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Dopamine HCl
Overview
What is Dopamine HCl?
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 HCl, USP (equivalent to 32.3 mg, 64.6 mg and 129.2 mg dopamine 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 HCl, a naturally occurring catecholamine, is an inotropic vasopressor agent. Its chemical name is 3,4 dihydroxyphenethylamine hydrochloride and its chemical structure is:
Dopamine HCl is sensitive to alkalis, iron salts and oxidizing agents. DOPAMINE must be diluted in an appropriate, sterile parenteral solution (see section) before intravenous administration.
What does Dopamine HCl look like?
What are the available doses of Dopamine HCl?
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What should I talk to my health care provider before I take Dopamine HCl?
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How should I use Dopamine HCl?
DOPAMINE 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.
Patients most likely to respond adequately to DOPAMINE 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, the better the prognosis.
WARNING:
Suggested Dilution:
DOPAMINE 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 Injection to Sodium Bicarbonate or other alkaline intravenous solutions, since the drug is inactivated in alkaline solution.
Mixing of dopamine with alteplase in the same container should be avoided as visible particulate matter has been observed.
It is recommended that dopamine not be added to amphotericin B solutions because amphotericin B is physically unstable in dopamine-containing solutions.
Rate of Administration:
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 HO or pulmonary wedge pressure is 14-18 mm Hg.
2. Begin administration of diluted solution at doses of 2-5 mcg/kg/minute DOPAMINE 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 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 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 dosage should be considered. Multiclinic trials have shown that more than 50% of the patients were satisfactorily maintained on doses of DOPAMINE 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 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 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.
What interacts with Dopamine HCl?
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What are the warnings of Dopamine HCl?
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What are the precautions of Dopamine HCl?
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What are the side effects of Dopamine HCl?
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What should I look out for while using Dopamine HCl?
DOPAMINE should not be used in patients with pheochromocytoma.
DOPAMINE should not be administered in the presence of uncorrected tachyarrhythmias or ventricular fibrillation.
Do NOT add DOPAMINE to any alkaline diluent solution, since the drug is inactivated in alkaline solution.
Patients who have been treated with monoamine oxidase (MAO) inhibitors prior to the administration of DOPAMINE will require substantially reduced dosage. See , below.
Contains sodium metabisulfite, 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.
What might happen if I take too much Dopamine HCl?
In case of accidental overdosage, as evidenced by excessive blood pressure elevation, reduce rate of administration or temporarily discontinue DOPAMINE until patient’s condition stabilizes. Since the duration of action of DOPAMINE 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.
How should I store and handle Dopamine HCl?
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.Dopamine HCl Injection, USP is available as follows:Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).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.AMERICANREGENT, INC.SHIRLEY, NY 11967IN1805Rev. 1/09Cardinal HealthZanesville, OH 43701IA61620612Dopamine HCl Injection, USP is available as follows:Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).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.AMERICANREGENT, INC.SHIRLEY, NY 11967IN1805Rev. 1/09Cardinal HealthZanesville, OH 43701IA61620612Dopamine HCl Injection, USP is available as follows:Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).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.AMERICANREGENT, INC.SHIRLEY, NY 11967IN1805Rev. 1/09Cardinal HealthZanesville, OH 43701IA61620612Dopamine HCl Injection, USP is available as follows:Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).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.AMERICANREGENT, INC.SHIRLEY, NY 11967IN1805Rev. 1/09Cardinal HealthZanesville, OH 43701IA61620612Dopamine HCl Injection, USP is available as follows:Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).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.AMERICANREGENT, INC.SHIRLEY, NY 11967IN1805Rev. 1/09Cardinal HealthZanesville, OH 43701IA61620612Dopamine HCl Injection, USP is available as follows:Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).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.AMERICANREGENT, INC.SHIRLEY, NY 11967IN1805Rev. 1/09Cardinal HealthZanesville, OH 43701IA61620612Dopamine HCl Injection, USP is available as follows:Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).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.AMERICANREGENT, INC.SHIRLEY, NY 11967IN1805Rev. 1/09Cardinal HealthZanesville, OH 43701IA61620612Dopamine HCl Injection, USP is available as follows:Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).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.AMERICANREGENT, INC.SHIRLEY, NY 11967IN1805Rev. 1/09Cardinal HealthZanesville, OH 43701IA61620612Dopamine HCl Injection, USP is available as follows:Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).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.AMERICANREGENT, INC.SHIRLEY, NY 11967IN1805Rev. 1/09Cardinal HealthZanesville, OH 43701IA61620612Dopamine HCl Injection, USP is available as follows:Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).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.AMERICANREGENT, INC.SHIRLEY, NY 11967IN1805Rev. 1/09Cardinal HealthZanesville, OH 43701IA61620612Dopamine HCl Injection, USP is available as follows:Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).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.AMERICANREGENT, INC.SHIRLEY, NY 11967IN1805Rev. 1/09Cardinal HealthZanesville, OH 43701IA61620612Dopamine HCl Injection, USP is available as follows:Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).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.AMERICANREGENT, INC.SHIRLEY, NY 11967IN1805Rev. 1/09Cardinal HealthZanesville, OH 43701IA61620612Dopamine HCl Injection, USP is available as follows:Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).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.AMERICANREGENT, INC.SHIRLEY, NY 11967IN1805Rev. 1/09Cardinal HealthZanesville, OH 43701IA61620612Dopamine HCl Injection, USP is available as follows:Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).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.AMERICANREGENT, INC.SHIRLEY, NY 11967IN1805Rev. 1/09Cardinal HealthZanesville, OH 43701IA61620612
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Dopamine is a natural catecholamine formed by the decarboxylation of 3,4-dihydroxyphenylalanine (DOPA). It is a precursor to norepinephrine in noradrenergic nerves and is also a neurotransmitter in certain areas of the central nervous system, especially in the nigrostriatal tract, and in a few peripheral sympathetic nerves.
