INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo Q-MED DOPAMINE 50 mg Concentrate Injection

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

Q-MED DOPAMINE 50 mg Concentrate Injection

COMPOSITION:
Each 10 mL contains 50 mg
dopamine hydrochloride with 0,5% m/v sodium metabisulphate.

PHARMACOLOGICAL CLASSIFICATION:
A 6.1 Cardiac stimulants.

PHARMACOLOGICAL ACTION:
Dopamine is the immediate metabolic precursor of norepinephrine and adrenaline. It is a central neuro-transmitter.
At low concentration the primary interaction of dopamine is with vascular D1 dopaminergic receptors, especially in the renal, mesenteric and coronary beds. As a consequence, dopamine is useful in the management of states of low cardiac output, associated with compromised renal function as with cardiogenic and hypovolemic shock. At higher concentrations dopamine exerts a positive inotropic effect on the myocardium, acting via the ß1 adrenergic receptors. Dopamine also causes the release of norepinephrine 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.
At high concentrations, dopamine activates vascular alpha1 adrenergic receptors, leading to vasoconstriction. Therefore, when dopamine is used in life-threatening states of shock, blood pressure and renal function must be monitored.

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

WARNINGS:
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.
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.

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.

Proposed dilution:
To obtain a concentration of 200 µg per mL, add one ampoule of Q-Med Dopamine Concentrate 50 mg/10 mL to 250 mL 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.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Central effects include fear, anxiety, restlessness, tremor, insomnia, confusion, irritability and psychotic states. Appetite may be reduced, and nausea and vomiting may occur.
Effects on the cardiovascular system are complex. Stimulation of alpha-adrenergic receptors produces vasoconstriction with resultant hypertension. This vasoconstriction is sometimes sufficiently severe to produce gangrene when sympathomimetics are infiltrated into the digits. The rise in blood pressure 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.
Extravasation of parenterally-administered catecholamines may result in tissue necrosis and sloughing.
Other effects that may occur include difficulty in micturition and urinary retention, dyspnoea, weakness, altered metabolism including disturbances of glucose metabolism, sweating, and hypersalivation. Headache is also common.
Side-effects that have been occasionally associated with dopamine infusion include bradycardia and aberrant cardiac conduction, and piloerection; raised blood urea nitrogen has also been reported.
Sympathomimetic agents should be used with caution in patients who may be particularly susceptible to their effects, particularly those with hyperthyroidism. Great care is also needed in patients with cardiovascular disease such as ischaemic heart disease, arrhythmia or tachycardia, occlusive vascular disorders including arteriosclerosis, hypertension, or aneurysms. Anginal pain may be precipitated in patients with angina pectoris.
Care is also required when sympathomimetic agents are given to patients with diabetes mellitus or closed-angle glaucoma. An increased risk of arrhythmias may also occur if sympathomimetic agents are given to patients receiving cardiac glycosides, quinidine, or tricyclic antidepressants.
Many sympathomimetics interact with monoamineoxidase inhibitors, and should not be given to patients receiving such treatment or within 14 days of its termination.
Sympathomimetics may increase blood pressure and therefore special care is advisable in patients receiving antihypertensive therapy. Interactions of sympathomimetic agents with alpha- and beta-blocking drugs may be complex. It has been recommended that on gradual discontinuation of dopamine, care should be taken to avoid undue hypotension associated with very low dosage levels where vasodilatation could predominate.

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 5 to 10 mg of phentolamine mesylate intravenously, repeated as necessary.
Relief from tissue necrosis and pain may be given by immediate infiltration with phentolamine.

IDENTIFICATION:
A clear colourless, to pale yellow solution in clear 10 mL (50 mg) ampoules.

PRESENTATION:
Q-Med Dopamine Concentrate Injection 50 mg is packed in boxes of 10 x 10 mL ampoules.

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

REGISTRATION NUMBER:
29/6.1/0786

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
February 1996

                PDO0031/4-96

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