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DOBUTamineINJECTION, USP | DOBUTAMINE [Hospira, Inc.] | BioPortfolio

12:43 EST 27th January 2019 | BioPortfolio

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Fliptop Vial

R only

MUST BE DILUTED PRIOR TO

ADMINISTRATION

Dobutamine Injection, USP is a clear, practically colorless, sterile, nonpyrogenic solution of dobutamine hydrochloride for intravenous use only. Each milliliter contains 12.5 mg (41.5 µmol) dobutamine, as the hydrochloride and sodium metabisulfite, 0.2 mg added as antioxidant. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH is 3.3 (2.5 to 5.5).

Dobutamine Hydrochloride, USP is chemically designated (±)-4-[2-[[3-(ρ-hydroxyphenyl)-1-methylpropyl] amino]ethyl]-pyrocatechol hydrochloride.

It is a synthetic catecholamine.

Molecular Weight: 337.85

Molecular Formula: CHNO• HCl

Dobutamine hydrochloride is a direct-acting inotropic agent whose primary activity results from stimulation of the β receptors of the heart while producing comparatively mild chronotropic, hypertensive, arrhythmogenic, and vasodilative effects. It does not cause the release of endogenous norepinephrine, as does dopamine. In animal studies, dobutamine hydrochloride produces less increase in heart rate and less decrease in peripheral vascular resistance for a given inotropic effect than does isoproterenol.

In patients with depressed cardiac function, both dobutamine hydrochloride and isoproterenol increase the cardiac output to a similar degree. In the case of dobutamine hydrochloride, this increase is usually not accompanied by marked increases in heart rate (although tachycardia is occasionally observed), and the cardiac stroke volume is usually increased. In contrast, isoproterenol increases the cardiac index primarily by increasing the heart rate while stroke volume changes little or declines.

Facilitation of atrioventricular conduction has been observed in human electrophysiologic studies and in patients with atrial fibrillation.

Systemic vascular resistance is usually decreased with administration of dobutamine hydrochloride. Occasionally, minimum vasoconstriction has been observed.

Most clinical experience with dobutamine hydrochloride is short-term − not more than several hours in duration. In the limited number of patients who were studied for 24, 48, and 72 hours, a persistent increase in cardiac output occurred in some, whereas output returned toward baseline values in others.

The onset of action of dobutamine is within 1 to 2 minutes; however, as much as 10 minutes may be required to obtain the peak effect of a particular infusion rate.

The plasma half-life of dobutamine hydrochloride in humans is 2 minutes. The principal routes of metabolism are methylation of the catechol and conjugation. In human urine, the major excretion products are the conjugates of dobutamine and 3-O-methyl dobutamine. The 3-O-methyl derivative of dobutamine is inactive.

Alteration of synaptic concentrations of catecholamines with either reserpine or tricyclic antidepressants does not alter the actions of dobutamine in animals, which indicates that the actions of dobutamine hydrochloride are not dependent on presynaptic mechanisms.

Dobutamine Injection, USP is indicated when parenteral therapy is necessary for 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.

In patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to institution of therapy with dobutamine hydrochloride.

Dobutamine hydrochloride is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and in patients who have shown previous manifestations of hypersensitivity to Dobutamine Injection, USP solution.

General

Usage Following Acute Myocardial Infarction − Clinical experience with dobutamine hydrochloride following myocardial infarction has been insufficient to establish the safety of the drug for this use. There is concern that any agent that increases contractile force and heart rate may increase the size of an infarction by intensifying ischemia, but it is not known whether dobutamine hydrochloride does so.

Laboratory Tests − Dobutamine, like other β-agonists, can produce a mild reduction in serum potassium concentration, rarely to hypokalemic levels. Accordingly, consideration should be given to monitoring serum potassium.

Drug Interactions − Animal studies indicate that dobutamine may be ineffective if the patient has recently received a β-blocking drug. In such a case, the peripheral vascular resistance may increase.

Preliminary studies indicate that the concomitant use of dobutamine and nitroprusside results in a higher cardiac output and, usually, a lower pulmonary wedge pressure than when either drug is used alone.

There was no evidence of drug interactions in clinical studies in which dobutamine was administered concurrently with other drugs, including digitalis preparations, furosemide, spironolactone, lidocaine, nitroglycerin, isosorbide dinitrate, morphine, atropine, heparin, protamine, potassium chloride, folic acid, and acetaminophen.

Carcinogenesis, Mutagenesis, Impairment of Fertility − Studies to evaluate the carcinogenic or mutagenic potential of dobutamine hydrochloride, or its potential to affect fertility, have not been conducted.

Pregnancy – Teratogenic Effects − Reproduction studies performed in rats at doses up to the normal human dose (10 mcg/kg/min for 24 h, total daily dose of 14.4 mg/kg), and in rabbits at doses up to twice the normal human dose, have revealed no evidence of harm to the fetus due to dobutamine hydrochloride. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery − The effect of dobutamine hydrochloride on labor and delivery is unknown.

