Composition, form of production and packaging
Solution for intravenous administration 1 ml 1 amp.
dopamine hydrochloride 40 mg 200 mg
Excipients: sodium pyrosulfate, disodium salt of ethylenediaminetetraacetic acid.
5 ml - ampoules (5) - plastic holders (2) - cardboard packs.
Solution for intravenous administration 1 ml 1 amp.
dopamine hydrochloride 10 mg 50 mg
Excipients: sodium pyrosulfate, disodium salt of ethylenediaminetetraacetic acid.
5 ml - ampoules (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Dopamine receptor agonist. Dopamine has a positive inotropic effect (increases the contractility of the heart), increases coronary and renal blood flow, expands mesenteric vessels, increases diuresis.
PHARMACOKINETICS
The effect of dopamine occurs rapidly in about 5 minutes from the moment of IV administration of the drug. The duration of the drug is short and is approximately 10 minutes. 75% of dopamine is metabolized in the liver, kidneys and plasma by means of the enzyme MAO (monoamine oxidase) and COMT (catechol-o-methyltransferase) to the inactive metabolite-derivative of vanillic acid (HVA) and 25% to norepinephrine. 80% of the drug is excreted in the urine for 24 hours in the form of inactive metabolites of homovanilic acid and its metabolites, as well as metabolites of norepinephrine. Only a small amount of the drug is excreted unchanged.T 1/2 in children - 7-26 min, and in adults - about 7 min.
INDICATIONS
- shock of various genesis (cardiogenic, postoperative, infectious-toxic, anaphylactic, hypovolemic (only after recovery of bcc);
- acute cardiac and vascular insufficiency in various pathological conditions.
DOSING MODE
The drug is used only in the hospital!
The dose is selected individually and depends on the degree of shock, as well as on the patient's response to treatment.
The drug is administered in the form of IV infusions (directly into the vein) or drip. The drug can be used only in diluted form. After the stabilization of the clinical situation, the infusion should be stopped not suddenly, but gradually. For dilution, use 0.9% sodium chloride solution or 5% glucose solution. The amount of diluent depends on the method of administration of the preparation. If the drug is administered by intravenous infusion, dopamine is diluted to 20 ml or 50 ml with 0.9% sodium chloride solution or 5% glucose solution, and in case of drip administration - up to 500 ml with one of these solutions. Usually, 200 mg of dopamine is diluted (4 ampoules of 1% solution or 1 ampoule of 4% solution). The rate of administration of the drug depends on the dose to be administered, calculated per kg of body weight per hour. Do not combine dopamine with agents that have an alkaline reaction. Do not apply the drug for more than 60 hours.
Dopamine is light sensitive, therefore it is recommended to protect the prepared solution from light.
The solution of dopamine should be freshly prepared, clear and colorless. The diluted solution remains active for 24 hours.
Shock states
Doses for children under the age of 18:
The initial IV dose is 2-5 Ојg per kg of body weight per minute; the dose can be increased every 15-30 minutes until a dose of 10 Ојg per kg of body weight per minute is reached.
Doses for adults:
The initial intravenous dose is 1-5 Ојg per kg body weight per minute; the dose can be increased every 15-30 minutes until the optimal dose is reached, at which the therapeutic effect (blood pressure and diuresis) is noted.
Cardiogenic shock
Doses for adults:
The initial IV dose is 2-5 Ојg per kg of body weight per minute; the dose can be increased to 10 Ојg per kg of body weight per minute.
Severe heart failure
Doses for adults:
The initial IV dose is 0.5-1 Ојg per kg of body weight per minute; and the optimal dose is 1-3 Ојg per kg of body weight per minute. If necessary, the dose can be increased to 5 Ојg per kg of body weight per minute. Further increase in dose does not cause an increase in diuresis.
Acute kidney failure
Doses for children and adults:
1-5 Ојg per kg of body weight per minute.
Treatment should begin with a minimal dose, gradually increasing it to a maximum dose of 5 Ојg per kg of body weight per minute. Further increase in dose does not cause an increase in diuresis.
Arterial hypotension, not caused by hypovolemia
Doses for children:
- premature, newborns, the recommended initial dose is 10 Ојg per kg of body weight per minute;
smaller doses also cause an increase in blood pressure, but the therapeutic effect is short-lived;
- at the age of 17 years: 2-10 Ојg per kg of body weight per minute;
the administration begins with a dose of 2-3 Ојg per kg of body weight per minute, gradually increasing it if necessary.
Doses for adults:
2-10 Ојg per kg of body weight per minute (in the case of compensatory volemia, this dose is optimal). If necessary, the dose of the drug can be increased every 15-30 minutes to a maximum, not exceeding 50 Ојg per kg of body weight per minute. The maximum dose is 50 Ојg per kg of body weight per minute.
