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Questions & Answers
Side Effects & Adverse Reactions
Do NOT add any alkalinizing substance, since dopamine is inactivated in alkaline solution.
Patients who have been treated with monoamine oxidase (MAO) inhibitors prior to administration of dopamine should receive substantially reduced dosage of the latter. See PRECAUTIONS, Drug Interactions, below.
Additive medications should not be delivered via this solution.
Dopamine Hydrochloride in 5% Dextrose Injection, USP 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.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Dopamine Hydrochloride in 5% Dextrose Injection, USP is indicated for the correction of hemodynamic imbalances present in shock due to myocardial infarction, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in refractory congestive failure.
When indicated, restoration of circulatory volume should be instituted or completed with a suitable plasma expander or whole blood, prior to administration of dopamine hydrochloride.
Patients most likely to respond to dopamine are those whose physiological parameters (such as urine flow, myocardial function and blood pressure) have not undergone extreme deterioration. Reports indicate that the shorter the time between onset of signs and symptoms and initiation of therapy with volume restoration and dopamine, the better the prognosis.
Poor Perfusion of Vital Organs: Although urine flow is apparently one of the better diagnostic signs for monitoring vital organ perfusion, the physician also should observe the patient for signs of reversal of mental confusion or coma. Loss of pallor, increase in toe temperature or adequacy of nail bed capillary filling also may be observed as indices of adequate dosage. Reported studies indicate that when dopamine is administered before urine flow has decreased to approximately 0.3 mL/minute prognosis is more favorable.
However, it has been observed that in some oliguric or anuric patients, administration of the drug has produced an increase in urine flow which may reach normal levels. The drug also may increase urine flow in patients whose output is within normal limits and thus may help in reducing the degree of pre-existing fluid accumulation. Conversely, at higher than optimal doses for a given patient, urinary flow may decrease, requiring a reduction of dosage. Concomitant administration of dopamine and diuretic agents may produce an additive or potentiating effect.
Low Cardiac Output: Dopamine’s direct inotropic effect on the myocardium which increases cardiac output at low or moderate doses is related to a favorable prognosis. Increased output has been associated with unchanged or decreased systemic vascular resistance (SVR). The association of static or decreased SVR with low or moderate increases in cardiac output is regarded as a reflection of differential effects on specific vascular beds, with increased resistance in peripheral beds (e.g., femoral), and concurrent decreases in mesenteric and renal vascular beds. Redistribution of blood flow parallels these changes so that an increase in cardiac output is accompanied by an increase in mesenteric and renal blood flow. In many instances the renal fraction of the total cardiac output has been found to increase. Increase in cardiac output produced by dopamine is not associated with substantial decreases in systemic vascular resistance as may occur with isoproterenol.
Hypotension: Low to moderate doses of dopamine, which have little effect on SVR, can be used to manage hypotension due to inadequate cardiac output. At high therapeutic doses, dopamine’s α‑adrenergic action becomes more prominent and thus may correct hypotension due to diminished SVR. As in other circulatory decompensation states, prognosis is better in patients whose blood pressure and urine flow have not undergone extreme deterioration. Therefore, it is suggested the physician administer dopamine as soon as a definite trend toward decreased systolic and diastolic pressure becomes apparent.
History
There is currently no drug history available for this drug.
Other Information
Dopamine Hydrochloride in 5% Dextrose Injection, USP is a sterile, nonpyrogenic, prediluted solution of dopamine hydrochloride in 5% dextrose injection. It is administered by intravenous infusion.
Each 100 mL contains dopamine hydrochloride 80 mg (0.8 mg/mL), 160 mg (1.6 mg/mL) or 320 mg (3.2 mg/mL) and dextrose, hydrous 5 g in water for injection, with sodium metabisulfite added 50 mg as a stabilizer; osmolar concentration, respectively 261, 269, or 286 mOsmol/liter (calc.), pH 3.8 (2.5 to 4.5). May contain hydrochloric acid and/or sodium hydroxide for pH adjustment.
Dopamine administered intravenously is a myocardial inotropic agent, which also may increase mesenteric and renal blood flow plus urinary output.
Dopamine Hydrochloride is chemically designated 3, 4-dihydroxyphenethylamine hydrochloride (C8H11NO2 • HCl), a white crystalline powder freely soluble in water. It has the following structural formula:
Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring endogenous catecholamine precursor of norepinephrine.
Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 • H2O), a hexose sugar freely soluble in water. It has the following structural formula:
Water for Injection, USP is chemically designated H2O.
