Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2325
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DOBUTamine Hydrochloride in Dextrose (Injection, Solution)
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Do NOT add sodium bicarbonate
or other alkalinizing substance, since dobutamine is inactivated in
alkaline solution. Dobutamine in 5% Dextrose Injection, USP is administered
only intravenously via a suitable catheter or needle infusion. The
less concentrated 0.5 mg/mL solution may be preferred when fluid
expansion is not a problem. The more concentrated 1 mg/mL, 2
mg/mL, or 4 mg/mL solutions may be preferred in patients with fluid
retention or when a slower rate of infusion is desired. Recommended Dosage: Infusion of dobutamine should be started at a low rate (0.5 to 1.0 mcg/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 to 20 mcg/kg/min but sometimes
slightly outside of this range. On rare occasions, infusion rates
up to 40 mcg/kg/min have been required to obtain the desired effect.
For the infusion rates necessary to achieve various delivery rates
(mcg/kg/min) for patients of different weights, refer to the Dobutamine
Infusion Rate (mL/hr) charts below. Rate of Administration: When administering
dobutamine (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 response to dobutamine. 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. As with all potent intravenously administered drugs, care
should be taken to control the rate of infusion so as to avoid inadvertent
administration of a bolus of the drug. Parenteral
drug products should be visually inspected for particulate matter
and discoloration prior to administration, whenever solution and container
permit (see PRECAUTIONS). 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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Dobutamine in 5% Dextrose Injection, USP is a sterile,
nonpyrogenic, prediluted solution of dobutamine hydrochloride and
dextrose in water for injection. It is administered by intravenous
infusion. Each 100 mL contains dobutamine hydrochloride
equivalent to 50 mg, 100 mg, 200 mg, or 400 mg of dobutamine;
dextrose, hydrous 5 g in water for injection, with sodium metabisulfite
25 mg and edetate disodium, dihydrate 10 mg added as stabilizers;
osmolar concentration, respectively, 260, 263, 270, or 284 mOsmol/liter
(calc.). The pH is 3.0 (2.5 to 5.5). May contain hydrochloric acid
and/or sodium hydroxide for pH adjustment. Dobutamine in 5% Dextrose
Injection, USP is oxygen sensitive. Dobutamine
Hydrochloride, USP is chemically designated (��)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol
hydrochloride. It is a synthetic catecholamine. 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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Dobutamine 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 stroke volume
is usually increased. In contrast, isoproterenol increases the cardiac
index primarily by increasing the heart rate while stroke volume changes
littleor 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 in 5% Dextrose Injection, USP is within 1 to 2 minutes;
however, as much as 10 minutes may be required to obtain the peak
effect of a particular infusion rate. The plasma
half-life of dobutamine in humans is 2 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 (see DOSAGE
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. (See Pediatric Use under PRECAUTIONS.)
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Dobutamine in 5% Dextrose Injection, USP is contraindicated
in patients with idiopathic hypertrophic subaortic stenosis and in
patients who have shown previous manifestations of hypersensitivity
to dobutamine. 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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DOBUTamine in 5% Dextrose Injection, USP is supplied
in 250 and 500 mL LifeCare flexible containers as
follows: List No. 2346���250 mg DOBUTamine
in 5% Dextrose Injection, USP 250 mL List No.
2346���500 mg DOBUTamine in 5% Dextrose Injection, USP 500
mL List No. 2347���500 mg DOBUTamine
in 5% Dextrose Injection, USP 250 mL List No.
3724���1000 mg DOBUTamine in 5% Dextrose Injection, USP 250
mL Store at 20 to 25��C (68 to 77��F).
[See USP Controlled Room Temperature.] Protect from freezing. June, 2006
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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 hydrochloride 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
and nitroprusside 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: Pregnancy Category B: Reproduction studies performed
in rats and rabbits have revealed no evidence of harm to the fetus
due to dobutamine. The drug, however, has not been administered to
pregnant women and should be used only when the expected benefits
clearly outweigh the potential risks to the fetus.<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 addedbenefit when
given to such infants already receiving optimal infusions of dopamine.<br/>Geriatric Use:: Clinical studies of dobutamine did not include sufficient
numbers of subjects aged 65 and over being treated for acute cardiac
decompensation to determine whether they respond differently from
younger subjects. Other reported clinical experience suggests that
the incidence of significant hypotension is a function of both dose
and age, older individuals having a greater incidence of hypotension.
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 other 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. Signs
and Symptoms: Toxicity from dobutamine hydrochloride is
usually due to excessive cardiac��-receptor stimulation. The
duration of action of dobutamine hydrochloride is generally short
(T= 2 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. 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 hydrochloride 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
hydrochloride.
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Dobutamine Hydrochloride
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DOBUTamine Hydrochloride in Dextrose (Injection, Solution)
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Increased Heart Rate, Blood
Pressure, and Ventricular Ectopic Activity: A 10- to 20-mm
increase in systolic blood pressure and an increase in heart rate
of 5 to15 beats/minute have been noted in most patients (see WARNINGS regarding exaggerated chronotropic
and pressor effects). Approximately 5% of patients have had increased
premature ventricular beats during infusions. These effects are dose
related. 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. Reactions at Sites of Intravenous Infusion: Phlebitis has occasionally been reported. Local inflammatory changes
have been described following inadvertent infiltration. Miscellaneous Uncommon Effects: The following adverse effects have been reported in 1% to 3% ofpatients: 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
levels (See PRECAUTIONS).
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Dobutamine in 5% Dextrose Injection, USP is indicated
when parenteral therapy is necessary for inotropic support in the short-term treatment of cardiac decompensation
due to depressed contractility resulting either from organic heart
disease or from cardiac surgical procedures. Experience with intravenousdobutamine 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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