DOPAMINE 160 MG/ML STERILE CONCENTRATE 160 Mg/Ml Concentrate for Soln for Inf

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

DOPAMINE HYDROCHLORIDE

Beschikbaar vanaf:

HOSPIRA UK Ltd

INN (Algemene Internationale Benaming):

DOPAMINE HYDROCHLORIDE

Dosering:

160 Mg/Ml

farmaceutische vorm:

Concentrate for Soln for Inf

Autorisatie-status:

Withdrawn

Autorisatie datum:

2006-05-01

Productkenmerken

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dopamine 160 mg/ml Sterile Concentrate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate contains 160mg dopamine hydrochloride.
Each 5 ml of concentrate contains 800mg
of dopamine hydrochloride.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
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 ADMINSTRATION
Dopamine is a potent drug; it must be diluted
before administration.
_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.
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 
20mcg/kg/min.
In patients who do not respond to these doses,
add