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DOBUTamine
Overview
What is DOBUTamine?
Dobutamine Injection, USP is 1,2-benzenediol, 4-[2-[[3-(4-hydro-xyphenyl)-1-methylpropyl]amino]ethyl]-hydrochloride, (±). It is a synthetic catecholamine.
Molecular Formula: CHNO∙HCl Molecular Weight: 337.85
The clinical formulation is supplied in a sterile form for intravenous use only. Each mL contains: Dobutamine hydrochloride, equivalent to 12.5 mg (41.5 µmol) dobutamine; 0.24 mg sodium metabisulfite (added during manufacture), and water for injection. pH adjusted between 2.5 to 5.5 with hydrochloric acid and/or sodium hydroxide. Dobutamine is oxygen sensitive.
What does DOBUTamine look like?
What are the available doses of DOBUTamine?
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What should I talk to my health care provider before I take DOBUTamine?
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How should I use DOBUTamine?
Dobutamine injection is indicated when parenteral therapy is necessary for inotropic support in the 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.
Note
Preparation and Stability
Recommended Dosage
Rates of infusion in mL/h for Dobutamine Injection concentrations of 500 mcg/mL, 1000 mcg/mL, and 2000 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.
What interacts with DOBUTamine?
Dobutamine hydrochloride is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and in patients who have shown previous manifestations of hypersensitivity to dobutamine injection.
What are the warnings of DOBUTamine?
Effective contraception must be used by all females during tretinoin capsules therapy and for 1 month following discontinuation of therapy. Contraception must be used even when there is a history of infertility or menopause, unless a hysterectomy has been performed. Whenever contraception is required, it is recommended that two reliable forms of contraception be used simultaneously, unless abstinence is the chosen method. If pregnancy does occur during treatment, the physician and patient should discuss the desirability of continuing or terminating the pregnancy.
1. Increase in Heart Rate or Blood Pressure
Dobutamine may cause a marked increase in heart rate or blood pressure, especially systolic pressure. Approximately 10% of 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 promptly 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.
2. Ectopic Activity
Dobutamine may precipitate or exacerbate ventricular ectopic activity, but it rarely has caused ventricular tachycardia.
3. Hypersensitivity
Reactions suggestive of hypersensitivity associated with administration of dobutamine injection, including skin rash, fever, eosinophilia, and bronchospasm, have been reported occasionally.
4. Dobutamine injection contains sodium metabisulfite, 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?
General
1. During the administration of dobutamine 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 hydrochloride.
2. Hypovolemia should be corrected with suitable volume expanders before treatment with dobutamine is instituted.
3. No improvement may be observed in the presence of marked mechanical obstruction, such as severe valvular aortic stenosis.
Usage Following Acute Myocardial Infarction
Laboratory Tests
Drug Interactions
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
Pregnancy-Teratogenic Effects-Pregnancy Category B
Labor and Delivery
Nursing Mothers
Pediatric Use
What are the side effects of DOBUTamine?
Hypotension
Reactions at Sites of Intravenous Infusion
Miscellaneous Uncommon Effects
Isolated cases of thrombocytopenia have been reported.
Administration of dobutamine, like other catecholamines, can produce a mild reduction in serum potassium concentration, rarely to hypokalemic levels (see PRECAUTIONS).
Longer-Term Safety
What should I look out for while using DOBUTamine?
Dobutamine hydrochloride is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and in patients who have shown previous manifestations of hypersensitivity to dobutamine injection.
1. Increase in Heart Rate or Blood Pressure
Dobutamine may cause a marked increase in heart rate or blood pressure, especially systolic pressure. Approximately 10% of 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 promptly 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.
2. Ectopic Activity
Dobutamine may precipitate or exacerbate ventricular ectopic activity, but it rarely has caused ventricular tachycardia.
3. Hypersensitivity
Reactions suggestive of hypersensitivity associated with administration of dobutamine injection, including skin rash, fever, eosinophilia, and bronchospasm, have been reported occasionally.
4. Dobutamine injection contains sodium metabisulfite, 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?
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
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. 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 emisis of 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?
