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CAS Number 49745-95-1
Dobutamine Injection, USP 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 is contraindicated in patients with idiopathic
hypertrophic subaortic stenosis and in patients who have shown previous
manifestations of hypersensitivity to Dobutamine Injection, USP solution.
1.Increase in Heart Rate or Blood Pressure
Dobutamine hydrochloride may cause a marked increase in heart rate or blood
pressure, especially systolic pressure. Approximately 10% of 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 promptly reverses these effects. Because
Dobutamine hydrochloride facilitates atrioventricular conduction, patients
with atrial fibrillation are at risk of developing rapid ventricular
response. Patients with pre-existing hypertension appear to face an
increased risk of developing an exaggerated pressor response.
Dobutamine hydrochloride may precipitate or exacerbate ventricular ectopic
activity, but it rarely has caused ventricular tachycardia.
Reactions suggestive of hypersensitivity associated with administration of
Dobutamine Injection, USP, including skin rash, fever, eosinophilia, and
bronchospasm, have been reported occasionally.
4.Dobutamine 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.
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 is usually due to excessive
cardiac β-receptor stimulation. The duration of action of Dobutamine is
generally short (T1/2 = 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.
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. 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 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 hemo-perfusion
have not been established as beneficial for an overdose of Dobutamine.
Dobutamine Injection, USP is supplied in 20 mL single-dose glass vials
containing 250 mg Dobutamine, as the hydrochloride (List No. 2344) packaged
in individual cartons or in a tray of 10.
Store at 20 to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
©Hospira 2004 EN-0565 Printed in USA
HOSPIRA, INC., LAKE FOREST, IL 60045 USA