DOBUTamine Hydrochloride in Dextrose

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Overview

What is DOBUTamine Hydrochloride in Dextrose?

Dobutamine in 5% Dextrose Injection, USP is a sterile, nonpyrogenic, prediluted solution of dobutamine hydrochloride and dextrose in water for injection. It is administered by intravenous infusion.

Each 100 mL contains dobutamine hydrochloride equivalent to 100 mg, 200 mg, or 400 mg of dobutamine; dextrose (derived from corn), hydrous 5 g in water for injection, with sodium metabisulfite 25 mg and edetate disodium, dihydrate 10 mg added as stabilizers; osmolar concentration, respectively, 263, 270, or 284 mOsmol/liter (calc.). The pH is 3.0 (2.5 to 5.5). May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Dobutamine in 5% Dextrose Injection, USP is oxygen sensitive.

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

Dextrose, USP is chemically designated D-glucose monohydrate (CHO • HO), a hexose sugar freely soluble in water. It has the following structural formula:

Water for Injection, USP is chemically designated HO.

The flexible plastic container is fabricated from a specially formulated CR3 plastic material. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

What does DOBUTamine Hydrochloride in Dextrose look like?

What are the available doses of DOBUTamine Hydrochloride in Dextrose?

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What should I talk to my health care provider before I take DOBUTamine Hydrochloride in Dextrose?

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How should I use DOBUTamine Hydrochloride in Dextrose?

Dobutamine in 5% Dextrose Injection, USP is indicated when parenteral therapy is necessary for inotropic support in the 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.

Recommended Dosage

Dobutamine in 5% Dextrose Injection, USP 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 to 1.0 µg/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 to 20 µg/kg/min but sometimes slightly outside of this range. On rare occasions, infusion rates up to 40 µg/kg/min have been required to obtain the desired effect.

Rates of infusion in mL/hour for dobutamine hydrochloride concentrations of 500, 1,000, 2,000 and 4,000 mg/L may be calculated using the following formula:



Example calculations for infusion rates are as follows:

Example 1:

                            (mL/h) =                                                                                  500 (µg/mL)

Example 2:

                            (mL/h) =                                                                                2,000 (µg/mL)

This container system may be inappropriate for the dosage requirements of pediatric patients under 30 kg.

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

Dobutamine in 5% Dextrose Injection, USP 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.

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

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

INSTRUCTIONS FOR USE

To Open

Tear outer wrap 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.

Preparation for Administration

(Use aseptic technique)

WARNING: Do not use flexible container in series connections.

What interacts with DOBUTamine Hydrochloride in Dextrose?

Dobutamine in 5% Dextrose Injection, USP is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and in patients who have shown previous manifestations of hypersensitivity to dobutamine or any of its components.

What are the warnings of DOBUTamine Hydrochloride in Dextrose?

Visual DisturbanceDifficulties with accommodation and blurring of vision have been reported with stimulant treatment.

Increase in Heart Rate or Blood Pressure

Dobutamine hydrochloride 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. In patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to institution of therapy with dobutamine. Patients with pre-existing hypertension appear to face an increased risk of developing an exaggerated pressure response.

Ectopic Activity

Dobutamine may precipitate or exacerbate ventricular ectopic activity, but it rarely has caused ventricular tachycardia.

Hypersensitivity

Reactions suggestive of hypersensitivity associated with administration of Dobutamine in 5% Dextrose Injection, USP, including skin rash, fever, eosinophilia, and bronchospasm, have been reported occasionally.

Dobutamine in 5% Dextrose Injection, USP 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.

What are the precautions of DOBUTamine Hydrochloride in Dextrose?

General

During the administration of dobutamine, 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 in 5% Dextrose Injection, USP.

Hypovolemia should be corrected with suitable volume expanders before treatment with Dobutamine in 5% Dextrose Injection, USP is instituted.

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.

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

Do not administer unless solution is clear and container is undamaged. Discard unused portion.

Usage Following Acute Myocardial Infarction:

Drug Interactions:

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Pregnancy

Pregnancy Category B:

Pediatric Use:

Geriatric Use:

What are the side effects of DOBUTamine Hydrochloride in Dextrose?

Hypotension:

Reactions at Sites of Intravenous Infusion:

Miscellaneous Uncommon Effects:

Administration of dobutamine, like other catecholamines, has been associated with decreases in serum potassium concentrations, rarely to hypokalemic values (See ).

What should I look out for while using DOBUTamine Hydrochloride in Dextrose?

Dobutamine in 5% Dextrose Injection, USP is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and in patients who have shown previous manifestations of hypersensitivity to dobutamine or any of its components.

Increase in Heart Rate or Blood Pressure

Dobutamine hydrochloride 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. In patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to institution of therapy with dobutamine. Patients with pre-existing hypertension appear to face an increased risk of developing an exaggerated pressure response.