Exceeding it is unacceptable!
During the use of the drug, it is necessary to control the level of arterial pressure, diuresis.
SIDE EFFECT
Sometimes mild nausea, vomiting, headache, anxiety, tremor of fingers, pain in the heart, tachycardia, increased blood pressure. As the dose increases, the risk of cardiac arrhythmias increases (sinus tachycardia, supraventricular and ventricular ectopia, and an undesirable increase in the end-diastolic pressure in the left ventricle of the heart).
In very rare cases, bleeding from the gastrointestinal tract is possible. If the product gets under your skin - necrosis of the skin, subcutaneous tissue.
CONTRAINDICATIONS
Thyrotoxicosis, pheochromocytoma, certain forms of glaucoma (closed-angle glaucoma), enlarged prostate with residual urine syndrome, tachyarrhythmias, ventricular fibrillation, hypersensitivity to the drug components.
PREGNANCY AND LACTATION
During pregnancy, use only in cases where the benefit to the mother exceeds the possible risk to the fetus.
There are no data on the penetration of dopamine into breast milk. Indications for the use of dopamine are the states of immediate danger to life; in such cases, the fact of breastfeeding the child is not a contraindication to the use of the drug.
APPLICATION FOR FUNCTIONS OF THE LIVER
If the kidney function is impaired, use with caution, according to the dosing regimen.
APPLICATION FOR CHILDREN
The application is possible according to the dosing regimen.
SPECIAL INSTRUCTIONS
Dopamine can not be used to treat patients with bronchial asthma with increased sensitivity to sulfites. Especially cautiously, the drug should be used in patients taking MAO inhibitors; in these cases, the dose of dopamine should be 1/10 of the normal dose.
Caution should be used in patients with angina pectoris. When dopamine is used in large doses, cardiac rhythm disturbances are possible. In patients who previously had heart rhythm disturbances, the use of dopamine may cause their exacerbation. It is necessary to reduce the dose or cancel the drug.
In case of impaired renal function, an increase in the dose of dopamine in excess of 5 Ојg per kg of body weight does not lead to an increase in the therapeutic effect.
Before using dopamine, it is necessary to restore the volume of circulating blood, KHS.
During the use of the drug should be very careful that there is no extravasation of the drug outside the blood vessels, due to a strong local action that causes tissue necrosis. Do not administer the drug into the arterial vessels.
In the event that the drug was injected outside the blood vessel, to limit the area of ​​necrosis, a solution of phentolamine (5-10 mg in 15 ml of 0.9% sodium chloride solution) should be injected at the place of extravasation with a thin needle for injections.
OVERDOSE
A large range of therapeutic doses of dopamine (2-20 Ојg per kg of body weight per minute, up to a maximum dose of 50 Ојg per kg of body weight per minute) does not allow unequivocally to determine the toxic dose at which symptoms of overdose appear.
Symptoms: significant arterial hypertension, heart rhythm disturbances, chest pain, rarely acute myocardial infarction, pallor or cyanosis of the palms and soles, anxiety, insomnia, nausea, vomiting, abdominal pain.
Treatment: withdrawal of dopamine, symptomatic therapy.
DRUG INTERACTION
In combination with monoamine oxidase (MAO) inhibitors, the effect of dopamine is increased (a dose of dopamine should be reduced by approximately 1/10 of the normal dose).
In combination with furazolidone, alpha-adrenergic effects of dopamine are possible. Metoclopramide, cimetidine and dehydrobenzopiperidol probably reduce the vasodilating effect of dopamine on the kidney vessels. In combination with albuterol, an increase in the arrhythmogenic effect of dopamine is possible. There are also known interactions between dopamine and a tricyclic antidepressant, analgesics (increased propensity to heart rhythm disturbances) or phenytoin (lowering blood pressure and bradycardia). The combination of dopamine and ergot alkaloids can lead to an excessive narrowing of the peripheral vessels.
Do not combine dopamine with alkaline solutions due to inactivation of the drug in an alkaline environment.
Do not combine dopamine with ampicillin, amikacin, gentamicin, tobramycin, furosemide, indomethacin, iron preparations, alteplase.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription. It is used in a hospital.
TERMS AND CONDITIONS OF STORAGE
Store the drug in a dark place at a temperature of 15 В° C-25 В° C. Keep out of the reach of children.
Shelf life - 3 years. After diluting with a 0.9% solution of sodium chloride or 5% glucose solution, the solution of dopamine is suitable for 24 hours. Do not apply the drug after the expiration date indicated on the package.
