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

    In 1 ampoule (10 ml):

    active substance: dopamine hydrochloride 200.0 mg;

    Excipients: sodium chloride 28.40 mg, L-cysteine ​​hydrochloride hydrate 0.6 mg, acid citric monohydrate 6.0 mg, sodium hydroxide 1.15 mg, water for injection up to 10 ml.

    Description:

    Transparent solution, from colorless to slightly yellowish in color.

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

    C.01.C.A.04   Dopamine

    Pharmacodynamics:

    Cardiotonic and hypertensive.

    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 low doses (0.5-3 μg / kg / min) acts primarily on dopamine receptors, causing the expansion of renal vessels, increases blood flow in them, as well as glomerular filtration, excretion of sodium ions and diuresis; There is also an expansion of mesenteric vessels (this effect on the renal and mesenteric vessels of dopamine differs from other catecholamines).

    In low and medium doses (2-10 μg / kg / min) stimulates postsynaptic beta1-adrenoceptors, which causes an increase in the minute volume of the heart. Systolic blood pressure (BP) and pulse pressure may increase; the diastolic blood pressure does not change or slightly increases. The common 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) additional stimulation of alpha is noted1-adrenoceptors, causing an increase in OPSS and narrowing of the kidney vessels (the latter can reduce previously increased renal blood flow and diuresis).Both systolic and diastolic blood pressure increases due to an increase in the minute volume of blood and OPSS.

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

    Pharmacokinetics:

    In the liver, kidneys and blood plasma dopamine is metabolized with the formation of inactive metabolites; 85% of the dose administered is excreted by the kidneys within 24 hours. About 25% of the dose is captured by neurosecretory vesicles, where hydroxylation occurs and the norepinephrine. Widely distributed in the body, slightly passes through the blood-brain barrier. The apparent volume of distribution (newborns) is 1.8 l / kg. Communication with blood plasma proteins - 50%, is rapidly metabolized in the liver, kidney and blood plasma monoamine oxidase (MAO) and catechol-O-methyltransferase (COMT) to inactive metabolites. The half-life (T1/2) - adults: from the blood plasma 2 min, from the tissues - 9 min; newborns - 6.9 minutes (within 5-11 minutes). It is excreted by the kidneys: 80% of the dose - in the form of metabolites for 24 hours, in small amounts - in unchanged form. The volume of distribution is 0.9 l / kg.

    Indications:

    Shock of various genesis (cardiogenic, postoperative, infectious-toxic, anaphylactic, hypovolemic / only after volume recovery circulating blood).

    Acute cardiac and vascular insufficiency in various pathological conditions.

    Contraindications:

    Hypersensitivity to the components of the drug (including other adrenomimetics), hyperthyroidism, pheochromocytoma, zakratougolnaya glaucoma, benign prostatic hyperplasia with clinical manifestations, tachyarrhythmia, ventricular fibrillation of the heart.

    Carefully:

    Hypovolemia, ischemic heart disease, angina pectoris, obliterating diseases of peripheral arteries (including arteriosclerosis, arterial thromboembolism, obliterating thromboangiitis (Buerger's disease)), cold trauma, including diabetic endarteritis, Raynaud's disease, frostbite, arrhythmias,

    Pregnancy and lactation:

    Clinical data on the use of the drug in pregnant women is currently insufficient. In animal studies, reproductive toxicity of dopamine has been demonstrated.

    In pregnancy, the drug should be used only if the intended benefit to the mother exceeds the potential risk to the fetus and / or the child.

    There are no data on the penetration of dopamine into breast milk. If you need to use the drug during lactation, breastfeeding should be discontinued.
    Dosing and Administration:

    Only for intravenous administration!

    The dose is selected individually and depends on the degree of severity of the shock, the magnitude of the blood pressure, as well as on the patient's reaction to the therapy.

    The duration of administration depends on the clinical situation and should be determined by the physician. The rate of injection should be selected individually to achieve the optimal response of the patient. If possible, administration should be performed through a central venous catheter.

