/ml Sterile
Concentrate
3. How to use Dopamine Hydrochloride 40 mg/ml Sterile Concentrate
4. Possible side effects
5. How to store Dopamine Hydrochloride 40 mg/ml Sterile Concentrate
6. Contents of the pack and other information
1.
WHAT DOPAMINE HYDROCHLORIDE 40 MG/ML STERILE CONCENTRATE IS AND WHAT
IT IS
USED FOR
Dopamine is a medicine that stimulates the heart and has effects on
the blood vessels.
WHAT IS IT USED FOR?
Dopamine Hydrochloride Sterile Concentrate can be used:
•
to treat 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)
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DOPAMINE HYDROCHLORIDE 40 MG/ML
STERILE CONCENTRATE
DO NOT USE DOPAMINE HYDROCHLORIDE
•
if you are allergic to dopamine hydrochloride or any of the other
ingredients of this
medicine (listed in section 6)
•
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 ha

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dopamine Hydrochloride 40 mg/ml Sterile Concentrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate contains 40 mg dopamine hydrochloride.
Each 5 ml ampoule contains 200 mg dopamine hydrochloride.
Excipient with known effect
Each ampoule contains 50 mg sodium metabisulphite equivalent to 10
mg/ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (Sterile concentrate).
Ampoules containing a clear colourless or pale yellow solution.
4.
CLINICAL PARTICULARS
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_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.
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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