Dopamine-Theo solution for infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

dopamine (dopamine hydrochloride)

Available from:

Laboratorio Medinfar-Produtos Farmaceuticos

ATC code:

C01CA04

INN (International Name):

dopamine (dopamine hydrochloride)

Dosage:

200mg/5ml

Pharmaceutical form:

solution for infusion

Units in package:

(10) ampoules 5ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-06-07

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DOPAMINE-THEO 200 MG/5 ML SOLUTION FOR INFUSION
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 or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness 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.
WHAT IS IN THIS LEAFLET:
1. What Dopamine-Theo is and what it is used for
2. What you need to know before you use Dopamine-Theo
3. How to use Dopamine-Theo
4. Possible side effects
5. How to store Dopamine-Theo
6. Contents of the pack and other information
1. WHAT DOPAMINE-THEO IS AND WHAT IT IS USED FOR
Dopamine-Theo is a solution for infusion intended to be administered
by intravenous route that
contains
dopamine
as
the
active
substance.
Dopamine
acts
on
the
cardiovascular
system
(Pharmacotherapeutic group: 3.3 Sympathomimetic).
Dopamine is an endogenous catecholamine that is the direct precursor
of norepinephrine, which
stimulates the adrenergic receptors of the sympathetic nervous system
(mainly beta-1-adrenergic
receptors), dopamine-specific receptors (dopaminergic) of the renal,
mesenteric, coronary and
intracerebral vasa and it also appears to have an indirect effect by
releasing norepinephrine from its
storage sites.
The effects of dopamine are dose dependent. At low to moderate doses,
dopamine causes cardiac
stimulation
(positive
inotropic
effect)
and
renal
vasodilation
and,
at
high
doses,
it
causes
vasoconstriction.
At low to moderate doses (0.5-10 micrograms/kg/min), dopamine
stimulates dopaminergic and
beta-1-adrenergic receptors and norepinephrine release, resulting in
an increase of the cardiac
output (due to increased myocardial contractility and s

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Dopamine-Theo
200 mg/5 ml solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml ampoule contains 200 mg of dopamine hydrochloride.
Excipient with known effect:
Potassium metabisulphite (E224) - Each 5 ml ampoule contains 5 mg of
potassium metabisulphite.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for infusion.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Dopamine-Theo is indicated for all states of shock:
- cardiogenic;
- post-infarction;
- surgical;
- hypovolaemic or haemorrhagic;
- traumatic;
- septic or anaphylactic.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Dopamine hydrochloride is administered by IV infusion, if possible in
the antecubital vein, very carefully to
avoid extravasation.
The dose and duration of the infusion must be adapted individually,
considering the desired renal and
haemodynamic effects.
Begin the infusion at a rate of 2-5 µg/kg/minute. Then, increase, 1-4
µg/kg/min at 10- to 30- minute
intervals, until the desired therapeutic effect is attained.
In severe cases, infusion may be initiated at a rate of 5 µg/kg/min
and gradually increased in increments of 5-
10 µg/kg/min, up to 20-50 µg/kg/min.
Most patients respond to a rate of 20 µg/kg/min, but some patients
may require higher rates (50 µg/kg/min).
Once the blood pressure, diuresis and general circulation conditions
improve, the infusion should be
maintained at the lowest rate that proved to be effective.
A solution at 400 µg of dopamine hydrochloride per ml is obtained by
diluting one ampoule of Dopamine-
Theo in 500 ml of physiological saline or dextrose. Since 1 ml of
solution for IV infusion, corresponds
approximately to 20 drops, each drop of this solution will contain 20
µg of dopamine hydrochloride.
After preparing this solution, Dopamine-Theo may be administered
according to the following diagram:
Weight in kg
Drops per minute
40 - 50
50 - 60
60 - 70
70 - 80
80 - 90
from 8 to 30
from 10