Storage and StabilitySIMPONI ARIA must be refrigerated at 2º C to 8º C (36º F to 46º F) and protected from light. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake.Storage and StabilitySIMPONI ARIA must be refrigerated at 2º C to 8º C (36º F to 46º F) and protected from light. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake.Dobutamine Injection, USP, 12.5 mg/mL is available as:20 mL Single-Dose Vials containing 250 mg dobutamine (as the hydrochloride), boxes of 10 (List 2025).40 mL Single-Dose Vials containing 500 mg dobutamine (as the hydrochloride), boxes of 10 (List 2025).Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: October, 2004.©Hospira 2004 EN-0623 Printed in USAHOSPIRA, INC., LAKE FOREST, IL 60045 USADobutamine Injection, USP, 12.5 mg/mL is available as:20 mL Single-Dose Vials containing 250 mg dobutamine (as the hydrochloride), boxes of 10 (List 2025).40 mL Single-Dose Vials containing 500 mg dobutamine (as the hydrochloride), boxes of 10 (List 2025).Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: October, 2004.©Hospira 2004 EN-0623 Printed in USAHOSPIRA, INC., LAKE FOREST, IL 60045 USADobutamine Injection, USP, 12.5 mg/mL is available as:20 mL Single-Dose Vials containing 250 mg dobutamine (as the hydrochloride), boxes of 10 (List 2025).40 mL Single-Dose Vials containing 500 mg dobutamine (as the hydrochloride), boxes of 10 (List 2025).Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: October, 2004.©Hospira 2004 EN-0623 Printed in USAHOSPIRA, INC., LAKE FOREST, IL 60045 USADobutamine Injection, USP, 12.5 mg/mL is available as:20 mL Single-Dose Vials containing 250 mg dobutamine (as the hydrochloride), boxes of 10 (List 2025).40 mL Single-Dose Vials containing 500 mg dobutamine (as the hydrochloride), boxes of 10 (List 2025).Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: October, 2004.©Hospira 2004 EN-0623 Printed in USAHOSPIRA, INC., LAKE FOREST, IL 60045 USADobutamine Injection, USP, 12.5 mg/mL is available as:20 mL Single-Dose Vials containing 250 mg dobutamine (as the hydrochloride), boxes of 10 (List 2025).40 mL Single-Dose Vials containing 500 mg dobutamine (as the hydrochloride), boxes of 10 (List 2025).Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: October, 2004.©Hospira 2004 EN-0623 Printed in USAHOSPIRA, INC., LAKE FOREST, IL 60045 USADobutamine Injection, USP, 12.5 mg/mL is available as:20 mL Single-Dose Vials containing 250 mg dobutamine (as the hydrochloride), boxes of 10 (List 2025).40 mL Single-Dose Vials containing 500 mg dobutamine (as the hydrochloride), boxes of 10 (List 2025).Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: October, 2004.©Hospira 2004 EN-0623 Printed in USAHOSPIRA, INC., LAKE FOREST, IL 60045 USADobutamine Injection, USP, 12.5 mg/mL is available as:20 mL Single-Dose Vials containing 250 mg dobutamine (as the hydrochloride), boxes of 10 (List 2025).40 mL Single-Dose Vials containing 500 mg dobutamine (as the hydrochloride), boxes of 10 (List 2025).Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: October, 2004.©Hospira 2004 EN-0623 Printed in USAHOSPIRA, INC., LAKE FOREST, IL 60045 USA
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Dobutamine is a direct-acting inotropic agent whose primary activity results from stimulation of the ß 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 -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 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.
Non-Clinical Toxicology
Dobutamine hydrochloride is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and in patients who have shown previous manifestations of hypersensitivity to dobutamine injection.1. Increase in Heart Rate or Blood Pressure
Dobutamine may cause a marked increase in heart rate or blood pressure, especially systolic pressure. Approximately 10% of 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 promptly 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.
2. Ectopic Activity
Dobutamine may precipitate or exacerbate ventricular ectopic activity, but it rarely has caused ventricular tachycardia.
3. Hypersensitivity
Reactions suggestive of hypersensitivity associated with administration of dobutamine injection, including skin rash, fever, eosinophilia, and bronchospasm, have been reported occasionally.
4. Dobutamine injection contains sodium metabisulfite, 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.
Nifedipine is mainly eliminated by metabolism and is a substrate of CYP3A. Inhibitors and inducers of CYP3A can impact the exposure to nifedipine and consequently its desirable and undesirable effects. and data indicate that nifedipine can inhibit the metabolism of drugs that are substrates of CYP3A, thereby increasing the exposure to other drugs. Nifedipine is a vasodilator, and coadministration of other drugs affecting blood pressure may result in pharmacodynamic interactions.
General
1. During the administration of dobutamine 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 hydrochloride.
2. Hypovolemia should be corrected with suitable volume expanders before treatment with dobutamine is instituted.
3. No improvement may be observed in the presence of marked mechanical obstruction, such as severe valvular aortic stenosis.
Usage Following Acute Myocardial Infarction
Laboratory Tests
Drug Interactions
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
Pregnancy-Teratogenic Effects-Pregnancy Category B
Labor and Delivery
Nursing Mothers
Pediatric Use
Hypotension
Reactions at Sites of Intravenous Infusion
Miscellaneous Uncommon Effects
Isolated cases of thrombocytopenia have been reported.
Administration of dobutamine, like other catecholamines, can produce a mild reduction in serum potassium concentration, rarely to hypokalemic levels (see PRECAUTIONS).
Longer-Term Safety
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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