Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1647
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Dobutamine Hydrochloride in Dextrose (Injection, Solution)
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Recommended Dosage: Dobutamine
Hydrochloride in 5% Dextrose Injection is administered
intravenously through a suitable intravenous catheter or needle.
A calibrated electronic infusion device is recommended for
controlling the rate of flow in mL/hour or drops/minute. Infusion of
dobutamine should be started at a low rate (0.5-1.0��g/kg/min)
and titrated at intervals of a few minutes, guided by the
patient's response, including systemic blood pressure, urine
flow, frequency of ectopic activity, heart rate, and (whenever
possible) measurements of cardiac output, central venous
pressure, and/or pulmonary capillary wedge pressure. In reported
trials, the optimal infusion rates have varied from patient to
patient, usually 2-20��g/kg/min but sometimes slightly outside
of this range. On rare occasions, infusion rates up to 40��g/kg/min have been required to obtain the desired effect. Rates of
infusion in mL/hour for dobutamine hydrochloride concentrations
of 500, 1,000, 2,000 and 4,000 mg/L are in Table 2. This
container system may be inappropriate for the dosage
requirements of pediatric patients under 30 kg. Other dosage forms may be more appropriate. Parenteral
drug products should be inspected visually for particulate
matter and discoloration prior to administration whenever
solution and container permit. Dobutamine
Hydrochloride in 5% Dextrose Injection solutions may exhibit a
pink color that, if present, will increase with time. This color
change is due to slight oxidation of the drug, but there is no
significant loss of potency. The rate of
administration and the duration of therapy should be adjusted
according to the patient's response, as determined by heart
rate, presence of ectopic activity, blood pressure, urine flow,
and, whenever possible, measurement of central venous or
pulmonary wedge pressure and cardiac output. Do not add
supplementary medications to Dobutamine Hydrochloride in 5% Dextrose Injection. Do not administer Dobutamine Hydrochloride
in 5% Dextrose Injection simultaneously with solutions
containing sodium bicarbonate or strong alkaline
solutions.
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dailymed-instance:descripti... |
Dobutamine
Hydrochloride in 5% Dextrose Injection is a sterile, nonpyrogenic solution of Dobutamine Hydrochloride, USP and Dextrose, USP in Water for
Injection, USP. Dobutamine hydrochloride is chemically designated as
(��)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol
hydrochloride. It is a synthetic catecholamine. Dextrose Hydrous, USP is
chemically designated as D-Glucopyranose monohydrate. Structural
formulas are shown below: Dobutamine
Hydrochloride in 5% Dextrose Injection is intended for intravenous use
only. It contains no antimicrobial agents. The pH is adjusted with
sodium hydroxide and/or hydrochloric acid. Sodium bisulfite is added as
a stabilizer. The solution is intended for single use only. When smaller
doses are required, the unused portion should be discarded. Composition,
osmolarity, pH and caloric content are given in Table 1. 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 theexpiration 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 culture toxicity studies.
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Dobutamine
hydrochloride is a direct-acting inotropic agent whose primary activity
results from stimulation of the��-receptors of the heart while producing
comparatively mild chronotropic, hypertensive, arrhythmogenic, and
vasodilative effects. It does not cause the release of endogenous
norepinephrine, as does dopamine. In animal studies, dobutamine produces
less increase in heart rate and less decrease in peripheral vascular
resistance for a given inotropic effect than does isoproterenol. In patients with
depressed cardiac function, both dobutamine and isoproterenol increase
the cardiac output to a similar degree. In the case of dobutamine, this
increase is usually not accompanied by marked increases in heart rate
(although tachycardia is occasionally observed), and the cardiac strokevolume is usually increased. In contrast, isoproterenol increases the
cardiac index primarily by increasing the heart rate while stroke volume
changes little or declines. Facilitation of atrioventricular conduction has been observed in human
electrophysiologic studies and in patients with atrial fibrillation. Systemic vascular resistance is usually decreased with administration of dobutamine.
Occasionally, minimum vasoconstriction has been observed. Most clinical experience with dobutamine is short-term - not more than several hours
in duration. In the limited number of patients who were studied for 24,
48, and 72 hours, a persistent increase in cardiac output occurred in
some, whereas output returned toward baseline values in others. The onset of action
of dobutamine is within one to two minutes; however, as much as ten
minutes may be required to obtain the peak effect of a particular
infusion rate. The plasma
half-life of dobutamine in humans is two minutes. The principal routes
of metabolism are methylation of the catechol and conjugation. In human
urine, the major excretion products are the conjugates of dobutamine and
3-O-methyl dobutamine. The 3-O-methyl derivative of dobutamine is
inactive. Alteration of synaptic concentrations of catecholamines with either reserpine or
tricyclic antidepressants does not alter the actions of dobutamine in
animals, which indicates that the actions of dobutamine are not
dependent on presynaptic mechanisms. The effective
infusion rate of dobutamine varies widely from patient to patient, and
titration is always necessary (seeDosage and
Administration). At least in pediatric patients,
dobutamine-induced increases in cardiac output and systemic pressure are
generally seen, in any given patient, at lower infusion rates than those
that cause substantial tachycardia (seePediatric
Use under Precautions). 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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Dobutamine
Hydrochloride in 5% Dextrose Injection is contraindicated in patients
with idiopathic hypertrophic subaortic stenosis and in patients who have
shown previous manifestations of hypersensitivity to dobutamine. Solutions
containing dextrose may be contraindicated in patients with known
allergy to corn or corn products.
