Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/150
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Dopamine Hydrochloride and Dextrose (Injection, Solution)
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Do NOT administer if solution is darker than slightly
yellow or discolored in any other way. Do NOT administer unless solution
is clear and container is undamaged. Discard unused portion. 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. Do NOT add sodium bicarbonate or other
alkalinizing substance, since dopamine is inactivated in alkaline
solution. Dopamine Hydrochloride in 5% Dextrose
Injection should be infused into a large vein whenever possible to
prevent the infiltration of perivascular tissue adjacent to the infusion
site. Extravasation may cause necrosis and sloughing of the surrounding
tissue. Large veins of the antecubital fossa are preferred to veins
of the dorsum of the hand or ankle. Less suitable infusion sites should
be used only when larger veins are unavailable and the patient's
condition requires immediate attention. The physician should switch
to a more suitable site as soon as possible and the infusion site
in use should be continuously monitored for free flow. 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: Administration into an umbilical artery catheter is not recommended. Dopamine in 5% Dextrose Injection should not be infused
through ordinary I.V. apparatus, regulated only by gravity and mechanical
clamps. Only an infusion pump, preferably a volumetric pump, should
be used. 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. If a disproportionate rise in
diastolic pressure (i.e., a marked decrease in pulse pressure) is
observed in patients receiving dopamine, the infusion rate should
be decreased and the patient observed carefully for further evidence
of predominant vasoconstrictor activity, unless such an effect is
desired. Administration rates greater than 50
mcg/kg/min have safely been used in adults 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. When discontinuing the infusion, it may be necessary to gradually
decrease the dose of dopamine HCl while expanding the blood volume
with I.V. fluids to prevent the development of marked hypotension. Suggested Regimen: 800 mcg/mL Dosing Chart
for Dopamine (mL/hr) Infusion Rate 1600 mcg/mL Dosing Chart
for Dopamine (mL/hr) Infusion Rate 3200 mcg/mL Dosing Chart for Dopamine (mL/hr) Infusion Rate Parenteral drug products should be visually inspected
for particulate matter and discoloration prior
to administration, whenever solution and container permit. INSTRUCTIONS FOR USE To Open Tear outer wrap at notch and remove solution
container. Some opacity of the plastic due to moisture absorption
during the sterilization process may be observed. This is normal and
does not affect the solution quality or safety. The opacity will diminish
gradually. Preparation
for Administration (Use aseptic technique) WARNING: Do not use flexible
container in series connections.
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Dopamine Hydrochloride in 5% Dextrose Injection,
USP is a sterile, nonpyrogenic, prediluted solution of dopamine hydrochloride
in 5% dextrose injection. It is administered by intravenous infusion. Each 100 mL contains dopamine hydrochloride 80 mg (0.8
mg/mL), 160 mg (1.6 mg/mL) or 320 mg (3.2 mg/mL) and dextrose, hydrous
5 g in water for injection, with sodium metabisulfite added 50 mg
as a stabilizer; osmolar concentration, respectively 261, 269, or
286 mOsmol/liter (calc.), pH 3.8 (2.5 to 4.5). May contain hydrochloric
acid and/or sodium hydroxide for pH adjustment. Dopamine administered intravenously is a myocardial inotropic agent,
which also may increase mesenteric and renal blood flow plus urinary
output. Dopamine Hydrochloride is chemically
designated 3, 4-dihydroxyphenethylamine hydrochloride (CHNO���HCl), a white crystalline powder
freely soluble in water. It has the following structural formula: Dopamine (also referred
to as 3-hydroxytyramine) is a naturally occurring endogenous catecholamine
precursor of norepinephrine. Dextrose, USP is
chemically designated D-glucose monohydrate (CHO���HO), a hexose sugar freely soluble
in water. It has the following structural formula: Water for Injection, USP is chemically designated
HO. The flexible plastic container
is fabricated from a specially formulated CR3 plastic material. Water
can permeate from inside the container into the overwrap but not in
amounts sufficient to affect the solution significantly. Solutions
in contact with the plastic container may leach out certain chemical
components from the plastic in very small amounts; however, biological
testing was supportive of the safety of the plastic container materials.
Exposure to temperatures above 25��C/77��F during transport
and storage will lead to minor losses in moisture content. Higher
temperatures lead to greater losses. It is unlikely that these minor
losses will lead to clinically significant changes within the expiration
period.
