Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3477
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Dopamine Hydrochloride and Dextrose (Injection, Solution)
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Rate of
Administration: Dopamine
Hydrochloride and 5% Dextrose Injection, USP is administered
intravenously through a suitable intravenous catheter or needle.
An IV 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 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 of dopamine hydrochloride at rates greater than
50 mcg/kg/min has safely been used in advanced circulatory
decompensation states. If unnecessary fluid expansion is of
concern, use of a more concentrated solution may be preferred
over increasing the flow rate of a less concentrated
solution.<br/>Suggested Regimen:: Parenteral
drug products should be inspected visually for particulate
matter and discoloration prior to administration, whenever
solution and container permit. Do not use
Dopamine Hydrochloride and 5% Dextrose Injection, USP if darker
than slightly yellow or discolored in any other way. All
injections in VIAFLEX Plus plastic containers are intended for
intravenous administration using sterile equipment. Drug additives should not be made to
Dopamine Hydrochloride and 5% Dextrose Injection,
USP.<br/>Pediatric Dosing
and Administration: In
publications, the most common starting doses were 1-5 micrograms/kilograms/minute. Particularly in neonates, such low doses
require considerable dilution of this product; careful
consideration should be given to the use of this product in
such circumstances. Dosing increments that were
reported ranged from 2.5 to 5.0 micrograms/kilogram/minute.
Usual maximum doses were 15-20 micrograms/kilogram/minute, with
occasional use as great as 50 micrograms/kilogram/minute. The
time course of dopamine kinetics are poorly defined. Increasing
infusion rates (or dose) should be approached cautiously and
only after it is apparent that hemodynamics (mainly systolic
blood pressure) have stabilized with respect to the current dose
and/or rate of infusion. There have
been occasional reports of vasospastic events when dopamine was
infused through umbilical vessels. Due caution should be
exercised if infusion of dopamine through umbilical vessels becomes necessary.
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Dopamine
Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic
solution of Dopamine Hydrochloride, USP and Dextrose, USP in Water for
Injection. Structural formulas are shown below: Dopamine
Hydrochloride and 5% Dextrose Injection, USP is intended for intravenous
use only. It contains no antimicrobial agents. The pH is adjusted with
hydrochloric acid and is 3.5 (2.5 to 4.5). Approximately 5 mEq/L sodium
bisulfite is added as a stabilizer. The solution provides a caloric
content of 170 kcal/L. The solution is intended for single use only.
When smaller doses are required, the unused portion should be discarded.
Composition and osmolarity are given below: 800 mcg/mL Dopamine Hydrochloride and 5% Dextrose
Injection, USP provides 800 mcg/mL Dopamine Hydrochloride,
USP and 50 g/L Dextrose Hydrous, USP with an osmolarity of 261 mOsmol/L
(calc). 1600 mcg/mL Dopamine Hydrochloride and 5% Dextrose
Injection, USP provides 1600 mcg/mL Dopamine
Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity
of 269 mOsmol/L (calc). 3200 mcg/mL Dopamine Hydrochloride and 5% Dextrose
Injection, USP provides 3200 mcg/mL Dopamine
Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an osmolarity
of 286 mOsmol/L (calc). Dopamine
administered intravenously is a myocardial inotropic agent which also
may increase mesenteric and renal blood flow plus urinary output. Dopamine
hydrochloride is designated chemically as 3,4-dihydroxyphenethylamine
hydrochloride, a white crystalline powder freely soluble in water.
Dopamine (also referred to as 3-hydroxytyramine) is a naturally
occurring biochemical catecholamine precursor of norepinephrine. This VIAFLEX Plus
plastic container is fabricated from a specially formulated polyvinyl
chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX Plus
containers, are made of flexible plastic and are for parenteral use.
VIAFLEX Plus on the container indicates the presence of a drug additive
in a drug vehicle.The amount of water that can permeate from inside the
container into the overwrap is insufficient to affect the solution
significantly. Solutions in contact with the plastic container can leach
out certain of its chemical components in very small amounts within the
expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts
per million. However, the safety of the plastic has been confirmed in
tests in animals according to USP biological tests for plastic
containers as well as by tissue culturetoxicity studies.
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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. 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, andplasma 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
beta1-adrenoceptors, resulting in improved myocardial contractility,
increased SA rate and enhanced impulse conduction in the heart. There is
little, if any, stimulation of the beta2-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 increased 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. Dextrose provides a source of calories. Dextrose is readily metabolized, may decrease losses
of body protein and nitrogen, promotes glycogen deposition and decreases
or prevents ketosis if sufficient doses are provided.
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Dopamine
hydrochloride should not be used in patients with pheochromocytoma. Dopamine
hydrochloride should not be administered in the presence of uncorrected
tachyarrhythmias or ventricular fibrillation. Solutions
containing dextrose may be contraindicated in patients with known
allergy to corn or corn products.
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Exposure of
pharmaceutical products to heat should be minimized. Avoid excessive
heat. Protect from freezing. It is recommended the product be stored at
room temperature (25���C); brief exposure up to 40���C does not adversely
affect the product. Avoid contact with
alkalies (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.
