Dobutamine

Dobutamine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Overview

Dobutamine is an adrenergic receptor agonist that is FDA approved for the {{{indicationType}}} of decreased cardiac output and heart failure. Common adverse reactions include hypertension, tachyarrhythmia, angina, and headache.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Decreased Cardiac Output

• 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
• Dosing Information

• Initial dose: 0.5 to 1 mcg/kg/min
• Maintenance dose: 2 to 40 mcg/kg/min

Heart Failure

• Dosing Information

• Initial dose: 0.5 to 1 mcg/kg/min
• Maintenance dose: 2 to 40 mcg/kg/min

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition 1

• Developed by: (Organisation)

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• Strength of Evidence: (Category A/B/C) (Link)

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Condition 2

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Non–Guideline-Supported Use

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Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Dobutamine FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Dobutamine in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dobutamine in pediatric patients.

Contraindications

• Patients with idiopathic hypertrophic subaortic stenosis.
• Patients who have shown previous manifestations of hypersensitivity to dobutamine.

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 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.

Ectopic Activity

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

Hypersensitivity

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

Adverse Reactions

Clinical Trials Experience

Cardiovascular

• 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.
• 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
• Angina
• Nonspecific chest pain
• Palpitations
• 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.

Longer-Term Safety

• Infusions of up to 72 hours have revealed no adverse effects other than those seen with shorter infusions

Postmarketing Experience

There is limited information regarding Dobutamine Postmarketing Experience in the drug label.

Drug Interactions

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Use in Specific Populations

Pregnancy

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Labor and Delivery

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Nursing Mothers

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Pediatric Use

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Geriatic Use

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Gender

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Race

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Hepatic Impairment

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Females of Reproductive Potential and Males

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Immunocompromised Patients

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Others

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Administration and Monitoring

Administration

(Oral/Intravenous/etc)

Monitoring

Condition 1

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Condition 2

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Condition 3

(Description regarding monitoring, from Warnings section)

IV Compatibility

Solution

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Not Tested

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Y-Site

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Variable

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Incompatible

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Admixture

Compatible

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Variable

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Incompatible

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Syringe

Compatible

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Variable

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Incompatible

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TPN/TNA

Compatible

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Not Tested

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Variable

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Incompatible

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Overdosage

• 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.

Management

• 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.

Pharmacology

Dobutamine
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Mechanism of Action

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Structure

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Pharmacodynamics

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Nonclinical Toxicology

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Clinical Studies

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How Supplied

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Storage

There is limited information regarding Dobutamine Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

(Patient Counseling Information)

Precautions with Alcohol

Alcohol-Dobutamine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Dobutamine Brand Names in the drug label.

Look-Alike Drug Names

• (Paired Confused Name 1a) — (Paired Confused Name 1b)
• (Paired Confused Name 2a) — (Paired Confused Name 2b)
• (Paired Confused Name 3a) — (Paired Confused Name 3b)

Drug Shortage Status

Drug Shortage

Price

References

The contents of this FDA label are provided by the National Library of Medicine.