INDICATIONS AND USAGE 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 hydrochloride.

Patients most likely to respond adequately to dopamine hydrochloride are those in whom physiological parameters, such as urine flow, myocardial function and blood pressure have not undergone profound deterioration.

Reports indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and 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 or 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.

Reported studies indicate that when dopamine hydrochloride is administered before urine flow has diminished to levels of approximately 0.3 mL/minute, prognosis is more favorable.

Nevertheless, in a number of oliguric or anuric patients, administration of dopamine hydrochloride has resulted in an increase in urine flow which in some cases reached normal levels.

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 hydrochloride and diuretic agents may produce an additive or potentiating effect.

Low Cardiac Output Increased cardiac output is related to dopamine hydrochloride’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 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.

Increase in cardiac output produced by 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 hydrochloride, which have little effect on SVR.

At high therapeutic doses, dopamine hydrochloride’s alpha-adrenergic activity 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 hydrochloride as soon as a definite trend toward decreased systolic and diastolic pressure becomes evident.

WARNINGS Patients who have been treated with monoamine oxidase (MAO) inhibitors prior to the administration of dopamine hydrochloride will require substantially reduced dosage.

See Drug Interactions , below.

Evidence is inadequate for fully defining proper dosage and limitations for use in children.

Contains sodium bisulfite, 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.

Do not add Dopamine Hydrochloride and 5% Dextrose Injection, USP to any alkaline diluent solution since dopamine hydrochloride is inactivated in alkaline solution.

Solutions containing dextrose should not be administered through the same administration set as blood, as this may result in pseudoagglutination or hemolysis.

The intravenous administration of solutions may cause fluid overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

Excess administration of potassium-free solutions may result in significant hypokalemia.

ADVERSE REACTIONS The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.

Cardiovascular System ventricular arrhythmia atrial fibrillation ectopic beats tachycardia anginal pain palpitation cardiac conduction abnormalities widened QRS complex bradycardia hypotension hypertension vasoconstriction Respiratory System dyspnea Gastrointestinal System nausea vomiting Metabolic/Nutritional System azotemia Central Nervous System headache anxiety Dermatological System piloerection Other Gangrene of the extremities has occurred when high doses were administered for prolonged periods or in patients with occlusive vascular disease receiving low doses of dopamine HCl.