Drug: Dopamine

Dopamine Hydrochloride Injection, USP is a clear, practically colorless, aqueous, additive solution for intravenous infusion after dilution. Each mL contains either 40 mg, 80 mg, or 160 mg dopamine (dopamine hydrochloride) HCl, USP (equivalent to 32.3 mg, 64.6 mg and 129.2 mg dopamine (dopamine hydrochloride) base respectively) in Water for Injection, USP, containing 9 mg sodium metabisulfite as an antioxidant. The pH range (2.5 to 5.0) may be adjusted with citric acid and/or sodium citrate. The solution is sterile and nonpyrogenic. Dopamine (dopamine hydrochloride) HCl, a naturally occurring catecholamine, is an inotropic vasopressor agent. Its chemical name is 3,4 dihydroxyphenethylamine hydrochloride and its chemical structure is: Dopamine (dopamine hydrochloride) HCl is sensitive to alkalis, iron salts and oxidizing agents. DOPAMINE (dopamine hydrochloride) must be diluted in an appropriate, sterile parenteral solution (see DOSAGE AND ADMINISTRATION section) before intravenous administration.

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The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency. Cardiovascular System ventricular arrhythmia (at very high doses)
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 moderate to high doses were administered for prolonged periods or in patients with occlusive vascular disease receiving low doses of dopamine (dopamine hydrochloride) HCl. A few cases of peripheral cyanosis have been reported. Read the Dopamine (dopamine hydrochloride) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

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:
  1. Sodium Chloride Injection, USP
  2. Dextrose (5%) Injection, USP
  3. Dextrose (5%) and Sodium Chloride (0.9%) Injection, USP
  4. 5% Dextrose in 0.45% Sodium Chloride Solution
  5. Dextrose (5%) in Lactated Ringer's Solution
  6. Sodium Lactate (1/6 Molar) Injection, USP
  7. 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. 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 14-18 mm Hg.
  2. 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.
  3. 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.
  4. 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.

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Cyclopropane or halogenated hydrocarbon anesthetics increase cardiac autonomic irritability and may sensitize the myocardium to the action of certain intravenously administered catecholamines, such as dopamine (dopamine hydrochloride) . The interaction appears to be related both to pressor activity and to the beta adrenergic stimulating properties of these catecholamines, and may produce ventricular arrhythmias. Therefore, EXTREME CAUTION should be exercised when administering dopamine (dopamine hydrochloride) HCl to patients receiving cyclopropane or halogenated hydrocarbon anesthetics. Results of studies in animals indicate that dopamine (dopamine hydrochloride) induced ventricular arrhythmias during anesthesia can be reversed by propranolol. Because dopamine (dopamine hydrochloride) is metabolized by monoamine oxidase (MAO), inhibition of this enzyme prolongs and potentiates the effect of dopamine (dopamine hydrochloride) . Patients who have been treated with MAO inhibitors within two to three weeks prior to the administration of dopamine (dopamine hydrochloride) should receive initial doses of dopamine (dopamine hydrochloride) HCl not greater than one-tenth (1/10) of the usual dose. Concurrent administration of low-dose dopamine (dopamine hydrochloride) HCl and diuretic agents may produce an additive or potentiating effect on urine flow. Tricyclic antidepressants may potentiate the cardiovascular effects of adrenergic agents. Cardiac effects of dopamine (dopamine hydrochloride) are antagonized by beta-adrenergic blocking agents, such as propranolol and metroprolol. The peripheral vasoconstriction caused by high doses of dopamine (dopamine hydrochloride) HCl is antagonized by alpha-adrenergic blocking agents. Dopamine (dopamine hydrochloride) -induced renal and mesenteric vasodilation is not antagonized by either alpha- or beta-adrenergic blocking agents. Butyrophenones (such as haloperidol) and phenothiazines can suppress the dopamine (dopamine hydrochloride) rgic renal and mesenteric vasodilation induced with low-dose dopamine (dopamine hydrochloride) infusion. The concomitant use of vasopressors, vasoconstricting agents (such as ergonovine) and some oxytocic drugs may result in severe hypertension. Administration of phenytoin to patients receiving dopamine (dopamine hydrochloride) HCl has been reported to lead to hypotension and bradycardia. It is suggested that in patients receiving dopamine (dopamine hydrochloride) HCl, alternatives to phenytoin should be considered if anticonvulsant therapy is needed. Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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.

