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Dobutrex

Generic Name: Dobutamine Hydrochloride
Class: Selective beta-1-Adrenergic Agonists
VA Class: AU100
CAS Number: 49745-95-1

Introduction

Synthetic sympathomimetic that is structurally related to dopamine; generally considered a relatively selective β1-adrenergic agonist.

Uses for Dobutrex

Cardiac Decompensation

Used for inotropic support in the short-term management of cardiac decompensation caused by depressed contractility from organic heart disease or cardiac surgery.113 114 116 165

Safety and efficacy in the long-term (e.g., >48 hours) treatment of congestive heart failure not established.114

Because positive inotropes have not demonstrated improved outcomes and can be potentially harmful (e.g., increased risk of arrhythmias) in patients with heart failure, some experts recommend that such use be reserved for patients with severe systolic dysfunction who have low cardiac index and evidence of systemic hypoperfusion and/or congestion, or for palliative therapy in those with end-stage heart failure.165 To minimize risk of adverse effects, use lowest possible dosage and evaluate regularly for need for continued inotropic therapy.165

Used in the treatment of septic or cardiogenic shock to improve myocardial contractility and maintain systemic perfusion.153 159 161 165 Current expert guidelines recommend a trial of dobutamine (alone or in addition to a vasopressor) in patients with septic shock if myocardial dysfunction is present, or if there is ongoing hypoperfusion despite adequate intravascular volume and mean arterial pressure.153 Early revascularization is standard of care in patients with cardiogenic shock; individualize use of inotropes in this setting.161 162

Advanced Cardiovascular Life Support (ACLS)

Has been used for postresuscitation stabilization in patients who require additional cardiac output and blood pressure support following cardiac arrest.403 404

Cardiac Diagnostic Testing

Has been used as a pharmacologic stress test agent during echocardiography in patients unable to exercise.120 122 124 125 126 127

Also has been used as an alternative to exercise stress testing in patients undergoing myocardial perfusion imaging.119 121 123 128 129 130 However, coronary vasodilating agents (e.g., adenosine, dipyridamole, regadenoson) are drugs of choice for this use; dobutamine generally recommended only as an alternative in patients who have contraindications (e.g., bronchospastic airway disease).119 121 123

Dobutrex Dosage and Administration

Administration

Administer by IV infusion.113 114

Also has been administered by intraosseous (IO) infusion in the setting of ACLS.401 403

IV Infusion

For solution and drug compatibility information, see Compatibility under Stability.

Administer using an infusion pump or other apparatus to control flow rate and avoid inadvertent rapid IV (“bolus”) administration.113 114

Dobutamine hydrochloride injection concentrate must be further diluted prior to IV infusion;113 alternatively, commercially available prediluted solutions of dobutamine hydrochloride in 5% dextrose injection may be used.114

Dobutamine hydrochloride in 5% dextrose injection is commercially available in flexible plastic containers.114 Do not use in series connections.114

Consult manufacturer's labeling for proper methods of administration and other associated precautions.113 114 115

Dilution

Must dilute dobutamine hydrochloride concentrate for injection with a compatible IV solution prior to administration (dilute 20 mL of concentrate in at least 50 mL of diluent and 40 mL of concentrate in at least 100 mL of diluent).113

Individualize concentration according to patient dosage and fluid requirements; concentrations up to 5000 mcg/mL have been used.113 114

Rate of Administration

Avoid rapid IV (“bolus”) administration.114

Individualize IV infusion rate to achieve the desired clinical response.113 114

Initiate at a slow rate (e.g., 0.5–1 mcg/kg per minute) and carefully adjust at intervals of a few minutes according to response; usually 2–20 mcg/kg per minute is needed to increase cardiac output.113 114

Dosage

Available as dobutamine hydrochloride; dosage expressed in terms of dobutamine.113 114

Individual response to dobutamine is variable; titrate dosage to achieve the desired clinical response.113 114

Carefully adjust rate and duration of infusion according to heart rate, BP, urine flow, presence of ectopic heartbeats, and, whenever possible, central venous or pulmonary wedge pressure and cardiac output.113 114

Pediatric Patients

Cardiac Decompensation
IV

Initiate at a slow rate (e.g., 0.5–1 mcg/kg per minute) and titrate to desired response.114

Usually, 2–20 mcg/kg per minute is needed to increase cardiac output.114

ACLS
IV/IO

For postresuscitation stabilization, usual dosage range is 2–20 mcg/kg per minute.403

