Expiration date: 07/2026

Composition and form of issue:

Powder lyophilized for the preparation of solution for injection of 1 FL.

dobutamine hydrochloride 280 mg (corresponding to 250 mg of dobutamine) 

in the paper cartons 1 a bottle.

Solution for infusions 1 amp. (50 ml)

dobutamine hydrochloride 280 mg (corresponding to 250 mg of dobutamine) 

in the paper cartons of 1 ampoule.

Pharmacological action:

Stimulates beta1-adrenergic receptors of the myocardium. It has a positive inotropic effect, moderately increases heart rate, stroke and minute volume of the heart, reduces the heart rate and vascular resistance in the small circle of blood circulation. Increases coronary blood flow, improves the supply of oxygen to the myocardium, reduces the pressure of filling the ventricles of the heart.

Pharmacokinetics:

Cmax is reached after 10-12 min. There is a linear correlation between the value of the constant level of concentration and the infusion rate. T1/2 is 2-3 min, the volume of distribution — ~ 0, 2 l/kg body weight, plasma clearance does not depend on the cardiac output and is 2, 4 l/min / m2. It is metabolized mainly in tissues and in the liver (due to conjugation with glucuronides, as well as with the formation of pharmacologically inactive 3-o-methyl-dobutamine). Excreted in the urine (more than 2/3 in the form of glucuronides and 3-o-methyl-dobutamine) and bile. The effect develops in 1-2 minutes after the start of infusion.

Clinical pharmacology:

In children, less pronounced decrease in HRV and ventricular filling pressure, with a more pronounced increase in heart rate and increased blood PRESSURE.

Indications:

Acute heart failure, exacerbation (acute decompensation) of chronic heart failure, chronic heart failure (as a temporary adjunct to the main therapy), low heart volume (as a side effect of mechanical ventilation with positive residual pressure on the exhalation).

Contraindications:

Hypersensitivity, idiopathic hypertrophic subaortic stenosis, pericardial tamponade, aortic stenosis, hypovolemia, simultaneous administration of MAO inhibitors, breastfeeding.

Use during pregnancy and breast-feeding:

Perhaps if the expected effect of therapy exceeds the potential risk to the fetus. At the time of treatment should stop breastfeeding.

Side effect:

From the nervous system and sensory organs: headache.

From the cardiovascular system and blood (hematopoiesis, hemostasis): tachycardia (incl.ventricular), atrial fibrillation, pain in the heart and chest, heartbeat, shortness of breath, increased blood PRESSURE, hypotension, hypokalemia (very rarely), transient inhibition of platelet aggregation (long-term use), petechial bleeding, phlebitis.

From the digestive tract: nausea.

From the skin: skin necrosis (at the site of administration).

Allergic reactions: rarely-skin rash, fever, bronchospasm, eosinophilia, etc.), polyuria (with the introduction of high doses).

Drug interaction:

Beta-adrenoceptor blockers weaken the action (the predominant alpha effects lead to increased blood PRESSURE and vasoconstriction). Sodium nitroprusside or nitroglycerin contribute to an increase in cardiac output, a decrease in systemic vascular resistance and ventricular filling pressure. Taking dobutamine diabetics increases the need for insulin. The combination with ACE inhibitors causes an increase in cardiac output (chest pain, arrhythmia). In combination with dopamine increases blood PRESSURE, increases renal blood flow, sodium excretion, diuresis.

Incompatible with alkaline solutions and solutions containing sodium sulphide, ethanol, acyclovir, aminofillinom, bretylium, calcium chloride and gluconate, zefamandola the formate, the sodium salts zefalotina, Cefazolin, ethacrynic acid, diazepam, digoxin, furosemide, heparin, hydrocortisone-sodium succinate, insulin, potassium chloride, magnesium sulfate, penicillin, phenytoin, streptokinase, verapamil.

Dosage and administration:

In/in the drip.

The powder is dissolved in 10 ml of water for injection, and then adjusted with 5% glucose solution or other solvents to a volume of 50 ml (intermittent infusion) or 500 ml (continuous).

Solution for infusions: if necessary, further dilution using the same solutions as for the powder. The dose is set individually. Usually adults-2, 5-10 (up to 40) µg / kg / min, children-1-15 µg / kg / min. 

Overdose:

Symptoms: nausea, vomiting, lack of appetite, tremor, anxiety, palpitations, headache, dyspnea, chest pain, hypertension, myocardial ischemia.

Treatment: discontinuation of the drug, ventilation of the lungs, with ventricular tachyarrhythmia-the appointment of propranolol or lidocaine, with erroneous oral administration — the reception of activated charcoal.

Precautionary measures:

With caution used in children (because of their lower breadth of therapeutic action). During treatment, it is necessary to control the heart rate, cardiac output, blood PRESSURE, venous pressure and pressure in the pulmonary capillaries, the amount of urine.

In the treatment of patients with diabetes, it is necessary to control the level of glucose in the blood.

Special instruction:

With continuous administration of the drug (more than 72 hours) may develop a phenomenon of tolerance (need to increase the dosage of the drug).

Dissolved in water for injection lyophilized powder dobutamine before further dilution should be stored at 2-8 °C for no longer than 48 h, and at room temperature for no more than 6 h. Further dilution should be made just before use of the drug. The prepared solution should be used within 24 hours.