COMPOSITION :
Dopamine HCl Injection 200 mg/5 ml, each ml contains : Dopamine HCl 40 mg.
DESCRIPTIONS :
Dopamine HCl with Dopamine HCl as active ingredient is available in injection 200 mg/5 ml.
INDICATIONS :
For the correction of haemodynamic imbalances in :
Acute hypotension or shock associated with myocardial infarction, endotoxic septicemia, trauma and renal failure.
As additional therapy after cardiac surgery, where there is persistent hypotension after correction of hypovolaemia.
Chronic cardiac decompensation in congestive failure.
DOSAGE AND ADMISNISTRATIONS :
In some cases, restoration of blood volume with whole blood or a appropriate plasma expanders is necessary until the central venous pressure reaches 10-15 cm H2O, or pulmonary wedge pressure is 14-18 mmHg.
Administration :
The range of administration should be controlled in order to prevent inadvertent bolus administration : Therapy evaluation must be carried out constantly (such as blood volume, augmentation of myocardial contractility and distribution of peripheral perfusion). It should be administered into a large vein (preferably of the antecubital fossa) to prevent extravasation of tissue which may cause necrosis.
Antidote for peripheral ischaemia after extravasation :
To prevent coagulation and necrosis in ischaemia areas, the area should be infiltrated as soon as possible with 10 – 15 ml of intravenous NaCl 0.9% containing from 5 – 10 mg Phentolamine, an adrenergic blocking agent. A syringe with a fine hypodermic needle should be used and the solution infiltrated into the ischaemia area. Sympathetic blockade with Phentolamine causes rapid changes in local hyperemia if the area is infiltered within 12 hours. Therefore, Phentolamine should be given as soon as possible after the extravasation is discovered.
Recommended solution :
The injection is diluted with a parenteral carrier suitable for intravenous infusion.
Aseptically transfer sterile Dopamine HCl concentrate into the IV solution as per the table below :
| Strength | Volume | IV solution volume | Final concentration |
| ml | ml | mcg/ml | |
| 200 mg/5 ml | 5 | 250 | 800 |
| 200 mg/5 ml | 5 | 500 | 400 |
In patients in whom greater fluid load is undesirable, an alternative regimen is suggested :
| Strength | Volume | IV solution volume | Final concentration |
| ml | ml | mcg/ml | |
| 200 mg/5 ml | 10 | 250 | 1600 |
| 200 mg/5 ml | 20 | 500 | 1600 |
The dilution solution in NaCl 0.9% or Dextrose 5% solution is stable for 24 hours at temperature below 30ºC (however, as with other intravenous mixtures, dilution shloud be carried out when it will begin to be given).
Rate of administration :
Dopamine, after diluted, is administered intravenously through a catheter or intravenous needle. An intravenous drip chamber or other metering device can be used to control the rate of flow in drops per minute.
Each patient must be titrated individually until a hemodynamic response and/or renal response is expected against Dopamine. In titrating to increase the desired systolic blood pressure, the optimum dosage for renal response may be exceeded thus necessitating a reduction in rate after the haemodynamic condition is stabilized.
Administration at rates greater than 50 mcg/kg/minute have safely been used in advanced circulatory decompensation states. If unnecessary fluid expansion is of concern, adjustment of drug concentration may be preferred over increasing the flow rate of a less concentrated dilution.
Adult dosage :
If needed, increase blood volume or plasma to central venous pressure is 10 – 15 cm H2O or pulmonary wedge pressure is 14 – 18 mmHg.
Begin administration of diluted solution at doses of 2.5 µg/kg/minute in patients who are tend to respond to a slight increase in cardiac strength and renal perfusion (see PHARMACOLOGY). In patients with serious pain, begin administration of diluted solution at doses of 5 mcg/kg/minute and increases the dose using 5 – 10 µg/kg/minute increments up to 20 – 50 µg/kg/minute if needed. If doses of Dopamine in increaseed to 50 µg/kg/minute, it is advisable to carry out urine output checks regularly.
If the urine flow rate begins to decrease without hypotension, it is recommended to reduce the dose. More than 50% of patients can survive on a Dopamine dose of less than 20 µg / kg / min. In patients who do not respond to these doses with adequate arterial pressures or urine flow, additional increments may be employed in an effort to produce an appropriate arterial pressure and central perfusion.
