Adrenaline-SOLOfarm - instructions for use, doses, side effects, contraindications

Active substanceEpinephrineEpinephrine

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Adrenalin

solution for injections

MOSCOW ENDOCRINE FACTORY, FSUE Russia

Adrenalin

solution locally

MOSCOW ENDOCRINE FACTORY, FSUE Russia

Adrenalin-SOLOfarm

solution for injections

GROTEKS, LLC Russia

Epinephrine hydrochloride-Vial

solution for injections

VIAL, LLC Russia

EPIDZHECT®

solution w / m

Meda AB Sweden

Dosage form: & nbspinjection

Composition:

1 ml of the preparation contains:

Active substance:

Adrenaline Tartrate

in terms of adrenaline (epinephrine) 1.0 mg

Excipients:

Sodium chloride 8.0 mg

Chlorobutanol Hemihydrate in terms of

chlorobutanol 5.0 mg

Disodium edetate dihydrate (Trilon B) 0.5 mg

Glycerol anhydrous 60.0 mg

The hydrochloric acid solution is 5 M or

sodium hydroxide solution 2 M to pH 2.2-5.0

Water for injection up to 1.0 ml.

Description:

Transparent colorless or slightly colored liquid with a characteristic odor.

Pharmacotherapeutic group:α- and β-adrenomimetic

ATX: & nbsp

C.01.C.A.24 Epinephrine

Pharmacodynamics:

The effect is due to the activation of receptor-dependent adenylate cyclase on the inner surface of the cell membrane, increased intracellular concentration of cyclic adenosine monophosphate (cAMP) and calcium ions (Ca²⁺). In very low doses, with an administration rate of less than 0.01 μg / kg / min, it can lower blood pressure due to expansion of the vessels of the skeletal muscle.At a rate of administration of 0.04-0.1 mcg / kg / min increases the frequency and strength of heartbeats, the shock volume of blood and the minute volume of blood, reduces the overall peripheral vascular resistance; above 0.02 μg / kg / min narrows vessels, raises blood pressure (mainly systolic) and general peripheral vascular resistance. The pressor effect can cause a short-term reflex slowing of the heart rate.

Relaxes the smooth muscles of the bronchi. Doses above 0.3 μg / kg / min, reduce renal blood flow, blood supply to the internal organs, tone and motility of the gastrointestinal tract.

Expand the pupils, help reduce the production of intraocular fluid and intraocular pressure. It causes hyperglycemia (increases glycogenolysis and gluconeogenesis) and increases the content of free fatty acids in the plasma.

Increases conduction, excitability and automatism of the myocardium. Increases myocardial oxygen demand.

Inhibits the antigen-induced release of histamine and leukotrienes, eliminates spasm of bronchioles, prevents the development of edema of their mucous membrane.Acting on α-adrenergic receptors located in the skin, mucous membranes and internal organs, causes vasoconstriction, a decrease in the rate of absorption of local anesthetics, prolongs the duration and reduces the toxic effect of local anesthesia.

Stimulation of β2-adrenoreceptors is accompanied by increased elimination of potassium ions (K⁺) from the cell and can lead to hypokalemia.

With intracavernous injection reduces blood filling of cavernous bodies. The therapeutic effect develops almost instantaneously with intravenous administration (duration of action is 1-2 minutes), 5-10 minutes after subcutaneous administration (maximum effect after 20 minutes), with intramuscular injection, the time of onset of the effect is variable.

Pharmacokinetics:

Suction

When intramuscular or subcutaneous injection is well absorbed. Entered parenterally, rapidly destroyed. Also absorbed in endotracheal and conjunctival administration. Time to reach the maximum concentration in the blood with subcutaneous and intramuscular injection - 3-10 minutes. Penetrates through the placenta, into breast milk, does not penetrate the blood-brain barrier.

Metabolism

Metabolized mainly monoamine oxidase and catechol-O-methyltransferase in the endings of sympathetic nerves and other tissues, as well as in the liver with the formation of inactive metabolites. Half-life with intravenous administration - 1-2 minutes.

