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. 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 anantioxidant. 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. 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 cardiacdecompensation 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
dilution should be made just prior to administration. 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. prognosis is better in patients whose blood pressure and urine flow have not undergone profound deterioration. 6.to increase. As in the case of other circulatory decompensation states. Mixing of dopamine (dopamine hydrochloride) with alteplase in the same container should be avoided as visible particulate matter has been observed. USP Lactated Ringer's Injection. drip chamber or other suitable metering device is essential for controlling the rate of flow in drops/minute. 3. the alpha adrenergic activity of DOPAMINE (dopamine hydrochloride) becomes more prominent and thus may correct hypotension due to diminished SVR. In titrating to the desired increase in systolic blood pressure. since the drug is inactivated in alkaline solution. . Therefore. At high therapeutic doses. thus necessitating a reduction in rate after the hemodynamic condition is stabilized. Rate of Administration: DOPAMINE (dopamine hydrochloride) . USP Dextrose (5%) and Sodium Chloride (0. 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. An i.9%) Injection. However. which have little effect on SVR.v. the optimum dosage rate for renal response may be exceeded. Each patient must be individually titrated to the desired hemodynamic and/or renal response with DOPAMINE (dopamine hydrochloride) . 5. 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. Suggested Dilution: Transfer contents of one or more ampuls or vials by aseptictechnique to either 250 mL or 500 mL of one of the following sterile intravenous solutions: 1. Administration rates greater than 50 mcg/kg/minute have safely been used in advanced circulatory decompensation states. 7. Suggested Regimen 1. as with all intravenous admixtures. USP 5% Dextrose in 0. USP Dextrose (5%) Injection. Sodium Chloride Injection.45% Sodium Chloride Solution Dextrose (5%) in Lactated Ringer's Solution Sodium Lactate (1/6 Molar) Injection. is administered intravenously through a suitable intravenous catheter or needle. adjustment of drug concentration may be preferred over increasing the flow rate of a less concentrated dilution. 4. Do NOT add DOPAMINE (dopamine hydrochloride) Injection to Sodium Bicarbonate or other alkaline intravenous solutions. When appropriate. Hypotension: Hypotension due to inadequate cardiac output can be managed by administration of low to moderate doses of DOPAMINE (dopamine hydrochloride) . DOSAGE AND ADMINISTRATION WARNING: This is a potent drug: It must be diluted before administration to patient. 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. If unnecessary fluid expansion is of concern. 2. it is suggested that the physician administer DOPAMINE (dopamine hydrochloride) as soon as a definite trend toward decreased systolic and diastolic pressure becomes evident. after dilution.
In patients who do not respond to these doses with adequate arterial pressures or urine flow. reduction of DOPAMINE (dopamine hydrochloride) dosage should be considered. IV INFUSION ONLY. 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. Avoid contact with alkalis (including sodium bicarbonate). How Packaged NDC 0517-1805-25 Packages of 25 vials (color-coded WHITE) Packages of 25 vials (color-coded GREEN) Packages of 25 vials (color-coded YELLOW) NDC 0517-1905-25 NDC 0517-1305-25 Store at controlled room temperature 15°-30°C (59°-86°F) (See USP). USP is available as follows: Dopamine HCl mg per volume fill 200 mg/5 mL Vial (40 mg/mL) 400 mg/5 mL Vial (80 mg/mL) 800 mg/5 mL Vial (160 mg/mL) 3. additional increments of DOPAMINE (dopamine hydrochloride) may be employed in an effort to produce an appropriate arterial pressure and central perfusion.Do not use the injection if it is darker than slightly yellow or discolored in any other way. In more seriously ill patients. and distribution of peripheral perfusion. 4.2. up to 20 to 50 mcg/kg/minute as needed. As with all potent intravenously administered drugs. augmentation of myocardial contractility. The following adverse reactions have been observed. Product No. MUST BE DILUTED BEFORE USE. 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. using 5 to 10 mcg/kg/minute increments. If doses of DOPAMINE (dopamine hydrochloride) in excess of 50 mcg/kg/minute are required. oxidizing agents or iron salts. Dosage of DOPAMINE (dopamine hydrochloride) should be adjusted according to the patient's response. Treatment of all patients requires constant evaluation of therapy in terms of the blood volume. begin administration of diluted solution at doses of 5 mcg/kg/minute DOPAMINE (dopamine hydrochloride) and increase gradually. it is suggested that urine output be checked frequently. HOW SUPPLIED Dopamine (dopamine hydrochloride) HCl Injection. whenever solution and container permit. increasing tachycardia or development of new dysrhythmias as indices for decreasing or temporarily suspending the dosage. Should the urine flow begin to decrease in the absence of hypotension. but there are not enough data to support an estimate of their frequency. with particular attention to diminution of established urine flow rate. Cardiovascular System ventricular arrhythmia (at very high doses) ectopic beats tachycardia . NOTE . Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. WARNING: NOT FOR DIRECT INTRAVENOUS INJECTION. care should be taken to control the rate of administration so as to avoid inadvertent administration of a bolus of drug.
