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Dobutrex

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

Introduction

Dobutamine is a synthetic sympathomimetic that is structurally related to dopamine and generally is considered a relatively selective β1-adrenergic agonist.

Uses for Dobutrex

Cardiac Decompensation, Shock, and CHF

Used to increase cardiac output in the short-term treatment of cardiac decompensation caused by depressed contractility from organic heart disease, cardiac surgical procedures, cardiac arrest (ACLS; see CPR under Uses), or acute MI (see MI under Uses).103 107 110 111 a b

May be particularly useful in the management of cardiogenic shock, including drug-induced cardiogenic shock, in patients with normal DBP and SBP >100 mm Hg, since the drug provides the best sympathomimetic support.104 112

May be preferable to dopamine in the period immediately following cardiopulmonary bypass surgery.b

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Safety and efficacy in the long-term (e.g., exceeding 48 hours) treatment of CHF have not been established.103 107 109 a b Patients with NYHA class IV disease appear at particular risk of adverse effects of long-term cAMP-dependent inotropic therapy.a

May be ineffective and potentially harmful in marked mechanical obstruction (e.g., severe valvular aortic stenosis).b

Should not be used alone in severely hypotensive patients (e.g., when SBP is <100 mm Hg).b

Should not be used in patients with drug-induced distributive shock, since the drug may worsen hypotension by further decreasing systemic vascular resistance.112

CPR

Used as a potent inotropic agent to increase cardiac output in ACLS during CPR.110 b

May be particularly useful for low cardiac output secondary to poor myocardial function, such as following cardiac arrest.110

Predominant β-adrenergic effects increase myocardial contractility in a dose-dependent manner and decrease left ventricular filling pressures.110

Arterial blood pressure may remain unchanged due to reflex peripheral vasodilation (baroreceptor mediated) in response to increased stroke volume.110

Useful in the management of postresuscitation shock (e.g., when combined with dobutamine).110 c

MI

Although the manufacturers state that safety following MI has not been established, use in combination with dopamine in acute MI management is recommended by the ACC and AHA for the management of heart failure and low-output syndromes associated with left ventricular dysfunction and for inotropic support following hypotension management associated with right ventricular ischemia.111

May be useful as an adjunct (to increase cardiac output) to volume replacement in patients with right ventricular infarction, since dopamine may increase pulmonary vascular resistance.b

Dobutrex Dosage and Administration

Administration

Usually administered by IV infusionb

Has also been administered by intraosseous infusion.110

IV Infusion

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

Infuse IV using an infusion pump or other apparatus to control the rate of flow and avoid inadvertent administration of a bolus of drug.107 a b

Commercially available premixed dobutamine hydrochloride in 5% dextrose should be administered only by IV infusion via a suitable catheter or needle.107

Do not use in series connections.107

When the commercially available IV infusion solution of dobutamine hydrochloride in 5% dextrose is used, the accompanying labeling should be consulted for proper methods of administration and other associated precautions.b

Dilution

The concentrate for injection must be diluted prior to administration; alternatively, commercially available diluted injections for IV infusion may be used.103 b

20 mL of the concentrate for injection should be diluted in at least 50 mL of diluent and 40 mL of concentrate should be diluted in at least 100 mL of diluent.b

The concentration used is individualized according to patient dosage and fluid requirements, but should not exceed 5000 mcg (5 mg)/mL.103 110 a b

Dilution of Concentrate for Injection for IV Infusion103b

Amount of Concentrate

Add (volume of concentrate)

To Compatible IV Solution (volume of solution)

To Make (final dilution concentration)

250 mg

20 mL

1 L

250 mcg (0.25 mg)/mL

250 mg

20 mL

500 mL

500 mcg (0.5 mg)/mL

250 mg

20 mL

250 mL

1000 mcg (1 mg)/mL

250 mg

20 mL

50 mL

5000 mcg (5 mg)/mL

Rate of Administration

Avoid bolus administration.b

Rate of IV infusion varies according to individual dose requirements titrated to response.103 107 110 a b

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;b usually 2–20 mcg/kg per minute is needed.103 107 110 a b