Excretion

It is excreted by the kidneys mainly in the form of metabolites: vanillylmandelic acid, sulfates, glucuronides. as well as in a small amount - unchanged.

Indications:

- Allergic reactions of immediate type (including urticaria, angioedema, anaphylactic shock), developing with the use of drugs, serums, blood transfusions, eating foods, insect bites or other allergens; asthma of physical effort.

- Bronchial asthma (relief of asthmatic status), bronchospasm during anesthesia.

- Asystole (including on the background of the sharply developing atrioventricular blockade III degree).

- Bleeding from the superficial vessels of the skin and mucous membranes (including gums).

- Arterial hypotension, not amenable to the effect of adequate volumes of replacement fluids (including shock, bacteremia, open heart surgery, kidney failure).

- Necessity of lengthening the action of local anesthetics.

- Episodes of complete atrioventricular blockade (with the development of the syncopal condition (Morgagni-Adams-Stokes syndrome)).

- Stop bleeding (as a vasoconstrictor).

Contraindications:

Hypersensitivity to any of the components of the drug, hypertension, severe atherosclerosis (including cerebral atherosclerosis), hypertrophic obstructive cardiomyopathy, tachyarrhythmia, ischemic heart disease, ventricular fibrillation, atrial fibrillation, ventricular arrhythmias, chronic heart failure grade 3-4, myocardial infarction, pheochromocytoma, thyrotoxicosis, diabetes mellitus, acute and chronic arterial insufficiency (including in the history - arterial embolism, atherosclerosis, diseases Buerger, Diabetic Endarteritis, Raynaud's Disease), hypovolemia, metabolic acidosis, hyperkalemia, hypoxia, pulmonary hypertension, shock of non-allergic genesis (including cardiogenic, traumatic, hemorrhagic), cold trauma, Parkinson's disease, organic brain damage, angle-closure glaucoma, convulsive syndrome, prostatic hyperplasia, age under 18 years (except for conditions,directly threatening life), pregnancy, lactation, simultaneous use of inhalation for general anesthesia (halothane), epinephrine in combination with local anesthetics are not used for local anesthesia of the fingers and toes due to the risk of ischemic tissue damage.

In urgent conditions, all contraindications are relative.

Carefully:

Hyperthyroidism, old age.

To prevent arrhythmias against the background of the drug prescribe β-blockers.

Pregnancy and lactation:

Application during pregnancy and during breastfeeding is contraindicated.

Dosing and Administration:

Subcutaneously, intramuscularly, intravenously drip.

Allergic reactions of immediate type (anaphylactic shock): intravenously slowly 0.1-0.25 mg diluted in 10 ml of 0.9% sodium chloride solution, if necessary continue intravenous drip introduction at a concentration of 1: 10,000. In the absence of an immediate threat to life, intramuscular or subcutaneous injection of 0.3-0.5 mg is preferred, if necessary, repeated administration 10-20 minutes up to 3 times.

Bronchial asthma: subcutaneously 0.3-0.5 mg, if necessary, repeated doses can be administered every 20 minutes up to 3 times, or intravenously, 0.1-0.25 mg with dilution at a concentration of 1: 10,000.

With asystole: intracardiac 0.5 mg (diluted with 10 ml of 0.9% sodium chloride solution or other solution); during resuscitation - 0.5-1.0 mg (diluted) intravenously every 3-5 minutes. If the patient is intubated. possible endotracheal instillation - the dose should be 2-2.5 times the dose for intravenous administration.

Stop bleeding: locally in the form of tampons moistened with a solution of the drug.

With arterial hypotension: intravenously drip 1 μg / min, the rate of administration can be increased to 2-10 μg / min.

To lengthen the action of local anesthetics: in a concentration of 0.005 mg / ml (the dose depends on the species used anesthetic), for spinal anesthesia - 0.2-0.4 mg.