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General: Avoid bolus
administration of dopamine hydrochloride. See DOSAGE AND
ADMINISTRATION.<br/>Avoid Hypovolemia: Prior to
treatment with dopamine hydrochloride, hypovolemia should be
fully corrected, if possible, with either whole blood, plasma,
or plasma expanders as indicated. Monitoring of central venous
pressure or left ventricular filling pressure may be helpful in
detecting and treating hypovolemia.<br/>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, and concurrently with,
administration of dopamine HCl.<br/>Ventricular
Arrhythmias: If an
increased number of ectopic beats is observed, the dose should
be reduced if possible.<br/>Decreased Pulse
Pressure: If a
disproportionate rise in the diastolic pressure (i.e., marked
decrease in the pulse pressure) is observed in patients
receiving 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.<br/>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.<br/>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 to the extremities, the benefits of
continueddopamine hydrochloride infusion should be weighed
against the risk of possible necrosis. This condition may be
reversed by either decreasing the rate or discontinuing the
infusion.<br/>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.<br/>Weaning: When
discontinuing the infusion, it may be necessary to gradually
decrease the dose of dopamine HCl while expanding blood volume
with IV fluids, since sudden cessation may result in marked
hypotension.<br/>Careful Monitoring
Required: Close
monitoring of the following indices - urine flow, cardiac output
and blood pressure - during dopamine hydrochloride infusion is
necessary as in the case of any adrenergic agent. Solutions
containing dextrose should be used with caution in patients with
known subclinical or overt diabetes mellitus. Do not
administer unless solution is clear and seal is intact. If
administration is controlled by a pumping device, care must be
taken to discontinue pumping action before the container runs
dry or air embolism may result.<br/>Laboratory Tests: Clinical
evaluation and periodic laboratory determinations are necessary
to monitor changes in fluid balance, electrolyte concentrations
and acid base balance during prolonged parenteral therapy or
whenever the condition of the patient warrants such
evaluation.<br/>Drug Interactions: 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. This 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 hydrochloride no 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 metoprolol. 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, vasoconstrictor 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.<br/>Carcinogenesis,
Mutagenesis, Impairment of Fertility: Long term
animal studies have not been performed to evaluate the
carcinogenic potential of dopamine HCl. Dopamine
HCl at doses approaching maximal solubility showed no clear
genotoxic potential in the Ames test. Although there was a
reproducible dose-dependent increase in the number of revertant
colonies with strains TA100 and TA98, both with and without
metabolic activation, the small increase was considered
inconclusive evidence of mutagenicity. In the L5178Y TK��mouse
lymphoma assay, dopamine HCl at the highest concentrations used
of 750��g/ml without metabolic activation, and 3000��g/ml with
activation, was toxic and associated with increases in mutant
frequencies when compared to untreated and solvent controls; at
the lower concentrations no increases over controls were noted. 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 HCl, respectively.<br/>Pregnancy:<br/>Pregnancy
Category C:<br/>Labor and Delivery: In
obstetrics, 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.<br/>Nursing Mothers: It is not known whether dopamine hydrochloride is excreted in human milk.
Because many drugs are excreted in human milk, caution should be
exercised when dopamine hydrochloride is administered to a
nursing woman.<br/>Pediatric Use: Safety and
effectiveness in children have not been established. The
clearance of dopamine is affected by age (as much as 2 fold
greater in children under 2 years of age), renal and hepatic
function (decreasing by 2 fold in the presence of either). In
younger children, particularly neonates, clearance is highly
variable. Newborn infants may be more sensitive to the
vasoconstrictive effects of dopamine. The most
consistent effects of dopamine in 57 publications (between the
years 1966 through 1997) were increases in systolic and mean
arterial pressure. Renal function was variably affected, except
that in a single publication renal function was preserved in the
face of treatment with indomethacin. No consistenteffect on
heart rate was described. Because of the variability of
clearance, especially in the neonate and newborn, low doses of
dopamine and slow deliberate titration should be employed (seeDOSAGE AND
ADMINISTRATION).
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In case of
accidental overdosage, as evidenced by excessive blood pressure
elevation, reduce rate of administration or temporarily discontinue
dopamine hydrochloride until patient's condition stabilizes. Since
dopamine hydrochloride'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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The following
adverse reactions have been observed, but there are not enough data to
support an estimate of their frequency.<br/>Cardiovascular
System: ventricular
arrhythmia (at very high doses) ectopic
beats tachycardia anginal
pain palpitation cardiac
conduction abnormalities widened QRS
complex bradycardia hypotension hypertension vasoconstriction<br/>Respiratory System: dyspnea<br/>Gastrointestinal
System: nausea vomiting<br/>Metabolic/Nutritional System: azotemia<br/>Central Nervous
System: headache anxiety<br/>Dermatological
System: piloerection<br/>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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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.
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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.<br/>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.<br/>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.<br/>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.
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Dopamine Hydrochloride and Dextrose
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