Dobutamine

Indications

INDICATIONS AND USAGE Dobutamine Hydrochloride in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with 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.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Recommended Dosage Dobutamine Hydrochloride in 5% Dextrose Injection is administered intravenously through a suitable intravenous catheter or needle. A calibrated electronic infusion device is recommended for controlling the rate of flow in mL/hour or drops/minute. Infusion of dobutamine should be started at a low rate (0.5-1.0 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.

Contraindications

CONTRAINDICATIONS Dobutamine Hydrochloride in 5% Dextrose Injection is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and in patients who have shown previous manifestations of hypersensitivity to dobutamine. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

Warnings and precautions

WARNINGS Increase in Heart Rate or Blood Pressure Dobutamine Hydrochloride in 5% Dextrose Injection 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.

Pregnancy

Pregnancy 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.

Storage and supply

HOW SUPPLIED Dobutamine Hydrochloride in 5% Dextrose Injection in Viaflex Plus plastic containers is available as follows: 2B0791 Dobutamine 250 mg/250 mL NDC 0338-1073-02 2B0792 Dobutamine 500 mg/250 mL NDC 0338-1075-02 2B0793 Dobutamine 1000 mg/250 mL NDC 0338-1077-02 Exposure of pharmaceutical products to heat should be minimized.

Source: Dobutamine Hydrochloride (Dobutamine Hydrochloride In Dextrose) — US FDA prescribing information, 2023-09-08, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.