Hydrocortisone ointment eye. 2.5% tube 2.5 g
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Ursapharm S01B A02 HYDROCORTISONUM
COMPOSITION AND FORM OF ISSUE
eye ointment. 10 mg / g tube 2.5 g, № 1
No. UA / 6522/01/01 from
eye ointment. 25 mg / g tube 2.5 g, № 1
No. UA / 6522/01/02 from
USPDDN, HSDB, RTECS, MESH: Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11β) -. USPDDN, MESH: (11β) -11,17,21-trihydroxypregn-4-ene-3,20-dione.
Mm = 362.47 Da. Melting point – 220 ° C; log P (octanol-water) = 1.61; solubility in water – 320 mg / l at a temperature of 25 ° C. White or almost white powder; odorless, very slightly soluble in water. Hydrocortisone in the form of acetate and cypionate (obtained synthetically) – insoluble in water and slightly soluble in alcohol and chloroform. In contrast, hydrocortisone sodium phosphate, hydrocortisone sodium succinate soluble in water, hygroscopic.
Product form: cream, ointment, ophthalmic ointment, powder for p-ra for injections, powder and solvent for p-ra for injections, suspension for injections, skin emulsion.
belongs to the GCS group. Affects protein and carbohydrate metabolism. Increases blood glucose levels, has a catabolic effect, causes a redistribution of adipose tissue. It shows mineralocorticoid activity, contributes to the retention of sodium and water in the body, excretion of calcium.
It has an immunosuppressive effect due to the effect on stem cells, the migration of B-lymphocytes and the interaction of T-and B-lymphocytes, as well as anti-inflammatory, desensitizing, antiallergic, anti-shock and anti-toxic action. Inhibits the release of inflammatory mediators, inhibits the metabolism of arachidonic acid.
After i / m administration, Cmax of hydrocortisone in the blood plasma is reached in 30–60 minutes. 40–90% of the active substance is bound to plasma proteins. It is metabolized mainly in the liver and is almost completely excreted from the body within 12 hours.
systemic use – endocrine diseases, for example, primary or secondary insufficiency of the adrenal cortex (drug of choice), non-purulent thyroiditis, hypercalcemia due to a neoplastic disease; inflammatory-degenerative and metabolic diseases of the joints, including psoriatic arthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute and subacute bursitis, acute and nonspecific tendosinovitis, acute gouty arthritis, posttraumatic osteoarthrosis Systemic diseases of the connective tissue (in the period of exacerbation or as maintenance therapy), including systemic lupus erythematosus, systemic dermatomyositis, acute rheumatic heart disease; with rheumatic diseases, the drug is used briefly as an adjunctive therapy during the exacerbation period; skin diseases such as pemphigus, bullous herpetiformis and exfoliative dermatitis, severe erythema multiforme, fungoid mycosis, severe psoriasis, severe seborrheic dermatitis; allergic conditions not susceptible to therapy by other means, such as seasonal or chronic allergic rhinitis, serum sickness, asthma, drug allergies, contact or atopic dermatitis, transfusion reactions, acute non-infectious laryngeal edema; ocular diseases (severe acute and chronic processes), in particular allergic corneal marginal ulcers, Herpes zoster, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmitis, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis; respiratory diseases, including sarcoidosis, Leffler syndrome, berylliosis, aspiration pneumonitis; hematological diseases such as idiopathic thrombocytopenic purpura in adults (the drug is administered only in / in), secondary thrombocytopenia in adults, autoimmune hemolytic anemia, congenital hypoplastic anemia, leukemia and lymphoma in adults (as part of combination therapy), acute leukemia in children ( combination therapy); ulcerative colitis, regional enteritis (as part of systemic therapy in the acute period of the disease); shock resistant to standard therapy; trichinosis with damage to the nervous system or myocardium.
Hydrocortisone is also used to increase diuresis and achieve remission in case of nephrotic syndrome, tuberculous meningitis with a subarachnoid block or with a threat of block (with simultaneous anti-tuberculosis therapy).
Topical administration – inflammatory and allergic diseases of the skin of non-microbial etiology, for example, allergic and contact dermatitis, eczema, neurodermatitis, toxicoderma (as part of complex therapy).
for adults in a dose of 125–200 mg. Intra-articular and periarticular in the appropriate dosage form is administered, depending on the size of the joints and the severity of their damage, hydrocortisone in a dose of 5-25 mg and higher.