The flexible plastic container is fabricated from a specially formulated CR3 plastic material. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.
Sources
Dopamine Hydrochloride And Dextrose Manufacturers
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Hospira, Inc.
Dopamine Hydrochloride And Dextrose | Hospira, Inc.
Do NOT administer if solution is darker than slightly yellow or discolored in any other way. Do NOT administer unless solution is clear and container is undamaged. Discard unused portion.
Dextrose solutions without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur.
Do NOT add sodium bicarbonate or other alkalinizing substance, since dopamine is inactivated in alkaline solution.
Dopamine Hydrochloride in 5% Dextrose Injection should be infused into a large vein whenever possible to prevent the infiltration of perivascular tissue adjacent to the infusion site. Extravasation may cause necrosis and sloughing of the surrounding tissue. Large veins of the antecubital fossa are preferred to veins of the dorsum of the hand or ankle. Less suitable infusion sites should be used only when larger veins are unavailable and the patient’s condition requires immediate attention. The physician should switch to a more suitable site as soon as possible and the infusion site in use should be continuously monitored for free flow.
The less concentrated 800 mcg/mL solution may be preferred when fluid expansion is not a problem. The more concentrated 1600 mcg/mL or 3200 mcg/mL solutions, may be preferred in patients with fluid retention or when a slower rate of infusion is desired.
Rate of Administration: Administration into an umbilical artery catheter is not recommended.
Dopamine in 5% Dextrose Injection should not be infused through ordinary I.V. apparatus, regulated only by gravity and mechanical clamps. Only an infusion pump, preferably a volumetric pump, should be used.
Each patient must be individually titrated to the desired hemodynamic or renal response to dopamine.
In titrating to the desired increase in systolic blood pressure, the optimum dosage rate for renal response may be exceeded, thus necessitating a reduction in rate after the hemodynamic condition is stabilized.
If a disproportionate rise in diastolic pressure (i.e., a marked decrease in pulse pressure) is observed in patients receiving dopamine, the infusion rate should be decreased and the patient observed carefully for further evidence of predominant vasoconstrictor activity, unless such an effect is desired.
Administration rates greater than 50 mcg/kg/min have safely been used in adults 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.
When discontinuing the infusion, it may be necessary to gradually decrease the dose of dopamine HCl while expanding the blood volume with I.V. fluids to prevent the development of marked hypotension.
Suggested Regimen:
When appropriate, increase blood volume with whole blood or plasma until central venous pressure is 10 to 15 cm H2O or pulmonary wedge pressure is 14 to 18 mm Hg. Begin infusion of dopamine hydrochloride solution at doses of 2 to 5 mcg/kg/min in adult or pediatric patients who are likely to respond to modest increments of heart force and renal perfusion.
In more seriously ill patients, begin infusion of dopamine hydrochloride at doses of 5 mcg/kg/min and increase gradually, using 5 to 10 mcg/kg/min increments, up to a rate of 20 to 50 mcg/kg/min as needed. If doses in excess of 50 mcg/kg/min are required, check urine output frequently. Should urinary flow begin to decrease in the absence of hypotension, reduction of dopamine dosage should be considered. More than 50% of adult patients have been satisfactorily maintained on doses less than 20 mcg/kg/min.
In patients who do not respond to these doses with adequate arterial pressures or urine flow, additional increments of dopamine may be given in an effort to produce an appropriate arterial pressure and central perfusion. Treatment of all patients requires constant evaluation of therapy in terms of blood volume, augmentation of cardiac contractility, urine flow, cardiac output, blood pressure, and distribution of peripheral perfusion.
