Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3811
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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 (C6H12O6���H2O), 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 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 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 in Flexible Plastic
Containers is supplied in the following: List No. 2347
- 500 mg DOBUTamine in 5% Dextrose Injection, USP 250 mL Exposure
of pharmaceutical products to heat should be minimized. Avoid excessive heat.
Protect from freezing. Store at 20 to 25��C (68 to 77��F). [See
USP Controlled Room Temperature.] Manufactured by Hospira,
Inc., Lake Forest, IL 60045 USA Novation and NOVAPLUS'
are trademarks of Novation, LLC. Rev: September,
2004 ��Hospira 2004 EN-0476 Printed in USA HOSPIRA, INC., LAKE FOREST, IL 60045 USA
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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 added benefit 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 and Dextrose monohydrate
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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 systolicblood 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 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% of 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 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 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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