DOPAMINE HYDROCHLORIDE 40 Mg/Ml Concentrate for Soln for Inf

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DOPAMINE HYDROCHLORIDE

Available from:

Hospira UK Limited

ATC code:

C01CA04

INN (International Name):

DOPAMINE HYDROCHLORIDE

Dosage:

40 Mg/Ml

Pharmaceutical form:

Concentrate for Soln for Inf

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Adrenergic and dopaminergic agents

Authorization status:

Authorised

Authorization date:

1986-05-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER  

DOPAMINE HYDROCHLORIDE 40 MG/ML STERILE CONCENTRATE 

READ
ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE.  
•  Keep this leaflet. You may need to read it again.  
•  If you have any further questions, ask your doctor.  
•  If any of the side effects gets
serious, or if you notice any side effects
not listed in this 
leaflet, please tell your doctor.  

IN THIS LEAFLET:  

1. What Dopamine Hydrochloride Sterile Concentrate is
and what it is used for  
2. Before Dopamine Hydrochloride Sterile Concentrate is used  
3. How Dopamine Hydrochloride Sterile Concentrate is used  
4. Possible side effects  
5. How Dopamine Hydrochloride Sterile Concentrate is stored  
6. Further information  

1. 
WHAT DOPAMINE HYDROCHLORIDE STERILE CONCENTRATE IS 
AND WHAT IT IS USED FOR  

Dopamine is a medicine that stimulates the heart and has
effects on the blood vessels.  

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)  

2. 
BEFORE  DOPAMINE HYDROCHLORIDE STERILE  CONCENTRATE IS 
USED  

DOPAMINE HYDROCHLORIDE STERILE CONCENTRATE SHOULD NOT BE USED  
•  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
have shown signs of hypersensitivity (severe allergy) to
dopamine or sodium 
metabisulphite in the past  

If possi

Summary of Product characteristics

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 of dopamine hydrochloride
Excipients: Each ampoule contains 50mg sodium metabisulphite (E223)
equivalent to 10mg per ml.
For a 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:-
a)
Acute hypotension or shock associated with myocardial infarction,
endotoxic septicaemia, trauma and renal
failure.
b)
As an adjunct after open heart surgery, where there is persistent
hypotension after correction of hypovolaemia.
c)
In chronic cardiac decompensation as in congestive failure.
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
5mcg/kg/min and increased gradually in 5 to
10mcg/kg/min increments up to 20 to 50mcg/kg/min as needed.
If doses in excess of 50mcg/kg/min are required, it is
advisable to check urine output frequently.
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