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Dobutamine
Hydrochloride in 5% Dextrose Injection in VIAFLEX Plus plastic containers is available as follows: 2B0791 Dobutamine
250 mg/250 mL NDC 0338-1073-02 2B0792 Dobutamine
500 mg/250 mL NDC 0338-1075-02 2B0793 Dobutamine
1000 mg/250 mL NDC 0338-1077-02 2B0795 Dobutamine
250 mg/500 mL NDC 0338-1071-03 2B0796 Dobutamine
500 mg/500 mL NDC 0338-1073-03 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.<br/>Directions for use
of VIAFLEX Plus Plastic Container: Do not
remove unit from overwrap until ready for use.<br/>To open: Tear
overwrap down side 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. Check for minute leaks by squeezing inner
bag firmly. If leaks are found, discard solution as sterility
may be impaired.<br/>Preparation for
Administration: Caution: Do not use plastic containers in series connections. Such use could result in air
embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary
container is completed. BAXTER, AND
VIAFLEX ARE TRADEMARKS OF BAXTER INTERNATIONAL, INC. ��Copyright
1991, 1993, Baxter Healthcare Corporation. All rights reserved. Baxter Healthcare Corporation Deerfield,
IL 60015 USA Printed in
USA 7-19-30-266 Rev July 2002 *BAR CODE
POSITION ONLY 071930266
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General: During the administration of
Dobutamine Hydrochloride in 5% Dextrose Injection, as with
any adrenergic agent, ECG and blood pressure should be
continuously monitored. In addition, pulmonary wedge pressure and cardiac output should be monitored whenever
possible to aid in the safe and effective infusion of
dobutamine. Hypovolemia
should be corrected with suitable volume expanders before
treatment with dobutamine is instituted. Animal
studies indicate that dobutamine may be ineffective if the
patient has recently received a��-blocking drug. In such a case, the peripheral vascular resistance may increase. No
improvement may be observed in the presence of marked mechanical
obstruction, such as severe valvular aortic stenosis. 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/>Usage Following
Acute Myocardial Infarction: Clinical
experience with dobutamine following myocardial infarction has
been insufficient to establish the safety of the drug for this
use. There is concern that any agent that increases contractile
force and heart rate may increase the size of an infarction by
intensifying ischemia, but it is not known whether dobutamine
does so.<br/>Drug Interactions: There was
no evidence of drug interactions in clinical studies in which
dobutamine was administered concurrently with other drugs,
including digitalis preparations, furosemide, spironolactone,
lidocaine, glyceryl trinitrate, isosorbide dinitrate, morphine,
atropine, heparin, protamine, potassium chloride, folic acid,
and acetaminophen. Preliminary studies indicate that the
concomitant use of dobutamine andnitroprusside results in a
higher cardiac output and, usually, a lower pulmonary wedge
pressure than when either drug is used alone.<br/>Carcinogenesis,
Mutagenesis, Impairment of Fertility: Studies to
evaluate the carcinogenic or mutagenic potential of dobutamine
or the potential of the drug to affect fertility adversely have
not been performed.<br/>Pregnancy:<br/>Pediatric Use: Dobutamine
has been shown to increase cardiac output and systemic pressure
in pediatric patients of every age group. In premature neonates,
however, dobutamine is less effective than dopamine in raising
systemic blood pressure without causing undue tachycardia, and
dobutamine has not been shown to provide any added benefit when
given to such infants already receiving optimal infusions of
dopamine.<br/>Geriatric Use: Clinical
studies of dobutamine 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
greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug
therapy.
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Overdoses of
dobutamine have been reported rarely. The following is provided to serve
as a guide if such an overdose is encountered.<br/>Signs and Symptoms: Toxicity
from dobutamine is usually due to excessive cardiac��-receptor
stimulation. The duration of action of dobutamine is generally
short (T1/2 = two minutes) because it is rapidly metabolized by
catechol-O-methyltransferase. The symptoms of toxicity may
include anorexia, nausea, vomiting, tremor, anxiety,
palpitations, headache, shortness of breath, and anginal and
nonspecific chest pain. The positive inotropic and chronotropic
effects of dobutamine on the myocardium may cause hypertension, tachyarrhythmias, myocardial ischemia, and ventricular
fibrillation. Hypotension may result from vasodilation. If the
product is ingested, unpredictable absorption may occur from the mouth and the gastrointestinal tract.<br/>Treatment: To obtain
up-to-date information about the treatment of overdose, a good
resource is your certified Regional Poison Control Center.