Nursing Mothers − It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when dobutamine hydrochloride is administered to a nursing woman. If a mother requires dobutamine hydrochloride treatment, breastfeeding should be discontinued for the duration of treatment.

Pediatric Use − The safety and effectiveness of Dobutamine Injection, USP for use in pediatric patients have not been studied.

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 (see WARNINGS regarding exaggerated chronotropic and pressor effects). 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, anginal pain, nonspecific chest pain, palpitations, and shortness of breath. Isolated cases of thrombocytopenia have been reported.

Administration of dobutamine hydrochloride, like other catecholamines, can produce a mild reduction in serum potassium concentration, rarely to hypokalemic levels (see PRECAUTIONS).

Longer-Term Safety − Infusions of up to 72 hours have revealed no adverse effects other than those seen with shorter infusions.

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 (T= 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.

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). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.

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.

Note − Do not add Dobutamine Injection, USP to 5% Sodium Bicarbonate Injection or to any other strongly alkaline solution. Because of potential physical incompatibilities, it is recommended that dobutamine hydrochloride not be mixed with other drugs in the same solution. Dobutamine hydrochloride should not be used in conjunction with other agents or diluents containing both sodium bisulfite and ethanol.

Preparation and Stability − At the time of administration, Dobutamine Injection, USP must be further diluted in an intravenous container to at least a 50 mL solution using one of the following intravenous solutions as a diluent: 5% Dextrose Injection, USP; 5% Dextrose and 0.45% Sodium Chloride Injection, USP; 5% Dextrose and 0.9% Sodium Chloride Injection, USP; 10% Dextrose Injection, USP; Isolyte M with 5% Dextrose Injection; Lactated Ringer's Injection; 5% Dextrose in Lactated Ringer's Injection; Normosol-M in D5-W; 20% Osmitrol in Water for Injection; 0.9% Sodium Chloride Injection, USP; or Sodium Lactate Injection, USP. Intravenous solutions should be used within 24 hours.

Recommended Dosage − The rate of infusion needed to increase cardiac output usually ranged from 2.5 to 15 mcg/kg/min (see Table 1). On rare occasions, infusion rates up to 40 mcg/kg/min have been required to obtain the desired effect.

Rates of infusion in mL/h for Dobutamine concentrations of 500 mcg/mL, 1,000 mcg/mL, and 2,000 mcg/mL are given in Table 2.

The rate of administration and the duration of therapy should be adjusted according to the patient's response as determined by heart rate, presence of ectopic activity, blood pressure, urine flow, and, whenever possible, measurement of central venous or pulmonary wedge pressure and cardiac output.

Concentrations of up to 5,000 mcg/mL have been administered to humans (250 mg/50 mL). The final volume administered should be determined by the fluid requirements of the patient.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Table 1 Dobutamine Infusion Rate (mL/kg/min) for Concentrations of 250, 500, and 1,000 mcg/mL
Drug Delivery
Rate
Infusion Delivery Rate
250 mcg/mL* 500 mcg/mL† 1,000 mcg/mL‡
(mcg/kg/min) (mL/kg/min) (mL/kg/min) (mL/kg/min)
2.5 0.01 0.005 0.0025
5 0.02 0.01 0.005
7.5 0.03 0.015 0.0075
10 0.04 0.02 0.01
12.5 0.05 0.025 0.0125
15 0.06 0.03 0.015
* 250 mcg/mL of diluent
† 500 mcg/mL or 250 mg/500 mL of diluent
‡ 1,000 mcg/mL or 250 mg/250 mL of diluent
Table 2
Drug Delivery
Rate
(mcg/kg/min)
Dobutamine Infusion Rate (mL/h) for 500 mcg/mL concentration
Patient Body Weight (kg)
 
30 40 50 60 70 80 90 100 110
2.5 9 12 15 18 21 24 27 30 33
5 18 24 30 36 42 48 54 60 66
7.5 27 36 45 54 63 72 81 90 99
10 36 48 60 72 84 96 108 120 132
12.5 45 60 75 90 105 120 135 150 165
15 54 72 90 108 126 144 162 180 198
 
Drug Delivery
Rate
(mcg/kg/min)
Dobutamine Infusion Rate (mL/h) for 1,000 mcg/mL concentration
Patient Body Weight (kg)
 
30 40 50 60 70 80 90 100 110
2.5 4.5 6 7.5 9 10.5 12 13.5 15 16.5
5 9 12 15 18 21 24 27 30 33
7.5 13.5 18 22.5 27 31.5 36 40.5 45 49.5
10 18 24 30 36 42 48 54 60 66
12.5 22.5 30 37.5 45 52.5 60 67.5 75 82.5
15 27 36 45 54 63 72 81 90 99
 
Drug Delivery
Rate
(mcg/kg/min)
Dobutamine Infusion Rate (mL/h) for 2000 mcg/mL concentration
Patient Body Weight (kg)
 
30 40 50 60 70 80 90 100 110
2.5 2 3 4 4.5 5 6 7 7.5 8
5 4.5 6 7.5 9 10.5 12 13.5 15 16.5
7.5 7 9 11 13.5 16 18 20 22.5 25
10 9 12 15 18 21 24 27 30 33
12.5 11 15 19 22.5 26 30 34 37.5 41
15 13.5 18 22.5 27 31.5 36 40.5 45 49.5