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DOPAMINE (dopamine hydrochloride) should not be used in patients with pheochromocytoma. DOPAMINE (dopamine hydrochloride) should not be administered in the presence of uncorrected tachyarrhythmias or ventricular fibrillation. Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

In case of accidental overdosage, as evidenced by excessive blood pressure elevation, reduce rate of administration or temporarily discontinue DOPAMINE (dopamine hydrochloride) until patient's condition stabilizes. Since the duration of action of DOPAMINE (dopamine hydrochloride) is quite short, no additional remedial measures are usually necessary. If these measures fail to stabilize the patient's condition, use of the short-acting alpha adrenergic blocking agent, phentolamine, should be considered.

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Dopamine (dopamine hydrochloride) 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) 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: 10/5/2002 Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General Careful monitoring required - Close monitoring of the following indices-urine flow, cardiac output and blood pressure - during DOPAMINE (dopamine hydrochloride) infusion is necessary as in the case of any adrenergic agent. Avoid hypovolemia - Prior to treatment with DOPAMINE (dopamine hydrochloride) , hypovolemia should be fully corrected, if possible with either whole blood or plasma as indicated. Monitoring of central venous pressure of left ventricular filling pressure may be helpful in detecting and treating hypovolemia. Hypoxia, Hypercapnia, Acidosis - These conditions which may also reduce the effectiveness and/or increase the incidence of adverse effects of dopamine (dopamine hydrochloride) , must be identified and corrected prior to, or concurrently with administration of dopamine (dopamine hydrochloride) HCl. Ventricular Arrhythmias - If an increased number of ectopic beats are observed, the dose should be reduced if possible. Decreased Pulse Pressure - If a disproportionate rise in the diastolic pressure (i.e., a marked decrease in the pulse pressure) is observed in patients receiving DOPAMINE (dopamine hydrochloride) , the infusion rate should be decreased and the patient observed carefully for further evidence of predominant vasoconstrictor activity, unless such an effect is desired. Hypotension - At lower infusion rates, if hypotension occurs, the infusion rate should be rapidly increased until adequate blood pressure is obtained. If hypotension persists, dopamine (dopamine hydrochloride) HCl should be discontinued and a more potent vasoconstrictor agent such as norepinephrine should be administered. Extravasation - DOPAMINE (dopamine hydrochloride) should be infused into a large vein whenever possible to prevent the possibility of extravasation into tissue adjacent to the infusion site. Extravasation may cause necrosis and sloughing of surrounding tissue. Large veins of the actecubital fossa are preferred to veins in the dorsum of the hand or ankle. Less suitable infusion sites should be used only if the patient's condition requires immediate attention. The physician should switch to more suitable sites as rapidly as possible. The infusion site should be continuously monitored for free flow. Occlusive vascular disease - Patients with a history of occlusive vascular disease (for example, atheroscierosis, arterial embolism, and Raynaud's disease, cold injury, diabetic endarteritis, and Buergers disease) should be closely monitored for any changes in color or temperature of the skin in the extremities. If a change in skin color or temperature occurs and is thought to be the result of compromised circulation to the extremities, the benefits of continued DOPAMINE (dopamine hydrochloride) infusion should be weighed against the risk of possible necrosis. This condition may be reversed by either decreasing or discontinuing the rate of infusion. IMPORTANT - Antidote for Peripheral Ischemia - To prevent sloughing and necrosis in ischemic areas, the area should be infiltrated as soon as possible with 10 to 15 mL of saline solution containing 5 to 10 mg of Regitine® (brand of phentolamine), an adrenergic blocking agent. A syringe with a fine hypodermic needle should be used, and the solution liberally infiltrated throughout the ischemic area. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours. Therefore, phentolamine should be given as soon as possible after the extravasation is noted.

Source: http://www.rxlist.com

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