Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1830
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DOBUTamine (Injection, Solution)
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dailymed-instance:dosage |
Note���Do not add dobutamine injection to 5% Sodium Bicarbonate Injection or to any
other strongly alkaline solution. Because of potential physical incompatibilities,
it is recommended that dobutamine hydrochloride not be mixed with other drugs
in the same solution. Dobutamine hydrochloride should not be used in conjunction
with other agents or diluents containing both sodium bisulfite and ethanol. Preparation and Stability���At the
time of administration, dobutamine injection must be further diluted in an
IV container. Dilute 20 mL of dobutamine in at least 50 mL of diluent and
dilute 40 mL of dobutamine in at least 100 mL of diluent. Use one of the following
intravenous solutions as a diluent: Dextrose Injection 5%, Dextrose 5% and
Sodium Chloride 0.45% Injection, Dextrose 5% and Sodium Chloride 0.9% Injection,
Dextrose Injection 10%, Isolyte M with 5% Dextrose Injection,
Lactated Ringer's Injection, 5% Dextrose in Lactated Ringer's
Injection, Normosol-M in D5-W, 20% Osmitrol in
Water for Injection, Sodium Chloride Injection 0.9%, or Sodium Lactate Injection.
Intravenous solutions should be used within 24 hours. Recommended Dosage���The rate of
infusion needed to increase cardiac output usually ranged from 2.5 to 15 mcg/kg/min
(see table). On rare occasions, infusion rates up to 40 mcg/kg/min have been
required to obtain the desired effect. * 250 mcg/mL of diluent ���500
mcg/mL or 250 mg/500 mL of diluent ���1,000
mcg/mL or 250 mg/250 mL of diluent Rates of infusion
in mL/h for Dobutamine Injection concentrations of 500 mcg/mL, 1000 mcg/mL,
and 2000 mcg/mL are given in Table 2. 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. Concentrations
of up to 5,000 mcg/mL have been administered to humans (250 mg/50 mL). The
final volume administered should be determined by the fluid requirements of
the patient. Parenteral drug products should be inspected
visually for particulate matter and discoloration prior to administration,
whenever solution and container permit.
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dailymed-instance:descripti... |
Dobutamine Injection, USP is 1,2-benzenediol, 4-[2-[[3-(4-hydro-xyphenyl)-1-methylpropyl]amino]ethyl]-hydrochloride,
(��). It is a synthetic catecholamine. The clinical formulation is supplied in a sterile form
for intravenous use only. Each mL contains: Dobutamine hydrochloride, equivalent
to 12.5 mg (41.5��mol) dobutamine; 0.24 mg sodium metabisulfite (added
during manufacture), and water for injection. pH adjusted between 2.5 to 5.5
with hydrochloric acid and/or sodium hydroxide. Dobutamine is oxygen sensitive.
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dailymed-instance:clinicalP... |
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
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.
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dailymed-instance:contraind... |
Dobutamine hydrochloride is contraindicated in patients with
idiopathic hypertrophic subaortic stenosis and in patients who have shown
previous manifestations of hypersensitivity to dobutamine injection.
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dailymed-instance:supply |
Dobutamine Injection, USP, 12.5 mg/mL is available as: 20
mL Single-Dose Vials containing 250 mg dobutamine (as the hydrochloride),
boxes of 10 (List 2025). 40 mL Single-Dose Vials containing
500 mg dobutamine (as the hydrochloride), boxes of 10 (List 2025). Store
at 20 to 25��C (68 to 77��F). [See USP Controlled Room Temperature.] HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
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dailymed-instance:precautio... |
General: Usage Following Acute
Myocardial Infarction���Clinical experience with dobutamine
injection 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/>Laboratory Tests: Dobutamine, like other��-agonists, can produce
a mild reduction in serum potassium concentration, rarely to hypokalemic levels.
Accordingly, consideration should be given to monitoring serum potassium.<br/>Drug Interactions: 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. 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. 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, nitroglycerin, isosorbide dinitrate, morphine,
atropine, heparin, protamine, potassium chloride, folic acid, and acetaminophen.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies to evaluate the carcinogenic or mutagenic potential
of dobutamine hydrochloride, or its potential to affect fertility, have not
been conducted.<br/>Pregnancy: Teratogenic Effects-Pregnancy
Category B���Reproduction studies performed in rats at doses
up to the normal human dose (10 mcg/kg/min for 24 h, total daily dose of 14.4
mg/kg) and in rabbits at doses up to 2 times the normal human dose have revealed
no evidence of harm to the fetus due to dobutamine. There are, however, no
adequate and well-controlled studies in pregnant women. Because animal reproduction
studies are not always predictive of human response, this drug should be used
during pregnancy only if clearly needed.<br/>Labor and Delivery: The effect of dobutamine injection on labor and delivery
is unknown.<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 dobutamine hydrochloride is administered to a nursing woman. If a mother
requires dobutamine treatment, breast-feeding should be discontinued for the
duration of the treatment.<br/>Pediatric Use: The safety and effectiveness of dobutamine injection for
use in pediatric patients have not been studied.
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dailymed-instance:overdosag... |
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-0-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. 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. If the product is ingested,
unpredictable absorption may occur from the mouth and the gastrointestinal
tract. Absorption of drugs from the gastrointestinal tract may be decreased
by giving activated charcoal, which, in many cases, is more effective than
emesis of 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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dailymed-instance:genericMe... |
Dobutamine hydrochloride
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dailymed-instance:fullName |
DOBUTamine (Injection, Solution)
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dailymed-instance:adverseRe... |
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 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. Isolated cases of cutaneous
necrosis (destruction of skin tissue) have been reported. 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. Isolated cases of thrombocytopenia
have been reported. Administration of dobutamine, like
other catecholamines, can produce a mild reduction in serum potassium concentration,
rarely to hypokalemic levels (see PRECAUTIONS). Longer-Term Safety���Infusions of
up to 72 hours have revealed no adverse effects other than those seen with
shorter infusions.
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dailymed-instance:indicatio... |
Dobutamine injection is indicated when parenteral therapy
is necessary for inotropic support in the short-term treatment of adults with cardiac decompensation due to depressed
contractility resulting either from organic heart disease or from cardiac
surgical procedures. In patients who have atrial fibrillation
with rapid ventricular response, a digitalis preparation should be used prior
to institution of therapy with dobutamine hydrochloride.
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DOBUTamine
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