Active substanceDopamineDopamine
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  • Dosage form: & nbspconcentrate for solution for infusion
    Composition:

    1 ml of concentrate for solution for infusion 5 mg / ml contains:

    active substance: dopamine hydrochloride 5 mg;

    Excipients: sodium disulfite 1 mg, 0.1 M hydrochloric acid solution to pH 3.5-5.0, water for injection up to 1 ml.

    1 ml of concentrate for the preparation of a solution for infusions of 10 mg / ml contains:

    active substance: dopamine hydrochloride 10 mg;

    Excipients: sodium disulfite 2 mg, 0.1 M hydrochloric acid solution to pH 3.5-5.0, water for injection up to 1 ml.

    1 ml of concentrate for the preparation of a solution for infusions of 20 mg / ml contains:

    active substance: dopamine hydrochloride 20 mg;

    Excipients: sodium disulfite 2.5 mg, 0.1 M hydrochloric acid solution to pH 3.5-5.0, water for injection up to 1 ml.

    1 ml concentrate for solution for infusions 40 mg / ml contains:

    active substance: dopamine hydrochloride 40 mg;

    Excipients: sodium disulfite 5 mg, 0.1 M hydrochloric acid solution to pH 3.5-5.0, water for injection up to 1 ml.

    Description:

    Transparent, colorless or slightly colored solution.

    Pharmacotherapeutic group:cardiotonic agent of non-glycosidic structure
    ATX: & nbsp

    C.01.C.A.04   Dopamine

    Pharmacodynamics:

    Cardiotonic, hypertensive, vasodilating, diuretic. Excites beta-adrenergic receptors (in small and medium doses) and alpha-adrenergic receptors (in high doses). Improvement of systemic hemodynamics leads to a diuretic effect. Has a specific stimulating effect on postsynaptic dopamine receptors in the smooth muscles of blood vessels and kidneys.

    In low doses (0.5-3 μg / kg / min) acts mainly on dopamine receptors, causing the expansion of renal, mesenteric, coronary and cerebral vessels. Expansion of the kidneys leads to increased renal blood flow, increased glomerular filtration rate, increased diuresis and elimination of sodium; There is also an expansion of mesenteric vessels (this effect of dopamine on renal and mesenteric vessels differs from that of other catecholamines).

    In low and medium doses (2-10 μg / kg / min) stimulates postsynaptic betasa1-adrenoceptors, which causes a positive inotropic effect and an increase in the minute volume of blood. Systolic blood pressure and pulse pressure may increase; the diastolic blood pressure does not change or slightly increases. The total peripheral vascular resistance (OPSS) usually does not change. Coronary blood flow and oxygen consumption of the myocardium, as a rule, increase.

    In high doses (10 μg / kg / min or more) stimulation prevails alpha1-adrenoceptors, causing an increase in OPSS, heart rate and narrowing of the kidney vessels (the latter can reduce previously increased renal blood flow and diuresis).Due to the increase in the minute volume of blood and OPSS, both systolic and diastolic arterial pressure increase.

    The beginning of the therapeutic effect is within 5 minutes against the background of intravenous administration and lasts for 10 minutes.

    Pharmacokinetics:

    Introduced only intravenously. About 25% of the dose is captured by neurosecretory vesicles, where hydroxylation occurs and the norepinephrine. Widely distributed in the body, partially passes through the blood-brain barrier. The apparent volume of distribution (newborns) is 1.8 l / kg. Communication with blood plasma proteins - 50%.

    Rapidly metabolized in the liver, kidney and blood plasma monoamine oxidase and catechol-O-methyltransferase to inactive metabolites. The half-life of the drug (T1/2) - adults: from the blood plasma - 2 min, from the body - 9 min; newborns - 6.9 minutes (within 5-11 minutes). It is excreted by the kidneys; 80% Doses - in the form of metabolites for 24 hours, in small amounts - in unchanged form.

    Indications:- Shock of different genesis (cardiogenic shock, after recovery of circulating blood volume - postoperative, hypovolemic, infectious-toxic and anaphylacticshock);
    - acute cardiovascular insufficiency, the syndrome of "low cardiac output" in cardiosurgical patients, arterial hypotension.
    Contraindications:

    Hypersensitivity to the drug components, thyrotoxicosis, pheochromocytoma, tachyarrhythmia, ventricular fibrillation.

