Dopamine - instructions for use, dose, side effects, contraindications

Active substance:
dopamine hydrochloride	5.0 mg	40.0 mg
Excipients:
sodium disulfite	1.0 mg	5.0 mg
0.1 M solution of hydrochloric acid	to pH 3.5-4.0	to pH 3.5-4.0
water for injections	up to 1.0 ml	up to 1.0 ml

Description:

Transparent, colorless or slightly colored liquid.

Pharmacotherapeutic group:cardiotonic agent of non-glycosidic structure

ATX: & nbsp

C.01.C.A.04 Dopamine

Pharmacodynamics:

Dopamine - catecholamine, identical to the natural neurotransmitter of the human body, dopamine, is also a precursor of norepinephrine.

Excites beta-adrenoreceptors (in low and medium doses) and alpha-adrenoreceptors (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 an increase in renal blood flow, an increase in the glomerular filtration rate, an increase in diuresis and the excretion of sodium ions. The action on renal and mesenteric vessels is different from that of other catecholamines.

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 the circulation. Systolic blood pressure and pulse pressure may increase; the diastolic arterialthe 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-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 circulation 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.

Strictly controlled studies of dopamine in children under 18 years of age have not been conducted.

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 is 0.89 l / kg. Communication with blood plasma proteins - 50%.

Rapidly metabolized in the liver, kidney and plasma monoamine oxidase (MAO) and catechol-O-methyltransferase to inactive metabolites - homovanilic acid and 3,4-dihydroxyphenylacetate.

Dopamine half-life: adults, from blood plasma - 2 min, from tissues - 9 min. The clearance of dopamine is 4.4 l / kg / h. It is excreted by the kidneys: 80% of the dose - in the form of metabolites for 24 hours, in small amounts (less than 10%) - unchanged.

Indications:

- Shock of different genesis: cardiogenic, postoperative, infectious-toxic, anaphylactic, hypovolemic (only after recovery of circulating blood volume);

- acute cardiovascular insufficiency, the syndrome of "low minute circulation" in cardiosurgical patients;

- acute arterial hypotension.

Contraindications:

- Hypersensitivity to the components of the drug, incl. to sulfites;

- hypertrophic obstructive cardiomyopathy;

- pheochromocytoma;

- thyrotoxicosis;

- tachyarrhythmia;

- ventricular fibrillation.

- angle-closure glaucoma;

- simultaneous application of cyclopropane and hydrocarbon derivatives for carrying out inhalation anesthesia, ergot alkaloids.

- age to 18 years (efficacy and safety not established).

Carefully:

Hypovolemia, myocardial infarction, cardiac rhythm disturbances (ventricular arrhythmias, atrial fibrillation), severe stenosis of the aortic aorta, metabolic acidosis, hypercapnia, hypoxia, arterial hypotension in the "small" circulation, obliterating vascular diseases (including atherosclerosis, thromboembolism, thromboangiitis obliterans , obliterating endarteritis, diabetic endarteritis, Raynaud's disease, frostbite), diabetes mellitus, pregnancy, the period of breastfeeding.

Pregnancy and lactation:

In pregnancy, use the drug Dopamine follows only when the intended benefit to the mother exceeds the potential risk to the fetus (in the experiment, an adverse effect on the fetus has been identified). Clinical data on the use of the drug in pregnant women is not enough. Pre-clinical studies have revealed reproductive toxicity of dopamine.

Does it penetrate dopamine in breast milk is not known. If it is necessary to use the drug Dopamine During lactation breastfeeding should be discontinued.

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 obtain an inotropic effect injected at a rate of 100-250 μg / min (1.5-3.5 μg / kg / min) - a small 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 that the dose be raised to 500 mcg / min or more, or at a constant dose of Dopamine, 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.

Most patients manage to maintain a satisfactory condition with doses of Dopamine less than 20 μg / kg / min.

Duration of application: the duration of administration is determined individually. 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: for dilution use 0.9% sodium chloride solution, 5% dextrose (glucose) solution (including mixtures thereof), 5% dextrose (glucose) solution in Ringer's lactate solution, sodium lactate and Ringer 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 (Dopamine concentration will be 1.6-3.2 mg / ml). Preparation of the infusion solution should be performed immediately before administration (the stability of the solution is maintained for 24 hours, except for the mixture with Ringer's lactate solution - a maximum of 6 hours).

Dopamine solution should be clear and colorless.

