Dobuzef

Each mL contains dobutamine (as hydrochloride) 50 mg.

Pharmacology: Pharmacokinetics: Like adrenalin, dobutamine is inactive when given by mouth and it is rapidly inactivated in the body by similar process. It has a half life of about 2 minutes. Conjugates of dobutamine and its major metabolite 3-O-methyldobutamine are excreted primarily in the urine, with small amounts eliminated in the feces.
The primary mechanism of clearance of dobutamine appears to be distribution to other tissues, and not metabolism or elimination. It has a half life of about 2 minutes and plasma concentration of dobutamine reached steady state of about 10-12 minutes after the start of the infusion. Dobutamine is used mainly for the short term treatment of heart failure and any pharmacokinetic changes in this condition have no clinical implications in dosage titration.

It is used to increase the contractility of the heart in acute heart failure, as occurs in cardiogenic shock and myocardial infarction. It is also useful during cardiac surgery and positive end expiratory pressure ventilation.

Dobutamine is given as the hydrochloride but doses are expressed in terms of the base: 1.12 micrograms of the hydrochloride is approximately equivalent to 1 microgram of base.
It is administered by intravenous infusion as a dilute solution (0.25 to 5 mg/mL) in Glucose 5% or Sodium Chloride 0.9%; other fluids may also be suitable.
In the management of acute heart failure, dobutamine is given at a usual rate of 2.5 to 10 micrograms/kg per minute, according to the patients heart rate, blood pressure, cardiac output and urine output. A range of 0.5 up to 40 micrograms/kg per minute has occasionally been required. It has been recommended that the treatment with dobutamine should be discontinued gradually.
Dobutamine is also used as an alternative to exercise in cardiac stress testing. A solution containing 1 mg/mL is employed for this purpose, given via an infusion pump. A dose of 5 micrograms/kg per minute is infused for 8 minutes; the dose is then increased by increments of 5 micrograms/kg per minute up to a usual maximum of 20 micrograms/kg per minute, with each dose being infused for 8 minutes before the next incremental increase of doses up to 40 micrograms/kg per minute has sometimes been used. The ECG should be monitored continuously and the infusion terminated if arrhythmias, marked ST segment depression, or other adverse effect occurs.
Or as prescribed by the physician.

Overdoses of Dobutamine have been reported rarely. The symptoms of toxicity include anorexia, nausea, vomiting, tremor, anxiety, palpitations, headache, shortness of breath, and angina and nonspecific chest pain. The positive inotropic and chronotropic effects of dobutamine may cause hypertension, tachyarrhythmias, myocardial ischemia and ventricular fibrillation. Hypotension may result from vasodilatation.
The duration of action of dobutamine hydrochloride is generally short (half-life, approximately 2 minutes).
Temporarily discontinue dobutamine until the patient's condition stabilizes. The patient should be monitored and any appropriate resuscitative measures initiated promptly.
Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of dobutamine hydrochloride.
If the product is ingested, unpredictable absorption may occur from the mouth and gastrointestinal tract.

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

Do not mix w/ NaHCO3 or any alkaline solution. Diluted Solutions must be used within 24 hours.
During the administration of Dobutamine hydrochloride 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 solution.
Hypovolemia should be corrected with suitable volume expanders before treatment with Dobutamine hydrochloride injection 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.
Usage Following Acute Myocardial Infarction: Clinical experience with Dobutamine hydrochloride injection 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.
It should be used w/ caution in patients with cardiogenic shock complicated by severe hypotension. Hypovolaemia should be corrected before treatment.
Pediatric Use: The safety and effectiveness of Dobutamine hydrochloride injection for use in children have not been studied.

Pregnancy: Reproduction studies performed in rats and rabbits have revealed no evidence of impaired fertility, harm to fetus, or teratogenic effects due to dobutamine. However, the drug has not been administered to pregnant women and should be used only when the expected benefits clearly outweigh the potential risks to the fetus.

Increased Heart Rate, Blood Pressure, Ventricular Ectopic Activity, Angina or chest pain and Palpitation: 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. Approximately 5% of patients have had increased premature ventricular beats during infusion. These effects are dose related. Dosage should be reduced or temporarily stopped.
Miscellaneous Uncommon Effects: The following adverse effects, if they occur: nausea, headache, shortness of breath, hypertension, dyspnea, paraesthesias, vomiting & leg cramp. Long-Term-Safety­ Infusion of up to 72 hours have revealed no adverse effects other than those seen with shorter infusions.

There was no evidence of drug interaction in clinical studies in which dobutamine hydrochloride injection was administered concurrently with other drug, 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 that when either drug is used alone.
Beta-adrenergic blocking agents antagonize the cardiac effects of dobutamine resulting in predominance of alpha-adrenergic effects and increased peripheral resistance.
In patients on general anaesthetics (halothane, cyclopropane), usual dose of dobutamine may cause ventricular arrhythmias.

Store at temperatures not exceeding 30°C.

Cardiac Drugs

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

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