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

    1 ml of a solution of 10 mg / ml

    active substance: dopamine hydrochloride 10 mg;

    Excipients: disodium edetate 0.25 mg, sodium metabisulphite 2.5 mg, water for injection up to 1 ml.

    1 ml of a solution of 40 mg / ml

    active substance: dopamine hydrochloride 40 mg;

    Excipients: disodium edetate 0.25 mg, sodium metabisulphite 10 mg, water for injection up to 1 ml.

    Description:

    Transparent, colorless or slightly yellowish liquid.

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

    C.01.C.A.04   Dopamine

    Pharmacodynamics:

    Excites beta-adrenoreceptors (in small and medium doses) and alpha-adrenoreceptors (in large 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 (from 0.5 μg / kg / min to 2 μg / kg / min) dopamine, primarily affects the dopamine receptors, causing the expansion of renal, mesenteric, coronary and cerebral vessels. Expansion of the renal vessels leads to an increase in renal blood flow (glomerular filtration), an increase in diuresis and elimination of sodium ions.

    In low and medium doses (2-10 μg / kg / min) stimulates postsynaptic beta1-adrenoceptors, which causes a positive inotropic effect and an increase in the minute volume of blood. Systolic blood pressure (BP) 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) alpha stimulation predominates1-adrenoreceptors, resulting in a narrowing of the peripheral blood vessels and an increase in blood pressure. 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.

    Widely distributed in the body tissues, partially penetrates the blood-brain barrier. Like all catecholamines, dopamine biotransformed with the participation of monoamine oxidase (MAO) and catechol-O-methyltransferase (COMT) in the liver, kidneys and plasma. Half-life in adults: from plasma - 2 min, from tissues - 9 min; in newborns - from 5 to 11 minutes.

    It is excreted by the kidneys: 80% in the form of metabolites within 24 hours in the form of inactive homovanilic acid and 1,4-dihydroxyphenylacetyl acid, in insignificant amounts is excreted unchanged.

    Indications:

    - Shock of different genesis (cardiogenic, postoperative, infectious-toxic, anaphylactic shock;

    - hypovolemic shock - after recovery of the volume of circulating blood);

    - acute cardiovascular insufficiency, the syndrome of "low cardiac output" in cardiosurgical patients, arterial hypotension.

    Contraindications:

    - Hypersensitivity to the components of the drug, as well as to other sympathomimetics;

    - thyrotoxicosis;

    - pheochromocytoma;

    - angle-closure glaucoma;

    - severe cardiac rhythm disturbances: ventricular fibrillation, decompensated forms of tachyarrhythmia;

    - benign prostatic hyperplasia with clinical manifestations;

    - age up to 12 years (efficacy and safety not established).

    Do not use with arrhythmia in combination with monoamine oxidase inhibitors, with cyclopropane and halogen-containing anesthetics.

    Carefully:

    Hypovolemia, ischemic heart disease, angina, heart rhythm disorders, obliterating diseases of peripheral vessels (incl. atherosclerosis, thromboembolism, obliterating thromboangiitis (Buerger's disease), obliterating endarteritis, diabetic endarteritis, Raynaud's disease, frostbite), bronchial asthma (if there was an increased sensitivity to disulfite in the anamnesis), renal and hepatic insufficiency.

    Pregnancy and lactation:

    In pregnant women, the drug should be used only if the intended benefit to the mother exceeds the potential risk to the fetus. Studies in animals have not revealed a teratogenic effect of dopamine.

    If it is necessary to use the drug, breastfeeding should be discontinued.

    Dosing and Administration:

    The drug should be administered by intravenous infusion after a preliminary dilution.

    For dilution use 5% glucose solution or 0.9% solution of sodium chloride. To obtain a solution for intravenous infusions, add 8-16 ampules of dopamine with a dosage of 10 mg / ml or 2-4 ampules of dopamine with a dosage of 40 mg / ml (400 mg-800 mg) to 250 ml of a solvent (5% glucose solution or 0.9% sodium chloride solution). The resulting solution contains respectively 1600-3200 μg of dopamine in 1 ml. Preparation of the infusion solution should be made immediately before use, the stability of the solution remains for 24 hours.

    Adults, the elderly

    The dose is set individually, depending on the degree of severity of the shock, the magnitude of blood pressure and the patient's response to treatment.The duration of administration depends on the clinical situation and should be determined by the physician.

    Unless otherwise prescribed, the following doses are recommended:

    Dosage

    The rate of administration

    The area of ​​low doses (for strengthening diuresis and obtaining an inotropic effect)

    1.5-3.5 μg / kg / min

    100-250 mcg / min

    The area of ​​medium doses (with intensive surgical therapy)

    4-10 mcg / kg / min

    300-700 μg / min

    Area of ​​maximum doses (with septic shock)

    10.5-21.5 μg / kg / min

    750-1500 μg / min

    First, intravenously drip in a dose of 1 μg / kg body weight / min to 5 μg / kg body weight / min. Then the dose can be increased every 10-30 min at 1-5 μg / kg body weight / min, maximal up to 20-50 μg / kg body weight / min. The average dose used in patients is a dose of 20 μg / kg body weight / min. Doses above 50 μg / kg body weight / min are used in severe forms of cardiovascular failure.

