COMPOSITION :
Dobutamine HCl Injection 250 mg/5 ml, each ml contains : Dobutamine HCl equivalent with Dobutamine 50 mg.
DESCRIPTIONS :
Dobutamine HCl is preparation of Dobutamine HCl (equivalent to Dobutamine), which is available in injection 250 mg/5 ml.
INDICATIONS :
Inotropic support of the myocardium in the treatment of acute congestive heart failure or cardiogenic shock.
DOSAGE AND ADMINISTRATIONS :
Dobutamine is administered intravenously in the dose range of 2.5 – 40 mcg/kg/minute. The usual dose is 2.5 – 10 mcg/kg/minute. The dosage should be adjusted individually according to the patient’s heart rate and rhythm, blood pressure and diuresis. Partial tolerance may develop if infusion time exceeds 72 hours and such cases may call for an increase in dosage.
Steril solution for injection 250 mg/5 ml :
The dosage is determined as follows :
|
DOSE mcg/kg/minute |
One (1)
ampoule |
Two (2)
ampoules |
Four (4)
ampoules |
| 250 mg Dobutamine in 1000 ml infusion | 500 mg Dobutamine in 1000 ml infusion | 1000 mg Dobutamine in 1000 ml infusion | |
| Infusion rate ml/kg/minute | Infusion rate ml/kg/minute | Infusion rate ml/kg/minute | |
| 2.5
5 7.5 10 12.5 15 |
0.01
0.02 0.03 0.04 0.05 0.06 |
0.005
0.01 0.015 0.02 0.025 0.03 |
0.0025
0.005 0.0075 0.01 0.0125 0.015 |
The infusion rate values corresponding to each dosage are multiplied by the patient’s weight. This gives infusion rate as millilitres per minute.
Dilution :
For infusion : The sterile solution for injection is diluted in physiological Sodium chloride 0.9% or Dextrose 5%. When stored at room temperature, the prepared infusion solution should be used within 12 hours, and when stored in a refrigerator, within 24 hours. Dobutamine should not be diluted in alkaline solutions.
CONTRAINDICATIONS :
- Patients with idiopathic hypertrophic subaortic stenosis.
- Known hypersensitivity to Dobutamine.
WARNINGS AND PRECAUTIONS :
- During treatment with Dobutamine, ECG and blood pressure should be monitored continuously. In addition, cardiac filling pressure and output should be monitored whenever possible.
- Hypovolaemia should always be corrected before instituting Dobutamine therapy.
- Dobutamine may provoke chest pain in patients with coronary heart disease. Therefore, the dosage should be carefully considered.
- Care should also be taken after acute myocardial infarction; excessive inotropism and tachycardia should be avoided as these may increase myocardial oxygen consumption and, consequently, infarct size.
- Dobutamine usually causes a slight increase in systolic blood pressure (10 – 20 mmHg) and heart rate (5 – 10 beats/minute). Unusually high blood pressure increases have been reported especially in patients with arterial hypertension.
- Sometimes excessive tachycardia may occur. Discontinuation of infusion or reduction of infusion rate usually normalize the situation rapidly.
- Dobutamine increases atrioventricular conduction. Therefore, care should be taken when determining the dosage for patients with atrial fibrillation. These patients should preferably be digitalized before Dobutamine therapy is instituted.
- Dobutamine may provoke ventricular ectopic activity.
- Usage in children : The safety and effectiveness of Dobutamine for use in children have not been established.
- Usage in pregnancy : As Dobutamine has not been administered to pregnant women, the physician should in each case weight the benefits against the potential risks.
- Usage in lactation : It is not known whether Dobutamine is distributed in human milk. Because many drugs are distributed in human milk, caution should be exercised when Dobutamine is administered to a nursing woman. If a nursing woman requires Dobutamine therapy, breast-feeding should be discontinued for the duration of drug therapy.
DRUG INTERACTIONS :
- Concomitant administration of Dobutamine and Nitroprusside increases cardiac output and usually reduces pulmonary capillary wedge pressure more than either of these drugs alone. Dobutamine may prove ineffective in patients recently treated with β-adrenoreceptor blocking drugs. In such cases, peripheral vascular resistance may increase.
- Dobutamine concentrate has been reported to be incompatible with alkaline solutions and should not be mixed with sodium bicarbonate 5%, or other strong alkaline solutions i.e., Aminophylline, Furosemide.
ADVERSE REACTIONS :
The adverse reaction are essentially dose-dependent and can therefore be controlled by reducing the infusion rate. Since Dobutamine is almost completely eliminated within 10 minutes, the adverse reaction will disappear promptly with a reduction of dose or discontinuation of infusion. Nausea, headache, palpitation, dyspnea and chest pain have been reported as the most common adverse reaction.
OVERDOSAGE :
- At overdosage, which manifests itself as excessive blood pressure changes or tachycardia, the infusion rate must be reduced or therapy discontinued until the patient is in balance.
- A patient received an accidental overdose of Dobutamine when given an intravenous infusion at a rate of more than 130 mcg/kg/minute for 30 minutes, this being three times the recommended maximum.
PRESENTATION :
Dobutamine HCl Injection 250 mg/5 ml Box, 10 ampoules @ 5 ml
Reg. No. GKL1602351943A1
STORAGE :
STORE BELOW 25°C AND DRY PLACE, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
PT BERNOFARM
Sidoarjo – Indonesia