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Dopamine exhibits an inotropic action on the myocardium,
resulting in increased cardiac output. It causes less increase in
myocardial oxygen consumption than isoproterenol and the effect of
dopamine usually is not associated with tachyarrhythmia. Reported
clinical studies have revealed that the drug usually increases systolic
and pulse pressure without any or only a minor elevating effect on
diastolic pressure. Total peripheral resistance at low and intermediate
doses is usually unchanged. Blood flow to peripheral vascular beds
may decrease while mesenteric blood flow is increased. The drug also
has been reported to produce dilation of the renal vasculature which
is accompanied by increases in glomerular filtration rate, renal blood
flow and sodium excretion. Increased urinary output produced by dopamine
is usually not associated with decreased urine osmolality. 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 to 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. The reported clearance rate of
dopamine in critically ill infants and children has ranged from 46
to 168 mL/kg/min, with the higher values seen in the younger patients.
The apparent volume of distribution in neonates is reported as 0.6
to 4 L/kg, leading to an elimination half-life of 5 to 11 minutes.
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Dopamine hydrochloride should not be used in patients
with pheochromocytoma. Dopamine should not be
administered in the presence of uncorrected tachyarrhythmias or ventricular
fibrillation.
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Dopamine Hydrochloride in 5% Dextrose Injection,
USP is supplied in 250 and 500 mL LifeCare flexible containers as
follows: NDC No. 0409-7808-22���200 mg
Dopamine HCl in 5% Dextrose Injection, USP 250 mL (800 mcg/mL) NDC No. 0409-7808-24���400 mg Dopamine HCl in 5% Dextrose Injection, USP 500 mL (800 mcg/mL) NDC No. 0409-7809-22���400 mg Dopamine HCl in 5% Dextrose Injection, USP 250 mL (1600 mcg/mL) NDC No. 0409-7809-24���800 mg Dopamine HCl in 5% Dextrose Injection, USP 500 mL (1600 mcg/mL) NDC No.
0409-7810-22���800 mg Dopamine HCl in 5% Dextrose Injection,
USP 250 mL (3200 mcg/mL) Store at 20 to 25��C (68 to 77��F). [See USP Controlled Room
Temperature.] Protect from freezing. 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. Revised:
April, 2007 EN-1494 Printed in USA Hospira, Inc., Lake Forest, IL 60045 USA
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General:: Solutions containing dextrose should be used with
caution in patients with known subclinical or overt diabetes mellitus. Fluid and Electrolyte
Balance: Excess administration of potassium-free solutions
may result in significant hypokalemia. The intravenous
administration of these solutions can cause fluid and/or solute overloading
resulting in dilution of serum electrolyte concentrations, overhydration,
congested states or pulmonary edema. Careful Monitoring Required: Close
monitoring of the following indices���urine flow, cardiac output
and blood pressure���during dopamine infusion is necessary
as in the case of any adrenergic agent. 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. Ventricular
Arrhythmias: If an increased number of ectopic beats are
observed the dose should be reduced if possible. 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. Occlusive Vascular Disease: Patients with a history of occlusive vascular disease (e.g., arteriosclerosis,
arterial embolism, Raynaud's disease, cold injury such as frostbite,
diabetic endarteritis, and Buerger's disease) should be closely
monitored for any changes in color or temperature of the skin of the
extremities. If a change in skin color or temperature occurs and is
thought to be the result of compromised circulation to the extremities,
the benefits of continued dopamine infusion should be weighed against
the risk of possible necrosis. These changes may be reversed by decreasing
the rate or discontinuing the infusion entirely. Extravasation: Dopamine
Hydrochloride in 5% Dextrose Injection, USP should be infused into
a large vein whenever possible to prevent the possibility of infiltration
of perivascular 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 of the dorsum of the
hand or ankle. Administration into an umbilical arterial catheter
is not recommended. Less suitable infusion sites should be used only
when larger veins are unavailable and the patient's condition
requires immediate attention. The physician should switch to a more
suitable site as soon as possible and the infusion site in use should
be continuously monitored for free flow.<br/>Laboratory Tests:: Infusion of dopamine suppresses pituitary secretion
of thyroid���stimulating hormone, growth hormone, and prolactin. Weaning: When discontinuing
the infusion, it may be necessary to gradually decrease the dose of
dopamine HCl while expanding blood volume with IV fluids. Sudden cessation
may result in marked hypotension.<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��-adrenergic stimulating properties of these
catecholamines, and may produce ventricular arrhythmias and hypertension.
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��-adrenergic blocking agents, such as propranolol and metoprolol.
