CARDIJECT

A beta-1 agonist catecholamine that has cardiac stimulant action without evoking vasoconstriction or tachycardia.

It is proposed as a cardiotonic after myocardial infarction or open heart surgery.

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.

Dobutamine is a direct-acting inotropic agent whose primary activity results from stimulation of the beta-adrenoceptors of the heart while producing comparatively mild chronotropic, hypertensive, arrhythmogenic, and vasodilative effects.

Dobutamine acts primarily on beta-1 adrenergic receptors, with negligible effects on beta-2 or alpha receptors.

It does not cause the release of endogenous norepinephrine, as does dopamine.

In human urine, the major excretion products are the conjugates of dobutamine and 3-O-methyl dobutamine.

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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.

Toxicity from dobutamine hydrochloride is usually due to excessive cardiac β-receptor stimulation.

The duration of action of dobutamine hydrochloride is generally short (T½ = 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.

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.

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.

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

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

Dobutamine in 5% Dextrose Injection, USP 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.

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 or any of its components.

Dobutamine in 5% Dextrose Injection, USP 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 to 1.0 µg/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 to 20 µg/kg/min but sometimes slightly outside of this range.

On rare occasions, infusion rates up to 40 µg/kg/min have been required to obtain the desired effect.

Rates of infusion in mL/hour for dobutamine hydrochloride concentrations of and 4,000 mg/L may be calculated using the following formula: This container system may be inappropriate for the dosage requirements of pediatric patients under 30 kg. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Dobutamine in 5% Dextrose Injection, USP solutions may exhibit a pink color that, if present, will increase with time.

This color change is due to slight oxidation of the drug, but there is no significant loss of potency.

Solutions containing dextrose should not be administered through the same administration set as blood, as this may result in pseudoagglutination or hemolysis.

Do not add supplementary medications to

Dobutamine in 5% Dextrose Injection, USP.

Do not administer

Dobutamine in 5% Dextrose Injection, USP simultaneously with solutions containing sodium bicarbonate or strong alkaline solutions.

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) 1.

Close flow control clamp of administration set. 2.

Remove cover from outlet port at bottom of container. 3.

Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated.

See full directions on administration set carton. 4.

Suspend container from hanger. 5.

Squeeze and release drip chamber to establish proper fluid level in chamber. 6.

Open flow control clamp and clear air from set.

Close clamp. 7.

Attach set to venipuncture device.

If device is not indwelling, prime and make venipuncture. 8.

Regulate rate of administration with flow control clamp.

Do not use flexible container in series connections.

DOBUTamine in 5% Dextrose Injection, USP is supplied in 250 LifeCare™ single-dose flexible containers as follows: NDC 51662-1664-2 250 mg/250 mL (1 mg/mL) Do not freeze.

Store at 20°C to 25°C (68°F to 77°F).

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