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Composition:


active ingredient: adrenaline (epinephrine);


1 ml of the solution contains 0.5 mg of epinephrine; 1 dose (0.3 ml) contains 0.15 mg of epinephrine;


excipients: Sodium Chloride, Sodium Metabisulfite (E 223), concentrated hydrochloric acid, water for injection.


Dosage form. Solution for injection.


Basic physical and chemical properties: clear solution without visible inclusions.


Pharmacotherapeutic group. Cardiological preparations. Non-glycoside cardiotonic agents. Adrenergic and dopaminergic drugs. Epinephrine. ATX code C01C A24.


Pharmacological properties.


Pharmacodynamics. Epinephrine is a catecholamine that excites the sympathetic nervous system (Alpha and beta receptors) and thus increases heart rate, cardiac output, and increases coronary circulation.


The action of epinephrine beta receptors on the smooth muscles of the bronchi causes their relaxation, which softens wheezing and reduces shortness of breath.


Epinephrine is rapidly inactivated, and most of the epinephrine dose is excreted as metabolites in the urine.


Pharmacokinetics. Epinephrine is a naturally occurring substance produced by the adrenal medulla in response to stress or stress. It is rapidly inactivated mainly by two enzymes: catechol-O-methyltransferase (COMT) and monoamine oxidase (Mao). A significant amount of these enzymes is found in the liver, which is important, but not the main one in the breakdown process. Most of the epinephrine dose is excreted as metabolites in the urine.


The plasma half-life of epinephrine is 2.5 minutes. However, when administered subcutaneously or intramuscularly, local vasoconstriction delays absorption, so the therapeutic effect proceeds without obvious symptoms and the duration of action is longer than the expected Half-Life. It is recommended to gently massage the injection site.


A single injection of 0.3 mg/0.3 ML into the outer thigh using a pre-filled EpiPen pen was administered and compared in a cross-sectional study with the dose administered using a hand-held syringe with needles specially adapted for delivery to the muscle layer. The results of studies showed that female subjects with a thick subcutaneous fat layer (the distance from the skin to the muscles at maximum pressure is > 20 mm) showed slower absorption of epinephrine, which was reflected in a tendency to decrease the concentration of epinephrine in blood plasma during the first ten minutes after administration (see the section "application features"). However, total epinephrine exposure from 0 to 30 minutes (AUC0 to 30 minutes) in all groups of subjects using pre-filled EpiPen pens exceeded exposure after injection with a syringe. It is important to note that the tendency to increase the concentration of epinephrine in blood plasma after administration with a pre-filled EpiPen Pen compared to manual intramuscular injection in healthy subjects with well-perfused subcutaneous tissue may not necessarily be extrapolated to patients with an established diagnosis of anaphylactic shock, who may have an outflow of blood from the skin to the leg muscles. Therefore, the possibility of narrowing of the skin's blood vessels during the injection should be considered.


Variability between patients and intraindividual variability was quite high in this study, so no reliable conclusions can be drawn.


Clinical characteristics.


Indications. Severe allergic reactions (anaphylaxis), for example: allergic reactions to insect bites, food, medicines, contact with other allergens, as well as idiopathic or exercise-related anaphylaxis.


Contraindications. There are no known absolute contraindications for the use of EpiPen Junior during emergency care for allergic reactions.


Interactions with other drugs and other types of interactions. Use with caution in patients taking medications that may cause cardiac arrhythmia, including cardiac glycosides and quinidine. The effect of epinephrine can be enhanced by the use of tricyclic antidepressants, monoamine oxidase (Mao) and catechol-O-methyltransferase (COMT) inhibitors, thyroid hormones, theophylline, oxytocin, parasympatholytics, some antihistamines (diphenhydramine, chlorpheniramine), levodopa and alcohol.


Epinephrine inhibits the secretion of insulin, thereby increasing blood glucose levels. Patients with diabetes mellitus who take epinephrine should increase the dose of insulin or oral hypoglycemic drugs.


Attention! The beta-stimulating effect may be reduced with simultaneous treatment with beta-blockers.


