Pharmacological properties
Hydrocortisone in the composition of the drug is a natural glucocorticosteroid. It has anti-inflammatory, antiallergic, antipruritic and anti-edematous effects. Stabilizes cellular (subcellular) membranes of mast cells, lysosome membranes. Inhibits the alteration phase, reduces cellular infiltrates of inflammation, suppresses the migration of inflammatory mediators to the site of the lesion. Reduces the binding of immunoglobulins and receptors on the cell surface, blocks the synthesis and release of cytokines from macrophages and lymphocytes. Reduces the synthesis of arachidonic acid metabolites (prostaglandins, leukotrienes, thromboxane). Inhibits the exudation reaction, reduces capillary permeability. Levels the severity of the immunological response. Induces the formation of lipocortins with anti-edematous activity. It exhibits antimetabolic effect, inhibits the proliferation of connective tissue, collagen deposits, and scarring. When used in therapeutic doses, it has almost no systemic effect.
Hydrocortisone ointment 1% 10g No. 1
Product description
Hydrocortisone.
Release form
Ointment for external use.
Dosage
1% 10 g Quantity per package: 1 pc.
Manufacturer
Nizhpharm OJSC.
INN
Hydrocortisone.
FTG
Glucocorticosteroid for local use.
Compound
1 g of ointment contains: active ingredient - hydrocortisone acetate - 0.01 g; excipients: petrolatum - 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
The ointment is white with a yellowish tint or light yellow. Pharmacotherapeutic group: Corticosteroids for local use in dermatology. Corticosteroids are weakly active (group I). ATX code: D07AA02.
Pharmacological properties
Pharmacodynamics Hydrocortisone is a synthetic glucocorticosteroid drug for local use, has anti-inflammatory, anti-edematous, antipruritic effects. 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. Local use 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 hydrocortisone is metabolized directly in the epidermis and subsequently in the liver. Excretion Metabolites and a small part of unchanged hydrocortisone are excreted by the kidneys and 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).
Directions for use and doses
Externally. The ointment is applied in a thin layer to the affected areas of the skin 1-3 times a day. As the condition improves, the frequency of applying the ointment can be reduced (once a day or 2-3 times a week). The duration 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. The drug should not be used for more 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. If the drug is used in children, the duration 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. Adverse reactions The assessment of undesirable adverse reactions is based on the following data on the frequency of occurrence: very often (≥1/10), often (≥1/100 to
Overdose
With prolonged use of the drug in large doses, symptoms of hypercortisolism may appear.
Precautionary measures
If after 7 days of treatment there is no improvement or worsening of the condition, the use of the drug should be stopped and consult a doctor. If symptoms of the disease recur a few days after stopping the drug, you should also consult a doctor. The drug should be used with caution in case of 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 for adrenocortical suppression with long-term use of the drug. The risk of systemic effects increases in the following cases: application using a dressing (warming, fixing and occlusive dressings or applying ointment to the skin folds); application on large areas of 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. In children, growth hormone production may also be suppressed. If long-term treatment with hydrocortisone drugs is necessary, the child’s height and weight should be regularly monitored, and 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 your eyes. Do not apply the 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. For long-term treatment and/or application of the drug to large surfaces of the body, it is recommended to prescribe a diet with limited sodium, high potassium content and sufficient protein. It is necessary to monitor blood pressure, blood glucose, blood clotting, diuresis, the patient’s body weight, and the level of cortisol in the blood plasma. In the event 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 breastfeeding. If it is necessary to use the drug during lactation, breastfeeding should be discontinued.
Impact on the ability to drive vehicles and operate machinery
types of activities that require increased concentration and speed of psychomotor reactions.
Interaction with other drugs
With long-term use, due to possible resorption into the systemic circulation, hydrocortisone can reduce the effectiveness of insulin, oral hypoglycemic and antihypertensive drugs, anticoagulants, and reduce the concentration of salicylates and praziquantel in the blood plasma. The risk of developing side effects of hydrocortisone increases: androgens, estrogens, oral contraceptives, anabolic steroids (hirsutism, acne); antipsychotic drugs, carbutamide, azathioprine (cataracts); anticholinergics, antihistamines, tricyclic antidepressants, nitrates (glaucoma); diuretics (hypokalemia); nonsteroidal anti-inflammatory drugs (increased risk of ulceration in the gastrointestinal tract); paracetamol (hepatotoxicity). When used with cardiac glycosides, digitalis intoxication may develop. Simultaneous use of lead and silver with preparations leads to mutual inactivation. When used together with amphotereptine B, the development of dilated myocardial damage and heart failure is possible. Barbiturates, antiepileptic and antihistamine drugs reduce the effectiveness of hydrocortisone. During the treatment period, smallpox vaccination or other types of immunization should not be performed due to the immunosuppressive effect of glucocorticosteroids, especially with long-term use over large areas of the skin. If you are currently using/taking other medications, tell your doctor.
