Instruction for use: Solu-Cortef

ATX Code H02AB09 Hydrocortisone

Active substance: Hydrocortisone

Pharmacological group

Glucocorticosteroid

Composition and form of release

Powder lyophilized for the preparation of solution for injection 1 fl.

Hydrocortisone (in the form of hydrocortisone sodium succinate) 100 mg

(Monohydrate monobasic sodium phosphate - sodium dihydrogen phosphate)

In the package 1 bottle.

Powder lyophilized for the preparation of solution for injection in the bottle 2-capacity. ACT-O-VIAL 1 fl.

I. Lower capacity:

Hydrocortisone (in the form of hydrocortisone sodium succinate) 100 mg

(Monohydrate monobasic sodium phosphate - sodium dihydrogen phosphate)

II. Upper capacity:

Benzyl alcohol 18 mg

Water for injection 2 ml

In a pack of cardboard 1 vial of two-shot (lyophilized hydrocortisone powder of sodium succinate and sterile aqueous solvent in 2 separated from each other in a single vial).

pharmachologic effect

Pharmacological action - glucocorticoid.

Dosing and Administration

In / in (intravenously), in the form of intravenous infusions, in / m (intramuscularly). As an emergency therapy for acute conditions, it is recommended to appoint IV. At the end of the acute period, parenterally prescribed dosage forms with a longer duration of action or oral forms of the drug are administered. Treatment is started with intravenous administration for 30 seconds (for example, 100 mg) and up to 10 minutes (for example, 500 mg or more) depending on the severity of the patient's condition.

High doses of corticosteroids should be prescribed only until the patient's condition stabilizes, but mostly not more than 48-72 hours. Undesirable effects in appointing high doses of corticosteroids over a short period of time develop rarely, but the development of peptic ulcers is possible.

Possible the appointment of preventive antacid therapy.

When administering high doses of hydrocortisone for longer than 48-72 hours, hypernatremia may develop. In this case, it is recommended to replace Sol Kortef with another corticosteroid drug, for example methylprednisolone sodium succinate, which causes little or no sodium retention in the body.

The dose of the drug is given repeatedly every 2-4-6 hours, depending on the response of the patient's body and the clinical picture of the disease. When the children are prescribed, the doses of the drug are correspondingly reduced, and the prescribed dose must first of all depend on the severity of the disease and the response of the body to the treatment being carried out, in addition, the age and weight of the child must be taken into account. The prescribed dose should be at least 25 mg / day and not more than 15 mg / kg.

If after a corticosteroid therapy in patients there is a stressful situation, such patients should be under strict supervision because of the possible development of insufficiency of the cortical layer of the adrenal glands.

Therapy with corticosteroids does not replace standard therapy, but is prescribed as an additional therapy.

Preparation of solutions.

Preparations for parenteral administration should be checked visually for changes in color or appearance of particles in all cases where the solution and utensils permit this.

Bottle of 100 mg

For intravenous or intramuscular injection, a solution is prepared by adding to the vial (following the rules of antiseptic) no more than 2 ml of bacteriostatic water for injection or a solution of sodium chloride for injection with a bacteriostatic additive and shaking the bottle until the powder is completely dissolved . For intravenous infusion, the solution is first prepared by adding to the vial no more than 2 ml of bacteriostatic water for injection, then this solution can be added to 100 or 1000 ml of a 5% dextrose solution in water (or saline or 5% dextrose in physiological Solution, if the patient does not need to limit the amount of sodium).

ACT-O-VIAL two-volume vial

1. Press the plastic activator to allow the solvent to flow into the lower container.

2. Gently shake the bottle until the powder dissolves.

3. Remove the plastic disc covering the center of the plug.

4. Treat the surface of the plug with a suitable antiseptic.

5. Pierce the center of the cork with the needle so that the tip of the needle is visible. Flip the bottle and take the necessary amount of the solution with a syringe.

For intravenous or intravenous injections, further dilution is not required. For IV infusion, a solution is prepared first as described above. Further, this solution is added to 100 or 1000 ml of a 5% dextrose solution in water (or saline solution or 5% dextrose solution in saline if the patient does not need to limit the amount of sodium). In cases where it is desirable to introduce a small volume of fluid, 100 to 3000 mg hydrocortisone (equivalent to hydrocortisone sodium succinate) can be added to 50 ml of the above solutions used for dilution. The solutions obtained are stable for 4 hours and can be administered intravenously or via a second dropper.

If the solutions of the preparation are prepared as indicated above, the pH will be from 7 to 8, and the osmolarity is 0.36 osmol (saline = 0.28 osmol).

Storage conditions

At a temperature of 20-25 ° C.

Keep out of the reach of children.

Shelf life

2 years.

Do not use after the expiry date printed on the package.