Dosage of dopamine should be adjusted according to the patient’s response. Diminution of established urine flow rate, increasing tachycardia or development of new dysrhythmias are reasons to consider decreasing or temporarily suspending the dosage. As with all potent intravenously administered drugs, care should be taken to control the rate of infusion so as to avoid inadvertent administration of a bolus of the drug. 800 mcg/mL Dosing Chart for Dopamine (mL/hr) Infusion RateInfusion rate
(mcg/kg/min)
Patient Body Weight (kg)
10
20
30
40
50
60
70
80
90
100
2.5
1.9
3.8
5.6
7.5
9.4
11.3
13.1
15
16.9
18.8
5
3.8
7.5
11.3
15
18.8
22.5
26.3
30
33.8
37.5
10
7.5
15
22.5
30
37.5
45
52.5
60
67.5
75
15
11.3
22.5
33.8
45
56.3
67.5
78.8
90
101.3
112.5
20
15
30
45
60
75
90
105
120
135
150
25
18.8
37.5
56.3
75
93.8
112.5
131.3
150
168.8
187.5
30
22.5
45
67.5
90
112.5
135
157.5
180
202.5
225
35
26.3
52.5
78.8
105
131.3
157.5
183.8
210
236.3
262.5
40
30
60
90
120
150
180
210
240
270
300
45
33.8
67.5
101.3
135
168.8
202.5
236.3
270
303.8
337.5
50
37.5
75
112.5
150
187.5
225
262.5
300
337.5
375
Infusion rate
Patient Body Weight (kg)
(mcg/kg/min)
10
20
30
40
50
60
70
80
90
100
2.5
0.9
1.9
2.8
3.8
4.7
5.6
6.6
7.5
8.4
9.4
5
1.9
3.8
5.6
7.5
9.4
11.3
13.1
15
16.9
18.8
10
3.8
7.5
11.3
15
18.8
22.5
26.3
30
33.8
37.5
15
5.6
11.3
16.9
22.5
28.1
33.8
39.4
45
50.6
56.3
20
7.5
15
22.5
30
37.5
45
52.5
60
67.5
75
25
9.4
18.8
28.1
37.5
46.9
56.3
65.6
75
84.4
93.8
30
11.3
22.5
33.8
45
56.3
67.5
78.8
90
101.3
112.5
35
13.1
26.3
39.4
52.5
65.6
78.8
91.9
105
118.1
131.3
40
15
30
45
60
75
90
105
120
135
150
45
16.9
33.8
50.6
67.5
84.4
101.3
118.1
135
151.9
168.8
50
18.8
37.5
56.3
75
93.8
112.5
131.3
150
168.8
187.5
Infusion rate
Patient Body Weight (kg)
(mcg/kg/min)
10
20
30
40
50
60
70
80
90
100
2.5
0.5
0.9
1.4
1.9
2.3
2.8
3.3
3.8
4.2
4.7
5
0.9
1.9
2.8
3.8
4.7
5.6
6.6
7.5
8.4
9.4
10
1.9
3.8
5.6
7.5
9.4
11.3
13.1
15
16.9
18.8
15
2.8
5.6
8.4
11.3
14.1
16.9
19.7
22.5
25.3
28.1
20
3.8
7.5
11.3
15
18.8
22.5
26.3
30
33.8
37.5
25
4.7
9.4
14.1
18.8
23.4
28.1
32.8
37.5
42.2
46.9
30
5.6
11.3
16.9
22.5
28.1
33.8
39.4
45
50.6
56.3
35
6.6
13.1
19.7
26.3
32.8
39.4
45.9
52.5
59.1
65.6
40
7.5
15
22.5
30
37.5
45
52.5
60
67.5
75
45
8.4
16.9
25.3
33.8
42.2
50.6
59.1
67.5
75.9
84.4
50
9.4
18.8
28.1
37.5
46.9
56.3
65.6
75
84.4
93.8
Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
Hospira, Inc.
Dopamine Hydrochloride And Dextrose | Hospira, Inc.
Do NOT add sodium bicarbonate or other alkalinizing substance, since dopamine is inactivated in alkaline solution.
Dopamine Hydrochloride and 5% Dextrose Injection, USP is administered only intravenously via a suitable I.V. catheter or needle infusion.
The less concentrated 800 mcg/mL solution may be preferred when fluid expansion is not a problem. The more concentrated 1600 mcg/mL or 3200 mcg/mL solutions, may be preferred in patients with fluid retention or when a slower rate of infusion is desired.
Rate of Administration — When administering dopamine (or any potent medication) by continuous intravenous infusion, it is advisable to use a precision volume control I.V. set. Each patient must be individually titrated to the desired hemodynamic or renal response to dopamine.
In titrating to the desired increase in systolic blood pressure, the optimum dosage rate for renal response may be exceeded, thus necessitating a reduction in rate after the hemodynamic condition is stabilized.
Administration at rates greater than 50 mcg/kg/min 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.
Suggested Regimen:
When appropriate, increase blood volume with whole blood or plasma until central venous pressure is 10 to 15 cm H2O or pulmonary wedge pressure is 14 to 18 mm Hg. Begin infusion of dopamine hydrochloride solution at doses of 2 to 5 mcg/kg/min in patients who are likely to respond to modest increments of heart force and renal perfusion.
