Product Description Hydrocortisone. Release formOintment for external use. Dosage 1% 10 g Quantity per pack: 1 pc. ProducerNizhpharm JSC. INN Hydrocortisone. FTGglucocorticosteroid for local use. Composition 1 g of ointment contains: active ingredient – hydrocortisone acetate – 0.01 g; excipients: vaseline – 0.45 g, lanolin – 0.1 g, pentaerythrityl dioleate (pentol) – 0.05 g, stearic acid 95 – 0.03 g, methyl parahydroxybenzoate – 0.0008 g, propyl parahydroxybenzoate – 0.0002 g , purified water – up to 1 g. Description Ointment white with a yellowish tinge or light yellow. Pharmacotherapeutic group: Corticosteroids for local use in dermatology. Corticosteroids are weakly active (group I). ATX code: D07AA02. Pharmacological propertiesPharmacodynamics Hydrocortisone is a synthetic glucocorticosteroid drug for topical use, has anti-inflammatory, anti-edematous, antipruritic effects. It inhibits the release of cytokines (interleukins and interferon) from lymphocytes and macrophages, inhibits the release of inflammatory mediators by eosinophils, reduces the metabolism of arachidonic acid and the synthesis of prostaglandins. By stimulating steroid receptors, it induces the formation of lipocortin. Reduces inflammatory cell infiltrates, reduces the migration of leukocytes and lymphocytes to the area of inflammation. Topical application of the drug in recommended doses does not cause systemic side effects. Pharmacokinetics Absorption After application to the skin, the active substance accumulates in the epidermis, mainly in the granular layer. Systemic absorption is negligible. A small amount of hydrocortisone is absorbed into the systemic circulation unchanged. Metabolism Most of the hydrocortisone is metabolized directly in the epidermis and, subsequently, in the liver. Withdrawal Metabolites and a small part of unchanged hydrocortisone are excreted by the kidneys and through the intestines. Indications for use Inflammatory and allergic skin diseases of non-microbial etiology: eczema, allergic and contact dermatitis, neurodermatitis, psoriasis, insect bites. Contraindications Hypersensitivity to hydrocortisone or other components of the drug, post-vaccination period, violation of the integrity of the skin (ulcers, wounds), bacterial, viral and fungal skin diseases, skin tuberculosis, syphilitic skin lesions, skin tumors, children under 2 years of age. Rosacea, acne vulgaris, perioral dermatitis. Pregnancy, breastfeeding (due to the lack of clinical data on the safety of use). Dosage and administration Externally. The ointment is applied in a thin layer to the affected areas of the skin 1-3 times a day. When the condition improves, the frequency of applying the ointment can be reduced (1 time per day or 2-3 times a week). The duration of the course of treatment is determined by the doctor and depends on the nature of the disease and the effectiveness of therapy. As a rule, the duration of treatment is 6-14 days. Do not use the drug for longer than 14 days. Use in children The drug is contraindicated in children under 2 years of age. For children under 12 years of age, the drug is prescribed under strict medical supervision. In the case of using the drug in children, the duration of the course of treatment should be reduced to 7 days and measures leading to increased resorption (absorption) of the steroid (warming, fixing and occlusive dressings) should be excluded. Undesirable reactions Evaluation of undesirable adverse reactions is based on the following data on the frequency of occurrence: very often (≥1/10), often (≥1/100 to <1/10), infrequently (≥1/1000 to <1/100), rarely (≥1/10000 to <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data). Immune system disorders: very rarely - hypersensitivity reactions. Endocrine system disorders: rarely - suppression of the adrenal cortex. On the part of the organ of vision: very rarely - increased intraocular pressure, increased risk of cataracts (with systematic contact with the drug on the conjunctiva). Skin and subcutaneous tissue disorders: rarely - dermatitis (including eczema, allergic contact dermatitis); pustular acne; skin atrophy, often irreversible, accompanied by thinning of the epidermis, telangiectasias, purpura and stretch marks; depigmentation, hypertrichosis; perioral (rosacea-like) dermatitis, which may be accompanied by skin atrophy; the effect of "rebound" that can lead to steroid addiction; slowing down wound healing. In the event of adverse reactions, including those not listed in this leaflet, you should stop using the drug and consult a doctor. Overdose With prolonged use of the drug in large doses, symptoms of hypercortisolism may occur. Precautions