Intraosseous Administration

When IV administration is not possible, dobutamine may be given by intraosseous infusion for emergency uses such as CPR.110 112

Limit intraosseous administration to personnel well trained in the technique.100

Place a cannula in a noncollapsible marrow venous plexus; such access often can be achieved in 30–60 seconds.100 Use a rigid needle, preferably a specially designed intraosseous or Jamshidi-type bone marrow needle; a styleted needle is preferred to prevent obstruction of the needle with cortical bone.100

Insert the intraosseous needle into the anterior tibial bone marrow; alternatively, the distal femur, medial malleolus, or anterior superior iliac spine can be used.100 In older children and adults, intraosseous cannulas also have been inserted successfully into the distal radius or ulna in addition to the proximal tibia.100

Successful placement outside the hospital (e.g., by emergency medical services) generally is more difficult in older than in younger children.100

Onset of action and systemic concentrations are comparable to those achieved with intravascular administration.100 112

Dilution

Same as those for IV infusion. (See Dilution under IV Infusion.)

Rate of Administration

Intraosseous infusion rates are the same as those for IV infusion.100 (See Rate of Administration under IV Infusion.)

Administration Risks

Complications are uncommon (less than 1% of patients), and include tibial fracture, lower-extremity compartment syndrome, extravasation, and osteomyelitis; careful technique can minimize the risk.100 Local effects on bone marrow and bone growth appear to be minimal.100 Risk of microscopic pulmonary fat and bone marrow emboli does not appear to be increased.100

Dosage

Available as dobutamine hydrochloride; dosage expressed in terms of dobutamine.103 107 a b

Hemodynamic end points rather than a specific dose should be used to optimize therapy.110 112

Individual response to dobutamine is variable, and infusion rate should be titrated to achieve the desired clinical response.b

Rate and duration should be carefully adjusted according to patient response as indicated by heart rate, BP, urine flow, peripheral perfusion, presence of ectopic heartbeats, and, whenever possible, by measurement of central venous or pulmonary wedge pressure and cardiac output.103 107 a b

Pediatric Patients

Pharmacokinetics and clinical responses to specific doses vary widely.110

Usually initiate slowly (e.g., 0.5–1 mcg/kg per minute).b

Cardiac Decompensation and Shock
IV or Intraosseous

Usually, 2–20 mcg/kg per minute is needed to increase cardiac output.110 b

CPR
IV or Intraosseous

Usually, 2–20 mcg/kg per minute is needed to increase cardiac output.110 112 b

MI
IV or Intraosseous

Usually, 2–20 mcg/kg per minute is needed to increase cardiac output.110 b

Adults

Individual response to dobutamine is variable, and infusion rate should be titrated to achieve the desired clinical response.103 107 110 a b

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.b

Dobutamine has been infused for up to 72 hours without decreased effectiveness.b

Cardiac Decompensation and Shock
IV or Intraosseous

Usually, 2–20 mcg/kg per minute is needed to increase cardiac output.112 b

CPR
IV or Intraosseous

Usually, 2–20 mcg/kg per minute is needed to increase cardiac output.112 b

MI
IV or Intraosseous

Usually, 2–20 mcg/kg per minute is needed to increase cardiac output.112 b

Prescribing Limits

Pediatric Patients

IV or Intraosseous

Dosages >20 mcg/kg per minute may produce tachycardia and ventricular ectopy and could induce or exacerbate myocardial ischemia.104 112

Adults

IV or Intraosseous

Dosages >20 mcg/kg per minute often increase heart rate by more than 10%, and such increases potentially could induce or exacerbate myocardial ischemia.104 112

Rarely, dosages as great as 40 mcg/kg per minute,103 107 112 but these may substantially increase adverse effects, (e.g. ,tachycardia, hypotension) and usually should be avoided.104 112

Special Populations

Hepatic Impairment

No specific hepatic dosage recommendations.a

Renal Impairment

No specific renal dosage recommendations.a

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.108 However, geriatric patients may exhibit a substantially decreased response.110 112

Cautions for Dobutrex

Contraindications

  • Idiopathic hypertrophic subaortic stenosis.

