Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3867
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DOPamine Hydrochloride and Dextrose (Injection, Solution)
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Do NOT add sodium bicarbonate or other alkalinizing substance,
since dopamine is inactivated in alkaline solution. Dopamine
Hydrochloride and 5% Dextrose Injection, USP is administered only intravenously
via a suitable I.V. catheter or needle infusion. The
less concentrated 800 mcg/mL solution may be preferred when fluid expansion
is not a problem. The more concentrated 1600 mcg/mL or 3200 mcg/mL solutions,
may be preferred in patients with fluid retention or when a slower rate of
infusion is desired. Rate
of Administration���When administering dopamine (or any potent
medication) by continuous intravenous infusion, it is advisable to use a precision
volume control I.V. 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:
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dailymed-instance:descripti... |
Dopamine Hydrochloride and 5% Dextrose Injection, USP is
a sterile, nonpyrogenic, prediluted solution of dopamine hydrochloride in
5% dextrose injection. It is administered by intravenous infusion. Dopamine,
a sympathomimetic amine vasopressor, is the naturally occurring immediate
precursor of norepinephrine. Dopamine hydrochloride is a white to off-white,
crystalline powder, which may have a slight odor of hydrochloric acid. It
is freely soluble in water and soluble in alcohol. Dopamine HCl is sensitive
to alkalies, iron salts, and oxidizing agents. Chemically it is designated
as 4���(2���aminoethyl)pyrocatechol hydrochloride, and its molecular
formula is CHNO���HCl (mol.
wt. 189.64). The structural formula is: Dopamine
hydrochloride injection is a clear, practically colorless, sterile, pyrogen-free,
aqueous solution of dopamine HCl for intravenous infusion after dilution. Dextrose,
USP is chemically designated D-glucose monohydrate (CHO���HO) mol. wt. 198.17, a hexose sugar freely soluble in water. It
has the following structural formula: Water
for Injection, USP is chemically designated HO. Each
100 mL contains dopamine hydrochloride 80 mg (equivalent to 64.6 mg dopamine
base), 160 mg (equivalent to 129.2 mg dopamine base) or 320 mg (equivalent
to 258.4 mg dopamine base) and dextrose, hydrous 5 g in water for injection,
with sodium metabisulfite 50 mg added as an antioxidant; osmolar concentration,
respectively 269, 277 or 294 mOsmol/liter (calc.). pH 3.6 (2.5 to
4.5). May contain hydrochloric acid and/or sodium hydroxide for pH adjustment.
Dopamine Hydrochloride and 5% Dextrose Injection, USP is oxygen sensitive.
The solution contains no bacteriostat, antimicrobial agent or added buffer
(except for pH adjustment), and is intended only for use as a single-dose
injection. When smaller doses are required the unused portion should be discarded.
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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. However, if monoamine oxidase (MAO) inhibitors
are present, 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 it should be noted
that 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 osmolality 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. Total peripheral resistance (alpha effects) at low and intermediate
doses 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 naturesis. Solutions containing carbohydrate in
the form of dextrose restore blood glucose levels and provide calories. Carbohydrate
in the form of dextrose may aid in minimizing liver glycogen depletion and
exerts a protein-sparing action. Dextrose injected parenterally undergoes
oxidation to carbon dioxide and water. Water is an essential
constituent of all body tissues and accounts for approximately 70% of total
body weight. Average normal adult daily requirement ranges from two to three
liters (1.0���1.5 liters each for insensible water loss due to
perspiration and urine production). Water balance is
maintained by various regulatory mechanisms. Water distribution depends primarily
on the concentration of electrolytes and sodium (Na) plays a major
role in maintaining physiologic equilibrium.
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Dopamine HCl should not be used in patients with pheochromocytoma. Dopamine
HCl should not be administered to patients with uncorrected tachyarrhythmias
or ventricular fibrillation. Dextrose solutions without
electrolytes should not be administered simultaneously with blood through
the same infusion set because of the possibility that pseudoagglutination
of red cells may occur.
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Dopamine Hydrochloride and 5% Dextrose Injection, USP is
supplied in 250 mL and 500 mL glass containers as follows: List
No. 4141-02���200 mg Dopamine HCl and 5% Dextrose
Injection, USP 250 mL List No. 4141-03���400
mg Dopamine HCl and 5% Dextrose Injection, USP 500
mL List No. 4142-02���400 mg Dopamine HCl and 5%
Dextrose Injection, USP 250 mL List No. 4142-03���800 mg Dopamine HCl and 5% Dextrose Injection, USP
500 mL Avoid contact with alkalies
(including sodium bicarbonate), oxidizing agents or iron salts. Exposure
of pharmaceutical products to heat should be minimized. Avoid excessive heat.
Protect from freezing. It is recommended that the product be stored at room
temperature (25��C); however, brief exposure up to 40��C does not
adversely affect the product. HOSPIRA, INC., LAKE FOREST,IL 60045 USA
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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 from 5 to 10 mg of phentolamine mesylate, 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.