Dopamine produces positive chronotropic and inotropic effects on the myocardium, resulting in increased heart rate and cardiac contractility. 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.
Dopamine’s onset of action occurs within five minutes of intravenous administration, and with dopamine’s plasma half-life of about two minutes, the duration of action is less than ten minutes. If monoamine oxidase (MAO) inhibitors are present, however, the duration may increase to one hour. The drug is widely distributed in the body but does not cross the blood-brain barrier to a significant extent. Dopamine is metabolized in the liver, kidney, and plasma by MAO and catechol-O-methyltransferase to the inactive compounds homovanillic acid (HVA) and 3,4-dihydroxyphenylacetic acid. About 25% of the dose is taken up into specialized neurosecretory vesicles (the adrenergic nerve terminals), where it is hydroxylated to form norepinephrine. It has been reported that about 80% of the drug is excreted in the urine within 24 hours, primarily as HVA and its sulfate and glucuronide conjugates and as 3,4-dihydroxyphenylacetic acid. A very small portion is excreted unchanged.
The predominant effects of dopamine are dose-related, although actual response of an individual patient will largely depend on the clinical status of the patient at the time the drug is administered. At low rates of infusion (0.5-2 mcg/kg/min) dopamine causes vasodilation that is presumed to be due to a specific agonist action on dopamine receptors (distinct from alpha and beta adrenoceptors) in the renal, mesenteric, coronary, and intracerebral vascular beds. At these dopamine receptors, haloperidol is an antagonist. The vasodilation in these vascular beds is accompanied by increased glomerular filtration rate, renal blood flow, sodium excretion, and urine flow. Hypotension sometimes occurs. An increase in urinary output produced by dopamine is usually not associated with a decrease in osmolarity of the urine.
At intermediate rates of infusion (2-10 mcg/kg/min) dopamine acts to stimulate the beta- adrenoceptors, resulting in improved myocardial contractility, increased SA rate and enhanced impulse conduction in the heart. There is little, if any, stimulation of the beta-adrenoceptors (peripheral vasodilation). Dopamine causes less increase in myocardial oxygen consumption than isoproterenol, and its use is not usually associated with a tachyarrhythmia. Clinical studies indicate that it usually increases systolic and pulse pressure with either no effect or a slight increase in diastolic pressure. Blood flow to the peripheral vascular beds may decrease while mesenteric flow increases due to increased cardiac output. At low and intermediate doses, total peripheral resistance (which would be raised by alpha activity) is usually unchanged.
At higher rates of infusion (10-20 mcg/kg/min) there is some effect on alpha-adrenoceptors, with consequent vasoconstrictor effects and a rise in blood pressure. The vasoconstrictor effects are first seen in the skeletal muscle vascular beds, but with increasing doses they are also evident in the renal and mesenteric vessels. At very high rates of infusion (above 20 mcg/kg/min), stimulation of alpha-adrenoceptors predominates and vasoconstriction may compromise the circulation of the limbs and override the dopaminergic effects of dopamine, reversing renal dilation and natriuresis.
Non-Clinical Toxicology
DOPAMINE should not be used in patients with pheochromocytoma.DOPAMINE should not be administered in the presence of uncorrected tachyarrhythmias or ventricular fibrillation.
Do NOT add DOPAMINE to any alkaline diluent solution, since the drug is inactivated in alkaline solution.
Patients who have been treated with monoamine oxidase (MAO) inhibitors prior to the administration of DOPAMINE will require substantially reduced dosage. See , below.
Contains sodium metabisulfite, 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.
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. 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 HCl to patients receiving cyclopropane or halogenated hydrocarbon anesthetics. Results of studies in animals indicate that dopamine induced ventricular arrhythmias during anesthesia can be reversed by propranolol.
Because dopamine is metabolized by monoamine oxidase (MAO), inhibition of this enzyme prolongs and potentiates the effect of dopamine. Patients who have been treated with MAO inhibitors within two to three weeks prior to the administration of dopamine should receive initial doses of dopamine HCl not greater than one-tenth (1/10) of the usual dose.
Concurrent administration of low-dose dopamine 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 are antagonized by beta-adrenergic blocking agents, such as propranolol and metroprolol. The peripheral vasoconstriction caused by high doses of dopamine HCl is antagonized by alpha-adrenergic blocking agents. Dopamine-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 dopaminergic renal and mesenteric vasodilation induced with low-dose dopamine 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 HCl has been reported to lead to hypotension and bradycardia. It is suggested that in patients receiving dopamine HCl, alternatives to phenytoin should be considered if anticonvulsant therapy is needed.
Careful monitoring required
Avoid hypovolemia
Hypoxia, Hypercapnia, Acidosis
Ventricular Arrhythmias
Decreased Pulse Pressure
Hypotension
Extravasation
Occlusive vascular disease
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 HCl.
A few cases of peripheral cyanosis have been reported.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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