Morgagni-Adams-Stokes Syndrome (bradyarrhythmic form): in a dose of 1 mg in 250 ml of a 5% solution of glucose intravenously, gradually increasing the infusion rate until a minimum sufficient number of cardiac contractions is reached.

As a vasoconstrictor: intravenously drip 1 μg / min, the rate of administration can be increased to 2-10 μg / min.

Application in children's practice:

Newborns (asystole): intravenously.10-30 mcg / kg every 3-5 min, slowly.

Children older than 1 month: intravenously, 10 mcg / kg (then, if necessary, every 100 min / kg every 100 min / kg (after administration of at least 2 standard doses, higher doses of 200 mcg / kg may be used every 5 min). endotracheal administration.

Children with anaphylactic shock: subcutaneously or intramuscularly at 0.01 mg / kg (maximum - 0.3 mg), if necessary, the administration of these doses is repeated every 15 minutes (up to 3 times).

Children with bronchospasm: subcutaneously 10 μg / kg (maximal - up to 0.3 mg), doses are repeated every 15 minutes (up to 3-4 times) or every 4 hours if necessary.

Side effects:

Classification of incidence of adverse events according to the World Organization Health (WHO):

very often (≥ 1/10);

often (from ≥ 1/100 to <1/10);

infrequently (from ≥ 1/1000 to <1/100);

rarely (from ≥ 1/10000 to <1/1000);

very rarely (from <1/10000, including individual messages).

From the cardiovascular system: infrequently - angina, bradycardia or tachycardia, palpitations, increased or decreased blood pressure, at high doses - ventricular arrhythmias (including ventricular fibrillation); rarely - arrhythmia, chest pain, pulmonary edema.

From the nervous system: often - headache, anxiety, tremor, tick; infrequent - dizziness, nervousness, fatigue, nausea, vomiting, personality disorders (psychomotor agitation, disorientation, memory impairment, psychotic disorders: aggressive or panic behavior, schizophrenia disorders, paranoia), sleep disturbance, muscle twitching.

From the digestive system: often - nausea, vomiting.

From the side of the urinary system: rarely - difficult and painful urination (with prostatic hyperplasia).

Local reactions: infrequently - pain or burning in the place of intramuscular injection. Allergic reactions: infrequently - angioedema, bronchospasm, skin rash, erythema multiforme.

Other: infrequently - increased sweating; rarely - hypokalemia.

If the side effects indicated in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

Overdose:

Symptoms: excessive increase in arterial pressure, tachycardia, followed by bradycardia, rhythm disturbances (including atrial and ventricular fibrillation), coldness and pallor of the skin, vomiting, headache, metabolic acidosis, myocardial infarction, craniocerebral hemorrhage (especially in elderly patients), pulmonary edema, death.

Treatment: stop the introduction, symptomatic therapy - for lowering blood pressure - α-adrenoblockers (phentolamine), with arrhythmia - β-adrenoblockers (propranolol).

Interaction:

Epinephrine antagonists are α- and β-adrenoreceptor blockers.

The efficacy of epinephrine has been reduced in patients with severe anaphylactic reactions taking beta-blockers. In this case, intravenously apply salbutamol.

Application in conjunction with other adrenomimetics can enhance the effect of epinephrine. Weakens the effects of narcotic analgesics and hypnotics.

When used concomitantly with cardiac glycosides, quinidine, tricyclic antidepressants, dopamine, agents for inhalation anesthesia (enflurane, halothane, isoflurane, methoxyflurane), the risk of arrhythmias increases with cocaine (together it should be used very carefully or not at all); with other adrenomimetics - increased severity of side effectseffects from the cardiovascular system; with antihypertensive agents - reducing their effectiveness.

With diuretics - it is possible to increase the pressor effect of epinephrine.

