Mehl Pharma


Pharmakon Pharma
Full Prescribing Info
Dobutamine hydrochloride.
Each mL contains Dobutamine Hydrochloride equivalent to Dobutamine, USP 50 mg.
Pharmacology: Pharmacokinetics: Dobutamine is inactive when given by mouth, and it is rapidly inactivated in the body by similar processes. It has a half-life of about 2 minutes. Conjugates of dobutamine and its major metabolite 3-O-methyldobutamine are excreted primarily in urine, with small amounts eliminated in the faeces.
Dobumine (Dobutamine Hydrochloride Injection) is used to increase the contractility of the heart in acute heart failure, as occurs in cardiogenic shock and myocardial infarction; it is also used in septic shock. Other circumstances in which its inotropic activity may be useful are during cardiac surgery and positive end-expiratory pressure ventilation.
Dosage/Direction for Use
Recommended Dosage for adults and the elderly: The rate of infusion needed to increase cardiac output usually ranged from 2.5 to 10 μg/kg/min (see table). Rarely, infusion rates up to 40 μg/kg/min have been required to obtain the desired effect. In patients who have an existing atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to initiation of therapy with dobutamine.
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 μg/mL have been administered to humans (250 mg/50 mL).
The final volume administered should be determined by the fluid requirements of the patient.
Dosage for infusion delivery system: One ampoule of Dobutamine 5 mg/mL (250 mg/50 mL) diluted to a solution volume of 500 mL (final concentration 0.5 mg/mL). (See table.)

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Preparation: At the time of administration, dobutamine must be further diluted in an IV container to at least a 50 mL solution using one of the following intravenous solutions as a diluent: 5% Dextrose Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, Lactated Ringer's Injection, or 0.9% Sodium Chloride Injection.
The stability of the dilution tested at 30°C shows that Diluted Dobumine (Dobutamine HCl) Injection 250 mg/5 mL (Solutions 5% Dextrose and 0.45% Sodium Chloride Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose in Water, Lactated Ringer's Injection, and 0.9% Sodium Chloride Injection) is stable for 48 hours.
In case of overdosage, as evidenced by tachycardia or excessive blood pressure alteration, reduce the rate of administration, or temporarily discontinue dobutamine until the patient's condition stabilizes. No additional remedial measures are usually necessary because the duration of action of dobutamine is short.
Patients with idiopathic hypertrophic subaortic stenosis.
Patients with hypersensitivity to dobutamine.
Patients with constrictive pericarditis and pericardial tamponade.
Dobutamine 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 non-asthmatic people.
Special Precautions
Increase in Heart Rate or Blood Pressure: Dobutamine may cause a marked increase in heart rate or blood pressure, especially 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. 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 preexisting hypertension appear to face an increased risk of developing an exaggerated pressor response.
Ectopic Activity: Dobutamine may precipitate or exacerbate ventricular ectopic activity, but it rarely has caused ventricular tachycardia.
Dobutamine concentrate should be used with caution in the presence of severe hypotension complicating cardiogenic shock.
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.
Clinical experience with dobutamine following myocardial infarction has been insufficient to establish the safety of the drug for this use.
Dobutamine, like other β-agonists, can produce a mild reduction in serum potassium concentration, rarely to hypokalemic levels.
Hypovolemia should be corrected with suitable volume expanders before treatment with dobutamine is instituted.
No improvement may be observed in the presence of marked mechanical obstruction, such as severe valvular aortic stenosis.
Precautions in Administration: For intravenous use only.
Phlebitis has occasionally been reported and local inflammatory changes have been described following inadvertent infiltration. Very rare cases of cutaneous necrosis have been reported.
Do not add dobutamine concentrate to 5% Sodium Bicarbonate intravenous infusion or to any other strong alkaline solutions.
Intravenous solution for administration should be used within 24 hours. Solutions containing dobutamine may exhibit a color, which, if present, will increase with time. This color change is due to slight oxidation of agent, but there is no significant loss of potency during the time period as stated previously.
Use in Children: The safety and effectiveness of dobutamine injection in children have not been studied.
Use in the Elderly: The elderly should be monitored closely with dosage adjustment and intervals.
Use In Pregnancy & Lactation
The safety of this medicinal product for use in human pregnancy has not been established, therefore, dobutamine should not be used during pregnancy.
It is not known whether this drug is excreted in human milk. Caution should be exercised when it is administered to a nursing woman. If a mother requires dobutamine treatment, breastfeeding should be discontinued during the course of treatment.
Adverse Reactions
Increased Heart Rate, Blood Pressure, and Ventricular Ectopic Activity: A 10-20-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 infusions. These effects are dose-related.
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.
Administration of dobutamine, like other catecholamines, can produce a mild reduction in serum potassium concentration, rarely to hypokalemic levels.
Long-Term Safety: Infusions of up to 72 hours have revealed no adverse effects other than those seen with shorter infusions.
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, glyceryl trinitrate, isosorbide dinitrate, morphine, atropine, heparin, protamine, potassium chloride, folic acid, and acetaminophen.
Store at temperatures not exceeding 30°C.
MIMS Class
Cardiac Drugs
ATC Classification
C01CA07 - dobutamine ; Belongs to the class of adrenergic and dopaminergic cardiac stimulants excluding glycosides. Used in the treatment of hypotension.
Dobumine soln for IV infusion 50 mg/mL
5 mL x 10 × 1's
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