Children aged 3 months to 1 year of intra-articular and periarticular are administered in a dose of 25 mg, from 1 year to 6 years – in a dose of 25-50 mg, from 6 to 14 years – in a dose of 50-75 mg (in small joints administered at a lower dose).
The therapeutic effect of intra-articular injection of hydrocortisone occurs within 6-24 hours and lasts from several days to several weeks.
Locally: a small amount of hydrocortisone in the appropriate dosage form is applied by massaging movements (for better penetration) to the skin lesion site 1-3 times a day. With the emergence of positive dynamics apply 1-3 times a week. In cases of resistant disease, for example, when localized psoriatic plaques are localized in the elbows, knees, hydrocortisone must be applied under occlusive dressings.
severe forms of hypertension, Itsenko – Cushing’s disease, gestation period, acute endocarditis, psychosis, pyelonephritis, osteoporosis, peptic ulcer and duodenal ulcer, syphilis, diabetes mellitus, hypersensitivity to hydrocortisone.
Contraindications for local application are bacterial, fungal, viral infections of the skin at the sites of the intended application, skin tuberculosis, skin manifestations of syphilis, skin neoplasms, skin ulcers, ichthyosis, juvenile plantar dermatosis, acne vulgaris, rosacea, fragility of skin vessels, and skin atrophy.
possible violations of the menstrual cycle, the development of cushingoid syndrome, depression of the pituitary-adrenal axis; decrease in tolerance to carbohydrates, manifestation of latent diabetes mellitus, increased insulin requirements or oral hypoglycemic agents in diabetes mellitus; growth retardation in children; steroid myopathy, muscle weakness, osteoporosis, pathological fractures, vertebral compression fractures, aseptic bone necrosis; erosive and ulcerative lesions of the digestive tract, perforation, gastrointestinal bleeding, pancreatitis, esophagitis; delayed wound healing, petechiae and ecchymosis, thinning of the skin; increased intracranial pressure, depression, insomnia, mood swings, seizures; posterior subcapsular cataract, increased intraocular pressure (described cases of the development of glaucoma with possible damage to the optic nerve), exophthalmos; increased susceptibility to infections, lack of pronounced clinical manifestations in infectious diseases, activation of latent infections, the development of opportunistic infections; suppressing the reaction to allergens during skin tests; violations of water and electrolyte balance (sodium retention, potassium loss, hypokalemic alkalosis, increased calcium excretion, fluid retention); negative nitrogen balance due to increased protein catabolism. With parenteral administration of GCS, allergic reactions of the anaphylactoid type can occur with or without collapse, cardiac arrest, bronchospasm, cardiac arrhythmias, hypertension or hypotension.
With the local application of hydrocortisone (especially in patients with hypersensitivity), hyperemia, swelling, itching may occur. Prolonged use in high doses, especially when applied under occlusive dressings, increases resorption and increases the risk of systemic effects of hydrocortisone.
the relative insufficiency of the adrenal cortex caused by systemic use of hydrocortisone can persist for several months after it is canceled, therefore hormone therapy is resumed in any stressful situation arising during this period. During treatment with hydrocortisone, vaccination and other immunization procedures cannot be carried out due to the high risk of neurological complications and suppression of antibody production.
The use of hydrocortisone with active tuberculosis is possible only in combination with appropriate anti-tuberculosis therapy. The use of hydrocortisone in patients with latent tuberculosis or during the turn of tuberculin specimens requires careful monitoring, and, if necessary, chemoprophylaxis.
With caution used for ulcerative colitis, diverticulitis, the presence of peptic ulcers of the stomach or duodenum in history, after the imposition of intestinal anastomoses, with purulent-inflammatory processes, renal failure, hypertension, osteoporosis, myasthenia, as well as in herpetic cramps, a heart disease. risk of corneal perforation).
Hydrocortisone can exacerbate emotional lability or psychotic tendencies.
To normalize the water-electrolyte balance prescribed a diet with a limited content of sodium and a high content of potassium.
Prescribing hydrocortisone during pregnancy and lactation should be only if the expected therapeutic effect outweighs the potential risk to the mother and fetus. In order to timely detect the symptoms of adrenal insufficiency, it is necessary to carefully monitor children born to mothers who received hydrocortisone during pregnancy.
Care should be taken with the simultaneous use of hydrocortisone and anticoagulants, NSAIDs (the risk of gastropathy increases dramatically), oral hypoglycemic drugs, barbiturates and diuretics.