Ectopic Activity

Dobutamine may precipitate or exacerbate ventricular ectopic activity, but it rarely has caused ventricular tachycardia.

Hypersensitivity

Reactions suggestive of hypersensitivity associated with administration of Dobutamine in 5% Dextrose Injection, USP, including skin rash, fever, eosinophilia, and bronchospasm, have been reported occasionally.

Dobutamine in 5% Dextrose Injection, USP 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.

What might happen if I take too much DOBUTamine Hydrochloride in Dextrose?

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:

If the product is ingested, unpredictable absorption may occur from the mouth and the gastrointestinal tract.

The initial actions to be taken in a dobutamine hydrochloride 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 hydrochloride.

How should I store and handle DOBUTamine Hydrochloride in Dextrose?

Store Megestrol acetate oral suspension, USP between 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from heat.DOBUTamine in 5% Dextrose Injection, USP is supplied in 250 and 500 mL LifeCare™ flexible containers as follows:NDC No. 0409-2346-32 – 250 mg DOBUTamine in 5% Dextrose Injection, USP 250 mLNDC No. 0409-2346-34 – 500 mg DOBUTamine in 5% Dextrose Injection, USP 500 mLNDC No. 0409-2347-32 – 500 mg DOBUTamine in 5% Dextrose Injection, USP 250 mLNDC No. 0409-3724-32 – 1000 mg DOBUTamine in 5% Dextrose Injection, USP 250 mLDo not freeze. Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.]Revised: 5/2016 EN-4336Hospira, Inc., Lake Forest, IL 60045 USA DOBUTamine in 5% Dextrose Injection, USP is supplied in 250 and 500 mL LifeCare™ flexible containers as follows:NDC No. 0409-2346-32 – 250 mg DOBUTamine in 5% Dextrose Injection, USP 250 mLNDC No. 0409-2346-34 – 500 mg DOBUTamine in 5% Dextrose Injection, USP 500 mLNDC No. 0409-2347-32 – 500 mg DOBUTamine in 5% Dextrose Injection, USP 250 mLNDC No. 0409-3724-32 – 1000 mg DOBUTamine in 5% Dextrose Injection, USP 250 mLDo not freeze. Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.]Revised: 5/2016 EN-4336Hospira, Inc., Lake Forest, IL 60045 USA DOBUTamine in 5% Dextrose Injection, USP is supplied in 250 and 500 mL LifeCare™ flexible containers as follows:NDC No. 0409-2346-32 – 250 mg DOBUTamine in 5% Dextrose Injection, USP 250 mLNDC No. 0409-2346-34 – 500 mg DOBUTamine in 5% Dextrose Injection, USP 500 mLNDC No. 0409-2347-32 – 500 mg DOBUTamine in 5% Dextrose Injection, USP 250 mLNDC No. 0409-3724-32 – 1000 mg DOBUTamine in 5% Dextrose Injection, USP 250 mLDo not freeze. Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.]Revised: 5/2016 EN-4336Hospira, Inc., Lake Forest, IL 60045 USA DOBUTamine in 5% Dextrose Injection, USP is supplied in 250 and 500 mL LifeCare™ flexible containers as follows:NDC No. 0409-2346-32 – 250 mg DOBUTamine in 5% Dextrose Injection, USP 250 mLNDC No. 0409-2346-34 – 500 mg DOBUTamine in 5% Dextrose Injection, USP 500 mLNDC No. 0409-2347-32 – 500 mg DOBUTamine in 5% Dextrose Injection, USP 250 mLNDC No. 0409-3724-32 – 1000 mg DOBUTamine in 5% Dextrose Injection, USP 250 mLDo not freeze. Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.]Revised: 5/2016 EN-4336Hospira, Inc., Lake Forest, IL 60045 USA DOBUTamine in 5% Dextrose Injection, USP is supplied in 250 and 500 mL LifeCare™ flexible containers as follows:NDC No. 0409-2346-32 – 250 mg DOBUTamine in 5% Dextrose Injection, USP 250 mLNDC No. 0409-2346-34 – 500 mg DOBUTamine in 5% Dextrose Injection, USP 500 mLNDC No. 0409-2347-32 – 500 mg DOBUTamine in 5% Dextrose Injection, USP 250 mLNDC No. 0409-3724-32 – 1000 mg DOBUTamine in 5% Dextrose Injection, USP 250 mLDo not freeze. Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.]Revised: 5/2016 EN-4336Hospira, Inc., Lake Forest, IL 60045 USA

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Dobutamine 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 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 in 5% Dextrose Injection, USP 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 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 are not dependent on presynaptic mechanisms.

The effective infusion rate of dobutamine varies widely from patient to patient, and titration is always necessary (see ). 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 Pediatric Use under ).

Non-Clinical Toxicology

Dobutamine in 5% Dextrose Injection, USP is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and in patients who have shown previous manifestations of hypersensitivity to dobutamine or any of its components.

