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dopamine hydrochloride injection, USP VIAL Dosage and Administration

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 – For the 40 mg/mL preparation, transfer by aseptic technique the contents containing either 5 mL, 200 mg or 10 mL, 400 mg of Dopamine Hydrochloride to either a 250 mL or 500 mL bottle of one of the sterile intravenous solutions listed below:

      0.9% Sodium Chloride Injection, USP
      5% Dextrose Injection, USP
      5% Dextrose and 0.9% Sodium Chloride Injection, USP
      5% Dextrose and 0.45% Sodium Chloride Injection, USP
      5% Dextrose and Lactated Ringer's Injection
      Sodium Lactate Injection, USP 1/6 Molar
      Lactated Ringer's Injection, USP

The resultant dilutions are summarized in the following chart:

Concentration of Dopamine Hydrochloride40 mg/mL
Volume of Dopamine Hydrochloride Injection, USP5 mL10 mL
  250 mL Bottle of I.V. Solution800 mcg/mL1600 mcg/mL
  500 mL Bottle of I.V. Solution400 mcg/mL800 mcg/mL
  1000 mL Bottle of I.V. Solution200 mcg/mL400 mcg/mL

Dopamine Hydrochloride Injection, USP has been found to be stable for a minimum of 24 hours after dilution in the foregoing intravenous solutions. 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 via 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.

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:

1.
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.
2.
Begin infusion of diluted solution at doses of 2 – 5 mcg/kg/min 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/min of Dopamine Hydrochloride 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 percent 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 or urine flow, additional increments of dopamine may be given in an effort to produce an appropriate arterial pressure and central perfusion.
3.
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.
4.
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 inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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