Full Prescribing Info
Dopamine HCl.
Each ampoule (5ml) contains Dopamine HCl 200 mg.
Pharmacology: Dopamine is an endogenous catecholamine that is the immediate precursor of norepinephrine and stimulates adrenergic receptors of the sympathetic nervous system.
The drug has principally a direct stimulatory effect on 1-adrenergic receptors, but also appears to have an indirect effect by releasing norepinephrine from its storage sites. Dopamine also appears to act on specific dopaminergic receptors in the renal, mesenteric, coronary, and intracerebral vascular beds to cause vasodilation. This drug has little or no effect on 2-adrenergic receptors. In IV doses of 0.5-2 µg/Kg per minute, the drug acts predominantly on dopaminergic receptors: in IV doses of 2-10 µg/Kg per minute. the drug also stimulates 1-adrenergic receptors. In higher therapeutic doses, α-adrenergic, 1-adrenergic and dopaminergic stimulation. In low doses, cardiac stimulation and renal vascular dilation occur and in larger does vasoconstirction occurs. The 1-adrenergic effects of dopamine exert a positive inotropic effect on the myocardiurn and result in an increase in cardiac output because of increased myocardial contractility and stroke volume in healthy individuals and in patients with shock or congestive heart failure. Systolic blood pressure and pulse pressure may be increased as a result of increased cardiac output; however, peripheral vasodilation and the resulting decrease in peripheral resistance may counteract these effects. Blood pressure, therefore, may remain unchanged or be only slightly elevated. Heart rate is usually not substantially changed. In low to moderate doses, dopamine causes renal vasodilation, which results in increased renal blood flow and glomeruular filtration rate. Urine flow is variable affected, but usually increases. In high doses, α-adrenergic effects become more prominent and may result in increase of peripheral resistance and renal vasoconstriction. Blood pressure may return to normal if hypotension initially existed and may increase to hypertensive levels with excessive doses.
Myocardial infarction, trauma, endotoxic septicemia, shocks due to surgery, renal failure & chronic cardiac compensation as in refractory congestive failure, oliguria, anuria, hypotension and other circulatory disorder due to inadequate cardiac output.
Dosage/Direction for Use
In adult, begin infusion of dopamine solution at doses of 2 to 5 μg/Kg per minute. In more severe cases, administration may be initiated at a rate of 5 μg/Kg per minute and increased gradually in 5- to 10 μg/Kg per minute increments up to a rate of 20 to 50 μg/Kg per minute as needed. Dose can be controlled according to condition of patients.
The venous pressure and the lobular pressure should be restored to 10 to 15 cmH2O and 14 to 18 mmHg with a suitable plasma expander or whole blood, prior to administration of dopamine hydrochloride.
If doses in excess of 50 μg/Kg per minute are required, it is advisable to check urine output frequently.
Preparation of infusion solutions: Dopamine Hydrochloride can be diluted with 250ml or 500ml of the following i.v. solutions: 0.9% Sodium Chloride injection, 5% Dextrose, 5% Dextrose and 0.9% Sodium Chloride injection, 5% Dextrose diluted with 0.45% Sodium Chloride injection, 5% Dextrose diluted with Ringer solution containing Sodium Lactate, Compound Sodium Lactate (Hartmann's) Solution, Ringer solution containing Sodium Lactate.
Special Precautions
Pressor therapy is not a substitute for replacement of blood, plasma, fluids and/or electrolytes. Blood volume depletion should be corrected as fully as possible before dopamine therapy is instituted. If excessive vasoconstriction, decreased urine output, increased heart rate or an arrhythmia occurs, the rate of infusion of dopamine should be decreased or temporarily suspended and the patient should be observed closedly. Patients with a history of occlusive vascular disease (e.g., atherosclerosis, arterial embolism, Raynaud's disease, cold injury, diabetic endarteritis, or buerger's disease) should be carefully monitored during dopamine therapy for decreased circulation to the extremities indicated by changes in color or temperwise of the skin or pain in the extremities. Dopamine should be used with caution in patients with ischemic heart disease. The drug is contraindicated in patients with pheochromocytoma and in patients with uncorrected tachyarrhythmias or ventricular fibrillation.
Pediatric Precautions: Safety and efficacy of dopamine in children have not been established. The drug has been used in a limited number of pediatric patients but data are insufficient to define optimum dosage requirements and criteria for usage in this patient population.
Use In Pregnancy & Lactation
The effect of dopamine on the human fetus is not known, therefore the drug should be used in pregnant women only when the possible benefits outweigh the potential risk. 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 women.
Adverse Reactions
Dopamine may cause ectopic heartbeats, tachycardia, angina, palpitation, vasoconstriction, hypotension dyspnea, nausea, vomiting and headache. Other less frequent adverse effects include cardiac conduction abnormalities: QRS complex, bradycardia, hypertension, azotemia, anxiety, and piloerection. Ventricular arrhythmias may occur with very high doses. Gangrene of extremities has occurred when high doses of dopamine were administered for prolonged periods and in patients with occlusive vascular disease receiving low doses of dopamine, and extravasation of dopamine may result in tissue necrosis and sloughing of surrounding tissues.
Drug Interactions
Cyclopropane and halogenated hydrocarbon anaesthetics should be avoided.
MAO (monoamine oxidase) inhibitors potentiate the effect of dopamine and its duration of action. Patients who have been treated with MAO inhibitors prior to dopamine should be given reduced doses: the starting dose should be one tenth (1/10th) of the usual dose.
Dopamine-induced renal vasodilation can be antagonised by either α- or β-adrenergic blocking agents, e.g., phenothiazines, butyrophenones.
When guanethidine, tricyclic antidepressant, reserpine, sympathomimetics, thyroid hormone, antihistamines are administered with dopamine, the sympathomimetic action may increase.
The change of blood pressure may be induced by α- or β-adrenergic blocking agents.
Caution For Usage
Dopamine should be infused into a large vein whenever possible to prevent the possibility of infiltration of perivascular tissue adjacent to the infusion site. lschemia can be reversed by infiltration of the affected area with 10-15ml of saline containing 5 to 10 mg adrenergic blocking agents.
Dopamine should not be added to any alkaline intravenous solutions, i.e. Sodium Bicarbonate.
Dilution in these fluids retains at least 95% if the original potency for 24 hours at room temperature. Dilutions should be discard immediately after use.
Preserve in a hermetic, light-resistant container.
MIMS Class
ATC Classification
C01CA04 - dopamine ; Belongs to the class of adrenergic and dopaminergic cardiac stimulants excluding glycosides. Used in the treatment of hypotension.
Inj (amp) 200 mg/5 mL (faint yellow or colorless transparent solution) x 5's.
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