"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is warning of several treatment-related serious adverse events in association with implantable left ventricular assist devices (LVADs) in heart-failure patients.
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DOPAMINE (dopamine hydrochloride) is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure, and chronic cardiac decompensation as in congestive failure.
Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of DOPAMINE (dopamine hydrochloride) .
Patients most likely to respond adequately to DOPAMINE (dopamine hydrochloride) 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 (dopamine hydrochloride) , the better the prognosis.
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 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 (dopamine hydrochloride) 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 (dopamine hydrochloride) has resulted in an increase in urine flow which in some cases reached normal levels. DOPAMINE (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 preexisting 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 (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 (dopamine hydrochloride) 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 increments 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. The increase in cardiac output produced by DOPAMINE (dopamine hydrochloride) is not associated with substantial decreases in systemic vascular resistance as may occur with isoproterenol.
Hypotension: Hypotension due to inadequate cardiac output can be managed by administration of low to moderate doses of DOPAMINE (dopamine hydrochloride) , which have little effect on SVR. At high therapeutic doses, the alpha adrenergic activity of DOPAMINE (dopamine hydrochloride) 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 (dopamine hydrochloride) 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 patient.
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
- Dextrose (5%) in Lactated Ringer's Solution
- Sodium Lactate (1/6 Molar) Injection, USP
- Lactated Ringer's Injection, USP
DOPAMINE (dopamine hydrochloride) 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 (dopamine hydrochloride) Injection to Sodium Bicarbonate or other alkaline intravenous solutions, since the drug is inactivated in alkaline solution.
Mixing of dopamine (dopamine hydrochloride) with alteplase in the same container should be avoided as visible particulate matter has been observed.
It is recommended that dopamine (dopamine hydrochloride) not be added to amphotericin B solutions because amphotericin B is physically unstable in dopamine (dopamine hydrochloride) -containing solutions.
Rate of Administration: DOPAMINE (dopamine hydrochloride) , after dilution, is administered intravenously through a suitable intravenous catheter or needle. An i.v. 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 (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 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 14-18 mm Hg.
- Begin administration of diluted solution at doses of 2-5 mcg/kg/minute
DOPAMINE (dopamine hydrochloride) in patients who are likely to respond to modest increments of heart
force and renal perfusion.
In more seriously ill patients, begin administration of diluted solution at doses of 5 mcg/kg/minute DOPAMINE (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 of DOPAMINE (dopamine hydrochloride) in excess of 50 mcg/kg/minute are required, it is suggested that urine output be checked frequently. Should the urine flow begin to decrease in the absence of hypotension, reduction of DOPAMINE (dopamine hydrochloride) dosage should be considered. Multiclinic trials have shown that more than 50% of the patients were satisfactorily maintained on doses of DOPAMINE (dopamine hydrochloride) 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 (dopamine hydrochloride) may be employed 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 myocardial contractility, and distribution of peripheral perfusion. Dosage of DOPAMINE (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.
Dopamine (dopamine hydrochloride) HCl Injection, USP is available as follows:
|Product No.||Dopamine HCl
mg per volume fill
|NDC 0517-1805-25||200 mg/5 mL Vial
|Packages of 25 vials
|NDC 0517-1905-25||400 mg/5 mL Vial
|Packages of 25 vials
|NDC 0517-1305-25||800 mg/5 mL Vial
|Packages of 25 vials
Store at controlled room temperature 15°-30°C (59°-86°F) (See USP).
Avoid contact with alkalis (including sodium bicarbonate), oxidizing agents or iron salts.
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.
IV INFUSION ONLY.
AMERICAN REGENT LABORATORIES, INC. SHIRLEY, NY 11967. FDA Rev date: 10/5/2002This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/4/2010
Additional Dopamine Information
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