New Release: Alpha testing version has been released.

Dobutamine

C01C - Cardiac stimulants excl. cardiac glycosides ATC C01CA07 Small molecule approved 1978 Parenteral Natural product

JFDA label: Dobuject Inf. Concentrate

Mechanism of Action

Dobutamine, a racemic mixture, stimulates myocardial beta1-adrenergic receptors primarily by the (+) enantiomer and some alpha1 receptor agonism by the (-) enantiomer, resulting in increased contractility and heart rate, and stimulates both beta2- and alpha1-receptors in the vasculature. Although beta2 and alpha1 adrenergic receptors are also activated, the effects of beta2 receptor activation may equally offset or be slightly greater than the effects of alpha1 stimulation, resulting in some vasodilation in addition to the inotropic and chronotropic actions (Leier 1988; Majerus 1989; Ruffolo 1987). Lowers central venous pressure and wedge pressure, but has little effect on pulmonary vascular resistance (Leier 1977; Leier 1978).

Indications

Approved

  • Cardiac decompensation
  • Cardiogenic shock
  • Inotropic support in advanced heart failure

Off-label

  • Advanced life support
  • Myocardial dysfunction related to sepsis (positive inotropic agent)
  • Stress echocardiography (diagnostic agent)

Contraindications

Source: Lexicomp

  • Hypersensitivity to dobutamine or sulfites (some contain sodium metabisulfate), or any component of the formulation Absolute
  • hypertrophic cardiomyopathy with outflow tract obstruction (formerly known as idiopathic hypertrophic subaortic stenosis [IHSS]) Note: When utilized for stress testing, additional contraindications according to the American Society of Nuclear Cardiology (ASNC) include patients with recent (200/110 mm Hg), aortic dissection or large aortic aneurysm, and patients on beta blockers where heart rate and inotropic responses to dobutamine will be attenuated (ASNC [Henzlova 2009]) Absolute

Adverse Reactions

Very Common >10%Common 1–10%Uncommon 0.1–1% Rare 0.01–0.1%Very Rare <0.01%Not Known

Cardiac disorders (9)

Not Known angina pectoris · chest pain · hypotension · increased blood pressure · increased heart rate · localized phlebitis · palpitations · ventricular ectopy (increased) · Ventricular premature contractions

Nervous system disorders (2)

Not Known Headache · paresthesia

Blood and lymphatic system disorders (1)

Not Known Thrombocytopenia (isolated cases)

Metabolism and nutrition disorders (1)

Not Known Decreased serum potassium (slight)

Gastrointestinal disorders (1)

Not Known Nausea

Skin and subcutaneous tissue disorders (1)

Not Known Skin necrosis (isolated cases)

Musculoskeletal and connective tissue disorders (1)

Not Known Leg cramps (mild)

General disorders and administration site conditions (3)

Not Known Fever · Local inflammation · local pain (from infiltration)

Respiratory, thoracic and mediastinal disorders (1)