The peripheral vasoconstriction caused by high doses of dopamine HCl
is antagonized by��-adrenergic blocking agents. Dopamine-induced
renal and mesenteric vasodilation is not antagonized by either��-
or��-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.<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 TKmouse 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:: Pregnancy Category C: Teratogenic Effects: Teratogenicity studies in rats and rabbits
at dopamine HCl dosages up to 6 mg/kg/day intravenously during organogenesis
produced no detectable teratogenic or embryotoxic effects, although
maternal toxicity consisting of mortalities, decreased body weight
gain, and pharmacotoxic signs were observed in rats. In a published
study, dopamine HCl administered at 10 mg/kg subcutaneously for 30
days, markedly prolonged metestrus and increased mean pituitary and
ovary weights in female rats. Similar administration to pregnant rats
throughout gestation or for 5 days starting on gestation day 10 or
15 resulted in decreased body weight gains, increased mortalities
and slight increases in cataract formation among the offspring. There
are no adequate and well-controlled studies in pregnant women, and
it is not known if dopamine HCl crosses the placental barrier. Dopamine
HCl should be used during pregnancy only if 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 the interaction
with some oxytocic drugs may cause severe hypertension.<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
mother.<br/>Pediatric Use:: Dopamine infusions have been used in patients of
every age from birth onwards. There are scattered reports of infusion
rates in neonates up to 125 mcg/kg/min, but most reports in pediatric
patients describe dosing that is similar (on a mcg/kg/min basis) to
that used in adults. Except for vasoconstrictive effects caused by
inadvertent infusion of dopamine into the umbilical artery, adverse
effects unique to the pediatric population have not been identified,
nor have adverse effects identified in adults been found to be more
common in pediatric patients.<br/>Geriatric Use:: Clinical studies of dopamine injection did not include
sufficient numbers of subjects aged 65 and over to determine whether
they respond differently from younger subjects. Other reported clinical
experience has not identified differences in responses between the
elderly and younger patients. In general, dose selection for an elderly
patient should be cautious, usually starting at the low end of the
dosing range, reflecting the frequency of decreased hepatic, renal
or cardiac function, and of concomitant disease or other drug therapy.
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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,
consider using an alpha-adrenergic blocking agent (e.g., phentolamine).
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Dopamine Hydrochloride
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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. 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 high doses were administered for prolonged periods
or in patients with occlusive vascular disease receiving low doses
of dopamine HCl.
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Do NOT add any alkalinizing substance, since dopamine
is inactivated in alkaline solution. Patients
who have been treated with monoamine oxidase (MAO) inhibitors prior
to administration of dopamine should receive substantially reduced
dosage of the latter. See PRECAUTIONS, Drug
Interactions, below. Additive medications should not be delivered via
this solution. Dopamine Hydrochloride
in 5% Dextrose Injection, USP 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.
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Dopamine Hydrochloride in 5% Dextrose Injection,
USP is indicated for the correction of hemodynamic imbalances present
in shock due to myocardial infarction, trauma, endotoxic septicemia,
open heart surgery, renal failure and chronic cardiac decompensation
as in refractory congestive failure. When indicated,
restoration of circulatory volume should be instituted or completed
with a suitable plasma expander or whole blood, prior to administration
of dopamine hydrochloride. Patients most likely
to respond to dopamine are those whose physiological parameters (such
as urine flow, myocardial function and blood pressure) have not undergone
extreme deterioration. Reports indicate that the shorter the time
between onset of signs and symptoms and initiation of therapy with
volume restoration and dopamine, the better the prognosis. Poor Perfusion of Vital
Organs: Although urine flow is apparently one of the better
diagnostic signs for monitoring vital organ perfusion, the physician
also should observe the patient for signs of reversal of mental confusion
or coma. Loss of pallor, increase in toe temperature or adequacy of
nail bed capillary filling also may be observed as indices of adequate
dosage. Reportedstudies indicate that when dopamine is administered
before urine flow has decreased to approximately 0.3 mL/minute prognosis
is more favorable. However, it has been observed
that in some oliguric or anuric patients, administration of the drug
has produced an increase in urine flow which may reach normal levels.
The drug also may increase urine flow in patients whose output is
within normal limits and thus may help in reducing the degree of pre-existing
fluid accumulation. Conversely, at higher than optimal doses for a
given patient, urinary flow may decrease, requiring a reduction of
dosage. Concomitant administration of dopamine and diuretic agents
may produce an additive or potentiating effect. Low Cardiac Output: Dopamine's
direct inotropic effect on the myocardium which increases cardiac
output at low or moderate doses is related to a favorable prognosis.
Increased output has been associated with unchanged or decreased systemic
vascular resistance (SVR). The association of static or decreased
SVR with low or moderate increases in cardiac output is regarded as
a reflection of differential effects on specific vascular beds, withincreased resistance in peripheral beds (e.g., femoral), and concurrent
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 may occur with isoproterenol. Hypotension: Low to moderate
doses of dopamine, which have little effect on SVR, can be used to
manage hypotension due to inadequate cardiac output. At high therapeutic
doses, dopamine's��-adrenergic action becomes more prominent
and thus may correct hypotension due to diminished SVR. As in other
circulatory decompensation states, prognosis is better in patients
whose blood pressure and urine flow have not undergone extreme deterioration.
Therefore, it is suggested the physician administer dopamine as soon
as a definite trend toward decreased systolic and diastolic pressure
becomes apparent.
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Dopamine Hydrochloride and Dextrose
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