NDC 0338-1075 Dobutamine Hydrochloride In Dextrose
Dobutamine Hydrochloride Injection Intravenous

Product Information

What is NDC 0338-1075?

The NDC code 0338-1075 is assigned by the FDA to the product Dobutamine Hydrochloride In Dextrose which is a human prescription drug product labeled by Baxter Healthcare Corporation. The generic name of Dobutamine Hydrochloride In Dextrose is dobutamine hydrochloride. The product's dosage form is injection and is administered via intravenous form. The product is distributed in a single package with assigned NDC code 0338-1075-02 18 bag in 1 carton / 250 ml in 1 bag. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0338-1075
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Dobutamine Hydrochloride In Dextrose
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Dobutamine Hydrochloride
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Prescription Drug
Dosage FormInjection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Intravenous - Administration within or into a vein or veins.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Baxter Healthcare Corporation
Labeler Code0338
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
NDA020255
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
09-27-1993
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Dobutamine Hydrochloride In Dextrose?


Product Packages

NDC Code 0338-1075-02

Package Description: 18 BAG in 1 CARTON / 250 mL in 1 BAG

Product Details

What are Dobutamine Hydrochloride In Dextrose Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • DOBUTAMINE HYDROCHLORIDE 200 mg/100mL - A catecholamine derivative with specificity for BETA-1 ADRENERGIC RECEPTORS. It is commonly used as a cardiotonic agent after CARDIAC SURGERY and during DOBUTAMINE STRESS ECHOCARDIOGRAPHY.

Dobutamine Hydrochloride In Dextrose Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Dobutamine Hydrochloride In Dextrose Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Dobutamine Hydrochloride In Dextrose Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Description



Dobutamine Hydrochloride in 5% Dextrose Injection is a sterile, nonpyrogenic solution of Dobutamine Hydrochloride, USP and Dextrose, USP in Water for Injection, USP. Dobutamine hydrochloride is chemically designated as (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose Hydrous, USP is chemically designated as D-Glucopyranose monohydrate. Structural formulas are shown below:

Dobutamine Hydrochloride, USP (D-Glucopyranose monohydrate) Dextrose Hydrous, USP

Dobutamine Hydrochloride in 5% Dextrose Injection is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide and/or hydrochloric acid. Sodium bisulfite is added as a stabilizer. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition, osmolarity, pH and caloric content are given in Table 1.

Table 1. Composition

Approximately 5 mEq/L sodium bisulfite is added as a stabilizer.

Dobutamine Hydrochloride in 5% Dextrose Injection.

Dobutamine (mg/Container)

Dobutamine (mcg/mL)

Dextrose Hydrous, USP (g/L)

Osmolarity (mOsmol/L) (calc)

Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage.

pH

kcal/L

250 mg/250 mL

1000

50

259

3.5
(2.5 to 5.5)

170

500 mg/250 mL

2000

50

266

3.5
(2.5 to 5.5)

170

1000 mg/250 mL

4000

50

280

3.5
(2.5 to 5.5)

170

This VIAFLEX PLUS plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX PLUS containers, are made of flexible plastic and are for parenteral use. VIAFLEX PLUS on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.


Clinical Pharmacology



Dobutamine hydrochloride is a direct-acting inotropic agent whose primary activity results from stimulation of the beta-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 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 and isoproterenol increase the cardiac output to a similar degree. In the case of dobutamine, 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. Occasionally, minimum vasoconstriction has been observed.

Most clinical experience with dobutamine 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 one to two minutes; however, as much as ten minutes may be required to obtain the peak effect of a particular infusion rate.

The plasma half-life of dobutamine in humans is two 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 are not dependent on presynaptic mechanisms.

The effective infusion rate of dobutamine varies widely from patient to patient, and titration is always necessary (see DOSAGE AND ADMINISTRATION). At least in pediatric patients, dobutamine-induced increases in cardiac output and systemic pressure are generally seen, in any given patient, at lower infusion rates than those that cause substantial tachycardia (see PRECAUTIONS, Pediatric Use).