Adults

Cardiac Decompensation
IV

Initiate at a slow rate (e.g., 0.5–1 mcg/kg per minute) and titrate to desired response.113 114

Usually, 2–20 mcg/kg per minute is needed to increase cardiac output.113 114

In rare cases, infusion rates up to 40 mcg/kg per minute have been required.113 114

Duration of therapy is based on patient response; clinical experience mostly short-term (e.g., not more than several hours).113 114

ACLS
IV

For postresuscitation stabilization, usual dosage range is 5–10 mcg/kg per minute.404

Special Populations

Hepatic Impairment

No specific hepatic dosage recommendations.113 114

Renal Impairment

No specific renal dosage recommendations.113 114

Geriatric Patients

Initiate therapy at lower end of usual range because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.114

Cautions for Dobutrex

Contraindications

  • Idiopathic hypertrophic subaortic stenosis.113 114

  • Known hypersensitivity to dobutamine hydrochloride or any ingredient in the formulation.113 114

Warnings/Precautions

Warnings

Cardiovascular Effects

Marked increases in heart rate and BP (especially systolic pressure) can occur.113 114 Heart rate increase of ≥30 beats per minute or an increase in systolic BP of ≥50 mm Hg reported.113 114

Cardiovascular effects are usually dose related, and dosage should be reduced or the infusion temporarily discontinued if such effects occur.113 114 b

Patients with preexisting hypertension are at increased risk of an exaggerated pressor response.113 114

Patients with atrial fibrillation should be digitalized because of the risk of developing a rapid ventricular response.113 114

Ectopic Activity

Can precipitate or exacerbate ventricular ectopic activity; rarely, causes ventricular tachycardia.113 114

Sensitivity Reactions

Hypersensitivity Reactions

Hypersensitivity, including skin rash, fever, eosinophilia, and bronchospasm, have been reported occasionally.113 114

Sulfites

Some formulations contain sulfites, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.113 114

General Precautions

Hypovolemia

Hypovolemia should be corrected with an appropriate plasma volume expander before initiating dobutamine.113 114

MI

Clinical experience insufficient to rule out possibility of intensified or extended myocardial ischemia.113 114

Cardiac Mechanical Obstruction

No benefit may be apparent in the presence of marked mechanical obstruction (e.g., severe valvular aortic stenosis).113 114

Monitoring Parameters

Monitor ECG, BP and, when possible, cardiac output and pulmonary wedge pressure.113 114

May produce slight reductions in serum potassium concentrations and hypokalemia may occur rarely; monitor serum potassium concentrations.113 114

Specific Populations

Pregnancy

Category B.113 114

Lactation

Not known whether dobutamine is distributed into human milk.113 Caution if used in nursing women.113

Pediatric Use

Some manufacturers state that safety and efficacy have not been evaluated in pediatric patients.113 Others state that dobutamine increases cardiac output and systemic pressure in pediatric patients of all age groups.114

In premature neonates, dobutamine may be less effective than dopamine in increasing systemic BP without causing undue tachycardia and has not been shown to provide any additional benefit when administered to such infants who are already receiving optimal dopamine therapy.114

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; some clinical experience suggest that geriatric patients may have higher incidence of substantial hypotension.114

Use with caution since renal, hepatic, and cardiovascular dysfunction and concomitant disease or other drug therapy are more common in this age group.114

Common Adverse Effects

Ectopic heartbeats, increased heart rate, elevations in BP, hypotension, phlebitis, local inflammatory changes.113 114

Interactions for Dobutrex

No evidence of interactions in clinical studies when used with atropine, cardiac glycosides (digoxin), furosemide, heparin, lidocaine, morphine, nitroglycerin, isosorbide dinitrate, potassium chloride, folic acid, protamine, acetaminophen, or spironolactone.113 114

Specific Drugs

Drug

Interaction

Comments

β-Adrenergic blocking agents (e.g., metoprolol, propranolol)

Cardiac effects of dobutamine are antagonized, resulting in predominant α-adrenergic effects and increased peripheral resistance; dobutamine may be ineffectiveb

Anesthetics, general (e.g., halogenated hydrocarbons [e.g., halothane], cyclopropane)

May increase cardiac irritability, resulting in ventricular arrhythmias with usual dobutamine dosesb