    The initial dose of the drug is recommended 2-5 μg / kg / min. In the case of a patient's severe condition, the initial dose should be 5 μg / kg / min. If necessary, it is possible to gradually increase the dose (every 15-30 minutes) by 5-10 μg / kg body weight per minute.

    In most patients, it is possible to maintain a satisfactory condition with doses less than 20 μg / kg / min.Doses exceeding this value can lead to a decrease in renal function, a decrease in renal blood flow.

    In the case of acute cardiovascular failure, cardiac decompensation Dopamine Admed is administered at a rate of more than 50 μg / kg / min.

    Duration of application: the duration of infusions depends on the individual characteristics of the patient.

    Dosage for drip administration (see table 1)

    If the contents of 1 ampoule of Dopamine Admed 200 mg are dissolved in 50 ml of solution for injection, 1 ml of this solution contains 4000 μg of dopamine.

    Table number 1

    Dosage

    50 kg of body weight

    70 kg of body weight

    90 kg of body weight

    2 μg / kg body weight / min

    1.5 ml / hr

    2.1 ml / hour

    2.7 ml / hr

    5 μg / kg body weight / min

    3.75 ml / hour

    5.25 ml / hr

    6.75 ml / hr

    10 μg / kg body weight / min

    7.5 ml / hr

    10.5 ml / hr

    13.5 ml / hr

    20 μg / kg body weight / min

    15.0 ml / hr

    21.0 ml / hr

    27.0 ml / hr

    50 μg / kg body weight / min

    37.5 ml / hr

    52.5 ml / hr

    67.5 ml / hr

    Dosages for infusion (hardware) (see Table 2)

    If the contents of 1 ampule of Dopamine Admed 200 mg are dissolved in 500 ml of solution for injection, 1 ml of this solution contains 400 μg of dopamine.

    Table number 2

    Dosage

    50 kg of body weight

    70 kg of body weight

    90 kg of body weight

    2 μg / kg body weight / min

    15 ml / hour

    (5 drops / min)

    21 ml / hour.

    (7 drops / min)

    27 ml / hour

    (9 drops / min)

    5 μg / kg body weight / min

    37.5 ml / hr

    (2.5 drops / min)

    52.5 ml / hr

    (17.5 drops / min)

    67.5 ml / hr

    (22.5 drops / min)

    10 μg / kg body weight / min

    75 ml / hr

    (25 drops / min)

    105 ml / hr

    (35 drops / min)

    135 ml / hr

    (45 drops / min)

    20 μg / kg body weight / min

    150 ml / hr

    (50 drops / min)

    210 ml / hr

    (70 drops / min)

    270 ml / hr

    (90 drops / min)

    50 μg / kg body weight / min

    375 ml / hr

    525 ml / hr

    675 ml / hr

    After the stabilization of the clinical situation, the drug is withdrawn gradually.

    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 region).

    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) (maximum dose area).

    In order to influence the blood pressure it is recommended to increase the dose to 500 mcg / min or more, or at a constant dose of the drug Dopamine Admeda 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 in the rhythm of the heart, regardless of the doses used, further increase in the drug 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, ie, starting with the lowest dose.

    Duration of use: duration of infusions depends on the individual characteristics of the patient. There is a positive experience of infusion lasting up to 28 days.

    Rules for the preparation of solution

    For dilution use: 0.9% solution of sodium chloride, 5% solution of dextrose (glucose), Ringer-lactate solution.

    Preparation of the infusion solution should be made immediately before use (the stability of the solution remains for 24 hours, except for the mixture with Ringer-lactate solution - a maximum of 6 hours). The drug Dopamine Admeda solution should be clear and colorless.