Dextrose provides a source of calories. Dextrose is readily metabolized, may decrease losses of body protein and nitrogen, promotes glycogen deposition and decreases or prevents ketosis if sufficient doses are provided.


Indications And Usage



Dobutamine 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.

Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.


Contraindications



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.


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 D5W.


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. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Solutions containing dextrose should not be administered through the same administration set as blood, as this may result in pseudoagglutination or hemolysis.

The intravenous administration of solutions may cause fluid overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration of the injections.

Excess administration of potassium-free solutions may result in significant hypokalemia.


General



During the administration of Dobutamine Hydrochloride in 5% Dextrose Injection, as with any adrenergic agent, ECG and blood pressure should be continuously monitored. In addition, pulmonary wedge pressure and cardiac output should be monitored whenever possible to aid in the safe and effective infusion of dobutamine.

Hypovolemia should be corrected with suitable volume expanders before treatment with dobutamine is instituted.

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

No improvement may be observed in the presence of marked mechanical obstruction, such as severe valvular aortic stenosis.

Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus.

Do not administer unless solution is clear and seal is intact.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.


Usage Following Acute Myocardial Infarction



Clinical experience with dobutamine 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 does so.


Drug Interactions



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, glyceryl trinitrate, isosorbide dinitrate, morphine, atropine, heparin, protamine, potassium chloride, folic acid, and acetaminophen. 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.


Carcinogenesis, Mutagenesis, Impairment Of Fertility



Studies to evaluate the carcinogenic or mutagenic potential of dobutamine or the potential of the drug to affect fertility adversely have not been performed.


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.


Pediatric Use



Dobutamine has been shown to increase cardiac output and systemic pressure in pediatric patients of every age group. In premature neonates, however, dobutamine is less effective than dopamine in raising systemic blood pressure without causing undue tachycardia, and dobutamine has not been shown to provide any added benefit when given to such infants already receiving optimal infusions of dopamine.


Geriatric Use



Clinical studies of dobutamine injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.


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.


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.


Overdosage



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). 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. 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 hemoperfusion have not been established as beneficial for an overdose of dobutamine.




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.

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.

Do not add supplementary medications to Dobutamine Hydrochloride in 5% Dextrose Injection. Do not administer Dobutamine Hydrochloride in 5% Dextrose Injection simultaneously with solutions containing sodium bicarbonate or strong alkaline solutions.


How Supplied



Dobutamine Hydrochloride in 5% Dextrose Injection in VIAFLEX PLUS plastic containers is available as follows:

2B0791 Dobutamine 250 mg/250 mL NDC 0338-1073-02

2B0792 Dobutamine 500 mg/250 mL NDC 0338-1075-02

2B0793 Dobutamine 1000 mg/250 mL NDC 0338-1077-02

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.


Directions For Use Of Viaflex Plus Plastic Container



Do not remove unit from overwrap until ready for use.


To Open



Tear overwrap down side at notch and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.


Preparation For Administration



Visually inspect the container. If the administration port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired.

Caution: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.

  • 1.Suspend container from eyelet support.
  • 2.Remove plastic protector from administration port at bottom of container.
  • 3.Attach administration set. Refer to complete directions accompanying set.
  • Table 2. Infusion Rate (mL/hr) of Dobutamine Hydrochloride in 5% Dextrose Injection.