Dobutamine Injection, USP is supplied in 20 mL single-dose glass vials containing 250 mg dobutamine, as the hydrochloride as follows:

Unit of Sale Concentration Each
NDC 0409-2344-01
Carton containing 1 Vial
250 mg/20 mL
(12.5 mg/mL)
NDC 0409-2344-01
20 mL Single-Dose Vial
NDC 0409-2344-02
Tray containing 10 Vials
250 mg/20 mL
(12.5 mg/mL)
NDC 0409-2344-62
20 mL Single-Dose Vial

Store at 20 to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

LAB-1055-3.0

11/2017

20 mL Single-dose Fliptop Vial

DOBUTamine Injection, USP

250 mg/20 mL (12.5 mg/mL)

MUST BE DILUTED PRIOR TO USE. FOR INTRAVENOUS USE ONLY.

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

NDC 0409-2344-01

20 mL Single-dose Fliptop Vial

DOBUTamine Injection, USP

250 mg/20 mL (12.5 mg/mL)

MUST BE DILUTED PRIOR TO USE.FOR INTRAVENOUS USE ONLY.

Rx only

Hospira

MADE IN ITALYDistributed by Hospira, Inc.,Lake Forest, IL 60045 USA

10 Units/NDC 0409-2344-01

20 mL Single-dose Fliptop Vials

DOBUTamine Injection, USP

250 mg/20 mL (12.5 mg/mL)Rx only

MUST BE DILUTED PRIOR TO USE. FOR INTRAVENOUS USE ONLY.

Hospira

20 mL Single-dose Fliptop Vial

DOBUTamine Injection, USP

250 mg/20 mL (12.5 mg/mL)

MUST BE DILUTED PRIOR TO USE.FOR INTRAVENOUS USE ONLY.

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

NDC 0409-2344-02

20 mL Single-dose10 Fliptop Vials

DOBUTamine Injection, USP

250 mg/20 mL (12.5 mg/mL)Rx only

MUST BE DILUTED PRIOR TO USE. FOR INTRAVENOUS USE ONLY.

Hospira

Manufacturer

Hospira, Inc.

Active Ingredients

Source

Clinical Trials [74 Associated Clinical Trials listed on BioPortfolio]

Levosimendan Versus Dobutamine in Shock Patients

The purpose of the study is to compare the efficacy of levosimendan with that of dobutamine in patients with unstable hemodynamics (shock).

Comparison of Dobutamine and Regadenoson Stress Cardiac Magnetic Resonance (MR)

The goal of this research is to determine the utility of Regadenoson (Lexiscan)for use as an imaging agent with cardiac MR. If found useful, it will help us establish a protocol for regade...

Dobutamine Echocardiography In Patients With Ischemic Heart Failure Evaluated for Revascularization

To define the role of the assessment of myocardial viability with dobutamine echocardiography (DE) in the clinical evaluation and selection of the best treatment for a high-risk subset of ...

Dobutamine Versus Placebo for Low Superior Vena Cava Flow in Newborns

Low systemic flow as measured by Doppler-echocardiography has been associated with poor neurological outcome. Yet, it has not been systematically evaluated whether the treatment of this he...

Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support: a Multicentre, Parallel-Group, Randomised, Double-Blind, Double-Dummy Study of Levosimendan Versus Dobutamine in Patients With Acute Heart Failure.

The primary objective of the study is to compare the efficacy of levosimendan and dobutamine on all-cause mortality in the 180 days following randomization.

PubMed Articles [17 Associated PubMed Articles listed on BioPortfolio]

Diagnostic Performance of Dobutamine Stress Echocardiography in End-Stage Liver Disease.

This study determined the test performance of dobutamine stress echocardiography (DSE) in end-stage liver disease (ESLD).

Anatomical location, sex, and age influence murine arterial circumferential cyclic strain before and during dobutamine infusion.

One of the primary biomechanical factors influencing arterial health is their deformation across the cardiac cycle, or cyclic strain, which is often associated with arterial stiffness. Deleterious cha...

Diagnostic accuracy of dobutamine stress echocardiography in the detection of cardiac allograft vasculopathy in heart transplant recipients: A systematic review and meta-analysis study.

Dobutamine stress echocardiography (DSE) is a well-established imaging modality used to screen patients with mild-to-moderate risk for coronary artery disease. In heart transplantation recipients, car...

Left ventricular blood flow patterns at rest and under dobutamine stress in healthy pigs.

Intracardiac blood flow patterns are affected by the morphology of cardiac structures and are set up to support the heart's pump function. Exercise affects contractility and chamber size as well as pr...

Effects of hypoxia-ischemia and inotropes on expression of cardiac adrenoceptors in the preterm fetal sheep.

Preterm infants frequently suffer cardiovascular compromise, with hypotension and/or low systemic blood flow, leading to tissue hypoxia-ischemia (HI). Many preterm infants respond inadequately to inot...

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