Solu-cortef (hydrocortisone) powder for solution for injection 100 mg. №1 vial

Description

Solu-cortef (hydrocortisone) powder for solution for injection 100 mg. №1 vial

Composition

active substance: hydrocortisone;

1 vial contains 100 mg of hydrocortisone in the form of sodium hydrocortisone succinate;

excipients: sodium dihydrogen phosphate, monohydrate; sodium hydrogen phosphate anhydrous.

Dosage form

Powder for solution for injection.

Basic physical and chemical properties: from white to almost white lyophilisate.

Pharmacotherapeutic group

Simple corticosteroid preparations for systemic use. Glucocorticoids. Hydrocortisone.
ATX code H02A B09.

Pharmacological properties

It is a hormonal agent for systemic use. Shows anti-shock, immunosuppressive, anti-toxic, anti-allergic, anti-exudative, anti-inflammatory, anti-allergic, desensitizing effects. Inhibits exudative and proliferative processes in the focus of inflammation.

Indications

Solu-Cortef is used:

• with acute adrenal insufficiency;
• with allergic reactions of an immediate type;
• with status asthmaticus;
• for the prevention / treatment of shock;
• with myocardial infarction, complicated by cardiogenic shock;
• with a thyrotoxic crisis;
• with thyroiditis;
• with congenital adrenal hyperplasia;
• with hypercalcemia due to tumor disease;
• in the acute period of rheumatic diseases, collagen diseases;
• with pemphigus, bullous herpetiform dermatitis (Duhring’s disease), polymorphic bullous erythema, exfoliative dermatitis, fungal mycosis, severe psoriasis or seborrheic dermatitis;
• with symptomatic sarcoidosis;
• with Leffler’s syndrome;
• with beryllium;
• with focal or disseminated tuberculosis;
• with aspiration pneumonitis;
• with idiopathic thrombocytopenic purpura in adults;
• with secondary thrombocytopenia in adults;
• with autoimmune hemolytic anemia, erythroblastopenia;
• with congenital hypoplastic anemia;
• with leukemia, lymphoma in adults, acute leukemia in children;
• to enhance diuresis;
• to reduce proteinuria;
• with nephrotic syndrome without uremia;
• with lupus erythematosus;
• with ulcerative colitis, regional enteritis;
• with tuberculous meningitis with the threat / development of a subarachnoid block;
• with trichinosis with damage to the nervous system, myocardium.

Contraindications

Solu-Cortef is not used:

• with intolerance to the components;
• with severe arterial hypertension;
• with Itsenko-Cushing’s disease;
• with psychosis;
• with jade;
• with osteoporosis;
• with gastric ulcer, duodenal ulcer;
• with an active form of tuberculosis;
• with diabetes mellitus;
• with a recent operation;
• with systemic fungal diseases.

Application during pregnancy and lactation

The drug is used only when necessary.
Application during pregnancy can lead to fetal abnormalities, intrauterine growth retardation.
If treatment is necessary, breastfeeding is discontinued.

Method of administration and dosage

Solu-Cortef is used parenterally (intramuscularly, intravenously, jet or drip).
Intravenous administration is indicated for emergency treatment.
The standard starting dose is 100-500 mg every 2-6 hours (depending on the clinical situation).
The standard dose for children is 3-7 mg / kg / day.
Daily doses during intensive care: for newborns – 5 mg / kg; children 1-5 years old – 4.5 mg / kg; children 6-10 years old – 4 mg / kg, children 11-14 years old – 3.5 mg / kg.

Overdose

Symptoms: increased blood pressure, hypokalemia, joint pain.
Treatment: antihypertensive treatment, potassium supplements.

Side effects:

• Digestive disorders: gastric bleeding, intestinal bleeding, perforation, pancreatitis, esophagitis, peptic ulcer, dry mouth.
• Laboratory abnormalities: negative nitrogen balance, hypercholesterolemia, hypokalemia, hypokalemic alkalosis, hypocalcemia, lymphopenia, leukocytosis, monocytopenia.
• Cardiovascular disorders: heart failure, arterial hypertension, edema, cardiac arrhythmia, necrotizing vasculitis / lymphangitis, obliterating endarteritis, thrombophlebitis.
• Neurological disorders: mental disorders, dizziness, seizures, headache, intracranial hypertension, loss of consciousness, neuritis, paresthesia.
• Ophthalmic disorders: cataract, exophthalmos, papilla edema, glaucoma, corneal ulcer, posterior subcapsular cataract, increased intraocular pressure, thinning of the cornea / sclera, exacerbation of viral / fungal diseases of the eye.
• Dermatological disorders: dermatitis, folliculitis, burning, acne, contact dermatitis, thinning of the skin, dryness, erythema, increased sweating, hirsutism, diaper rash, skin atrophy, itching, hypopigmentation, striae, irritation, telangiectasia, delayed wound healing, hypopigmentation.
• Musculoskeletal disorders: aseptic necrosis, growth retardation in children, osteoporosis, steroid myopathy, osteonecrosis, muscle weakness, loss of muscle mass, aseptic necrosis of the femur / humeral head, compression fractures of the spine, long bones, spontaneous tendon ruptures.
• Immune disorders: allergic reactions (urticaria, angioedema, burning, tingling at the injection site, hot flashes, chills, headache, hypotension, nausea, lethargy, anxiety, chest tightness, tachycardia, ringing in the ears, vomiting, paresthesias, breathing with wheezing, anaphylaxis).
• Endocrine disorders: suppression of adrenal function, stunting of children, Cushing’s syndrome, worsening of diabetes mellitus, hypoglycemia, dys- / amenorrhea, increased body weight, increased appetite, negative nitrogenous, calcium balance.
• Mental disorders: insomnia, euphoria, depression, seizures, affective disorders, mania, delirium, complications of schizophrenia, hallucinations, behavioral disorders, fear, irritability, cognitive dysfunction, amnesia, confusion.
• Infections: activation of latent infections, opportunistic infections, aseptic necrosis.