  • Known hypersensitivity to dobutamine hydrochloride or any ingredient in the formulation.103 106 107 a b

  • Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.107 a

Warnings/Precautions

Warnings

Cardiovascular Effects

Marked increases in heart rate and BP (especially systolic pressure) can occur.103 a b Heart rate of ≥30 beats per minute or an increase in systolic BP of ≥50 mm Hg reported.b

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

Patients with preexisting hypertension are at increased risk of an exaggerated pressor response.103 a b

Patients with atrial fibrillation should be digitalized because of the risk of developing a rapid ventricular response.103 a b

Ectopic Activity

Can precipitate or exacerbate ventricular ectopic activity; rarely, causes ventricular tachycardia.103

Sensitivity Reactions

Hypersensitivity Reactions

Hypersensitivity, including skin rash, fever, eosinophilia, and bronchospasm, have been reported occasionally.103 107

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.102 103 106 107 a b

Corn

Dextrose-containing solutions may be contraindicated in patients who are sensitive to corn or corn products.107 a

General Precautions

Hypovolemia

Hypovolemia should be corrected with an appropriate plasma volume expander before initiating dobutamine.103 107 a b

MI

Clinical experience insufficient to rule out possibility of intensified or extended myocardial ischemia; use with extreme caution following MI.103 107 a b (See MI under Uses.)

Cardiac Mechanical Obstruction

No benefit may be apparent in the presence of marked mechanical obstruction (e.g., severe valvular aortic stenosis).103 107 a

Monitoring Parameters

Monitor ECG, BP and, when possible, cardiac output and pulmonary wedge pressure.103 107 a b

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

Specific Populations

Pregnancy

Category B.103 a

Lactation

Not known whether dobutamine is distributed into human milk.103 Caution if used in nursing women.103

Pediatric Use

May increase cardiac output and systemic pressure in pediatric patients of all age groups.103 107 Such increases generally are seen at lower infusion rates than those associated with substantial tachycardia.103 107

Premature neonates: May be less effective in increasing systemic BP without causing undue tachycardia, and dobutamine has not been shown to provide any additional benefit when administered to such infants who are already receiving optimal dopamine therapy.103 107

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; some clinical experience showed no differences.a

Use with caution since renal, hepatic, and cardiovascular dysfunction and concomitant disease or other drug therapy are more common in this age group.108 a However, geriatric patients generally have a substantially reduced response to dobutamine.110 112

Common Adverse Effects

Ectopic heartbeats, increased heart rate, elevations in BP, hypotension, phlebitis, local inflammatory changes.103 a b

Interactions for Dobutrex

No evidence of interactions in clinical studies when used with atropine, cardiac glycosides (digoxin), furosemide, heparin, lidocaine, morphine, nitrates, potassium chloride, or spironolactone.103 103 a

Specific Drugs

Drug

Interaction

Comments

β-Adrenergic blocking agents

Cardiac effects of dobutamine are antagonized, resulting in predominant α-adrenergic effects and increased peripheral resistance; dobutamine may be ineffective103 a b

Use concomitantly with cautionb

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 pressurea

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.103 b

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.a 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.b

Store at 15–30°C.b

Solutions of dobutamine hydrochloride in 5% dextrose should be protected from excessive heat or freezing and stored at room temperature (25°C); however, brief exposure of the solutions to temperatures up to 40°C does not adversely affect the products.107

Solutions diluted for IV infusion should be used within 24 hours; unused portions should be discarded.b

Concentrate for Injection for IV Infusion

15–30°C.103 b

Injection for IV Infusion

25°C; may be exposed briefly to temperatures up to 40°C.a Do not freeze.a

Compatibility

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

Incompatible with strongly alkaline solutions.103 a b

Should not be used in conjunction with other drugs or diluents containing both sodium bisulfite and ethanol.103 b

Parenteral

Solution CompatibilityHID

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.103

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.a 107

Since dobutamine dosage must be titrated according to response, other drugs generally should not be added to the infusion fluid.c