    1000 mcg/mL Patient's Weight (kg)

    Drug Delivery Rate (mcg/kg/min)

    5

    10

    20

    30

    40

    50

    60

    70

    80

    90

    100

    110

    0.5

    0.15

    0.30

    0.60

    0.90

    1.2

    1.5

    1.8

    2.1

    2.4

    2.7

    3.0

    3.3

    1

    0.30

    0.60

    1.2

    1.8

    2.4

    3.0

    3.6

    4.2

    4.8

    5.4

    6.0

    6.6

    2.5

    0.75

    1.5

    3.0

    4.5

    6.0

    7.5

    9.0

    11

    12

    14

    15

    17

    5

    1.5

    3.0

    6.0

    9.0

    12

    15

    18

    21

    24

    27

    30

    33

    7.5

    2.3

    4.5

    9.0

    14

    18

    23

    27

    32

    36

    41

    45

    50

    10

    3.0

    6.0

    12

    18

    24

    30

    36

    42

    48

    54

    60

    66

    12.5

    3.8

    7.5

    15

    23

    30

    38

    45

    53

    60

    68

    75

    83

    15

    4.5

    9.0

    18

    27

    36

    45

    54

    63

    72

    81

    90

    99

    17.5

    5.3

    11

    21

    32

    42

    53

    63

    74

    84

    95

    105

    116

    20

    6.0

    12

    24

    36

    48

    60

    72

    84

    96

    108

    120

    132

     

    2000 mcg/mL Patient's Weight (kg)

    Drug Delivery Rate (mcg/kg/min)

    5

    10

    20

    30

    40

    50

    60

    70

    80

    90

    100

    110

    0.5

    0.08

    0.15

    0.30

    0.45

    0.60

    0.75

    0.90

    1.1

    1.2

    1.4

    1.5

    1.7

    1

    0.15

    0.30

    0.60

    0.90

    1.2

    1.5

    1.8

    2.1

    2.4

    2.7

    3.0

    3.3

    2.5

    0.38

    0.75

    1.5

    2.3

    3.0

    3.8

    4.5

    5.3

    6.0

    6.8

    7.5

    8.3

    5

    0.75

    1.5

    3.0

    4.5

    6.0

    7.5

    9.0

    11

    12

    14

    15

    17

    7.5

    1.1

    2.3

    4.5

    6.8

    9.0

    11

    14

    16

    18

    20

    23

    25

    10

    1.5

    3.0

    6.0

    9.0

    12

    15

    18

    21

    24

    27

    30

    33

    12.5

    1.9

    3.8

    7.5

    11

    15

    19

    23

    26

    30

    34

    38

    41

    15

    2.3

    4.5

    9.0

    14

    18

    23

    27

    32

    36

    41

    45

    50

    17.5

    2.6

    5.3

    11

    16

    21

    26

    32

    37

    42

    47

    53

    58

    20

    3.0

    6.0

    12

    18

    24

    30

    36

    42

    48

    54

    60

    66

     

    4000 mcg/mL Patient's Weight (kg)

    Drug Delivery Rate (mcg/kg/min)

    5

    10

    20

    30

    40

    50

    60

    70

    80

    90

    100

    110

    0.5

    0.04

    0.08

    0.15

    0.23

    0.30

    0.38

    0.45

    0.53

    0.60

    0.68

    0.75

    0.83

    1

    0.08

    0.15

    0.30

    0.45

    0.60

    0.75

    0.90

    1.1

    1.2

    1.4

    1.5

    1.7

    2.5

    0.19

    0.38

    0.75

    1.1

    1.5

    1.9

    2.3

    2.6

    3.0

    3.4

    3.8

    4.1

    5

    0.38

    0.75

    1.5

    2.3

    3.0

    3.8

    4.5

    5.3

    6.0

    6.8

    7.5

    8.3

    7.5

    0.56

    1.1

    2.3

    3.4

    4.5

    5.6

    6.8

    7.9

    9.0

    10

    11

    12

    10

    0.75

    1.5

    3.0

    4.5

    6.0

    7.5

    9.0

    11

    12

    14

    15

    17

    12.5

    0.94

    1.9

    3.8

    5.6

    7.5

    9.4

    11

    13

    15

    17

    19

    21

    15

    1.1

    2.3

    4.5

    6.8

    9.0

    11

    14

    16

    18

    20

    23

    25

    17.5

    1.3

    2.6

    5.3

    7.9

    11

    13

    16

    18

    21

    24

    26

    29

    20

    1.5

    3.0

    6.0

    9.0

    12

    15

    18

    21

    24

    27

    30

    33


Other



Baxter, Viaflex and Viaflex Plus are trademarks of Baxter International Inc.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Printed in USA

