Treatment of patients in severe condition requiring rapid glucocorticosteroid administration, e.g. primary or secondary adrenal insufficiency; shock states (post-traumatic, postoperative, cardiogenic, anaphylactic, transfusion, post-burn shock); severe bronchial spasticity (asthmatic condition); acute allergic conditions (angioedema Quincke); severe form of erythema multiforme (Stevens-Johnson syndrome); acute forms of auto-aggression; acute hypersensitivity reaction to drugs.
Composition:
One vial contains 25 mg or 100 mg of Hydrocortisone as the sodium succinate.
Action:
Synthetic glucocorticosteroid, a water-soluble hydrocortisone derivative. It exerts anti-inflammatory, antiallergic, anti-rheumatic, anti-shock, immunosuppressive effects, inhibits the action of hyaluronidase, inhibits capillary permeability and reduces swelling. In addition, it increases the concentration of Glucose in the blood, accelerates the breakdown and inhibits protein synthesis and weakens the body's resistance to infection. It also stops sodium and water in the body, increases urinary excretion of potassium. It intensifies Calcium resorption from the bones, causes the development of osteoporosis. It reduces the absorption of calcium ions from the gastrointestinal tract, increases the excretion of calcium in the urine and inhibits growth in children. It blocks the secretion of the adrenocorticotropic hormone by the pituitary gland, which causes adrenocortical insufficiency. It reduces the number of lymphocytes, monocytes and eosinophils. After prolonged use, it leads to the characteristic distribution of adipose tissue. After intravenous administration, the maximum concentration in the blood is reached immediately after administration; after intramuscular administration - within 60-90 min. It binds to specific proteins that condition the transport of adrenocortical hormones. Hydrocortisone is metabolized mainly in the liver to inactive metabolites that are excreted in the urine. T0,5 is 2-2.5 hours. Hydrocortisone passes through the placental barrier and into breast milk.
Contraindications:
In ACUTE, life-threatening conditions, there are no contraindications, especially if the drug is expected to be used for a short time (24-36 h). In other cases, contraindications are hypersensitivity to hydrocortisone or other corticosteroids and systemic mycoses.
Precautions:
During the period of glucocorticoid administration, no vaccination should be carried out because immune responses are weakened and the production of antibodies may be impaired. In the case of long-term treatment, the drug should not be discontinued suddenly due to the possibility of symptoms of acute adrenal insufficiency. During long-term treatment, the dose of hydrocortisone should be increased in the event of a concomitant illness, injury or surgery. Hydrocortisone may mask the symptoms of fungal, viral or bacterial infections and new infections may occur with the use of hydrocortisone. When a patient is treated with hydrocortisone systemically or has been using corticosteroids during the last 3 months and is in contact with a person infected with chicken pox or herpes zoster, he must undergo passive immunization by using chickenpox / herpes zoster which must be administered within 10 days of contact with a person suffering from chickenpox or shingles. The use of glucocorticosteroids with antituberculous therapy should be limited to cases of fulminant miliary tuberculosis. If glucocorticosteroids must be used in patients with latent tuberculosis or hypersensitivity to tuberculin, they should be closely monitored for disease activation; during long-term glucocorticotherapy, patients should receive anti-tuberculosis drugs. Sometimes a severe allergic reaction may occur after parenteral use of hydrocortisone - appropriate preventive measures should be taken before administering the drug, especially if the patient has experienced hypersensitivity to medications in the past. Caution should be exercised in patients receiving cardiac medication (ie digoxin), as hydrocortisone induces electrolyte disturbances.In addition, extreme caution and frequent clinical control of health is required in patients with: active or latent peptic ulcer, osteoporosis (especially in postmenopausal women), hypertension, congestive heart failure, diabetes, ongoing or severe manic depressive psychosis (especially with past history), tuberculosis, glaucoma (also if the disease is present in the family), liver damage or cirrhosis, kidney failure, epilepsy, gastrointestinal ulceration, fresh intestinal anastomosis, predisposition to thrombophlebitis, in people with purulent infection, ulcerative colitis, diverticulitis, myasthenia gravis, herpes of the eye threatening corneal perforation, hypothyroidism. Hydrocortisone causes growth retardation - treatment should be limited to the use of a minimum dose as short as possible; the growth and development of the child should be closely monitored. Caution should be exercised in elderly patients due to possible worsening of side effects.