Increase in Heart Rate or Blood Pressure

Dobutamine hydrochloride 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. In patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to institution of therapy with dobutamine. Patients with pre-existing hypertension appear to face an increased risk of developing an exaggerated pressure response.

Ectopic Activity

Dobutamine may precipitate or exacerbate ventricular ectopic activity, but it rarely has caused ventricular tachycardia.

Hypersensitivity

Reactions suggestive of hypersensitivity associated with administration of Dobutamine in 5% Dextrose Injection, USP, including skin rash, fever, eosinophilia, and bronchospasm, have been reported occasionally.

Dobutamine in 5% Dextrose Injection, USP 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.

Acidifying AgentsGastrointestinal acidifying agents (guanethidine, reserpine, glutamic acid HCl, ascorbic acid, fruit juices, etc.) lower absorption of amphetamines. Urinary acidifying agents (ammonium chloride, sodium acid phosphate, etc.) increase the concentration of the ionized species of the amphetamine molecule, thereby increasing urinary excretion. Both groups of agents lower blood levels and efficacy of amphetamines.

Adrenergic BlockersAdrenergic blockers are inhibited by amphetamines.

Alkalinizing AgentGastrointestinal alkalinizing agents (sodium bicarbonate, etc.) increase absorption of amphetamines. Urinary alkalinizing agents (acetazolamide, some thiazides) increase the concentration of the non-ionized species of the amphetamine molecule, thereby decreasing urinary excretion. Both groups of agents increase blood levels and therefore potentiate the actions of amphetamines.

Antidepressants, TricyclicAmphetamines may enhance the activity of tricyclic or sympathomimetic agents; d-amphetamine with desipramine or protriptyline and possibly other tricyclics cause striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated.

CYP2D6 InhibitorsThe concomitant use of dextroamphetamine sulfate tablets and CYP2D6 inhibitors may increase the exposure of dextroamphetamine sulfate tablets compared to the use of the drug alone and increase the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during dextroamphetamine sulfate tablets initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine sulfate tablets and the CYP2D6 inhibitor [see ]. Examples of CYP2D6 Inhibitors include paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir.

Serotonergic DrugsThe concomitant use of dextroamphetamine sulfate tablets and serotonergic drugs increases the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during dextroamphetamine sulfate tablets initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine sulfate tablets and the concomitant serotonergic drug(s) [see and]. Examples of serotonergic drugs include selective serotonin reuptake inhibitors (SSRI), serotonin norepinephrine reuptake inhibitors (SNRI), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s Wort.

MAO InhibitorsMAOI antidepressants, as well as a metabolite of furazolidone, slow amphetamine metabolism. This slowing potentiates amphetamines, increasing their effect on the release of norepinephrine and other monoamines from adrenergic nerve endings; this can cause headaches and other signs of hypertensive crisis. A variety of neurological toxic effects and malignant hyperpyrexia can occur, sometimes with fatal results.

AntihistaminesAmphetamines may counteract the sedative effect of antihistamines.

AntihypertensivesAmphetamines may antagonize the hypotensive effects of antihypertensives.

ChlorpromazineChlorpromazine blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines, and can be used to treat amphetamine poisoning.

EthosuximideAmphetamines may delay intestinal absorption of ethosuximide.

HaloperidolHaloperidol blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines.

Lithium CarbonateThe stimulatory effects of amphetamines may be inhibited by lithium carbonate.

MeperidineAmphetamines potentiate the analgesic effect of meperidine.

Methenamine TherapyUrinary excretion of amphetamines is increased, and efficacy is reduced, by acidifying agents used in methenamine therapy.

NorepinephrineAmphetamines enhance the adrenergic effect of norepinephrine.

PhenobarbitalAmphetamines may delay intestinal absorption of phenobarbital; co-administration of phenobarbital may produce a synergistic anticonvulsant action.

PhenytoinAmphetamines may delay intestinal absorption of phenytoin; co-administration of phenytoin may produce a synergistic anticonvulsant action.

PropoxypheneIn cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur.

Veratrum AlkaloidsAmphetamines inhibit the hypotensive effect of veratrum alkaloids.

General

During the administration of dobutamine, 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 in 5% Dextrose Injection, USP.

Hypovolemia should be corrected with suitable volume expanders before treatment with Dobutamine in 5% Dextrose Injection, USP is instituted.

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.

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

Do not administer unless solution is clear and container is undamaged. Discard unused portion.

Usage Following Acute Myocardial Infarction:

Drug Interactions:

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Pregnancy

Pregnancy Category B:

Pediatric Use:

Geriatric Use:

Hypotension:

Reactions at Sites of Intravenous Infusion:

Miscellaneous Uncommon Effects:

Administration of dobutamine, like other catecholamines, has been associated with decreases in serum potassium concentrations, rarely to hypokalemic values (See ).

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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