Medicinal Products

DOBUTAMINE QUALIMED 250 mg / 20 ml Concentrate for solution for infusion Box of 10 20 ml ampoules

Generic drug of the therapeutic class: Anesthesia, resuscitation, analgesics
Active ingredients: Dobutamine
laboratory: Qualimed

Solution for solution for IV infusion
All forms

Indication

1. Low flow syndromes, among others of the following etiology:
- low flow during or after cardiac surgery,
- shock states of toxic-infectious origin after vascular filling and after verification of myocardial function,
- myocardial infarction in a low-speed state immediately threatening,
- serious pulmonary embolism,
- non-obstructive valvulopathies and cardiomyopathies in decompensation thrust,
- modification of the preload associated with high levels of PEEP (telexpiratory positive pressure),
2. Usable in cardiovascular functional exploration, when the stress test is not feasible or insufficient.

Dosage DOBUTAMINE QUALIMED 250 mg / 20 ml Concentrate for solution for infusion Box of 10 20 ml ampoules

STRICT INTRAVENOUS PATH.
The administration of dobutamine should always be by continuous intravenous infusion with the aid of an electric syringe, to ensure a stable and regular administration of the drug.
Before infusion, DOBUTAMINE QUALIMED 250 mg / 20 ml, solution for injection for infusion, should be diluted in 5% glucose or 0.9% sodium chloride solution, to obtain a final volume of at least 50 ml.
The rate of infusion to obtain a significant increase in cardiac output is of the order of 2.5 to 10 μg per kilogram of body weight per minute.
In the context of out-of-hospital administration, the criteria for adjusting the dosage are specified in the section on warnings and precautions for use.
It has been shown that tolerance can develop during continuous infusions of 72 hours or more; therefore, higher doses may be required to achieve the same effects (doses of 40 μg / kg / min were administered).
Choice of the infusion rate:
2.5 μg / kg / min:
. 250 μg / ml *: 0.01 ml / kg / min.
. 500 μg / ml **: 0.005 ml / kg / min.
. 1000 μg / ml ***: 0.0025 ml / kg / min.
- 5 μg / kg / min:
. 250 μg / ml *: 0.02 ml / kg / min.
. 500 μg / ml **: 0.01 ml / kg / min.
. 1000 μg / ml ***: 0.005 ml / kg / min.
- 7.5 μg / kg / min:
. 250 μg / ml *: 0.03 ml / kg / min.
. 500 μg / ml **: 0.015 ml / kg / min.
. 1000 μg / ml ***: 0.0075 ml / kg / min.
- 10 μg / kg / min:
. 250 μg / ml *: 0.04 ml / kg / min.
. 500 μg / ml **: 0.02 ml / kg / min.
. 1000 μg / ml ***: 0.01 ml / kg / min.
- 12.5 μg / kg / min:
. 250 μg / ml *: 0.05 ml / kg / min.
. 500 μg / ml **: 0.025 ml / kg / min.
. 1000 μg / ml ***: 0.0125 ml / kg / min.
- 15 μg / kg / min:
. 250 μg / ml *: 0.06 ml / kg / min.
. 500 μg / ml **: 0.03 ml / kg / min.
. 1000 μg / ml ***: 0.015 ml / kg / min.
* 250 mg per liter of solvent.
** 500 mg per liter or 250 mg per 500 ml of solvent.
*** 1000 mg per liter or 250 mg per 250 ml of solvent.
In children, the use of dobutamine should be closely monitored (see warnings and precautions for use).
In cardiovascular functional exploration, the myocardial ischemia trigger test uses supratherapeutic doses (reached in increments of 10 μg / kg / min every 2 minutes and not exceeding 40 μg / kg / min), with or without atropine, under surveillance. heart rate, blood pressure, all-lead ECG and echocardiogram with appropriate equipment.
It can also be combined with myocardial tomoscintigraphy.
It is practiced in an establishment with a resuscitation service, and in a room with resuscitation equipment including a defibrillator.

Against indications

This medicine should never be used in case of:
- hypersensitivity to dobutamine,
- mechanical obstacle to filling or ejection, including obstructive cardiomyopathy, aortic valve disease,
- patients with intraventricular dynamic obstruction.

Adverse effects Dobutamine Qualimed

- Increased heart rate and blood pressure : a rise in systolic pressure of 10 to 20 mmHg and an increase in heart rate of 5 to 15 beats per minute have been noted in many patients.
- Rapid decrease in blood pressure : Cases have been reported occasionally with dobutamine. Reducing the dosage or stopping the infusion generally results in a rapid return of blood pressure to the initial values. However, in rare cases symptomatic treatment may be necessary, and reversibility is not always immediate.
- Ectopic ventricular activity : Ventricular arrhythmias (mainly extrasystoles) were found in about 5% of the patients. hundred of patients.
- Acceleration of ventricular rhythm : it has been observed in cases of atrial fibrillation or flutter.
- Injection site reactions : There have been some reports of phlebitis. Local inflammatory reactions have been described after accidental extravasation.
- Other effects : Infrequent occurrence (1 to 3% of patients) of the following adverse reactions has been reported: nausea, headache, anginal pain, nonspecific chest pain, palpitations or dyspnea.
The administration of dobutamine may cause a slight decrease in serum potassium, or even rare cases of hypokalemia in patients at risk, especially in patients undergoing treatment with diuretics hypokalaemic (see precautions for use).
- Prolonged administration : infusions up to 72 hours have not revealed any new adverse effects.
Hypersensitivity : reactions suggestive of hypersensitivity related to administration of dobutamine, rash type skin, fever, eosinophilia and bronchospasm have sometimes been reported.
- Due to the presence of sodium metabisulfite, risk of allergic reactions, including anaphylactic reactions and bronchospasm.

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