    In patients with severe, treatment-resistant, chronic cardiovascular failure, treatment should be started at a dose of 0.5 μg / kg body weight / minute to 2 μg / kg body weight / min, and then the dose should be increased by 1-3 μg / kg body weight / min until the diuresis is increased.

    Note: During the administration of the drug should be monitored Blood pressure, heart rate and diuresis.

    Children aged 12 years and over

    Enter in a dose of 4-6 (max. 10) μg / kg / min.

    Side effects:

    From the cardiovascular system: angina pectoris, tachycardia or bradycardia, palpitations, chest pain, increased or decreased blood pressure, conduction disorders, expansion of the complex QRS, vasospasm, increased end-diastolic pressure in the left ventricle; when used in high doses - ventricular or supraventricular arrhythmias.

    From the digestive system: nausea, vomiting, bleeding from the gastrointestinal tract.

    From the central nervous system: headache, anxiety, motor anxiety, tremor of fingers.

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

    Local Reactions: Extravasation of the drug may cause local tissue necrosis.

    Other: mydriasis, dyspnea, azotemia, piloerection, polyuria, the possibility of gangrene development.

    Overdose:

    Symptoms: excessive increase in blood pressure, spasm of the peripheral arteries, tachycardia, ventricular extrasystole, angina, shortness of breath, headache, psychomotor agitation.

    Treatment: in connection with the rapid excretion of dopamine from the body, these phenomena stop with a decrease in dose or discontinuation of administration, with ineffectiveness - short-acting alpha-blockers (with excessive increase in blood pressure) and beta-blockers (for heart rhythm disturbances).

    Interaction:

    Pharmaceutically incompatible with alkaline solutions (inactivate dopamine), acyclovir, alteplase, amikacin, amphotericin B, ampicillin, cephalothin, dacarbazine citrate, theophylline with ethylene-amide, theophylline calcium solution, furosemide, gentamicin, heparin, iron salts, nitroprusside, benzypenicillin, tobramycin.

    Sympathomimetic effect is enhanced by adrenostimulants, monoamine oxidase inhibitors (incl. furazolidone, procarbazine, selegiline), guanetidine (prolongation of duration and enhancement of cardiostimulating and pressor effects); diuretic - diuretics; cardiotoxic effect - inhalants 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 antihypertensive 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 depending on the achievement of the necessary therapeutic effect).

    Special instructions:

    Before administration to patients in shock, hypovolemia should be corrected by the administration of plasma and other blood-substituting fluids.

    To reduce the risk of extravasation, the drug should be injected into a large vein or central vein system after dilution. Do not administer intraarterially and bolusily. To prevent tissue necrosis in the case of extravasal ingestion of the drug, 10-15 ml of a 0.9% solution of sodium chloride with 5-10 mg of phentolamine should be infiltrated immediately. To prevent the development of arterial hypotension, the elimination of the infusion of the drug should occur gradually.

    In the case of ischemia resulting from vasoconstriction, the possibility of continuing dopamine administration should be weighed, given the danger of developing necrotic changes. This condition can be prevented by lowering the dose of dopamine or stopping its administration.To counteract ischemia, 5-10 mg of phentolamine can be administered intravenously.

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

    The drug improves atrial-ventricular conduction, patients with atrial fibrillation, so cardiac glycosides should be administered prior to prescribing the drug.

    The use of the drug against the background of peripheral vascular occlusion and / or DIC syndrome (DVS - disseminated intravascular coagulation) in the 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).

    MAO inhibitors, increasing the pressor effect of sympathomimetics, can cause the onset of headache, arrhythmia, vomiting and other manifestations of hypertensive crisis, therefore, in patients receiving MAO inhibitors during the last 2-3 weeks, initial dopamine doses should not exceed 10% of the usual dose.

    Effect on the ability to drive transp. cf. and fur:

    Not studied.

    Form release / dosage:

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

    Packaging:

    5 ml per ampoule of colorless glass (Heb. F.). Above the point of the ampulla fracture is a point of white or red color and one strip in the form of a green ring (for a dosage of 10 mg / ml) or two strips in the form of green rings (for a dosage of 40 mg / ml).

    5 ampoules are placed in a tray for ampoules made of PVC. Two pallets in a cardboard box with instructions for use.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Stability of the solution after dilution 24 h.

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

    Terms of leave from pharmacies:On prescription
    Registration number:P N 015579/01
    Date of registration:14.05.2009 / 30.06.2014
    Date of cancellation:2018-02-01
    The owner of the registration certificate:Warsaw Pharmaceutical Plant Polfa, JSCWarsaw Pharmaceutical Plant Polfa, JSC Poland
    Manufacturer: & nbsp
    Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia
    Information update date: & nbsp01.02.2018
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