Pharmaniaga Dopamine HCl

Pharmaniaga Dopamine HCl

dopamine

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Pharmaniaga LifeScience

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Full Prescribing Info
Contents
Dopamine hydrochloride.
Description
Each mL contains Dopamine Hydrochloride 40mg.
The compatible infusion solutions for intravenous use are as follows: Sodium Chloride 0.9% solution; Dextrose 5% solution.
The solution should be colourless to pale yellow solution when diluted.
Following dilution in the recommended diluents, chemical and physical in-use stability has been demonstrated for 24 hours at room temperature (<30°C). However, from a microbiological point of view, the product should be used immediately.
Action
Pharmacology: Pharmacodynamics: Dopamine hydrochloride exerts an inotropic effect on the myocardium resulting in an increased cardiac output. Dopamine hydrochloride produce less increase in myocardial oxygen consumption than isoproterenol and its use is usually not associated with a tachyarrhythmia. Dopamine hydrochloride usually increases systolic and pulse pressure with either no effect or a slight increase in diastolic pressure. Blood flow to peripheral vascular beds may decrease while mesenteric flow increases. Dopamine hydrochloride has also been reported to dilate the renal vasculature presumptively by activation of "dopaminergic" receptor. This action is accompanied by increases in glomerular filtration rate, renal blood flow and sodium excretion. An increase in urinary output produced by dopamine is usually not associated with a decrease in osmolality of the urine.
Pharmacokinetics: Absorption: Orally administered dopamine is rapidly metabolised in the GI tract. Following intravenous (IV) administration, the onset of action of dopamine occurs within 5 minutes, and the drug has a duration of action of less than 10 minutes.
Distribution: Dopamine is widely distributed in the body but does not cross blood-brain barrier to a substantial extent. It is not known if dopamine crosses the placenta.
Elimination: Dopamine has a plasma half-life of about 2 minutes. Dopamine is metabolised in the liver, kidneys, and plasma by monoamine oxidase (MAO) and catechol-O-methyltransferase to the inactive compounds homovanillic acid (HVA) and 3,4-dihydroxyphenylacetic acid. In patients receiving MAO inhibitors, the duration of action of dopamine may be as long as 1 hour. About 25% of a dose of dopamine is metabolised to norepinephrine within the adrenergic nerve terminals.
Dopamine is excreted in urine principally as HVA and its sulphate and glucuronide conjugates and as 3,4-dihydroxyphenylacetic acid. A very small fraction of a dose is excreted unchanged. Following administration of radiolabeled dopamine, approximately 80% of the radioactivity reportedly is excreted in urine within 24 hours.
Indications/Uses
Dopamine hydrochloride is indicated for the correction of haemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicaemia, open heart surgery, renal failure and chronic cardiac decompensation as in congestive failure.
Poor Perfusion of Vital Organs: Urine flow appears to be one of the better diagnostic signs by which adequacy of vital organ perfusion can be monitored. Nevertheless, the physician should also observe the patient for signs of reversal of confusion or comatose condition. In a number of oliguric or anuric patients, administration of dopamine hydrochloride has resulted in an increase in urine flow which in some cases reached normal levels. Dopamine hydrochloride may also increase urine flow in patients whose output is within normal limits and thus may be of value in reducing the degree of pre-existing fluid accumulation. It should be noted that at doses above those optimal for the individual patient, urine flow may decrease, necessitating reduction of dosage. Concurrent administration of dopamine hydrochloride and diuretic agents may produce an additive or potentiating effect.
Low Cardiac Output: Increased cardiac output is related to the direct inotropic effect of dopamine hydrochloride on the myocardium. Increased cardiac output at low or moderate doses appears to be related to a favourable prognosis. In many instances, the renal fraction of the total cardiac output has been found to increase. Increase in cardiac output produced by dopamine hydrochloride is not associated with substantial decreases in systemic vascular resistance (SVR) as may occur with isoproterenol.
Hypotension: Hypotension due to inadequate cardiac output can be managed by administration of low to moderate doses of dopamine hydrochloride which have little effect on SVR. At high therapeutic doses, the alpha adrenergic activity of dopamine hydrochloride becomes more prominent and thus may correct hypotension due to diminished SVR. It is suggested that the physician administer dopamine hydrochloride as soon as a definite trend toward decreased systolic and diastolic pressure becomes evident.
Dosage/Direction for Use
Warning: This is a potent drug. It must be diluted before administration to patient.
Suggested dilution: Add 5mL containing 200 mg Dopamine hydrochloride injection, to either a 250mL or 500mL IV container of a suitable intravenous solution. Sodium Chloride Injection or Dextrose 5% Injection have been found suitable. These solutions will yield a final concentration for administration as follows: 250mL dilution contains 800mcg/ml of dopamine hydrochloride; 500mL dilution contains 400mcg/ml of dopamine hydrochloride.
Dilution of dopamine hydrochloride should be made just prior to administration.
Rate of administration: Dopamine hydrochloride, after dilution, is administered intravenously through a suitable intravenous catheter or needle. An IV drip chamber or other suitable metering device is essential for controlling the rate of flow in drops per minute.
