pharmacopeia
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/api/v1/drug/dobutamine

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Adrenergic beta-Agonists; Adrenergic beta1-Agonists.

Indications

Sourced from openFDA
  • 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.

Contraindications

Sourced from openFDA
  • 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.contraindicated

Dosage & administration

Sourced from openFDA

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. In reported trials, the optimal infusion rates have varied from patient to patient, usually 2-20 mcg/kg/min but sometimes slightly outside of this range. On rare occasions, infusion rates up to 40 mcg/kg/min have been required to obtain the desired effect. Rates of infusion in mL/hour for dobutamine hydrochloride concentrations of 1,000, 2,000 and 4,000 mcg/mL are in Table 2. This container system may be inappropriate for the dosage requirements of pediatric patients under 30 kg. Other dosage forms may be more appropriate. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Dobutamine Hydrochloride in 5% Dextrose Injection 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.

Warnings & precautions

Sourced from openFDA

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. Patients with preexisting hypertension appear to face an increased risk of developing an exaggerated pressor response. In patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to institution of therapy with Dobutamine in D 5 W. Ectopic Activity Dobutamine Hydrochloride in 5% Dextrose Injection may precipitate or exacerbate ventricular ectopic activity, but it rarely has caused ventricular tachycardia. Hypersensitivity Reactions suggestive of hypersensitivity associated with administration of dobutamine including skin rash, fever, eosinophilia, and bronchospasm, have been reported occasionally. Dobutamine Hydrochloride 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.

Adverse reactions

Sourced from openFDA

Increased Heart Rate, Blood Pressure, and Ventricular Ectopic Activity A 10 to 20-mm Hg increase in systolic blood pressure and an increase in heart rate of 5 to 15 beats/minute have been noted in most patients (see WARNINGS regarding exaggerated chronotropic and pressor effects). Approximately 5% of adult 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. Stress Cardiomyopathy Stress cardiomyopathy has been reported with dobutamine in association with cardiac stress testing. Reactions at Sites of Intravenous Infusion Phlebitis has occasionally been reported. Local inflammatory changes have been described following inadvertent infiltration. Miscellaneous Uncommon Effects The following adverse effects have been reported in 1% to 3% of adult patients: nausea, headache, anginal pain, nonspecific chest pain, palpitations, and shortness of breath. Administration of dobutamine, like other catecholamines, has been associated with decreases in serum potassium concentrations, rarely to hypokalemic values.

Use in specific populations

Sourced from openFDA

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.

Overdosage

Sourced from openFDA

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 beta-receptor stimulation. The duration of action of dobutamine is generally short (T1/2 = two 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. 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).

Approval history

Sourced from openFDA
  • Sep 27, 1993NDANDA020255Baxter Hlthcare
  • Sep 27, 1993NDANDA020201Hospira
  • Nov 29, 1993ANDAANDA074086Hospira
  • Oct 31, 1994ANDAANDA074277Hikma
  • Dec 21, 2022ANDAANDA216131Slate Run Pharma

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Dobutamine Hydrochloride, Injection, 12.5 mg/1 mL (NDC 0409-2344-88)To be discontinued
    Sponsor: Pfizer Inc.
    Updated
  • Dobutamine Hydrochloride, Injection, 250 mg/20 mL (NDC 70436-203-80)Active
    Sponsor: Hainan Poly Pharm. Co., Ltd.
    Updated
  • Dobutamine Hydrochloride, Injection, 250 mg/20mL (12.5 mg/1 mL) (NDC 0409-2344-01)Active
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Dobutamine Hydrochloride, Injection, 250 mg/20mL (12.5 mg/1 mL) (NDC 0409-2344-02)Active
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Dobutamine Hydrochloride, Injection, 250 mg/20mL (12.5 mg/1 mL) (NDC 0409-2344-88)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Other
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
4,807 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective86718%
  2. 2Off Label Use60413%
  3. 3Death49110%
  4. 4Cardiogenic Shock4579.5%
  5. 5Multiple Organ Dysfunction Syndrome4218.8%
  6. 6Condition Aggravated4068.4%
  7. 7Sepsis4038.4%
  8. 8General Physical Health Deterioration3447.2%
  9. 9Nausea3407.1%
  10. 10Stress3367.0%
  11. 11Vomiting3126.5%
  12. 12Hyponatraemia2956.1%
  13. 13Ascites2946.1%
  14. 14Abdominal Distension2906.0%
  15. 15Abdominal Pain2745.7%

Literature

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Recent PubMed references pinned to Dobutamine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 221 ClinicalTrials.gov registrations naming Dobutamine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Dobutamine work?
Mechanism-of-action classes: Adrenergic beta-Agonists; Adrenergic beta1-Agonists.
What is Dobutamine used for?
According to FDA labeling, Dobutamine carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Dobutamine?
Dobutamine is classified as Adrenergic and dopaminergic agents, beta-Adrenergic Agonist, Adrenergic beta-Agonists, Adrenergic beta1-Agonists, Positive Chronotropy, Positive Inotropy.
What are the contraindications for Dobutamine?
Dobutamine labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.
Note. Data for dobutamine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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