Telephone numbers of certified poison control centers are listed
in the Physicians' Desk Reference (PDR). In managing overdosage,
consider the possibility of multiple drug overdoses, interaction
among drugs, and unusual drug kinetics in your patient. The initial
actions to be taken in a dobutamine overdose are discontinuing
administration, establishing an airway, and ensuring oxygenation
and ventilation. Resuscitative measures should be initiated
promptly. Severe ventricular tachyarrhythmias may be
successfully treated with propranolol or lidocaine. Hypertension
usually responds to a reduction in dose or discontinuation of
therapy. Protect the
patient's airway and support ventilation and perfusion. If needed, meticulously monitor and maintain, within acceptable
limits, the patient's vital signs, blood gases, serum
electrolytes, etc. Absorption of drugs from the gastrointestinal
tract may be decreased by giving activated charcoal, which, in
many cases, is more effective than emesis or lavage; consider
charcoal instead of or in addition to gastric emptying. Repeated
doses of charcoal over time may hasten elimination of some drugs
that have been absorbed. Safeguard the patient's airway when
employing gastric emptying or charcoal. Forced
diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an
overdose of dobutamine.
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Dobutamine hydrochloride and dextrose monohydrate
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dailymed-instance:fullName |
Dobutamine Hydrochloride in Dextrose (Injection, Solution)
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Increased Heart
Rate, Blood Pressure, and Ventricular Ectopic Activity: A 10 to
20-mm Hg increase in systolic blood pressure and an increase in
heart rate of 5 to 15 beats/minute have been noted in most
patients (see Warnings
regarding exaggerated chronotropic and pressor effects).
Approximately 5% of adult patients have had increased premature
ventricular beats during infusions. These effects are dose
related.<br/>Hypotension: Precipitous
decreases in blood pressure have occasionally been described in
association with dobutamine therapy. Decreasing the dose or
discontinuing the infusion typically results in rapid return of
blood pressure to baseline values. In rare cases, however,
intervention may be required and reversibility may not be
immediate.<br/>Reactions at Sites
of Intravenous Infusion: Phlebitis
has occasionally been reported. Local inflammatory changes have
been described following inadvertent infiltration.<br/>Miscellaneous
Uncommon Effects: The
following adverse effects have been reported in 1% to 3% of
adult patients: nausea, headache, anginal pain, nonspecific
chest pain, palpitations, and shortness of breath. Administration of dobutamine, like other catecholamines, has been associated with decreases in serum potassium
concentrations, rarely to hypokalemic values.
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Increase in Heart
Rate or Blood Pressure: Dobutamine
Hydrochloride in 5% Dextrose Injection may cause a marked
increase in heart rate or blood pressure, especially systolic
pressure. Approximately 10% of adult patients in clinical
studies have had rate increases of 30 beats/minute or more, and
about 7.5% have had a 50-mm Hg or greater increase in systolic
pressure. Usually, reduction of dosage reverses these effects.
Because dobutamine facilitates atrioventricular conduction,
patients with atrial fibrillation are at risk of developing
rapid ventricular response. Patients with preexisting
hypertension appear to face an increased risk of developing an
exaggerated pressor response. In patients who have atrial
fibrillation with rapid ventricular response, a digitalis
preparation should be used prior to institution of therapy with
Dobutamine in DW.<br/>Ectopic Activity: Dobutamine
Hydrochloride in 5% Dextrose Injection may precipitate or exacerbate ventricular ectopic activity, but it rarely has
caused ventricular tachycardia.<br/>Hypersensitivity: Reactions
suggestive of hypersensitivity associated with administration of
dobutamine including skin rash, fever, eosinophilia, and
bronchospasm, have been reported occasionally. Dobutamine
Hydrochloride in 5% Dextrose Injection 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 sensitivityin the general
population is unknown and probably low. Sulfite sensitivity is
seen more frequently in asthmatic than in nonasthmatic people. 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. The risk of dilutional states is inversely proportional
to the electrolyte concentrations of the injections. The risk of
solute overload causing congested states with peripheral and
pulmonary edema is directly proportional to the electrolyte
concentration of the injections. Excess
administration of potassium-free solutions may result in
significant hypokalemia.
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Dobutamine
Hydrochloride in 5% Dextrose Injection is indicated when parenteral
therapy is necessary for inotropic support in the short-term treatment of patients
with cardiac decompensation due to depressed contractility resulting
either from organic heart disease or from cardiac surgical procedures.
Experience with intravenous dobutamine in controlled trials does not
extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given
orally, continuously intravenously, or intermittently intravenously,
neither dobutamine nor any other cyclic-AMP-dependent inotrope has been
shown in controlled trials to be safe or effective in the long-term
treatment of congestive heart failure. In controlled trials of chronic
oral therapy with various such agents, symptoms were not consistently
alleviated, and the cyclic-AMP-dependent inotropes were consistently
associated with increased risks of hospitalization and death. Patients
with NYHA Class IV symptoms appeared to be at particular
risk.
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Dobutamine Hydrochloride in Dextrose
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