Treatment of all patients requires constant evaluation of therapy in terms of the blood volume, augmentation of myocardial contractility, and distribution of peripheral perfusion and urinary output. Dosage of dopamine hydrochloride should be adjusted according to the patient's response, with particular attention to diminution of established urine flow rate, increasing tachycardia or development of new dysrhythmias as indications for decreasing or temporarily suspending the dosage. As with all potent intravenous administered drugs, care should be taken to control the rate of administration of a bolus of drug.
Administration and Adult Dosage, IV for shock, by infusion only (in any non-alkaline IV fluid): 2 to 5 mcg/kg bodyweight/min initially, increasing gradually in increments of 5 to 10 mcg/kg/min up to 20 to 50 mcg/kg/min, titrating dosage to desire response in each patient. Most patients can be maintained on 20 mcg/kg/min or less. Dosages over 50 mcg/kg/min should be used only with careful monitoring of hemodynamic parameters. IV for chronic refractory congestive heart failure 0.5 mcg/kg/min initially, increasing gradually until increases in urine flow, diastolic blood pressure or heart rate is observed. Most patients respond to 1 to 3 mcg/kg/min.
Care must be taken in patients with cardiac decompensation to avoid alpha-adrenoreceptor induced vasoconstriction and increased afterload. These patients should be started on a dose of 1 to 2 mcg/kg/minute and the rate of infusion increased with caution. Patients with occlusive vascular disease should also be commenced on a similar low dose.
Elderly patients: Should be monitored for signs of peripheral ischaemia.
Paediatric dosage: Safety and efficacy not established.
Route of Administration: Parenteral.
[For Intravenous (IV) infusion use only.]
Overdosage
In the case of accidental overdosage, as evidenced by excessive elevation of blood pressure, reduce rate of administration or temporarily discontinue dopamine hydrochloride until patient's condition stabilizes. Since dopamine's duration of action is quite short, no additional remedial measures are usually necessary. If these measures fail to stabilize the patient's condition, use of the short-acting alpha-adrenergic blocking agent phentolamine should be considered.
Contraindications
Dopamine hydrochloride should not be used in patients with phaeochromocytoma or hyperthyroidism.
Dopamine hydrochloride should not be used in the presence of uncorrected atrial or ventricular tachyarrhythmias.
Cyclopropane and halogenated hydrocarbon anaesthetics should be avoided.
Warnings
This product contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
This preparation contains sodium metabisulphite that may cause serious allergic type reactions in certain susceptible patients. Do not use if known to be hypersensitive to bisulphites.
Special Precautions
General: Monitoring: Careful monitoring of the following indices is necessary during dopamine hydrochloride infusion, as with any adrenergic agent: blood pressure, urine flow, and, when possible, cardiac output and pulmonary wedge pressure.
Hypovolemia: Prior to treatment with dopamine hydrochloride, hypovolemia should be fully corrected, if possible, with either whole blood or plasma as indicated. Monitoring of central venous pressure or left ventricular filling pressure may be helpful in detecting and treating hypovolemia.
Hypoxia, Hypercapnia, Acidosis: These conditions, which may also reduce the effectiveness and/or increase the incidence of adverse effects of dopamine, must be identified and corrected prior to, or concurrently with, administration of dopamine hydrochloride.
Decreased Pulse Pressure: If a disproportionate increase in diastolic blood pressure and a marked decrease in pulse pressure are observed in patients receiving dopamine hydrochloride, the rate of infusion should be decreased and the patient observed carefully for further evidence of predominant vasoconstrictor activity, unless such effect is desired.
Ventricular Arrhythmias: If an increased number of ectopic beats are observed, the dose should be reduced if possible.
Hypotension: At lower infusion rates, if hypotension occurs, the infusion rate should be rapidly increased until adequate blood pressure is obtained. If hypotension persists, dopamine hydrochloride should be discontinued and a more potent vasoconstrictor agent such as norepinephrine should be administered.
Extravasation: Dopamine hydrochloride in 5% Dextrose Injection, should be infused into a large vein whenever possible to prevent the possibility of extravasation into tissue adjacent to the infusion site. Extravasation may cause necrosis and sloughing of surrounding tissue. Large veins of the antecubital fossa are preferred to veins in the dorsum of the hand or ankle. Less suitable infusion sites should be used only if the patient's condition requires immediate attention. The physician should switch to more suitable sites as rapidly as possible. The infusion site should be continuously monitored for free flow.
Occlusive Vascular Disease: Patients with a history of occlusive vascular disease (for example, atherosclerosis, arterial embolism, Raynaud's disease, cold injury, diabetic endarteritis, and Buerger's disease) should be closely monitored for any changes in color or temperature of the skin in the extremities. If a change in skin color or temperature occurs and is thought to be the result of compromised circulation in the extremities, the benefits of continued dopamine hydrochloride infusion should be weighed against the risk of possible necrosis. The condition may be reversed by either decreasing the rate or discontinuing the infusion.
