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Dobutamine

(doe byoo' ta meen)

PCaution when used during lactation - Caution when used during pregnancy

Molecule Info

 | See TERMINOLOGY & ABBREVIATIONS |

Indication(s) & Usage

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.

Administration

May be taken with or without food.  May be taken with meals if GI upset occurs.

Overdosage

Symptoms may include anorexia, nausea, vomiting, tremor, anxiety, palpitations, headache, shortness of breath, and anginal and nonspecific chest pain.  Treatment includes discontinuing drug admin, establishing an airway, ensuring oxygenation and ventilation.  Initiate resuscitative measures immediately.  Severe ventricular tachyarrhythmias may be treated with propranolol or lidocaine.  Hypertension usually responds to dose reduction or therapy discontinuation.

Contraindications

Hypersensitivity; idiopathic hypertrophic subaortic stenosis.

Warnings

  • 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 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 hydrochloride facilitates atrioventricular conduction, patients with atrial fibrillation are at risk of developing rapid ventricular response. Patients with pre-existing hypertension appear to face an increased risk of developing an exaggerated pressor response.

  • Ectopic Activity

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

  • Hypersensitivity

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

  • Dobutamine Injection, USP 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.

Precautions

General

  1. During the administration of Dobutamine Injection, USP, 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 hydrochloride 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 - 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 ß2-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 - Pregnancy Category B. 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.

Adverse Drug Reaction(s)

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.

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

Drug Interactions

Increased cardiac output when used with nitroprusside.  Increased vasopressor effect of dobutamine when used with bretylium, guanethidine, oxytocic drugs or TCAs.

Pregnancy Category (FDA) 

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect that was not confirmed in controlled studies in women in the 1sttrimester.

Storage

Intravenous: Store at 15-30°C.

Pharmacology

CLINICAL PHARMACOLOGY

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.

ATC Classification

C01CA07 - dobutamine; Belongs to the class of adrenergic and dopaminergic cardiac stimulants excluding glycosides.  Used in the treatment of heart failure.

 

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Brand/Product Info


Total Products : 3   
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
DOBUMIN ACI Ltd. Dobutamine 250mg/20ml Injection 20ml: 250.94 MRP
DOBUTAMINE Panpharma/City Overseas Dobutamine 250mg/20ml Injection 20ml: 285.00 TP
DOBUTIN Incepta Pharmaceuticals Limited Dobutamine 250mg/20ml Injection Injection 20ml: 250.00 MRP

Gen. MedInfo

About dobutamine

Your doctor has ordered dobutamine to improve your heart function.  The drug will be added to an intravenous fluid that will drip through a needle or catheter placed in your vein over 12 hours, usually every other day.

Dobutamine is used to help your heart pump better by strengthening the heart muscle.  Dobutamine also improves blood flow and relieves symptoms of heart failure.  This medication is sometimes prescribed for other uses; ask your Doctor for more information.

Your health care provider may measure the effectiveness and side effects of your treatment using laboratory tests and physical examinations.  It is important to keep all appointments with your doctor and the laboratory.  The length of treatment depends on how you respond to the medication.

Precautions

Before administering dobutamine,

  • tell your Doctor if you are allergic to dobutamine or any other drugs.
  • tell your Doctor what prescription and nonprescription medications you are taking, especially antidepressants, beta blockers, bretylium, guanethidine, and vitamins.
  • tell your doctor if you have or have ever had heart valve disease or high blood pressure.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding.  If you become pregnant while taking dobutamine, consult your doctor immediately.

Administering your medication

Before you administer dobutamine, look at the solution closely.  It should be clear and free of floating material.  Gently squeeze the bag or observe the solution container to make sure there are no leaks.  Do not use the solution if it is discolored, if it contains particles, or if the bag or container leaks.  Use a new solution, but show the damaged one to your health care provider.

It is important that you use your medication exactly as directed.  Do not stop your therapy on your own for any reason.  Do not change your dosing schedule without talking to your health care provider.  Your health care provider may tell you to stop your infusion if you have a mechanical problem; if you have to stop an infusion, call your health care provider immediately so your therapy can continue.

Side effects

Dobutamine may cause side effects.  Tell your health care provider if any of these symptoms are severe or do not go away:

  • upset stomach
  • vomiting
  • tingling sensations
  • fever
  • leg cramps
  • headaches
  • irregular heartbeat
  • increases in blood pressure and heart rate
  • chest pain
  • shortness of breath
  • swelling of the lower legs and ankles
  • increasing fatigue
  • lightheadedness, dizziness, or faintness
  • skin rash

If you experience any of the following symptoms, call your health care provider immediately:

If you experience a serious side effect, you or your doctor may send a report to the Office of Directorate General, Drugs Administration.

Storing your medication

  • Your health care provider probably will give you several days supply of dobutamine at a time.  You may be told to store it in a cool, dry area or in the refrigerator.
  • If you refrigerate your dose, take your next dose from the refrigerator 1 hour before using it; place it in a clean, dry area to allow it to warm to room temperature.

Store your medication only as directed.  Make sure you understand what you need to store your medication properly.

Keep your supplies in a clean, dry place when you are not using them, and keep all medications and supplies out of reach of children.  Your health care provider will tell you how to throw away used needles, syringes, tubing, and containers to avoid accidental injury. 

In case of emergency/overdose

In case of overdose, consult your Doctor.  If the victim has collapsed or is not breathing, consult local medical emergency services..

Signs of infection

If you are receiving dobutamine in your vein or under your skin, you need to know the symptoms of a catheter-related infection.  If you experience any of these effects near your intravenous catheter, tell your health care provider as soon as possible:

  • tenderness
  • warmth
  • irritation
  • drainage
  • redness
  • swelling
  • pain

Ref: U.S. Natl. Library of Medicine

____________________________________________________________________________________

 This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.

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