Not Known Dyspnea

Dosing

Source: Lexicomp

Cardiac decompensation: IV infusion: Initial dose: 0.5 to 1 mcg/kg/minute (per the manufacturer); may also initiate at higher doses (eg, 2.5 mcg/kg/minute) depending on severity of decompensation with titration to desired response (Leier 1977). Maintenance dose: 2 to 20 mcg/kg/minute. Note: In patients with heart failure, lower doses are preferred to minimize adverse effects (ACCF/AHA [Yancy 2013]; AHA [van Diepen 2017]). Maximum dose: 40 mcg/kg/minute. The ACCF/AHA 2013 heart failure guidelines recommend a maximum dose of 20 mcg/kg/minute (ACCF/AHA [Yancy 2013]). Adult Advanced Cardiovascular Life Support (ACLS) guideline recommendation (in the immediate post-cardiac arrest care setting) (off-label use): IV infusion: Initial: 5 to 10 mcg/kg/minute; titrate to effect (AHA [Peberdy 2010]) Stress echocardiography (diagnostic agent) (off-label use): IV infusion: Initial: 5 to 10 mcg/kg/minute; increase at 3-minute intervals to 20 mcg/kg/minute, then 30 mcg/kg/minute, and then 40 mcg/kg/minute. May coadminister atropine in patients who do not achieve target heart rate (ASNC [Henzlova 2009]).
(For additional information see "Dobutamine: Pediatric drug information") Pediatric Advanced Life Support (PALS) guideline recommendation (to maintain cardiac output and for postresuscitation stabilization) (off-label dose): Infants, Children, and Adolescents: Continuous IV or Intraosseous infusion: Initial: 0.5 to 1 mcg/kg/minute, titrate gradually every few minutes until desired response achieved; usual range: 2 to 20 mcg/kg/minute (AHA [Kleinman 2010]).
Refer to adult dosing.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.

Warnings & Precautions

Source: Lexicomp

Arrhythmias

Ventricular arrhythmias, including nonsustained ventricular tachycardia and supraventricular arrhythmias, have been reported (Tisdale1995). Observe closely for arrhythmias in patients with acute heart failure; sudden cardiac death has been observed (O’Connor 1999; Pickworth 1992; Young 2000). Ensure that ventricular rate is controlled in atrial fibrillation/flutter before initiating; may increase ventricular response rate. In heart transplant candidates, institute appropriate measures to protect patient against risks of sudden cardiac death (Young 2000).

Blood pressure effects

An increase in blood pressure is more common due to augmented cardiac output, but occasionally a patient may become hypotensive.

Heart failure complications

An increased risk of hospitalization and death has been observed with prolonged use in New York Heart Association Class III/IV heart failure patients (O’Connor 1999).

Tachycardia

May cause dose-related increases in heart rate.

Ventricular ectopy

May exacerbate ventricular ectopy (dose-related). Disease-related concerns:

Aortic stenosis

Ineffective therapeutically in the presence of mechanical obstruction such as severe aortic stenosis.

Electrolyte imbalance

Correct electrolyte disturbances, especially hypokalemia or hypomagnesemia, prior to use and throughout therapy to minimize the risk of arrhythmias (ACC/AHA/ESC [Zipes 2006]; Tisdale 1995).

Hypovolemia

If needed, correct hypovolemia first to optimize hemodynamics.

Active myocardial ischemia/myocardial infarction (post)

Use with caution in patients with active myocardial ischemia or recent myocardial infarction; can increase myocardial oxygen demand. Concurrent drug therapy issues:

Monoamine oxidase inhibitors (MAO-I)

Use with extreme caution in patients taking MAO inhibitors; prolong hypertension may result from concurrent use. Dosage form specific issues:

Sodium sulfite

Product may contain sodium sulfite. Special populations:

Elderly

Use with caution in the elderly; start at lower end of the dosage range. Other warnings/precautions:

Long-term therapy

According to the ACCF/AHA 2013 heart failure guidelines, long-term use of intravenous inotropic therapy without a specific indication or for reasons other than palliation is potentially harmful (ACCF/AHA [Yancy 2013]).

Pregnancy & Lactation

Pregnancy

FDA category B Teratogenic

Adverse events have not been observed in animal reproduction studies. Dobutamine should not be used as a diagnostic agent during stress testing in pregnant women (Regitz-Zagrosek 2011). Medications used for the treatment of cardiac arrest in pregnancy are the same as in the non-pregnant woman. Appropriate medications should not be withheld due to concerns of fetal teratogenicity. Dobutamine use during the post-resuscitation phase may be considered; however, the effects of inotropic support on the fetus should also be considered. Doses and indications should follow current Advanced Cardiovascular Life Support (ACLS) guidelines (Jeejeebhoy [AHA] 2015).