In more seriously ill patients, begin infusion of dopamine hydrochloride at doses of 5 mcg/kg/min and increase gradually using 5 to 10 mcg/kg/min increments up to a rate of 20 to 50 mcg/kg/min as needed. If doses in excess of 50 mcg/kg/min are required, it is advisable to check urine output frequently. Should urinary flow begin to decrease in the absence of hypotension, reduction of dopamine dosage should be considered. Multiclinic trials have shown that more than 50% of patients have been satisfactorily maintained on doses less than 20 mcg/kg/min.
In patients who do not respond to these doses with adequate arterial pressures of urine flow, additional increments of dopamine may be given in an effort to produce an appropriate arterial pressure and central perfusion. Treatment of all patients requires constant evaluation of therapy in terms of blood volume, augmentation of cardiac contractility, and distribution of peripheral perfusion.
Dosage of dopamine 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 indices for decreasing or temporarily suspending the dosage. As with all potent intravenously administered drugs, care should be taken to control the rate of administration to avoid inadvertent administration of a bolus of the drug.Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration, whenever solution and container permit.
Do not use if the injection is darker than slightly yellow or discolored in any other way.
-
Baxter Healthcare Corporation
Dopamine Hydrochloride And Dextrose | Baxter Healthcare Corporation
Rate of AdministrationDopamine Hydrochloride and 5% Dextrose Injection, USP 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/minute. Each patient must be individually titrated to the desired hemodynamic and/or renal response with dopamine hydrochloride. In titrating to the desired increase in systolic blood pressure, the optimum dosage rate for renal response may be exceeded, thus necessitating a reduction in rate after the hemodynamic condition is stabilized.
Administration of dopamine hydrochloride at rates greater than 50 mcg/kg/min has safely been used in advanced circulatory decompensation states. If unnecessary fluid expansion is of concern, use of a more concentrated solution may be preferred over increasing the flow rate of a less concentrated solution.
Suggested Regimen When appropriate, increase blood volume with whole blood, plasma, or plasma expanders until central venous pressure is 10 to 15 cm H2O or pulmonary wedge pressure is 14 to 18 mm Hg. Begin infusion of Dopamine Hydrochloride and 5% Dextrose Injection, USP at doses of 2 to 5 mcg/kg/min in patients who are likely to respond to modest increments of heart force and renal perfusion.In more seriously ill patients, begin administration of Dopamine Hydrochloride and 5% Dextrose Injection, USP at rates of 5 mcg/kg/min and increase gradually using 5 to 10 mcg/kg/min increments up to a rate of 20 to 50 mcg/kg/min as needed. If rates in excess of 50 mcg/kg/min are required, it is suggested that urine output be checked frequently. Should urine flow begin to decrease in the absence of hypotension, reduction of dopamine hydrochloride dosage should be considered. Reports have shown that more than 50% of the patients were satisfactorily maintained on doses of dopamine hydrochloride administered at rates of less than 20 mcg/kg/min. In patients who do not respond to these doses with adequate arterial pressures or urine flow, additional increments of dopamine hydrochloride may be given in an effort to produce an appropriate arterial pressure and central perfusion.
Treatment of all patients requires constant evaluation of therapy in terms of blood volume, augmentation of myocardial contractility and distribution of peripheral perfusion. 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 indices for decreasing or temporarily suspending the dosage. As with all potent intravenously administered drugs, care should be taken to control the rate of administration so as to avoid inadvertent administration of a bolus of drug.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Do not use Dopamine Hydrochloride and 5% Dextrose Injection, USP if darker than slightly yellow or discolored in any other way.
All injections in VIAFLEX Plus plastic containers are intended for intravenous administration using sterile equipment.
Drug additives should not be made to Dopamine Hydrochloride and 5% Dextrose Injection, USP.
Pediatric Dosing and AdministrationIn publications, the most common starting doses were 1-5 micrograms/kilograms/minute. Particularly in neonates, such low doses require considerable dilution of this product; careful consideration should be given to the use of this product in such circumstances. Dosing increments that were reported ranged from 2.5 to 5.0 micrograms/kilogram/minute. Usual maximum doses were 15-20 micrograms/kilogram/minute, with occasional use as great as 50 micrograms/kilogram/minute. The time course of dopamine kinetics is poorly defined. Increasing infusion rates (or dose) should be approached cautiously and only after it is apparent that hemodynamics (mainly systolic blood pressure) have stabilized with respect to the current dose and/or rate of infusion.
There have been occasional reports of vasospastic events when dopamine was infused through umbilical vessels. Due caution should be exercised if infusion of dopamine through umbilical vessels becomes necessary.
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