If after 7 days of treatment there is no improvement or worsening of the condition, the use of the drug should be discontinued and consult a doctor. In case of resumption of symptoms of the disease a few days after discontinuation of the drug, you should also consult a doctor. The drug should be used with caution in diabetes mellitus, immunodeficiency states (including HIV infection, AIDS). Systemic adverse reactions with topical corticosteroids in adults are extremely rare but can be serious. This is especially true of adrenocortical suppression with prolonged use of the drug. The risk of systemic effects increases in the following cases: application with a dressing (warming, fixing and occlusive dressings or applying ointment in the area of skin folds); application on large areas of the skin; long-term treatment; use in children. Long-term continuous topical therapy with hydrocortisone in children can lead to suppression of adrenal function even without the use of an occlusive dressing. Growth hormone production may also be suppressed in children. In case of need for long-term treatment with hydrocortisone preparations, the height and body weight of the child should be regularly monitored, as well as the level of cortisol in the blood plasma should be determined. It is not recommended to apply the ointment to the skin of the face, scalp and anogenital area. Avoid getting the ointment in the eyes. Do not apply ointment to the area around the eyes and eyelids due to the possibility of contact with the conjunctiva, which increases the risk of developing glaucoma and / or subcapsular cataracts. With long-term treatment and / or application of the drug to large areas of the body, it is recommended to prescribe a diet with sodium restriction, high potassium content and a sufficient amount of protein. It is necessary to control blood pressure, blood glucose, blood clotting, diuresis, body weight of the patient, the level of cortisol in the blood plasma. In case of accession of a bacterial or fungal infection, the drug is recommended to be prescribed in combination with antibacterial and antifungal agents. Use during pregnancy and lactation The use of the drug is contraindicated during pregnancy and lactation. If necessary, the use of the drug during lactation, breastfeeding should be discontinued. Influence on the ability to drive vehicles and control mechanisms of activities that require increased concentration of attention and speed of psychomotor reactions. Interaction with other drugs With prolonged use, due to possible resorption into the systemic circulation, hydrocortisone can reduce the effectiveness of insulin, oral hypoglycemic and antihypertensive drugs, anticoagulants, reduce the concentration of salicylates and praziquantel in blood plasma. The risk of side effects of hydrocortisone is increased by: androgens, estrogens, oral contraceptives, anabolic steroids (hirsutism, acne); antipsychotic drugs, carbutamide, azathioprine (cataract); anticholinergics, antihistamines, tricyclic antidepressants, nitrates (glaucoma); diuretics (hypokalemia); non-steroidal anti-inflammatory drugs (increased risk of ulceration in the gastrointestinal tract); paracetamol (hepatotoxicity). When used with cardiac glycosides, digitalis intoxication may develop. Simultaneous use with lead and silver preparations leads to mutual inactivation. When combined with amphoterpcin B, the development of dilated myocardial damage and heart failure is possible. Barbiturates, antiepileptic and antihistamp drugs reduce the effectiveness of hydrocortisone. During the period of treatment, vaccination against smallpox or other types of immunization should not be carried out due to the immunosuppressive effect of glucocorticosteroids, especially with prolonged use on large areas of the skin. If you are currently using/taking other medicines, tell your doctor. Release formOintment for external use 1%. 10 g in aluminum tubes. Each tube, along with instructions for the medical use of the drug, is placed in a cardboard pack. Storage conditions At temperatures from 2 to 20 ° C. Keep out of the reach of children. Shelf life 3 years. Do not use the drug after the expiration date indicated on the package. Conditions for dispensing from pharmacies By prescription. Buy Hydrocortisone ointment 1% 10g No. 1 Price for Hydrocortisone ointment 1% 10g No. 1
INN | HYDROCORTISONE |
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The code | 62 |
Barcode | 46 002 785 |
Dosage | 1% 10g |
Active substance | Hydrocortisone |
Manufacturer | Nizhpharm AO, Russia |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
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