    It should not be used with arrhythmia in combination with monoamine oxidase inhibitors, with cyclopropane and halogen containing anesthetics.

    Carefully:

    Hypovolemia, severe stenosis of the aortic aorta, myocardial infarction, cardiac arrhythmias (ventricular arrhythmias, atrial fibrillation), metabolic acidosis, hypercapnia, hypoxia, hypertension in the "small" circulation, occlusive vascular diseases (including atherosclerosis, thromboembolism, thromboangiitis obliterans, obliterating endarteritis, diabetic endarteritis, Raynaud's disease, frostbite), diabetes mellitus, bronchial asthma (if there was a history of hypersensitivity to disulfite), pregnancy, tation, age 18 years.

    Pregnancy and lactation:

    In pregnant women, the drug should be used only in the case,if the intended benefit to the mother exceeds the potential risk to the fetus (in the experiment, adverse effects on the fetus have been identified) and / or the child.

    Does it penetrate dopamine in breast milk is not known.

    Dosing and Administration:

    Enter intravenously drip.

    Dose set individually, depending on the severity of the shock, the magnitude of blood pressure and the patient's response to treatment.

    To enhance diuresis and obtain an inotropic effect (an increase in the contractile activity of the myocardium) is administered at a rate of 100-250 μg / min (1.5-3.5 μg / kg / min) - low dose area.

    With intensive surgical therapy -300-700 μg / min (4-10 μg / kg / min) - medium dose area; with septic shock - 750-1500 μg / min (10.5-21 μg / kg / min) - the maximum dose area.

    In order to influence blood pressure it is recommended to increase the dose to 500 mcg / min or more, or at a constant dose of dopamine is additionally prescribed norepinephrine (norepinephrine) at a dose of 5 μg / min with a body weight of about 70 kg.

    If there is a disturbance of the heart rhythm, regardless of the doses used, a further increase in the dose is contraindicated.

    Children injected at a dose of 4-6 (maximum 10) μg / kg / min. Unlike adults, in children the dose should be increased gradually, that is, starting with the lowest dose.

    The rate of administration should be selected individually to achieve the optimal response of the patient. Most patients manage to maintain a satisfactory state with doses of less than 20 μg / kg / min.

    Duration of application: the duration of infusions depends on the individual characteristics of the patient. There is a positive experience of infusion lasting up to 28 days. After the stabilization of the clinical situation, the drug is withdrawn gradually.

    The rule of solution preparation: 0.9% solution of sodium chloride, 5% dextrose solution (including mixtures thereof), 5% dextrose solution in Ringer's lactate solution, sodium lactate and Ringer's lactate solution. In order to prepare a solution for intravenous infusion 400-800 mg of dopamine should be added to 250 ml of the solvent (the concentration of dopamine will be 1.6-3.2 mg / ml).

    Preparation of the infusion solution should be performed immediately before use (stability of the solution is maintained for 24 hours, except for the mixture with Ringer-lactate solution - maximum 6 hours). The solution of dopamine should be clear and colorless.

    Side effects:

    From the side of the heart-cardiovascular system: less often - angina, tachycardia or bradycardia, palpitation, chest pain, increased or decreased blood pressure, conduction disorders, expansion of the complex QRS (QRS - the first phase of the ventricular complex, which reflects the process of depolarization of the ventricles), vasospasm, an increase in the end diastolic pressure in the left ventricle; when used in high doses - ventricular or supraventricular arrhythmias.

    From the digestive system: more often - nausea, vomiting.

    From the central nervous system: more often - headache; less often - anxiety, motor anxiety, mydriasis.

    Allergic reactions: in patients with bronchial asthma - bronchospasm, shock.

    Other: less often - dyspnea, azotemia, piloerection; rarely - polyuria (when administered in low doses).

    Local reactions: when the product gets under the skin - necrosis of the skin, subcutaneous tissue.

    Overdose:

    Symptoms: excessive increase in arterial pressure, spasm of peripheral arteries, tachycardia, ventricular extrasystole, angina, dyspnoea, headache, psychomotor agitation.

    Treatment: in connection with the rapid excretion of dopamine from the body, these phenomena stop when the dose is reduced or if the administration is stopped when ineffectiveness - short-acting alpha-adrenoblockers (with excessive blood pressure increase) and beta-blockers (in case of cardiac arrhythmias).