The interaction appears to be related both to pressor activity and to the beta adrenergic stimulating properties of these catecholamines. Inhibits HPV DRUG INTERACTIONS Cyclopropane or halogenated hydrocarbon anesthetics increase cardiac autonomic irritability and may sensitize the myocardium to the action of certain intravenously administered catecholamines. A few cases of peripheral cyanosis have been reported. 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. EXTREME CAUTION should be exercised when administering dopamine (dopamine hydrochloride) HCl to patients receiving cyclopropane or halogenated hydrocarbon anesthetics. . Therefore. such as dopamine (dopamine hydrochloride) . inhibition of this enzyme prolongs and potentiates the effect of dopamine (dopamine hydrochloride) . Because dopamine (dopamine hydrochloride) is metabolized by monoamine oxidase (MAO). Results of studies in animals indicate that dopamine (dopamine hydrochloride) induced ventricular arrhythmias during anesthesia can be reversed by propranolol. and may produce ventricular arrhythmias.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.
alternatives to phenytoin should be considered if anticonvulsant therapy is needed. Ventricular Arrhythmias . Avoid hypovolemia .during DOPAMINE (dopamine hydrochloride) infusion is necessary as in the case of any adrenergic agent. Monitoring of central venous pressure of left ventricular filling pressure may be helpful in detecting and treating hypovolemia. The overall prevalence of sulfite sensitivity in the general population is unknown.If an increased number of ectopic beats are observed. Hypercapnia. cardiac output and blood pressure . a marked decrease in the pulse pressure) is observed in patients receiving DOPAMINE (dopamine hydrochloride) . Contains sodium metabisulfite.e. since the drug is inactivated in alkaline solution. 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. Acidosis . below. Administration of phenytoin to patients receiving dopamine (dopamine hydrochloride) HCl has been reported to lead to hypotension and bradycardia. Hypoxia.These conditions which may also reduce the effectiveness and/or increase the incidence of adverse effects of dopamine (dopamine hydrochloride) . the infusion rate should . or concurrently with administration of dopamine (dopamine hydrochloride) HCl. See DRUG INTERACTIONS. and probably low. The peripheral vasoconstriction caused by high doses of dopamine (dopamine hydrochloride) HCl is antagonized by alpha-adrenergic blocking agents.If a disproportionate rise in the diastolic pressure (i.Concurrent administration of low-dose dopamine (dopamine hydrochloride) HCl and diuretic agents may produce an additive or potentiating effect on urine flow. Dopamine (dopamine hydrochloride) induced renal and mesenteric vasodilation is not antagonized by either alpha. the dose should be reduced if possible. Cardiac effects of dopamine (dopamine hydrochloride) are antagonized by beta-adrenergic blocking agents. vasoconstricting agents (such as ergonovine) and some oxytocic drugs may result in severe hypertension. The concomitant use of vasopressors. a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmaticepisodes in certain susceptible people. must be identified and corrected prior to. It is suggested that in patients receiving dopamine (dopamine hydrochloride) HCl. Tricyclic antidepressants may potentiate the cardiovascular effects of adrenergic agents. Decreased Pulse Pressure . hypovolemia should be fully corrected..Prior to treatment with DOPAMINE (dopamine hydrochloride) . if possible with either whole blood or plasma as indicated. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. Patients who have been treated with monoamine oxidase (MAO) inhibitors prior to the administration of DOPAMINE (dopamine hydrochloride) will require substantially reduced dosage.Close monitoring of the following indices-urine flow. such as propranolol and metroprolol. PRECAUTIONS General Careful monitoring required .or beta-adrenergic blocking agents. WARNINGS Do NOT add DOPAMINE (dopamine hydrochloride) to any alkaline diluent solution.