Side effects:

From the side of the cardiovascular system: tachycardia or bradycardia, palpitations, chest pain, angina pectoris, an increase or decrease in the arterial pressure, conduction disturbance, expansion of the complex QRS; vasospasm, increased the final diastolic pressure in the left ventricle; when used in high doses - ventricular or supraventricular arrhythmia.

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

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

Allergic reactions: severe hypersensitivity reactions and bronchospasm (due to the presence of sulfites in the formulation), shock.

Local reactions: when dopamine enters the skin - necrosis of the skin, subcutaneous tissue, may develop gangrene.

Other: dyspnea, azotemia, piloerection, polyuria (when administered in low doses).

Overdose:

Symptoms: excessive increase in arterial pressure, spasm of peripheral arteries, arrhythmia, tachycardia, ventricular extrasystole, angina, dyspnoea, 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 blood pressure increase) and beta-blockers (in case of rhythm disturbances).

Interaction:

The sympathomimetic effect is enhanced by adrenostimulants, monoamine oxidase inhibitors (including furazolidone, procarbazine, selegiline), guanethidine (increasing the duration and strengthening of pacemaker and pressor effects).

Dopamine can potentiate the action of diuretics.

The cardiotonic effect of dopamine is enhanced by inhalation drugs for general anesthesia, derivatives of hydrocarbons 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).

Dopamine weakens the antihypertensive effect of guanadrel, guanetiline, mecanilamine, methyldopa, rauwolfia alkaloids (the latter prolong the effect of dopamine).

With simultaneous application with levodopa - increased risk 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.

With cardiac glycosides, an increased risk of arrhythmias, an additive inotropic effect (ECG monitoring is required) is possible.

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).

Pharmaceutical incompatibility

Incompatible with acyclovir, alteplase, amikacin, amphotericin B, ampicillin, cephalothin, dacarbazine citrate, theophylline ethyleneamide (euphyllin), theophylline calcium (eufillin calcium), furosemide, gentamicin, sodium heparin, sodium nitroprusside, benzylpenicillin, tobramycin, alkaline solutions, oxidizing agents , salts of iron, thiamine (contributes to its destruction).

Special instructions:

Dopamine is only for intravenous infusions and can only be used in a diluted form!

Dopamine improves atrial-ventricular conduction, so patients with atrial fibrillation should be given cardiac glycosides before using the drug; hypoxia, hypercapnia and acidosis reduce the effectiveness of dopamine, increasing the likelihood of side effects.

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

Infusion should be performed under the control of diuresis, minute blood volume; arterial pressure, ECG, heart rate. 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, can cause the onset of headache, arrhythmia, vomiting and other manifestations of hypertensive crisis, therefore, in patients who received during the last 2-3 weeks monoamine oxidase inhibitors, initial dopamine doses should not exceed 10% of the usual dose .

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.

The use of the drug against the backdrop of obliterating peripheral vascular disease and / or the syndrome of desynvised intravascular coagulation in history can cause a sharp and pronounced narrowing of the vessels, leading to skin necrosis and gangrene (careful monitoring should be done and if the signs of peripheral ischemia are detected, discontinue injection immediately).

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

Dopamine is a drug for use in hospital with a very short half-life. After discharge from the hospital, there is no possibility of drug influence on reaction rate when driving or working with other mechanisms.

Form release / dosage:

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

Packaging:

5 ml per ampoule of colorless neutral glass type I with a color fracture ring or with a colored dot and notch or without a rupture ring, a colored dot and a notch.One, two or three color rings and / or a two-dimensional bar code, and / or alphanumeric coding or without additional color rings, a two-dimensional bar code, and alphanumeric coding can additionally be applied to the ampoules.

5 ampoules per circuit cell packaging made of polyvinylchloride film and aluminum foil foil or polymer film or without foil and without film.

Or 5 ampoules are placed in a prefabricated form (tray) made of cardboard with cells for laying ampoules.

One or two contour squares or cardboard trays, together with the instruction for use and the ampoule ampoule or ampoule scarifier or ampoule ampoule and ampoule scarifier, are placed in a cardboard package.

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 the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002642

Date of registration:01.10.2014

Date of cancellation:2019-10-01

The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia

Manufacturer: & nbsp

OZON PHARM, LLC Russia

Representation: & nbspOZON PHARM, LLCOZON PHARM, LLC

Information update date: & nbsp19.01.2016

Illustrated instructions

Instructions

Dopamine (Dopamine)