Concomitant use of epinephrine with cardiac glycosides, quinidine, tricyclic antidepressants, dopamine, inhaled anesthesia agents (enflurane, halothane, Isoflurane, methoxyflurane), cocaine increases the risk of arrhythmias.


Concomitant use of epinephrine with other sympathomimetic agents may increase the severity of side effects from the cardiovascular system.


Concomitant use of epinephrine with antihypertensive agents (including diuretics) may reduce their effectiveness. 


Concomitant use of epinephrine with monoamine oxidase inhibitors (including furazolidone, procarbazine, selegiline) may cause a sudden and pronounced increase in blood pressure, hyperthyretic crisis, headache, cardiac arrhythmias, vomiting.


With the simultaneous use of epinephrine with thyroid hormone preparations, a mutual increase in the effect is possible.


Concomitant use of epinephrine with astemizole, cisapride, terfenadine may prolong the QT interval on the ECG.


With the simultaneous use of epinephrine with ergot alkaloids, it is possible to increase the vasoconstrictor effect up to severe ischemia and the development of gangrene.


Concomitant use of epinephrine with hypoglycemic drugs (including insulin) may reduce the hypoglycemic effect.


Application features.


All patients who are prescribed EpiPen Junior should be carefully instructed to understand the indications for use and learn the correct method of administration. It is also strongly recommended to train the patient's direct partners (for example, parents, caregivers, teachers) in the correct use of the pre-filled EpiPen Junior pen in case of emergency support.


Patients should be informed that if anaphylactic shock occurs, an ambulance should be called. After the first dose of the drug is administered, you should immediately seek help from a doctor to undergo a thorough medical examination and prescribe further treatment if necessary.


The drug is applied intramuscularly to the outer part of the thigh. Patients should be informed that the drug is not injected into the buttocks.


If the injection is made by another person, the patient's leg should be fixed to minimize the risk of needle bending, leg damage, or other injuries.


The drug in a pre-filled handle is intended for one-time use and in no case should the used handle be reused.

Usually, patients with cardiovascular diseases, as well as patients with diabetes mellitus, hyperthyroidism, arterial hypertension and the elderly, epinephrine is used with extreme caution, as prescribed by a doctor and provided that the potential benefit exceeds the risk. When using epinephrine, adverse reactions are possible in patients with increased intraocular pressure, severe renal insufficiency, prostate adenoma, which leads to urinary retention, hypercalcemia and hypokalemia. In patients with Parkinson's disease, the use of epinephrine may cause a temporary exacerbation of the symptoms of this disease, such as stiffness and trembling.


The patient and their partner should be informed about the possibility of biphasic anaphylaxis, which is characterized by initial relief followed by a recurrence of symptoms after a few hours.


Patients with concomitant asthma may have an increased risk of severe anaphylactic reaction.


Accidental injections into the muscles of the arms or legs have been reported, resulting in peripheral ischemia. In case of erroneous administration of the drug, the patient should consult a doctor to prescribe treatment.


In patients with a thick subcutaneous fat layer, epinephrine may not reach muscle tissue and not give an optimal effect, so there is a risk that one dose of EpiPen Junior may not be enough. A second injection may be necessary.


EpiPen Junior contains sodium metabisulfite, which can rarely cause serious hypersensitivity reactions, including symptoms of anaphylactic shock and bronchospasm, especially in people with asthma. Patients with such diseases should carefully read the instructions for medical use before using EpiPen Junior.


One dose of the drug contains less than 1 mmol of sodium (23 mg), that is, it is actually "sodium-free".


Patients should be warned about concomitant allergens and, if possible, conduct a study so that their allergens can be specifically characterized.


Use during pregnancy or lactation.


Pregnancy. Clinical experience with pregnant women is limited. Epinephrine is used during pregnancy only if the potential benefit justifies the potential risk to the fetus.


Breast-feeding. There is no biologically available form of epinephrine for oral administration, and any dose of epinephrine in breast milk does not harm the infant.


Reproductive function. Since epinephrine is a substance that is naturally produced in the body, the drug does not harm reproduction.


Ability to influence the reaction rate when driving vehicles or other mechanisms. During treatment with the drug, it is not recommended to drive vehicles or other mechanisms, as patients may experience symptoms of anaphylactic shock.