Pregnancy and lactation:
It can only be used during pregnancy if the anticipated benefits to the mother outweigh the potential risk to the fetus. There is some evidence that pharmacological doses of corticosteroids may increase the risk of placental insufficiency, lead to a reduction in birth weight and the birth of dead fetuses. In pregnant women with pre-eclampsia, close monitoring is necessary in the field of water and electrolyte management. Newborns born to mothers who during pregnancy received significant doses of hydrocortisone should be observed due to the risk of adrenal insufficiency. Hydrocortisone is excreted in breast milk in women and may inhibit the production of endogenous glucocorticoids in a breastfed infant, inhibit growth and cause other side effects. For breastfeeding mothers at high doses of Hydro Cortisone, it is recommended to stop breast-feeding while taking the medicine.
Side effects:
During use, you may experience: sodium retention, fluid retention, congestive heart failure, potassium loss, hypokalemic alkalosis, hypertension, hypocalcaemia, burning and tingling at the injection site; sterile osteonecrosis of the femoral and humerus head, muscle weakness, posteroidal myopathy, loss of muscle mass, osteoporosis, spontaneous fractures including compression spinal fractures and pathological fractures of long bones; nausea, vomiting, loss of appetite (which may cause weight loss), increased appetite (which may result in weight gain), diarrhea or constipation, abdominal distension, gastric irritation and oesophagitis with ulcerations, gastric ulcer with the possibility of perforation and bleeding, perforation small and large intestines - mainly in inflammatory bowel diseases; impaired wound healing, thinning of the skin (which becomes susceptible to damage and sensitive), ecchymosis and haemorrhages, erythema on the face, dermatoses, hirsutism, acne-like eruptions, decreased reactivity in skin tests, hypersensitivity reactions - allergic dermatitis, urticaria, angioneurotic edema, hypopigmentation or hyperpigmentation, scarring, hardening of the skin, reduced pain perception, disappearance of the skin or subcutaneous tissue and abscesses at the injection site; convulsions, due to discontinuation of the glucocorticoid, there may be an increase in intracranial pressure with the congestive disc - an alleged brain tumor, neuritis, paresthesia, insomnia; menstrual disorders, symptoms of Cushing's syndrome, inhibition of growth in children, secondary suppression of pituitary-adrenal axis function, reduction of carbohydrate tolerance, latent diabetes mellitus, increased insulin demand or oral antidiabetic agents in diabetic patients; increased intraocular pressure, secondary glaucoma, exophthalmos, optic nerve damage, subcapsular cataract of the posterior part of the lens; negative nitrogen balance due to increased catabolism of proteins; pain and dizziness, hallucinations, psychosis, euphoria, mood changes, symptoms of an alleged brain tumor caused by increased intracranial pressure and the occurrence of congestive disc; thromboembolism, fatbloodness, hypercholesterolemia, accelerated atherosclerosis, necrotizing vasculitis, thrombophlebitis,arrhythmias or ECG changes associated with hypokalemia, fainting, worsening of hypertension, heart rupture as a consequence of a recent myocardial infarction, sudden cardiac arrest; leukocytosis, thrombocytopenia, lymphopenia; intensification or masking of symptoms of infection; anaphylactic reactions. The withdrawal syndrome occurs after a rapid discontinuation of hydrocortisone after prolonged use - it can be life-threatening.
Dosage:
The medicine can be given by injection into a vein, intravenous infusion or intramuscular injection. The dose of the drug is determined individually depending on the indications, the patient's condition and its response to the drug. Usually, the starting doses are higher, and after obtaining the desired therapeutic effect, the smallest doses that support the therapeutic effect are established. Adults and children over 14 years old: the usual single dose is 100-250 mg; within a day to 1.5 g. In severe conditions 100-500 mg intravenously in a slow intravenous injection lasting 1-10 min. In the case of indications, the dose may be repeated after 2, 4 or 6 h. Usually, the treatment with high doses of glucocorticoids is used no longer than 48-72 h. If high-dose treatment must be continued, it is recommended to replace the sodium salt of hydrocortisone succinate with sodium salt of methylprednisolone succinate that does not cause sodium retention in the body to a small or no degree. If possible, it is recommended to reduce the dose and reduce the duration of use of glucocorticoids due to the possibility of complications. The use of the drug in the elderly does not require special dosage.Children up to 14 years old: usually once; infants - 8-10 mg / kg, 2-14 years - 4-8 mg / kg per day. In justified cases, the doses may be higher, children do not use doses lower than 25 mg per day. If possible, corticosteroids should not be prolonged in infants and children. If it is necessary to continue treatment with glucocortoids, consideration should be given every other day. The growth and development of the child should be monitored during treatment. If continuing treatment in children over 72 h, consideration should be given to replacing the sodium salt of hydrocortisone succinate with sodium salt of methylprednisolone succinate, which does not cause sodium retention in the body. It is recommended that the daily dose distribution should take into account the biological rhythm of hormone secretion: the morning dose, administered between 6 and 8 should be 50%, the midday - 20% and evening - 30% of the daily dose.