7-19-00-0138
Rev. October 2017


Principal Display Panel - Packaging Labeling



Container Label

LOT

EXP

NDC 0338-1073-02

DOBUTamine

Dobutamine Hydrochloride in
5% Dextrose Injection

250 mg
per
250 mL
(1,000 mcg / mL)

250 ml Sterile single dose
container Each 100 mL contains
Dobutamine HCl USP equivalent to
100 mg Dobutamine and 5 g
Dextrose Hydrous USP 5 mEq/L
Sodium Bisulfite added as a
stabilizer pH 3.5 (2.5 to 5.5)
Osmolarity 259 mOsmol/L (CALC)
Usual Dosage See Insert
Do not add supplementary medication
Store in moisture and oxygen
barrier overwrap at room
temperature (77°F or 25°C) until
ready to use Rx Only

Baxter Logo
USA

2B0791

Carton Label
  •  Lot: T123456 Exp: JAN 9999

    QTY: 18-250 mL Code: 2B0791
    NDC 0338-1073-02
  • DOBUTamine 250mg per 250mL
    Dextrose 5% INJ

    Bar Code
    (01)50303381073027(17)990100(21)000000000071(10)T123456

    08/12/216 04:53:57 PALIS#2

    (01)50303381073027
    (17)990100
    (21)000000000071
    (10)T123456

    Container Label

    LOT

    EXP

    NDC 0338-1075-02

    DOBUTamine

    Dobutamine Hydrochloride in
    5% Dextrose Injection

    500 mg
    per
    250 mL
    (2,000 mcg / mL)

    250 ml Sterile single dose
    container Each 100 mL contains
    Dobutamine HCl USP equivalent to
    200 mg Dobutamine and 5 g
    Dextrose Hydrous USP 5 mEq/L
    Sodium Bisulfite added as a
    stabilizer pH 3.5 (2.5 to 5.5)
    Osmolarity 266 mOsmol/L (CALC)
    Usual Dosage See Insert
    Do not add supplementary medication
    Store in moisture and oxygen
    barrier overwrap at room
    temperature (77°F or 25°C) until
    ready to use Rx Only

    Baxter Logo
    USA

    2B0792

    Carton Label
    •  Lot: T123456 Exp: JAN 9999
    •  QTY: 18-250 mL Code: 2B0792
    • NDC 0338-1075-02

      DOBUTamine 500mg per 250mL

      Dextrose 5% INJ

      Bar Code

      (01)50303381075021(17)990100(21)000000000004(10)T123456

      08/12/216 04:55:25 PALIS#2

      (01)50303381075021
      (17)990100
      (21)000000000004
      (10)T123456

      Container Label

      LOT

      EXP

      NDC 0338-1077-02

      DOBUTamine

      Dobutamine Hydrochloride in
      5% Dextrose Injection

      1,000 mg
      per
      250 mL
      (4,000 mcg / mL)

      250 ml Sterile single dose
      container Each 100 mL contains
      Dobutamine HCl USP equivalent to
      400 mg Dobutamine and 5 g
      Dextrose Hydrous USP 5 mEq/L
      Sodium Bisulfite added as a
      stabilizer pH 3.5 (2.5 to 5.5)
      Osmolarity 280 mOsmol/L (CALC)
      Usual Dosage See Insert
      Do not add supplementary medication
      Store in moisture and oxygen
      barrier overwrap at room
      temperature (77°F or 25°C) until
      ready to use Rx Only