Dosage and administration.


Dosage


Children weighing from 15 kg to 30 kg


The usual recommended dose is 0.15 mg, administered intramuscularly.


Children weighing less than 15 kg


The drug is not intended for children weighing less than 15 kg.


The drug is used at the first symptoms of anaphylactic shock.


If there are no clinical signs of improvement or if the condition worsens after the first injection, a second injection may be used. A second injection is given after about 5-15 minutes. Therefore, patients are advised to always have two pre-filled EpiPen Junior pens with them.


After using the drug, the patient should consult a doctor for appropriate measures, further examination and/or further treatment.


The doctor should make sure that the patient understands the indications for use and the rules for using EpiPen Junior.


The doctor should familiarize the patient in detail with the instructions for medical use of the drug, proper use and possible symptoms of anaphylactic shock.


Method of application


EpiPen Junior is intended for immediate use in patients at risk of anaphylactic shock, as well as in patients who have a history of anaphylactic reactions.


The drug is administered intramuscularly in the outer part of the thigh. The drug is not injected into the buttocks. The drug can be administered through clothing or subcutaneously.


Use and disposal.


Check the solution through the window of the pre-filled pen: the solution should be clear and colorless. Do not use a pre-filled pen if the solution is stained or contains sediment, do not apply after the expiration date.


Each pre-filled pen contains 2 ml of 0.5 mg/mL epinephrine injection, which is a single dose (0.3 ml) of 0.15 mg epinephrine. After use, 1.7 ml of the substance remains in the pre-filled handle.


Never touch the orange tip of the pre-filled EpiPen Junior pen with your fingers or hands. Accidental injections into the hand or finger have been reported, resulting in peripheral ischemia. The drug in a pre-filled EpiPen Junior pen should be applied to the outer part of the thigh. The injection is activated immediately when the orange tip comes into contact with the skin or other surface.


blue protective cover window orange tip


Follow the instructions below only when you are ready to use a pre-filled pen

Children.


EpiPen Junior is used for children with a body weight from 15 kg to 30 kg.


Children with a body weight of less than 15 kg are not recommended to use a dosage of less than 0.15 mg due to the complexity of calculating the dose.


Children with a body weight of more than 30 kg use EpiPen, the dose of which contains 0.3 mg of epinephrine.


Overdose.


Overdose or accidental intravascular administration of epinephrine can lead to craniocerebral hemorrhage due to a sharp increase in blood pressure. Fatal cases may be caused by pulmonary edema due to peripheral vascular narrowing along with cardiac stimulation.


Pulmonary edema can be eliminated with Alpha-blocking medications, such as phentolamine. For arrhythmia, beta-blockers are prescribed.


Adverse reactions.


Side effects are associated with the effects of epinephrine on Alpha - and beta-adrenergic receptors and include symptoms such as tachycardia and hypertension, as well as adverse reactions from the central nervous system.

sides of the psyche: frequency unknown – anxiety state.


Nervous system disorders: frequency unknown-headache, dizziness, tremor.


From the cardiovascular system: rarely – stress cardiomyopathy; frequency unknown – tachycardia, cardiac arrhythmia, palpitations, angina pectoris, ventricular fibrillation, arterial hypertension, pallor, peripheral ischemia, which may occur due to accidental administration of the drug into the muscles of the arms or legs.


Respiratory, thoracic and mediastinal disorders: frequency unknown – difficulty breathing.


From the gastrointestinal tract: frequency unknown-nausea, vomiting.


From the skin and subcutaneous tissues: frequency unknown – increased sweating.


General disorders and complications at the injection site: frequency unknown – fatigue, accidental injections can lead to injuries such as hemorrhage, bruising, discoloration, erythema, or skeletal injury.


Expiration date. 19 months.


Storage conditions. Keep out of reach of children. Store at a temperature not exceeding 25°C in the original packaging to protect from light. Do not freeze.


Incompatibility.


Epinephrine and its salts are quickly destroyed in a solution with oxidizing agents. The color of the solution becomes darker when exposed to air or light.

Tags: Epinephrine