INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
Q-MED DOPAMINE 200 mg Concentrate Injection

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

Q-MED DOPAMINE 200 mg Concentrate Injection

COMPOSITION:
Each 5 mL contains 200 mg dopamine hydrochloride and 0,5% m/v sodium metabisulphite as anti-oxidant.

PHARMACOLOGICAL CLASSIFICATION:
A 6.1 Cardiac stimulants.

PHARMACOLOGICAL ACTION:
Dopamine is the immediate metabolic precursor of noradrenaline and adrenaline. It is a central neurotransmitter.
At low concentration the primary interaction of dopamine is with vascular D1 dopaminergic receptors, especially in the renal, mesenteric and coronary beds. By activating adenylyl cyclase and raising intracellular concentration of cyclic AMP, Direceptor stimulation leads to vasodilatation. Infusion of low doses of dopamine causes an increase in glomerular filtration rate, renal blood flow and Na+ excretion.
At higher concentrations dopamine exerts a positive inotropic effect on the myocardium, acting via the ß1 adrenergic receptors. Dopamine also causes the release of noradrenaline from nerve terminals, which contributes to its effects on the heart. Dopamine usually increases the systolic and pulse pressure and either has no effect on the diastolic blood pressure or increases it slightly. Total peripheral resistance is usually unchanged when low or intermediate doses are given.

INDICATIONS:
Dopamine hydrochloride is used in the treatment of:

a)	Shock which does not respond to replacement of fluid loss, especially where renal function is impaired.
b)	Haemodynamic imbalance associated with myocardial infarction, trauma, septic shock and cardiac surgery.
c)	It is also used in the management of congestive heart failure.

CONTRA-INDICATIONS:

–	Hypersensitivity to any of the ingredients.
–	Patients with pheochromocytoma
–	In the presence of tachyarrhythmias or ventricular arrhythmias

Dopamine should be avoided or used with extreme caution during anaesthesia with cyclopropane, halothane and other halogenated anaesthetics.

WARNINGS:
Do not use if the solution is dark yellow or otherwise discoloured.
Dilute before use - see dosage and directions for use. Do not dilute with alkaline infusions such as those containing sodium bicarbonate, as dopamine will be inactivated. Use only Dextrose 5% and/or Sodium Chloride 0,9% infusion solutions.
Diluted solutions must be used within 24 hours after dilution and stored below 25°C.

DOSAGE AND DIRECTIONS FOR USE:
Dopamine hydrochloride is administered as a diluted solution in Dextrose 5% Injection and or Sodium Chloride 0,9% Injection by intravenous infusion. Diluted solutions must be used within 24 hours after dilution and stored below 25°C.

Proposed dilution:
To obtain a concentration of 200 µg per mL, add one ampoule of Q-Med Dopamine Concentrate 200 mg/5 mL to one litre of diluent.

Rate of infusion:
The initial rate is 2 to 5 µg/kg body mass per minute, gradually increased by 5 to 10 µg/kg/minute according to the patient's blood pressure, cardiac output and urine output.
Up to 20 to 50 µg/kg/minute may be required in seriously ill patients. Higher doses have been given. A reduction in urine flow, without hypotension, may indicate a need to reduce the dose. To avoid tissue necrosis, dopamine is administered into a large vein high up in a limb, preferably the arm. If dosages in excess of 50 µg/kg/minute are required, urine output must be checked frequently.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Central effects include fear, anxiety, restlessness, tremor, insomnia, confusion, irritability, weakness and psychotic states. Nausea and vomiting may occur.
Effects on the cardiovascular system are complex: Stimulation of alpha-adrenergic receptors produces vasoconstriction with possible gangrene, when infiltrated into the digits; hypertension that may produce cerebral haemorrhage and pulmonary oedema. There may also be a reflex bradycardia, but stimulation of ß1-adrenergic receptors of the heart may produce tachycardia and cardiac arrhythmias, anginal pain, palpitations and cardiac arrest. Hypotension with dizziness and fainting, and flushing may occur.
Other effects may be difficulty in micturition and urinary retention, dyspnoea, weakness, altered metabolism including disturbances of glucose metabolism, sweating and hypersalivation. Headache is common. Extravasation of parenterally administered dopamine may result in tissue necrosis and sloughing.
It is recommended that, on gradual discontinuation of dopamine, care should be taken to avoid undue hypotension associated with very low dosage levels where vasodilation could predominate.
At high concentrations, dopamine activates vascular alfa 1 adrenergic receptors, leading to vasoconstriction.
Therefore, when dopamine is used in life-threatening states of shock, blood pressure and renal function must be monitored. Great care is needed in patients with cardiovascular disease such as ischaemic heart disease, arrhythmia or tachycardia; occlusive vascular diseases, including arteriosclerosis, hypertension or aneurysms.
Anginal pain may be precipitated in patients with angina pectoris.

KNOWN SYMPTOMS OF OVERDOSAGE AND ITS TREATMENT:
See Side-effects and Special Precautions.
Since the half-life of dopamine is only about 2 minutes, most adverse effects can be corrected by discontinuing or reducing the rate of infusion. If these measures fail excessive vasoconstriction and hypertension may be treated with an alpha-adrenoceptor blocking agent such as phentolamine mesylate intravenously.
Relief from tissue necrosis and pain may be given by immediate infiltration with phentolamine.

IDENTIFICATION:
A clear, colourless or pale yellow solution in clear 5 mL ampoules.

PRESENTATION:
Q-Med Dopamine Concentrate Injection 200 mg is packed in boxes of 10 x 5 mL ampoules.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from light.
Keep out of reach of children.

REGISTRATION NUMBER:
30/6.1/0169

NAME AND BUSINESS ADDRESS OF APPLICANT:
Quatromed Limited
10 Lindley Street
BETHLEHEM
9700

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
July 1996
                Pro-Print PD00071/8-96
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