      Baxter Logo
      USA

      2B0793

      Carton Label Container Label

      LOT

      EXP

      NDC 0338-1073-02

      DOBUTamine

      Dobutamine Hydrochloride in
      5% Dextrose Injection

      250 mg
      per
      250 mL
      (1,000 mcg / mL)

      250 ml Sterile single dose
      container Each 100 mL contains
      Dobutamine HCl USP equivalent to
      100 mg Dobutamine and 5 g
      Dextrose Hydrous USP 5 mEq/L
      Sodium Bisulfite added as a
      stabilizer pH 3.5 (2.5 to 5.5)
      Osmolarity 259 mOsmol/L (CALC)
      Usual Dosage See Insert
      Do not add supplementary medication
      Store in moisture and oxygen
      barrier overwrap at room
      temperature (77°F or 25°C) until
      ready to use Rx Only

      Baxter Logo
      USA

      2B0791

      Carton Label
      •  Lot: T123456 Exp: JAN 9999

        QTY: 18-250 mL Code: 2B0791
        NDC 0338-1073-02
      • DOBUTamine 250mg per 250mL
        Dextrose 5% INJ

        Bar Code
        (01)50303381073027(17)990100(21)000000000071(10)T123456

        08/12/216 04:53:57 PALIS#2

        (01)50303381073027
        (17)990100
        (21)000000000071
        (10)T123456

        Container Label

        LOT

        EXP

        NDC 0338-1075-02

        DOBUTamine

        Dobutamine Hydrochloride in
        5% Dextrose Injection

        500 mg
        per
        250 mL
        (2,000 mcg / mL)

        250 ml Sterile single dose
        container Each 100 mL contains
        Dobutamine HCl USP equivalent to
        200 mg Dobutamine and 5 g
        Dextrose Hydrous USP 5 mEq/L
        Sodium Bisulfite added as a
        stabilizer pH 3.5 (2.5 to 5.5)
        Osmolarity 266 mOsmol/L (CALC)
        Usual Dosage See Insert
        Do not add supplementary medication
        Store in moisture and oxygen
        barrier overwrap at room
        temperature (77°F or 25°C) until
        ready to use Rx Only

        Baxter Logo
        USA

        2B0792

        Carton Label
        •  Lot: T123456 Exp: JAN 9999
        •  QTY: 18-250 mL Code: 2B0792
        • NDC 0338-1075-02

          DOBUTamine 500mg per 250mL

          Dextrose 5% INJ

          Bar Code

          (01)50303381075021(17)990100(21)000000000004(10)T123456

          08/12/216 04:55:25 PALIS#2

          (01)50303381075021
          (17)990100
          (21)000000000004
          (10)T123456

          Container Label

          LOT

          EXP

          NDC 0338-1077-02

          DOBUTamine

          Dobutamine Hydrochloride in
          5% Dextrose Injection

          1,000 mg
          per
          250 mL
          (4,000 mcg / mL)

          250 ml Sterile single dose
          container Each 100 mL contains
          Dobutamine HCl USP equivalent to
          400 mg Dobutamine and 5 g
          Dextrose Hydrous USP 5 mEq/L
          Sodium Bisulfite added as a
          stabilizer pH 3.5 (2.5 to 5.5)
          Osmolarity 280 mOsmol/L (CALC)
          Usual Dosage See Insert
          Do not add supplementary medication
          Store in moisture and oxygen
          barrier overwrap at room
          temperature (77°F or 25°C) until
          ready to use Rx Only

          Baxter Logo
          USA

          2B0793

          Carton Label
          •  Lot: T123456 Exp: JAN 9999
          •  QTY: 18-250 mL Code: 2B0793
          • NDC 0338-1077-02

            DOBUTamine 1000mg per 250mL

            Dextrose 5% INJ

            Bar Code

            (01)50303381077025(17)990100(21)000000000015(10)T123456

            08/12/216 04:56:23 PALIS#2

            (01)50303381077025
            (17)990100
            (21)000000000015
            (10)T123456


* Please review the disclaimer below.