Epipen Junior (epinephrine) solution for injections 0.15 mg/dose 2 ml. Solution syringe №1

Description

Epipen Junior Composition
active substance: adrenaline (epinephrine)

1 ml of 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.

Epipen Junior Dosage form
Injection.

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

Pharmacotherapeutic group
Cardiac drugs. Non-glycosidic cardiotonic drugs. Adrenergic and dopaminergic drugs. Epinephrine. ATX code C01C A24.

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

The action of beta-receptors of adrenaline on the smooth muscles of the bronchi causes their relaxation, softening wheezing and reduces shortness of breath.

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

Epipen Junior Pharmacokinetics
Adrenaline is a natural substance that is produced by the adrenal medulla in response to stress or stress. It is rapidly inactivated mainly by two enzymes: catechol-O-methyltransferase (COMT) and MAO (MAO). A significant amount of these enzymes are found in the liver, which is important, but not the main one in the breakdown process. Most of the adrenaline dose is excreted as metabolites.

The plasma half-life of adrenaline is 2.5 minutes. However, with subcutaneous or administration, local vasoconstriction delays absorption, therefore the therapeutic effect occurs without overt symptoms and the duration of action is longer than the expected half-life. It is recommended to gently massage the injection site.

In a pharmacokinetic study of 35 healthy volunteers, grouped by different degrees of subcutaneous fat layer thickness and distributed by sex, a single injection of 0.3 mg / 0.3 ml was injected into the outer thigh using a pre-filled Epipen pen and compared in a cross-over study with a dose, was injected using a manual syringe with needles specially adapted for delivery to the muscle layer. The research results showed that female subjects with a thick subcutaneous fat layer (the distance from the skin to the muscles at maximum pressing is> 20 mm) showed a slow absorption of adrenaline, which was reflected in a tendency towards a decrease in the concentration of adrenaline in the blood plasma during the first ten minutes after the introduction (see the section “Peculiarities of application”). However, the total exposure of epinephrine from 0 to 30 min (AUC 0-30 min) in all groups of subjects who used pre-filled Epipen pens exceeded the exposure after syringe administration. It is important that the tendency to an increase in the concentration of adrenaline in the 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, in which be the outflow of blood from the skin to the muscles of the legs. Therefore, consideration should be given to the possibility of skin vasoconstriction occurring during injection.

Variability between patients and intra-individual variability was high enough in this study, so no reliable conclusions can be drawn.

Indications
Severe allergic reactions (anaphylaxis), for example: allergic reactions to insect bites, food, drugs, contact with other allergens, and idiopathic or exercise-induced anaphylaxis.

Contraindications
There are no known absolute contraindications to the use of Epipen Junior in emergency treatment for allergic reactions.