Medicinal Products

DOBUTAMINE AGUETTANT 250 mg / 20 mL

Generic drug from Dobutrex
Therapeutic class: Anesthesia, resuscitation, analgesics
Active ingredients: Dobutamine
laboratory: Aguettant

Solution for solution for IV infusion
Box of 10 ampoules of 20 ml
All forms

Indication

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,

· Low-speed myocardial infarction immediately threatening,

· Severe pulmonary embolism,

· Non-obstructive valvulopathies and cardiomyopathies in decompensation,

· Modification of the preload associated with high levels of PEEP (telexpiratory positive pressure),

Usable in cardiovascular functional exploration, when the stress test is not feasible or insufficient.

Dosage DOBUTAMINE AGUETTANT 250 mg / 20 mL Concentrate for solution for infusion IV Box of 10 ampoules of 20 ml

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 AGUETTANT 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 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:

doses

mcg / kg / min

Rhythm of administration

250 μg / ml *

(Ml / kg / min)

500 μg / ml **

(Ml / kg / min)

1000 μg / ml ***

(Ml / kg / min)

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

* 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 ).

In cardiovascular functional exploration, the myocardial ischemia trigger test uses supra-therapeutic doses (reached in increments of 10 μg / kg / min every 2 minutes and not exceeding 40 μg / kg / min), with or without atropine, under supervision of the cardiac rhythm, the blood pressure, the ECG all derivations and the echocardiogram with an adapted apparatus.

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:

· Mechanical barrier to filling or ejection, including obstructive cardiomyopathy, aortic valve disease

· Hypersensitivity to dobutamine or any of the excipients, including sulphites

· Patients with intraventricular dynamic obstruction.

Adverse effects Dobutamine Aguettant

· 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 approximately 5% of patients.

· Acceleration of ventricular rhythm: it has been observed in cases of atrial fibrillation or flutter.

· Fatal myocardial rupture: rare cases have been reported during dobutamine stress testing.

· Injection site reactions: There have been reports of some cases of phlebitis. Local inflammatory reactions have been described after accidental extravasation.

· Other effects: Infrequent occurrence (1-3% 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 hypokalaemia in patients at risk, especially in patients undergoing treatment with hypokalemic diuretics (see section 4.4). use / precautions for use).

· Prolonged administration: Infusions up to 72 hours have not revealed any new side effects.

Hypersensitivity: reactions suggestive of dobutamine-related hypersensitivity, rash, 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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