Therefore. Although there was a reproducible dose-dependent increase in the number of revertant colonies with strains TA100 and TA98. although maternal toxicityconsisting of mortalities. both with and without metabolic activation. Extravasation . Dopamine hydrochloride at doses approaching maximal solubility shows no clear genotoxic potential in the Ames test. an adrenergic blocking agent. and 3000 mcg/mL with activation. Pregnancy: Pregnancy Category C Teratogenic Effects: Teratogenicity studies in rats and rabbits at dopamine hydrochloride dosages up to 6 mg/kg/day intravenously during organogenesis produced no detectable teratogenic or embryotoxic effects.Antidote for Peripheral Ischemia . Large veins of the actecubital fossa are preferred to veins in the dorsum of the hand or ankle.mouse lymphoma assay. since sudden cessation may result in marked hypotension. phentolamine should be given as soon as possible after the extravasation is noted. 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). Extravasation may cause necrosis and sloughing of surrounding tissue. the infusion rate should be rapidly increased until adequate blood pressure is obtained. if hypotension occurs. If a change in skin coloror temperature occurs and is thought to be the result of compromised circulation to the extremities. respectively. unless such an effect is desired. was toxic and associated with increases in mutant frequencies when compared to untreated and solvent controls. and Buergers disease) should be closely monitored for any changes in color or temperature of the skin in the extremities. and pharmacotoxic signs were .When discontinuing the infusion. Hypotension . IMPORTANT .Patients with a history of occlusive vascular disease (for example.At lower infusion rates. This condition may be reversed by either decreasing or discontinuing the rate of infusion. Mutagenesis. at the lower concentrations no increases over controls were noted. Weaning .be decreased and the patient observed carefully for further evidence of predominant vasoconstrictor activity. Less suitable infusion sites should be used only if the patient's condition requires immediate attention. the benefits of continued DOPAMINE (dopamine hydrochloride) infusion should be weighed against the risk of possible necrosis. dopamine (dopamine hydrochloride) HCl should be discontinued and a more potent vasoconstrictor agent such as norepinephrine should be administered. the small increase was considered inconclusive evidence of mutagenicity. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours. and the solution liberally infiltrated throughout the ischemic area.To prevent sloughing and necrosis in ischemic areas. and Raynaud's disease. dopamine hydrochloride at the highest concentrations used of 750 mcg/mL without metabolic activation. Carcinogenesis. atheroscierosis. arterial embolism. Impairment of Fertility: Long-term animal studies have not been performed to evaluate carcinogenic potential of dopamine hydrochloride. A syringe with a fine hypodermic needle should be used. decrease body weight gain. If hypotension persists.DOPAMINE (dopamine hydrochloride) should be infused into a large vein whenever possible to prevent the possibility of extravasation into tissue adjacentto the infusion site. In the L5178Y TK+/. Occlusive vascular disease . cold injury. it may be necessary to gradually decrease the dose of dopamine (dopamine hydrochloride) HCl while expanding blood volume with IV fluids. The physician should switch to more suitable sites as rapidly as possible. The infusion site should be continuously monitored for free flow. diabetic endarteritis. No clear evidence of clastogenic potential was reported in the in vivo mouse or male rat bone marrow micronucleus test when the animals were treated intravenously with up to 224 mg/kg and 30 mg/kg of dopamine hydrochloride.
and in a few peripheral sympathetic nerves. CLINICAL PHARMACOLOGY Dopamine (dopamine hydrochloride) is a natural catecholamine formed by the decarboxylation of 3. and it is not known if dopamine hydrochloride crosses the placental barrier. OVERDOSE In case of accidental overdosage. especially in the nigrostriatal tract. caution should be exercised when DOPAMINE (dopamine hydrochloride) is administered to a nursing mother. There are no adequate and well-controlled studies in pregnant women. Since the duration of action of DOPAMINE (dopamine hydrochloride) is quite short. dopamine hydrochloride administered at 10 mg/kg subcutaneously for 30 days. DOPAMINE (dopamine hydrochloride) should not be administered in the presence of uncorrected tachyarrhythmias or ventricular fibrillation HOCM. This is accomplished directly by exerting an agonist action on beta-adrenoceptors and indirectly by causing release of norepinephrine from storage sites in sympathetic nerve endings. It is a precursor to norepinephrine in noradrenergic nerves and is also a neurotransmitter in certain areas of the central nervous system. if vasopressor drugs are used to correct hypotension or are added to a local anesthetic solution the interaction with some oxytocic drugs may cause severe hypertension.4-dihydroxyphenylalanine (DOPA). Because many drugs are excreted in human milk. Dopamine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Pediatric Use: Safety and effectiveness in children have not been established. . should be considered. Dopamine (dopamine hydrochloride) HCl has been used in a limited number of pediatric patients. In a published study. Labor and Delivery: In obstetrics. no additional remedial measures are usually necessary. phentolamine. markedly prolonged metestrus and increased mean pituitary and ovary weights in female rats. increased mortalities and slight increases in cataractformation among the offspring. use of the short-acting alpha adrenergic blocking agent. If these measures fail to stabilize the patient's condition. CONTRAINDICATIONS DOPAMINE (dopamine hydrochloride) should not be used in patients with pheochromocytoma. Peripheral gangrene has been reported in neonates and children. Nursing Mothers: It is not known whether this drug is excreted in human milk. Dopamine (dopamine hydrochloride) produces positive chronotropic and inotropic effects on the myocardium. Similar administration to pregnantrats throughout gestation or for 5 days starting on gestation day 10 or 15 resulted in decreased body weight gains. resulting in increased heart rate and cardiac contractility.observed in rats. but such use has been inadequate to fully define proper dosage and limitations for use. reduce rate of administration or temporarily discontinue DOPAMINE (dopamine hydrochloride) until patient's condition stabilizes. as evidenced by excessive blood pressure elevation.