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General: 1. Monitoring���Careful monitoring of the following indices is necessary during dopamine HCl
infusion, as with any adrenergic agent: blood pressure, urine flow, and, when
possible, cardiac output and pulmonary wedge pressure. 2. Hypovolemia���Prior to treatment with
dopamine HCl, hypovolemia should be fully corrected, if possible, with either
whole blood or plasma as indicated. Monitoring of central venous pressure
or left ventricular filling pressure may be helpful in detecting and treating
hypovolemia. 3. Hypoxia, Hypercapnia,
Acidosis���These conditions, which may also reduce the effectiveness
and/or increase the incidence of adverse effects of dopamine, must be identified
and corrected prior to, or concurrently with, administration of dopamine HCl. 4. Decreased Pulse Pressure���If a disproportionate
increase in diastolic blood pressure and a marked decrease in pulse pressure
are observed in patients receiving dopamine HCl, the rate of infusion should
be decreased and the patient observed carefully for further evidence of predominant
vasoconstrictor activity, unless such effect is desired. 5. Ventricular Arrhythmias���If an increased
number of ectopic beats are observed, the dose should be reduced if possible. 6. 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 HCl
should be discontinued and a more potent vasoconstrictor agent such as norepinephrine
should be administered. 7.
Extravasation���Dopamine Hydrochloride and 5% Dextrose Injection,
USP 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
antecubital 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. 8. Occlusive
Vascular Disease���Patients with a history of occlusive vascular
disease (for example, atherosclerosis, arterial embolism, Raynaud's
disease, cold injury, diabetic endarteritis, and Buerger's 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 in the extremities,
the benefits of continued dopamine HCl infusion should be weighed against
the risk of possible necrosis. The condition may be reversed by either decreasing
the rate or discontinuing the 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 from 5 to 10 mg of phentolamine mesylate, 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. 9. Weaning���When
discontinuing the infusion, it may be necessary to gradually decrease the
dose of dopamine HCl while expanding blood volume with I.V. fluids, since
sudden cessation may result in marked hypotension.<br/>Drug Interactions:<br/>Pregnancy:: Teratogenic Effects:Pregnancy Category C���Animal studies
have revealed no evidence of teratogenic effects due to dopamine. However,
in one study, administration of dopamine HCl to pregnant rats resulted in
a decreased survival rate of the newborn and a potential for cataract formation
in the survivors. There are no adequate and well-controlled studies in pregnant
women and it is not known if dopamine crosses the placental barrier. Because
animal reproduction studies are not always predictive of human response, this
drug should be used during pregnancy only if, in the judgment of the physician,
the potential benefit justifies the potential risk to the fetus.<br/>Labor and Delivery: In obstetrics, if vasopressor drugs are used to correct hypotension
or are added to a local anesthetic solution, some oxytocic drugs may cause
severe persistent hypertension and may even cause rupture of a cerebral blood
vessel to occur during the postpartum period.<br/>Nursing Mothers: It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised
when dopamine HCl is administered to a nursing woman.<br/>Pediatric Use: Safety and effectiveness in children have not been established.
Dopamine HCl has been used in a limited number of pediatric patients, but
such use has been inadequate to fully define proper dosage and limitations
for use.
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In the case of accidental overdosage, as evidenced by excessive
blood pressure elevation, reduce rate of infusion, or temporarily discontinue
administration of the drug until patient's condition stabilizes. Since
dopamine's duration of action 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 Hydrochloride and Dextrose
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DOPamine Hydrochloride and Dextrose (Injection, Solution)
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dailymed-instance:adverseRe... |
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
and vasoconstriction. Respiratory
System: Dyspnea. Gastrointestinal
System: Nausea and vomiting. Metabolic/Nutritional
System: Azotemia. Central
Nervous System: Headache and 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.
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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. Do NOT add any alkalinizing substance, since
dopamine is inactivated in alkaline solution. Patients
who have been receiving MAO inhibitors prior to the administration of dopamine
HCl will require substantially reduced dosage. See Drug Interactions below.
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dailymed-instance:indicatio... |
Dopamine Hydrochloride and 5% Dextrose Injection, USP is
indicated for the correction of hemodynamic imbalances present in the shock
syndrome due to myocardial infarction, trauma, endotoxic septicemia, open-heart
surgery, renal failure and chronic cardiac decompensation as in congestive
failure. Patients most likely to respond adequately
to dopamine HCl 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 blood volume
correction and dopamine HCl, the better the prognosis. Where appropriate,
blood volume restoration with a suitable plasma expander or whole blood should
be accomplished prior to administration of dopamine HCl. 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 reversal 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 HCl 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 HCl has resulted in an increase in urine flow,
which in some cases reached normal levels. Dopamine HCl 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. Low Cardiac Output���Increased cardiac
output is related to dopamine'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 movements 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 is not associated
with substantial decreases in systemic vascular resistance as mayoccur with
isoproterenol. Hypotension���Hypotension due to inadequate cardiac output can be managed
by administration of low to moderate doses of dopamine HCl which have little
effect on SVR. At high therapeutic doses, dopamine'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 HCl as soon as a definite trend toward decreased systolic and diastolic
pressure becomes evident.
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DOPamine Hydrochloride and Dextrose
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