Lactation

It is not known if dobutamine is present in breast milk. The manufacturer recommends that caution be exercised when administering dobutamine to breastfeeding women.

Monitoring

Clinical pearlBlood pressure, ECG, heart rate, CVP, RAP, MAP; serum glucose, renal function; urine output; if pulmonary artery catheter is in place, monitor CI, PCWP, and SVR; ScvO2 or SvO2 Consult individual institutional policies and procedures.

Chemistry & Properties

2D structure
FormulaC18H23NO3
Molecular weight301.39 g/mol
IUPAC name4-[2-[4-(4-hydroxyphenyl)butan-2-ylamino]ethyl]benzene-1,2-diol
CAS34368-04-2
PubChem CID36811
InChIKeyJRWZLRBJNMZMFE-UHFFFAOYSA-N
logP2.96 (XLogP 3.4)
Polar surface area72.72 Ų
H-bond acceptors / donors4 / 4
Drug-likeness (QED)0.59
Lipinski violations0
SMILESCC(CCc1ccc(O)cc1)NCCc1ccc(O)c(O)c1

Biology & Pharmacokinetics

Pharmacokinetics predicted

Bioavailability70.0%
Half-life1.607 h
Volume of distribution1.581 L/kg
Protein binding48.4%
BBB penetrantNo

Enzyme interactions

EnzymeRoleDetail
CYP1A2Substrate
CYP2C8Inhibitor
CYP2C9Substrate
CYP2D6Substrate

Receptor binding (top 1)

TargetActionAffinity
&beta;1-adrenoceptor (ADRB1) Agonist pEC50 6.8

Transporters

BCRP (Inhibitor)BSEP (Inhibitor)BSEP (Inhibitor)MRP1 (Inhibitor)OATP1B1 (Inhibitor)OATP1B1 (Inhibitor)OATP1B3 (Inhibitor)OCT1 (Inhibitor)P-gp (Inhibitor)P-gp (Substrate)

Drug–drug interactions (73, DDInter)

Interacting drugSeverityManagement
Cocaine (nasal) major
Cocaine (topical) major
Doxepin major
Acarbose moderate
Acetohexamide moderate
Albiglutide moderate
Alogliptin moderate
Canagliflozin moderate
Chlorpropamide moderate
Cimetidine moderate
Dapagliflozin moderate
Desmopressin moderate
Diatrizoate moderate
Diethylpropion moderate
Doxapram moderate
Dulaglutide moderate
Empagliflozin moderate
Ertugliflozin moderate
Exenatide moderate
Formoterol moderate
Glimepiride moderate
Glipizide moderate
Glyburide moderate
Indacaterol moderate
Insulin aspart (aspart protamine) moderate
Insulin aspart (aspart) moderate
Insulin degludec moderate
Insulin detemir moderate
Insulin glargine moderate
Insulin glulisine moderate
Insulin human moderate
Insulin human (inhalation, rapid acting) moderate
Insulin human (isophane) moderate
Insulin human (regular) moderate
Insulin human (zinc extended) moderate
Insulin human (zinc) moderate
Insulin lispro moderate
Insulin lispro (protamine) moderate
Isoprenaline moderate
Levothyroxine moderate

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Registered Products (5)

BrandForm / strengthPackAgentCitizen (JOD)
DOBUTREX VIAL Vial 250 mg 1 vial THE ARAB DRUG STORE P.S.C
Dobuject Inf. Concentrate Concentrate 250 mg/5 ml 5 ml The Jordan Drugstore Co
Dobutamine Vial 250 mg 20 ml Petra Drug Store
Dobutamine Hikma Vial ( as Hcl) 12.5 mg/ml 1 vial Hikma Pharmaceuticals Co.Ltd/Jordan
MEKARD 250 mg/20 ml Concentrated Solution For I.V. Infusion Infusion Dobutamine 250 mg/20 ml 10 amp JAWEDA INT. DRUD STORE