Simultaneous use with drugs that inhibit monoamine oxidase (procarbazine, selegiline, and furazolidone), can cause a sudden and pronounced increase in blood pressure, hyperpyretic crisis, headache, cardiac arrhythmias, vomiting; with nitrates - weakening of their therapeutic effect; with phenoxybenzamine - strengthening the hypotensive effect and tachycardia: with phenytoin - a sudden decrease in blood pressure and bradycardia (depends on the dose and rate of administration); with preparations of thyroid hormones - mutual reinforcement of action; with drugs that extend QT-Interval (including astemizole, cisapride, terfenadine) - lengthening QT-Interval; with diatriazoatami, iotalamovoy or yoksaglovoj acids - strengthening of neurological effects, with ergot alkaloids - strengthening vasoconstrictor effect (up to the expressed ischemia and gangrene development).

Reduces the effect of insulin and other hypoglycemic drugs.

Special instructions:

A random intravenous injection of epinephrine can cause a sharp increase in blood pressure.

Increased blood pressure when injecting the drug can cause attacks of angina pectoris. Epinephrine can cause the constriction of capillaries of the kidneys, thereby reducing diuresis.

For infusion, a device with a measuring device should be used to regulate the infusion rate.

Infusion should be carried out in a large (better in the central) vein.

Intra-cardinally administered with asystole, if other methods are not available, because there is a risk of cardiac tamponade and pneumothorax.

During the treatment period, it was recommended to determine the concentration of potassium ions (K⁺) in blood serum, measurement of blood pressure, diuresis, minute volume of blood circulation, electrocardiogram, central venous pressure, pulmonary artery pressure and wedging pressure in the pulmonary capillaries.

Excessive doses of myocardial infarction can increase ischemia by increasing myocardial oxygen demand.

Increases the glycemia, and therefore in diabetes requires higher doses of insulin and sulfonylurea derivatives.

With endotracheal injection, the absorption and final concentration of the drug in the plasma can be unpredictable.

The introduction of epinephrine in shock states does not replace transfusion of blood, plasma, blood-substituting fluids and / or saline solutions.

Epinephrine is inexpedient to apply for a long time (narrowing of peripheral vessels, leading to the possible development of necrosis or gangrene).

Strictly controlled studies of the use of epinephrine in pregnant women have not been conducted. A statistically consistent relationship between the appearance of malformations and inguinal hernia in children whose mothers were used epinephrine during the first trimester or throughout the entire pregnancy, there was also reported in one case the occurrence of anoxia in the fetus after intravenous administration of the epinephrine mother.

Use to correct low blood pressure during labor is not recommended because it can delay the second stage of labor; when administered at high doses to reduce uterine contractions, can cause a prolonged atony of the uterus with bleeding.

Can be used in children with cardiac arrest, but caution should be used.

At the termination of treatment of a dose it is necessary to reduce gradually, since sudden withdrawal of therapy can lead to lower blood pressure.

Easily destroyed by alkylating substances and oxidizing agents, including chlorides, bromides, nitrites, iron salts, peroxides.

If the solution has become pinkish or brown or contains sediment, it can not be administered. Unused portion should be destroyed.

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

After application of the drug, the doctor must individually, in each case, decide whether to admit the patient to drive or engage in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Solution for injection 1 mg / ml.

Packaging:

1 ml per ampoule of colored glass.

By 1, 5 or 10 ampoules in a contoured cell pack of a film of polyvinyl chloride or polyethylene terephthalate with a film of polymer or foil of aluminum lacquered or without a polymer film and foil of aluminum lacquered or in the form of a cardboard with cells for laying ampoules.

1 contour pack or cardboard shape with 1, 5 or 10 ampoules or 2 out-of-round packagings or cardboard molds with 5 ampoules together with instructions for use and a scapegrator with or without ampoule in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 15 ° C.

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-004465

Date of registration:19.09.2017

Expiration Date:19.09.2022

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

Manufacturer: & nbsp

GROTEKS, LLC Russia

Information update date: & nbsp05.10.2017

Illustrated instructions

Instructions

Adrenalin-SOLOfarm (Adrenaline-SOLOpharm)