Treatment of all patients requires constant therapeutic evaluation to maintain blood volume, augmentation of myocardial contractility and distribution of peripheral perfusion. The dose must be adjusted based on the response of the patient with special attention to the decrease in the status of the flow of urine, increased tachycardia or the development of arrhythmias as an indication for the reduction or maintenance of the dose.
As with all potent intravenously administered drugs, care should be taken to control the rate of administration to avoid inadvertent administration of bolus of drug.
Paediatric :
It is not recommended to use Dopamine injection in children because the safety and efficacy of this group has not been established.
Geriatric :
There is no recommended dosage variation for geriatric patients. However, close monitoring is needed such as blood pressure, urine flow rate and peripheral tissue perfusion.
In patients with impaired hepatic function :
Dopamine is metabolized in tissues and blood through monoamine oxidase (MAO) and catechol-O-methyltransferase (COMT). Because the effects on damage to liver function are not yet known, close monitoring of this group of patients is recommended.
In patients with impaired renal function :
Dopamine and its metabolites are almost entirely excreted in the urine. Because the effects on damage to kidney function are not yet known, close monitoring of this group of patients is recommended.
OVERDOSIS :
Clinical symptoms :
Excessive increase in blood pressure can be thought to be caused by an overdose (see ADVERSE EFFECTS).
Treatment :
In cases of overdose, the rate of Dopamine administration should be reduced or the intravenous should be discontinue temporarily until the patient’s condition is stable. Because the duration of Dopamine’s action is quite short, usually no special treatment is needed. If the treatment fails to stabilize the patient’s condition in a relatively short time, giving fast acting α-adrenergic agents, Phentolamine must be considered.
CONTRAINDICATIONS :
Pheochromocytoma : Dopamine may release catecholamines into the circulation, producing an additive effect to an already abnormally high catecholamine level and causing acute hypertension.
Ventricular tand atrial tachyarrhythmias.
Concurrent use cyclopropane and halogenated hydrocarbon anaesthetics (see DRUG INTERACTION).
Hyperthyroidism.
Concurrent use with ergotamine (see DRUG INTERACTION).
WARNINGS AND PRECAUTIONS :
Patients receiving monoamine oxidase inhibitors of tricyclic antidepressants require a substantial initial dose reduction, about 1/10th the usual dose (see DRUG INTERACTION).
Dopamine should not be added to alkaline diluents (see DRUG INTERACTION).
Hypovolemia
Hypovolemia should be monitored for administration of Dopamine by increasing blood or plasma volume until the central venous pressure is 10 – 15 cm H2O or the pulmonary wedge pressure is 14 – 18 mmHg.
Overdose
An overdose is characterized by a disproportional increase in diastole pressure (such as a decrease in arterial pressure). Infusion rates must be reduced or stopped.
Excessive doses can be indicated by a disproportionate increase in diastolic pressure (i.e., marked decrease in blood pressure). Infusion rates must be reduced or discontinue.
Peripheral vascular disease
Patients who have peripheral vascular disease, such as those caused by atherosclerosis, Raynaud’s disease, diabetes or cold injury (e.g., frostbite), are more prone to experience peripheral ischemia and subsequent gangrene and careful observation of changes in color or temperature of the skin on the extremities. If ischemia occurs, the dose of Dopamine must be adjusted, or the IV be discontinue because of the possible risk of necrosis.
Cardiac ischaemia
As with any cardiac stimulant, care should be exercised when administering Dopamine to patients with cardiac ischaemia.
Acidosis, hypercapnia or hypoxia
This conditions may reduce the effectiveness and/or increase the incidence of adverse effects of Dopamine. This condition should be corrected prior or concurrently with administration of Dopamine.
Pulmonary hypertension
This condition may occur because Dopamine-induced pulmonary vasocontriction. Where Dopamine-induced pulmonary hypertension to appear, isoproterenol may be considered as an alternative inotropic agent.
Careful monitoring required
Routine monitoring of blood pressure, cardiac status and renal output, is necessary in all patients.
Sterile Dopamine HCl concentrate contains sodium bisulphite, which may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people.
Use during pregnancy :
Dopamine may be use during pregnancy when the benefits outweigh the potential risk to the foetus, as it is not known whether Dopamine penetrate the placental membrane.