    Side effects:

    From the cardiovascular system: less often - angina, tachycardia or bradycardia, palpitations, chest pain, increased or decreased blood pressure, conduction disorders, QRS complex expansion (QRS - the first phase of the ventricular complex, reflecting the process of ventricular depolarization); vasospasm, increased end-diastolic pressure in the left ventricle; when used in high doses - ventricular or supraventricular arrhythmia.

    From the digestive tract: more often - nausea, vomiting, bleeding from the gastrointestinal tract.

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

    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.

    We ask you to report each detected side effect that is not listed in the instructions for use.

    Overdose:

    Symptoms: excessive increase in blood pressure, tachycardia, tachyarrhythmias, an increase in the terminal diastolic volume in the left ventricle, followed by the development of pulmonary edema, angina pectoris (especially in patients with coronary heart disease, nonspecific chest pain, palpitation, nausea, vomiting, peripheral arterial spasm, cyanosis, ventricular extrasystole.

    Treatment: reduce the dose, or temporarily stop the intravenous infusion until the patient's condition is stabilized, since dopamine has a short half-life.In severe cases, the use of beta-blockers or nitroglycerin should be considered.

    Interaction:

    Dopamine is unstable in alkaline solutions (pH more than 7), for example, in a solution of sodium hydrogencarbonate.

    The following are the connections with which dopamine pharmaceutically incompatible:

    - acyclovir

    - alteplase

    - amikacin

    - amphotericin

    - ampicillin

    - cephalothin

    - dacarbazine citrate (due to the presence of cysteine)

    - Theophylline ethyleneamide (euphyllin)

    - Theophylline calcium solution (a solution of calcium euphyllin)

    - furosemide

    - gentamicin

    - heparin

    - iron salts

    - nitroprusside

    - benzylpenicillin (penicillin G)

    - tobramycin.

    Sympathomimetic effect is enhanced by adrenostimulators, monoamine oxidase (MAO) inhibitors (including furazolidone, procarbazine, selegiline), guanetidine (prolongation of duration and enhancement of cardiostimulating and pressor effects); diuretic - diuretics; cardiotonic 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 arterial hypertension or hyperpyrexia), cocaine, other sympathomimetics; weaken - butyrophenones and beta-blockers (propranolol).

    Weaken the hypotensive effect of guanadrel, guanetiline, mecanilamine, 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 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 therapeutic effect).

    Special instructions:

    The drug Dopamine Admed is intended only for intravenous infusions and can only be used in a diluted form!

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

    The rate of infusion should be constantly adjusted to the patient's condition. 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 Admeda.

    Because Dopamine Admeda improves atrial-ventricular conduction, cardiac glycosides should be administered to patients with atrial fibrillation and a rapid ventricular response before dopamine Admed.

    With prolonged parenteral nutrition and in all cases (according to indications), the volume of circulating blood, water-electrolyte balance, acid-base state, the state of liver and kidney function should be regularly evaluated.

    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 who received MAO inhibitors during the last 2-3 weeks, the initial doses of Dopamine Admed 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, the drug should be injected into large veins. To prevent tissue necrosis in case of extravasal ingestion, 10-15 ml of a 0.9% solution of sodium chloride with 5-10 mg of phentolamine should be infiltrated immediately.

    Given the pharmacological properties of the drug, you should pay special attention to the inadmissibility of intra-arterial infusions and bolus injections!

    Patients in a coma should ensure the patency of the airways.

    Appointment of the drug against the background of occlusive diseases of peripheral vessels and / or DIC-syndrome (ICE - desyminirovannoe intravascular coagulation) in 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 found immediately stop the preparation).

    Form release / dosage:Concentrate for solution for infusion, 20 mg / ml.
    Packaging:10 ml in a colorless glass ampoule; 5 ampoules in a cardboard holder together with instructions for use are placed in a cardboard box.
    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.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N015933 / 01
    Date of registration:30.06.2011
    The owner of the registration certificate:Admeda Arzneimittel GmbHAdmeda Arzneimittel GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspLEX CJSCLEX CJSCRussia
    Information update date: & nbsp19.01.2016
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