    Interaction:

    Pharmaceutically incompatible with alkaline solutions (inactivate dopamine), oxidants, iron salts, thiamine (contributes to the destruction of the vitamin AT1).

    The sympathomimetic effect is enhanced by adrenostimulants, monoamine oxidase inhibitors (including furazolidone, procarbazine, selegiline), guanetidine (prolongation of duration and enhancement of cardiostimulating and pressor effects); diuretic - diuretics; cardiotoxic effect - inhalation drugs for general anesthesia, hydrocarbon derivatives - such as cyclopropane, chloroform, enflurane, halothane, isoflurane, methoxyflurane (increased risk of severe atrial or ventricular arrhythmias), tricyclic antidepressants, including maprotiline (risk of heart rhythm disturbances, severe hypertension or hyperpyrexia), cocaine, other sympathomimetics; weaken - butyrophenones and beta-blockers (propranolol).

    Weaken the hypotensive effect of guanadrel, guanethidine, meqamylamine, methyldopa, alkaloids rauwolfia (the latter prolong the effect of dopamine).

    With simultaneous application with levodopa - an increased likelihood of arrhythmias; with hormones of the thyroid gland - it is possible to increase the effect of both dopamine and thyroid hormones.

    Ergometrine, ergotamine, methylergomethrin, oxytocin increase the vasoconstrictor effect and the risk of occurrence of ischemia and gangrene, as well as severe arterial hypertension, up to intracranial hemorrhage.

    Phenytoin can promote the development of arterial hypotension and bradycardia (depends on the dose and rate of administration); alkaloids of ergot - vasoconstriction and development of gangrene.

    Compatible with cardiac glycosides (possibly increased risk of cardiac arrhythmias, additive inotropic effect, ECG monitoring required).

    Reduces the antianginal effect of nitrates, which in turn can reduce the pressor effect of sympathomimetics and increase the risk of arterial hypotension (simultaneous use is allowed independing on the achievement of the necessary therapeutic effect).

    Special instructions:

    Before administering to patients who are in a state of shock, hypovolemia should be corrected by the introduction of blood plasma and other blood-substituting fluids.

    Infusion should be performed under the control of diuresis, heart rate, minute blood volume, blood pressure, ECG. Reducing diuresis without concomitant decrease in blood pressure indicates the need to reduce the dose of Dopamine.

    Inhibitors of monoamine oxidase, increasing the pressor effect of sympathomimetics, may cause the onset of headache, arrhythmia, vomiting and other manifestations of hypertensive crisis, therefore, in patients who received monoamine oxidase inhibitors during the last 2-3 weeks, initial doses of Dopamine should not exceed 10% of the usual dose .

    Strictly controlled studies of the use of the drug in patients under the age of 18 years have not been carried out (there are isolated reports of the occurrence of arrhythmias and gangrene associated with intravenous drug extravasation in this group of patients). To reduce the risk of extravasation, if possible, should be injected into large veins.To prevent tissue necrosis in the case of extravasal ingestion of the drug, infiltrate 10-15 ml of 0.9% solution of sodium chloride with 5-10 mg of phentolamine.

    The appointment of Dopamine in the background of peripheral vascular occlusion and / or DIC syndrome (DVS - disseminated intravascular coagulation) in a history can cause a sharp and pronounced narrowing of the vessels, leading to necrosis of the skin and gangrene (careful monitoring should be carried out, and if signs of peripheral ischemia are detected immediately stop the preparation).

    Form release / dosage:

    Concentrate for the preparation of a solution for infusions, 5 mg / ml, 10 mg / ml, 20 mg / ml and 40 mg / ml.

    Packaging:

    5 ml of the drug in neutral glass ampoules:

    5 ampoules in contour plastic packaging (pallet) or in contour acheive packaging.

    1, 2 contour plastic packages (pallets) or contour mesh packages together with instructions for use in a pack of cardboard.

    Packing for hospitals

    50, 100 contour plastic packages (pallets) or contour mesh packages together with instructions for use in a cardboard box.

    Storage conditions:

    In the dark place at a temperature of 8 to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-000444
    Date of registration:01.03.2011 / 30.07.2014
    Date of cancellation:2016-03-01
    The owner of the registration certificate:BINERGIYA, CJSC BINERGIYA, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp19.01.2016
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