Use concomitantly with cautionb

Sodium nitroprusside

Potentiated effects on cardiac output and pulmonary wedge pressure113 114

Dobutrex Pharmacokinetics

Absorption

Onset

Onset occurs within 2 minutes after initiation of IV infusion; peaks within 10 minutes.b

Duration

Effects cease shortly after infusion discontinuance.b

Distribution

Extent

Not known if dobutamine crosses the placentab or is distributed into milk.113

Elimination

Metabolism

Metabolized in the liver and other tissues by catechol-O-methyltransferase (COMT) to an inactive compound, 3-O-methyldobutamine, and by conjugation with glucuronic acid.b

Elimination Route

Conjugates of dobutamine and 3-O-methyldobutamine excreted mainly in urine and to a minor extent in feces.b

Half-life

About 2 minutes.b

Stability

Storage

Parenteral

Pink discoloration indicates slight oxidation of the drug; however, there is no important loss of potency if administered within the recommended time period.114

Concentrate for Injection for IV Infusion

20–25°C.113 Do not freeze.113

Following dilution, use within 24 hours.113

Injection in 5% Dextrose for IV Infusion

20–25°C; may be exposed briefly to temperatures up to 40°C.114 115 Do not freeze or expose to excessive heat.114 115

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Incompatible with strongly alkaline solutions.113 114

Should not be used in conjunction with other drugs or diluents containing both sodium bisulfite and ethanol.113

Parenteral

Solution Compatibility131

Stable for 24 hours in dextrose 5 or 10%, dextrose 5% in sodium chloride 0.45 or 0.9%, dextrose 5% in lactated Ringer’s injection, Isolyte M with 5% dextrose, lactated Ringer's, Normosol-M with 5% dextrose, Osmitrol in water, sodium chloride 0.9%, and sodium lactate (1/6) M.113 131

Compatible

Dextrose 2.5% in half-strength Ringer’s injection, lactated

Dextrose 5% in Ringer’s injection, lactated

Dextrose 2.5% in sodium chloride 0.45%

Dextrose 5% in sodium chloride 0.45 or 0.9%

Dextrose 5 and 10% in water

Normosol M in Dextrose 5%

Ringer’s injection, lactated

Sodium chloride 0.45 or 0.9%

Sodium lactate 1/6 M

Incompatible

Sodium bicarbonate 5%

Drug Compatibility

Additives should not be introduced into the injection containers.114

Admixture Compatibility131

Compatible

Amiodarone HCl

Atracurium besylate

Atropine sulfate

Ciprofloxacin

Dopamine HCl

Enalaprilat

Epinephrine HCl

Flumazenil

Hydralazine HCl

Isoproterenol HCl

Lidocaine HCl

Meperidine HCl

Meropenem

Morphine sulfate

Nitroglycerin

Norepinephrine bitartrate

Phentolamine mesylate

Phenylephrine HCl

Procainamide HCl

Propranolol HCl

Ranitidine HCl

Zidovudine

Incompatible

Acyclovir sodium

Alteplase

Aminophylline

Bumetanide

Calcium gluconate

Diazepam

Digoxin

Floxacillin sodium

Furosemide

Magnesium sulfate

Phenytoin sodium

Potassium phosphates

Sodium bicarbonate

Variable

Calcium chloride

Heparin sodium

Nitroglycerin with sodium nitroprusside

Potassium chloride

Verapamil HCl

Y-Site Compatibility131

Compatible

Alprostadil

Amifostine

Amiodarone HCl

Anidulafungin

Argatroban

Atracurium besylate

Aztreonam

Calcium chloride

Calcium gluconate

Caspofungin acetate

Ciprofloxacin

Cisatracurium besylate

Cladribine

Clarithromycin

Clonidine HCl

Dexmedetomidine HCl

Diazepam

Diltiazem HCl

Docetaxel

Dopamine HCl

Dopamine HCl with lidocaine HCl

Dopamine HCl with nitroglycerin

Dopamine HCl with sodium nitroprusside

Doripenem

Doxorubicin HCl liposome injection

Enalaprilat

Epinephrine HCl

Etoposide phosphate

Famotidine

Fenoldopam mesylate

Fentanyl citrate

Fluconazole

Gemcitabine HCl

Granisetron HCl

Haloperidol lactate

Hetastarch in lactated electrolyte injection (Hextend)