There is little. and intracerebral vascular beds. the duration may increase to one hour. It has been reported that about 80% of the drug is excreted in the urine within 24 hours. An increase in urinary output produced by dopamine (dopamine hydrochloride) is usually not associated with a decrease in osmolarity of the urine. . coronary. kidney. the duration of action is less than ten minutes. and its use is not usually associated with a tachyarrhythmia. Hypotension sometimes occurs. Dopamine (dopamine hydrochloride) is metabolized in the liver. Dopamine (dopamine hydrochloride) causes less increase in myocardial oxygen consumption than isoproterenol.4-dihydroxyphenylacetic acid. sodium excretion. renal blood flow. increased SA rate and enhanced impulse conduction in the heart. however. At intermediate rates of infusion (2-10 mcg/kg/min) dopamine (dopamine hydrochloride) acts to stimulate the beta1-adrenoceptors. mesenteric. haloperidol is an antagonist. At low rates of infusion (0. If monoamine oxidase (MAO) inhibitors are present. if any. resulting in improved myocardial contractility. where it is hydroxylated to form norepinephrine. Clinical studies indicate that it usually increases systolic and pulse pressure with either no effect or a slight increase in diastolic pressure.4- dihydroxyphenylacetic acid. and with dopamine (dopamine hydrochloride) 's plasma half-life of about two minutes. The drug is widely distributed in the body but does not cross the blood-brain barrier to a significant extent. At these dopamine (dopamine hydrochloride) receptors. At low and intermediate doses. The vasodilation in these vascular beds is accompanied by increased glomerular filtration rate. total peripheral resistance (which would be raised by alpha activity) is usually unchanged. stimulation of the beta2adrenoceptors (peripheral vasodilation). About 25% of the dose is taken up into specialized neurosecretory vesicles (the adrenergic nerve terminals). The predominant effects of dopamine (dopamine hydrochloride) are dose-related. and urine flow.Dopamine (dopamine hydrochloride) 's onset of action occurs within five minutes of intravenous administration. Blood flow to the peripheral vascular beds may decrease while mesenteric flow increases due to increased cardiac output. A very small portion is excreted unchanged. primarily as HVA and its sulfate and glucuronide conjugates and as 3. and plasma by MAO and catechol-Omethyltransferase to the inactive compounds homovanillic acid (HVA) and 3.5-2 mcg/kg/min) dopamine (dopamine hydrochloride) causes vasodilation that is presumed to be due to a specific agonist action on dopamine (dopamine hydrochloride) receptors (distinct from alpha and beta adrenoceptors) in the renal. although actual response of an individual patient will largely depend on the clinical status of the patient at the time the drug is administered.
with consequent vasoconstrictor effects and a rise in blood pressure. At very high rates of infusion (above 20 mcg/kg/min). The vasoconstrictor effects are first seen in the skeletal muscle vascular beds. stimulation of alphaadrenoceptors predominates and vasoconstriction may compromise the circulation of the limbs and override the dopamine (dopamine hydrochloride) rgic effects of dopamine (dopamine hydrochloride) . reversing renal dilation and natriuresis HYPERGLYCEMIA: DOPmine receptors : . but with increasing doses they are also evident in the renal and mesenteric vessels.At higher rates of infusion (10-20 mcg/kg/min) there is some effect on alpha-adrenoceptors.
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