Weaning: When discontinuing the infusion, it may be necessary to gradually decrease the dose of dopamine hydrochloride while expanding blood volume with I.V. fluids, since sudden cessation may result in marked hypotension.
IMPORTANT: Antidote for Peripheral Ischemia: To prevent sloughing and necrosis in areas in which extravasation has taken place, the area should be infiltrated as soon as possible with 10 mL to 15 mL of saline solution containing from 5 mg to 10 mg of phentolamine, an adrenergic blocking agent. A syringe with a fine hypodermic needle should be used, with the solution being infiltrated liberally throughout the area, which is easily identified by its cold, hard and pallid appearance. Sympathetic blockage with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours. Therefore, phentolamine should be given as soon as possible after the extravasation is noted.
Use In Pregnancy & Lactation
Pregnancy: There are no adequate and well controlled studies to date using dopamine hydrochloride in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. It is not known whether dopamine crosses the placenta.
Lactation: It is not known whether dopamine is distributed into human milk. Because many drugs are distributed into milk, the drug should be used with caution in nursing mother.
Side Effects
Adverse reactions to dopamine are related to its pharmacological action.
More common reactions include: Cardiovascular : Ectopic heart beats, tachycardia, anginal pain, palpitation, hypotension, vasoconstriction.
Gastrointestinal : Nausea, vomiting.
Nervous System: Headache.
Respiratory: Dyspnoea.
Less common reactions include: Biochemical Abnormalities: Azotaemia.
Cardiovascular: Aberrant conduction, bradycardia, widened QRS complex, hypertension, gangrene, fatal ventricular arrhythmias have been reported on rare occasions.
Eye Disorders: Mydriasis.
Nervous System: Piloerection.
Serious or Life-threatening Reactions: Gangrene of the feet has occurred following doses of 10-14 microgram/kg/min and higher in a few patients with pre-existing vascular disease.
Drug Interactions
Because dopamine is metabolized by monoamine oxidase (MAO), inhibition of this enzyme prolongs and potentiates the effect of dopamine. Patients who have been treated with MAO inhibitors within two to three weeks prior to the administration of dopamine hydrochloride should receive initial doses of dopamine hydrochloride no greater than one-tenth (1/10) of the usual dose.
Concurrent administration of dopamine hydrochloride and diuretic agents may produce an additive or potentiating effect on urine flow.
Tricyclic antidepressants may potentiate the pressor response to adrenergic agents.
Cardiac effects of dopamine are antagonized by beta-adrenergic blocking agents, such as propranolol and metoprolol. The peripheral vasoconstriction caused by high doses of dopamine hydrochloride is antagonized by alpha-adrenergic blocking agents. Dopamine-induced renal and mesenteric vasodilation is not antagonized by either alpha- or beta-adrenergic blocking agents.
Haloperidol appears to have strong central antidopaminergic properties. Haloperidol and haloperidol like drugs suppress the dopaminergic renal and mesenteric vasodilation induced at low rates of dopamine infusion.
Cyclopropane or halogenated hydrocarbon anesthetics increase cardiac autonomic irritability and may sensitize the myocardium to the action of certain intravenously administered catecholamines, such as dopamine. This interaction appears to be related both to pressor activity and to beta-adrenergic stimulating properties of these catecholamines and may produce ventricular arrhythmias and hypertension. Therefore, EXTREME CAUTION should be exercised when administering dopamine hydrochloride to patients receiving cyclopropane or halogenated hydrocarbon anesthetics. It has been reported that results of studies in animals indicate that dopamine-induced ventricular arrhythmias during anesthesia can be reversed by propranolol.
The concomitant use of vasopressors and some oxytocic drugs may result in severe persistent hypertension.
Administration of phenytoin to patients receiving dopamine hydrochloride has been reported to lead to hypotension and bradycardia. It is suggested that in patients receiving dopamine hydrochloride, alternatives to phenytoin should be used if anticonvulsant therapy is needed.
The ergot alkaloids should be avoided because of the possibility of excessive vasoconstriction.
Incompatibilities: Do not add dopamine hydrochloride to any alkaline solution since it is inactivated in alkaline solution. Dopamine is also sensitive to oxidizing agents and iron salts.
Storage
Store below 30°C.
Do not freeze.
Protect from light. Retain in carton till time of use.
Following dilution in the recommended diluents, chemical and physical in-use stability has been demonstrated for 24 hours at room temperature (<30°C). However, from a microbiological point of view, the product should be used immediately.
Shelf-Life: 3 years.
Following dilution in the recommended diluents, chemical and physical in-use stability has been demonstrated for 24 hours at room temperature (<30°C). However, from a microbiological point of view, the product should be used immediately.
MIMS Class
ATC Classification
C01CA04 - dopamine ; Belongs to the class of adrenergic and dopaminergic cardiac stimulants excluding glycosides. Used in the treatment of hypotension.
Presentation/Packing
Soln for inj (colourless to pale yellow solution in ampoule) 40 mg/mL x 5 mL x 10's.
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