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Dopamine HCl is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarction, trauma, endotoxic septicemia, open-heart surgery, renal failure, and chronic cardiac decompensation as in congestive failure.
Patients most likely to respond adequately to dodpamine HCl are those in whom physiological parameters, such as urine flow, myocardial function, and blood pressure, have not undergone profound deterioration. Multiclinic trials indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and dopamine HCl, the better the prognosis. Where appropriate, blood volume restoration with a suitable plasma expander or whole blood should be accomplished or completed prior to administration of dopamine HCl.
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 reversal of comatose condition. Loss of pallor, increase in toe temperature, and/or adequacy of nail bed capillary filling may also be used as indices of adequate dosage. Clinical studies have shown that when dopamine HCl is administered before urine flow has diminished to levels approximating 0.3 mL/minute, prognosis is more favorable. Nevertheless, in a number of oliguric or anuric patients, administration of dopamine HCl has resulted in an increase in urine flow which in some cases reached normal levels. Dopamine HCl 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.
Low Cardiac Output
Increased cardiac output is related to dopamine's direct inotropic effect on the myocardium. Increased cardiac output at low or moderate doses appears to be related to a favorable prognosis. Increase in cardiac output has been associated with either static or decreased systemic vascular resistance (SVR). Static or decreased SVR associated with low or moderate movements in cardiac output is believed to be a reflection of differential effects on specific vascular beds with increased resistance in peripheral beds (e.g., femoral) and concomitant 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 due to inadequate cardiac output can be managed by administration of low to moderate doses of dopamine HCl, which have little effect on SVR. At high therapeutic doses, the alphaadrenergic activity of dopamine becomes more prominent and thus may correct hypotension due to diminished SVR. As in the case of other circulatory decompensation states, prognosis is better in patients whose blood pressure and urine flow have not undergone profound deterioration. Therefore, it is suggested that the physician administer dopamine HCl as soon as a definite trend toward decreased systolic and diastolic pressure becomes evident.
DOSAGE AND ADMINISTRATION
WARNING: This is a potent drug: It must be diluted before administration to the patient.
Dopamine Hydrochloride Injection, USP is administered (only after dilution) by intravenous infusion.
Suggested Dilution: Transfer contents of one or more ampuls or vials by aseptic technique to either 250 mL or 500 mL of one of the following sterile intravenous solutions:
- Sodium Chloride Injection, USP
- Dextrose (5%) Injection, USP
- Dextrose (5%) and Sodium Chloride (0.9%) Injection, USP
- 5% Dextrose in 0.45% Sodium Chloride Solution Injection, USP
- Dextrose (5%) and Lactated Ringer'™s Solution Injection
- Sodium Lactate Injection, USP (1/6 Molar)
- Lactated Ringer'™s Injection, USP
Dopamine Hydrochloride Injection, USP has been found to be stable for a minimum of 24 hours after dilution in the sterile intravenous solutions listed above. However, as with all intravenous admixtures, dilution should be made just prior to administration.
Do NOT add Dopamine Hydrochloride to Sodium Bicarbonate Injection, USP or other alkaline intravenous solutions, since the drug is inactivated in alkaline solution.
Rate of Administration: Dopamine Hydrochloride Injection, USP, after dilution, is administered intravenously by infusion through a suitable intravenous catheter or needle. When administering Dopamine Hydrochloride (or any potent medication) by continuous intravenous infusion, it is advisable to use a precision volume control intravenous set. Each patient must be individually titrated to the desired hemodynamic or renal response to dopamine.
Administration 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.
- 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 diluted solution at doses of 2 to 5
mcg/kg/minute of Dopamine Hydrochloride in patients who are likely to respond
to modest increments of heart force and renal perfusion.
In more seriously ill patients, begin infusion of diluted solution at doses of 5 mcg/kg/minute of Dopamine Hydrochloride and increase gradually using 5 to 10 mcg/kg/minute increments up to 20 to 50 mcg/kg/minute as needed. If doses in excess of 50 mcg/kg/minute 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 the patients have been satisfactorily maintained on doses of dopamine less than 20 mcg/kg/minute. 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 the 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 drug.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Dopamine HCl Injection, USP is available as follows:
|Product No.||Dopamine HCl mg per||volume fill How Packaged|
|NDC 0517-1805-25||200 mg/5 mL Vial (40 mg/mL)||Packages of 25 vials (color-coded WHITE)|
|NDC 0517-1905-25||400 mg/5 mL Vial (80 mg/mL)||Packages of 25 vials (color-coded GREEN)|
|NDC 0517-1305-25||800 mg/5 mL Vial (160 mg/mL)||Packages of 25 vials (color-coded YELLOW)|
Avoid contact with alkalies (including sodium bicarbonate), oxidizing agents or iron salts.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).
NOTE - Do not use the injection if it is darker than slightly yellow or discolored in any other way.
WARNING: NOT FOR DIRECT INTRAVENOUS INJECTION, MUST BE DILUTED BEFORE USE.
INTRAVENOUS INFUSION ONLY.
The vial stopper is not made with natural rubber latex.
American Regent, Inc., Shirley, NY 11967. Revised: Dec 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/10/2016
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