Use in lactation :
It is not known whether Dopamine is excreted in breast milk. Likewise the effect on the infant is unknown.
Effects on laboratory tests :
No information available. However, there is a possibility of increased catecholamine metabolites that appear in the urine after administration of Dopamine infusion.
DRUG INTERACTIONS :
Alcohol :
There are no information.
Food :
Not yet known.
Other drugs :
Intravenous incompatibility
Dopamine bocomes inactive in an alkaline solutions such as Sodium bicarbonate (see WARNINGS AND PRECAUTIONS). Because of possible incompatibility, other drugs should not be admixed in the Dopamine infusion until further information is available.
Anaesthetics
Myocardium can be sensitized by the effect of Dopamine, administration of cyclopropane or anaesthetics halogenated hydrocarbon should be avoided. The interaction applies both to pressure activity and cardiac β-adrenergic stimulation of the heart.
Monoamine oxidase inhibitors (MAO)
Monoamine oxidase inhibitors MAO can increase and extend the duration of Dopamine action. Patients who receive treatment with MAO inhibitors together with Dopamine, it is recommended to reduce the dose substantially (the initial dose should be reduced to around 1/10 the usual dose) (see WARNINGS AND PRECAUTIONS).
α and β blockers
α and β-adrenergic receptor blocking drugs will interfere with the α and β-adrenergic responses induced by Dopamine. The use of other amines pressors can produce complex interactions.
Butyrophenones
Large doses of Butyrophenones blocked the Dopaminergic which mediated renal vasodilation. Whether this occurs in man is not known.
Tricyclic antidepressants
These drugs may potentiate the cardiovascular effects of Dopamine, resulting in arrhythmias, tachycardia or severe hypertension or hyperpyrexia (see WARNINGS AND PRECAUTIONS).
Digital glycosides
Concurrent use with Dopamine and digitalis glycosides may increase the risk of cardiac arrhythmias. Caution and ECG monitoring are very important if concurrent use Dopamine and glycoside digitalis.
Ergotamine, Methysergide, oxytocin and ergot alkaloids
The concurrent use of ergot alkaloids or Methysergide with Dopamine may result in enhanced vasoconstriction, dosage adjustments should be made if this ooccurs.
The use of Ergotamine with Dopamine may produce vascular and gangrene ischemia. Ergot alkaloids or oxytocin may potentiate the effect of Dopamine pressure and cause severe hypertension and damage to brain blood vessels.
Intravenous Phenytoin
Concurrent use of intravenous Phenytoin with Dopamine can produce dose dependent, sudden hypotension and bradycardia. If anticonvulsant therapy is necessary during administration of Dopamine, an alternative to Phenytoin should be considered. Caution is also recommended for use with other hydantoins.
Compatibility/incompatibility :
Compatible solution
Dopamine is compatible with : NaCl infusion 0.9%, Dextrose 5%.
It is recommended that the location of administration or administration to the location of the second injection should be appropriate to avoid the mixture of potential drugs with Dopamine.
Note :
Dopamine should not be added to Sodium bicarbonate or other alkaline solutions (see WARNINGS AND PRECAUTIONS) because it can activate Dopamine. If Sodium bicarbonate is simultaneously indicated for the treatment of acidosis, then administration must be given via a different infusion line from a separate package.
ADVERSE REACTIONS :
Most common reactions (often) :
Cardiovascular : Ectopic beats, tachycardia, angina pain, palpitation, hypotension, vasoconstriction.
Gastrointestinal : Nausea, vomiting.
Nervous system : Headache.
Respiratory system : Dyspnea.
Common reactions (rare) :
Biochemical abnormalities : Azotaemia.
Cardiovascular : Ventricular conduction deviation, bradycardia, widened QRS complex, hypertension, gangrene.
Nervous system : Piloerection.
Serious or life threatening reactions :
Gangrene of feet has occurred after administration of doses of 10 – 14 µg/kg/minute and is higher and in some patients with vascular disorders (see WARNINGS AND PRECAUTIONS).
PRESENTATION :
Dopamine HCl Injection 200 mg/5 ml Box, 10 ampoules @ 5 ml
Reg. No. GKL2002363343A1
STORAGE :
STORE BELOW 30ºC, PROTECT FROM LIGHT
The dilution solution in NaCl 0.9% or Dextrose 5% solution is stable for 24 hours at temperature below 30ºC.
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
