Prescribing Information
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WARNINGS

WARNINGS

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 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. In patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to institution of therapy with dobutamine. Patients with pre-existing hypertension appear to face an increased risk of developing an exaggerated pressure response.

Ectopic Activity

Dobutamine may precipitate or exacerbate ventricular ectopic activity, but it rarely has caused ventricular tachycardia.

Hypersensitivity

Reactions suggestive of hypersensitivity associated with administration of Dobutamine in 5% Dextrose Injection, including skin rash, fever, eosinophilia, and bronchospasm, have been reported occasionally.

Dobutamine 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 sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

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