Admixture CompatibilityHID

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

Furosemide

Magnesium sulfate

Phenytoin sodium

Potassium phosphates

Sodium bicarbonate

Variable

Calcium chloride

Heparin sodium

Nitroglycerin with sodium nitroprusside

Potassium chloride

Verapamil HCl

Y-Site CompatibilityHID

Compatible

Alprostadil

Amifostine

Amiodarone HCl

Anidulafungin

Argatroban

Atracurium besylate

Aztreonam

Calcium chloride

Calcium gluconate

Caspofungin acetate

Ciprofloxacin

Cisatracurium besylate

Cladribine

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.100 101 110

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

  • β1-Adrenergic effects exert a potent positive inotropic effect, resulting in increased myocardial contractility and cardiac output.110 b

    Increased left ventricular filling pressure decreases in CHF.b 110

  • Therapeutic doses cause decreased peripheral resistance; however, systolic blood pressure 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.

Advice to Patients

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

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

  • Importance of informing patients of other important precautionary information.a b (See Cautions.)

Preparations

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

* 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 for Injection

Dobutrex Solution

Lilly

* 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

0.5 mg (of dobutamine) per mL (125 or 250 mg) in 5% Dextrose*

Dobutamine in 5% Dextrose Injection (Lifecare)

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, 2004-2014, Selected Revisions June 20, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, 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.

100. Leier CV, Unverferth DV. Dobutamine. Ann Intern Med. 1983; 99:490-6. [IDIS 176707] [PubMed 6625384]

101. Ruffolo RR Jr. The mechanism of action of dobutamine. Ann Intern Med. 1984; 100:313-4. [IDIS 181321] [PubMed 6140893]

102. Food and Drug Administration. Sulfiting agents; labeling in drugs for human use; warning statement: final rule [21 CFR Part 201]. Fed Regist. 1986; 51:43900-5.

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

104. Emergency Cardiac Care Committee and Subcommittees, American Heart Association. Guidelines for cardiopulmonary resuscitation and emergency cardiac care. JAMA. 1992; 268:2171-2302. [PubMed 1404767]

105. Robison-Strane SR, Bubik JS. Dobutamine-induced fever. Ann Pharmacother. 1992; 26:1523-4. [IDIS 306620] [PubMed 1482808]

106. Gensia Laboratories, Inc. Dobutamine hydrochloride injection prescribing information. Irvine, CA; 1993 Apr.

107. Abbott Laboratories. Dobutamine in 5% dextrose injection prescribing information. North Chicago, IL: 1998 Aug.

108. Food and Drug Administration. Dobutamine in 5% dextrose in flexible containers [September 1, 1999; Abbott]. MedWatch drug labeling changes. Rockville, MD; September 1999. From FDA website ().

109. Food and Drug Administration. Dobutamine in 5% dextrose in plastic container [April 21, 1999; Baxter]. MedWatch drug labeling changes. Rockville, MD; April 1999. From FDA website ().

110. The American Heart Association in Collaboration with the International Liaison Committee on Resuscitation. Guidelines 2000 for cardiopulmonary resuscitation and emergency cardiovascular care. Circulation. 2000; 102(Suppl I) I-132,I-328.

111. Ryan TJ, Antman EM, Brooks NH et al. ACC/AHA guidelines for the management of patients with acute myocardial infarction: 1999 update: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Acute Myocardial Infarction). Circulation. 1999; 100:1016-30. [IDIS 437967] [PubMed 10468535]

112. The American Heart Association. Guidelines 2005 for cardiopulmonary resuscitation and emergency cardiovascular care. Circulation. 2005; 112(Suppl I): IV1-211.

pdh. Schilling McCann JA, Publisher. Pharmacists drug handbook. 2nd ed. Philadelphia, PA: Lippincott Williams and Wilkins and American Society of Health-System Pharmacists; 2003.

HID. Trissel LA. Handbook on injectable drugs. 17th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2013:383-93.

a. Baxter Healthcare Corporation. Dobutamine hydrochloride in 5% injection prescribing information. Deerfield, IL; 2002 Jul.

b. AHFS drug information 2008. McEvoy GK, ed. Dobutamine. Bethesda, MD: American Society of Health-System Pharmacists; 2008:1334-6

c. AHFS drug information 2008. McEvoy GK, ed. Dopamine. Bethesda, MD: American Society of Health-System Pharmacists; 2008:1336-9

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