Release form
Ointment for external use 1%. 10 g in aluminum tubes. Each tube, along with instructions for 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.
Best before date
3 years. Do not use the drug after the expiration date indicated on the package.
Conditions for dispensing from pharmacies
On prescription.
Buy Hydrocortisone ointment 1% 10g No. 1 in the pharmacy
Price for Hydrocortisone ointment 1% 10g No. 1
Instructions for use for Hydrocortisone ointment 1% 10g No. 1
Contraindications
- Reactions of individual intolerance.
- Viral and fungal infectious diseases of the eyes.
- Trachoma.
- Tuberculosis.
- Violations of the integrity of the corneal epithelium.
- Vaccination period.
- Breastfeeding period.
Hydrocortisone ophthalmic ointment should be used with caution in patients with diabetes and hypertension.
For pregnant women, the drug is prescribed according to strict indications and is used for no more than 7-10 days.
Hydrocortisone (eye ointment), 0.5%, eye ointment, 5 g, 1 pc.
The incidence and severity of side effects depend on the method, duration of use, dose used and the ability to comply with the circadian rhythm of drug administration.
Systemic effects
Metabolic: Na+ and fluid retention in the body, hypokalemia, hypokalemic alkalosis, negative nitrogen balance, hyperglycemia, glucosuria, weight gain.
From the endocrine system: secondary adrenal and hypothalamic-pituitary insufficiency (especially during stressful situations such as illness, injury, surgery); Cushing's syndrome; growth suppression in children; menstrual irregularities; decreased tolerance to carbohydrates; manifestation of latent diabetes mellitus, increased need for insulin or oral antidiabetic drugs in patients with diabetes mellitus.
From the cardiovascular system and blood (hematopoiesis, hemostasis): increased blood pressure, development (in predisposed patients) or increased severity of chronic heart failure, hypercoagulation, thromboembolism, ECG changes characteristic of hypokalemia; in patients with acute and subacute myocardial infarction - spread of necrosis, slowdown in the formation of scar tissue with possible rupture of the heart muscle, obliterating endarteritis, hematological changes.
From the musculoskeletal system: muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, compression fracture of the spine, aseptic necrosis of the head of the femur and humerus, pathological fractures of long tubular bones, tendon ruptures, primarily the Achilles.
From the gastrointestinal tract: steroid ulcer with possible perforation and bleeding, pancreatitis, flatulence, ulcerative esophagitis, indigestion, nausea, vomiting, increased/decreased appetite; after treatment with corticosteroids, an increase in the levels of ALT, AST and alkaline phosphatase in the blood serum was observed; usually these changes are minor, not associated with any clinical syndromes and are reversible after cessation of treatment.
From the skin: atrophic stripes, acne, delayed wound healing, thinning of the skin, petechiae and ecchymosis, erythema, increased sweating.
From the nervous system and sensory organs: convulsions, increased intracranial pressure with optic nerve congestion syndrome (pseudotumor of the brain - more often in children, usually after too rapid dose reduction, symptoms - headache, deterioration of visual acuity or double vision); vertigo, headache, malaise, mental disorders; formation of posterior subcapsular cataract, increased intraocular pressure, glaucoma; steroid exophthalmos.
Allergic reactions: generalized (allergic dermatitis, urticaria, anaphylactic shock) and local.
Other: masking symptoms of infectious diseases, withdrawal syndrome; reactions at the injection site - burning, numbness, pain, paresthesia and infection, hyper- or hypopigmentation, scarring; atrophy of the skin and subcutaneous tissue, sterile abscess.
When applied to the skin: irritation, burning, dry skin, local allergic reactions, incl. hyperemia, swelling, itching; with long-term use, especially under impermeable dressings or on large areas of skin - systemic side effects; steroid acne, purpura, telangiectasia; development of hypercortisolism as a manifestation of a resorptive effect (in these cases the drug is discontinued); with long-term use, it is also possible to develop secondary infectious skin lesions, atrophic changes, and hypertrichosis.
Eye ointment: allergic reactions, burning, scleral injection, increased intraocular pressure, exophthalmos; if the integrity of the corneal epithelium is violated, delayed healing and perforation of the cornea are possible; with long-term use, the development of steroid glaucoma is possible; frequent repeated courses of treatment can lead to the formation of posterior subcapsular cataracts; addition of a secondary infection.