Hydromorphone HCl

Hydroxyethyl starch 130/0.4 in sodium chloride 0.9%

Insulin, regular

Labetalol HCl

Levofloxacin

Lidocaine HCl

Lidocaine HCl with dopamine HCl

Lidocaine HCl with nitroglycerin

Lidocaine HCl with sodium nitroprusside

Linezolid

Lorazepam

Magnesium sulfate

Meperidine HCl

Milrinone lactate

Morphine sulfate

Nicardipine HCl

Nitroglycerin

Nitroglycerin with dopamine HCl

Nitroglycerin with lidocaine HCl

Nitroglycerin with sodium nitroprusside

Norepinephrine bitartrate

Oxaliplatin

Pancuronium bromide

Potassium chloride

Propofol

Ranitidine HCl

Remifentanil HCl

Sodium nitroprusside

Sodium nitroprusside with dopamine HCl

Sodium nitroprusside with lidocaine HCl

Sodium nitroprusside with nitroglycerin

Tacrolimus

Telavancin HCl

Theophylline

Thiotepa

Tigecycline

Tirofiban HCl

Vasopressin

Vecuronium bromide

Verapamil HCl

Zidovudine

Incompatible

Acyclovir sodium

Alteplase

Aminophylline

Amphotericin B cholesteryl sulfate complex

Foscarnet sodium

Indomethacin sodium trihydrate

Micafungin sodium

Pantoprazole sodium

Pemetrexed disodium

Phytonadione

Piperacillin sodium–tazobactam sodium

Warfarin sodium

Variable

Bivalirudin

Cefepime HCl

Ceftaroline fosamil

Ceftazidime

Furosemide

Heparin sodium

Midazolam HCl

Actions

  • The main effect of therapeutic doses is cardiac stimulation.b

  • Principally a selective, direct stimulatory effect on β1-adrenergic receptors, but the mechanisms of action are complex.100 101

  • In therapeutic doses, also mild β2- and α1-adrenergic receptor agonist effects.100

  • β1-Adrenergic effects exert a potent positive inotropic effect, resulting in increased myocardial contractility and cardiac output.b

    Increased left ventricular filling pressure decreases in patients with congestive heart failure.b

  • Therapeutic doses cause decreased peripheral resistance; however, systolic BP and pulse pressure may remain unchanged or be increased because of augmented cardiac output.b

  • Usual doses do not substantially change heart rate.b

  • Coronary blood flow and myocardial oxygen consumption are usually increased because of increased myocardial contractility.b

  • May facilitate AV conduction and shorten or cause no important change in intraventricular conduction.b

  • Pulmonary vascular resistance may decrease if it is elevated initially and mean pulmonary artery pressure may decrease or remain unchanged.b

  • Unlike dopamine, dobutamine does not seem to affect dopaminergic receptors and causes no renal or mesenteric vasodilation; however, urine flow may increase because of increased cardiac output.b

Advice to Patients

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.113 114

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.113 114

  • Importance of informing patients of other important precautionary information.113 114 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

DOBUTamine Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection concentrate, for IV infusion

12.5 mg (of dobutamine) per mL*

DOBUTamine Hydrochloride Injection

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

DOBUTamine Hydrochloride in Dextrose

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for IV infusion

1 mg (of dobutamine) per mL (250 or 500 mg) in 5% Dextrose*

DOBUTamine in 5% Dextrose Injection (Lifecare; Viaflex)

2 mg (of dobutamine) per mL (500 mg) in 5% Dextrose*

DOBUTamine in 5% Dextrose Injection (Lifecare; Viaflex)

4 mg (of dobutamine) per mL (1000 mg) in 5% Dextrose*

DOBUTamine in 5% Dextrose Injection (Lifecare; Viaflex)

AHFS DI Essentials. © Copyright 2017, Selected Revisions November 1, 2016. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

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103. Eli Lilly and Company. Dobutrex (dobutamine hydrochloride) solution prescribing information. Indianapolis, IN: 1999 Feb.

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129. Schinkel AF, Elhendy A, van Domburg RT et al. Prognostic value of dobutamine-atropine stress (99m)Tc-tetrofosmin myocardial perfusion SPECT in patients with known or suspected coronary artery disease. J Nucl Med. 2002; 43:767-72. [PubMed 12050321]

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b. AHFS drug information 2017. McEvoy GK, ed. Dobutamine. Bethesda, MD: American Society of Health-System Pharmacists; 2017

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