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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 d/nar.prim. 1% in tubes 10g per pack. No. 1 in pharmacy

Price for Hydrocortisone ointment d/nar.approx. 1% in tubes 10g per pack. No. 1

Instructions for use for Hydrocortisone ointment d/nar.prim. 1% in tubes 10g per pack. No. 1

Hydrocortisone Acetate suspension for injection 2.5%, 2 ml per ampoule, 10 pcs.

Because joints and tissues have an increased susceptibility to infection after corticosteroid injections, local injections of this drug should be performed under aseptic conditions.

Adrenal suppression

Adrenal cortical atrophy develops with long-term therapy and may persist for years after cessation of treatment. Therefore, withdrawal of corticosteroids after long-term therapy should always be gradual to avoid acute adrenal insufficiency, with a gradual taper over weeks or months depending on the dose and duration of treatment. During long-term therapy, any intercurrent illness, injury or surgery requires a temporary increase in the dose. If corticosteroids are discontinued after long-term therapy, temporary reintroduction may be necessary.

Patients should be given clear instructions on precautionary measures to minimize risk, with details of the prescriber, drug, dosage and duration of treatment.

Anti-inflammatory/immunosuppressive effects and infection

Suppression of the inflammatory response and immune function increases susceptibility to infection and its severity. The clinical presentation may often be atypical, and serious infections such as septicemia and tuberculosis may be masked and reach an advanced stage before being recognized. New infections may occur while using corticosteroids.

Chickenpox is of particular concern because this usually minor disease can be fatal in immunocompromised patients. Patients (or parents of children) with an unclear history of chickenpox should be advised to avoid close personal contact with chickenpox or herpes zoster and should seek emergency medical attention if exposed. Passive immunization with chickenpox/herpes zoster immunoglobulin is required in patients who have been in contact with the patient, who have a weakened immune system and who are receiving systemic corticosteroids or who have used them in the previous 3 months; if the result is positive, the disease requires specialized care and urgent treatment. Corticosteroids should not be stopped and the dose may need to be increased.

Patients should be advised to take extreme care to avoid exposure to measles and to seek immediate medical attention if exposure occurs. Prophylaxis with normal intramuscular immunoglobulin may be required.

Live vaccines should not be given to persons with a weakened immune response caused by high doses of corticosteroids. Inactivated vaccines or toxoids can be administered, although their effect may be reduced.

Particular caution and regular monitoring are required when prescribing systemic corticosteroids to patients with the following diseases:

history of tuberculosis or a characteristic pattern on a chest x-ray. However, the development of active tuberculosis can be stopped by prophylactic use of antituberculosis therapy;
diabetes mellitus (or family history of diabetes);
osteoporosis (postmenopausal women are especially at risk);
hypertension or congestive heart failure;
presence or history of severe affective disorders (especially history of steroid psychosis);
glaucoma (or family history of glaucoma);
previous myopathy caused by corticosteroids;
stomach ulcer;
epilepsy;
liver failure;
renal failure.

Large volumes should be used with caution and only when necessary, especially in patients with impaired liver or kidney function due to the risk of accumulation and toxicity (metabolic acidosis).

Recent myocardial infarction

During treatment, the patient should be monitored for psychotic reactions, muscle weakness, electrocardiographic changes, hypertension, and adverse hormonal effects.

Corticosteroids should be used with caution in patients with hypothyroidism.

Children

Corticosteroids cause growth retardation in early childhood, childhood, and adolescence; it may be irreversible. Treatment should be limited to the minimum dosage for the shortest possible time to minimize hypothalamic-pituitary-adrenal (HPA) axis suppression and growth retardation (see Dosage and Administration).

Increased risk due to accumulation in young children.

Elderly patients

Common side effects of systemic corticosteroids may be associated with more serious consequences in older age, especially osteoporosis, hypertension, hypokalemia, diabetes, susceptibility to infections, and thinning of the skin. Careful clinical monitoring is necessary to avoid life-threatening reactions (see section "Dosage and Administration").

Withdrawal symptoms

In patients receiving doses above physiological doses of systemic corticosteroids (approximately 40 mg cortisone or equivalent) for more than 3 weeks, discontinuation should not be abrupt. The method of dose reduction depends largely on the likelihood of disease relapse when the dose of systemic corticosteroids is reduced. Clinical assessment of disease activity may be required during withdrawal. If the disease is unlikely to recur when systemic corticosteroids are discontinued, but there is uncertainty regarding HPA axis suppression, the dose of systemic corticosteroid can be rapidly reduced to physiological levels. Once a daily dose equivalent to 40 mg of cortisone is reached, the dose must be reduced more slowly to restore the HPA axis.

Abrupt cessation of systemic corticosteroid treatment that has been continued for up to 3 weeks is appropriate if the disease is considered unlikely to recur. Abrupt discontinuation of cortisone up to 200 mg daily or equivalent for 3 weeks is unlikely to result in clinically significant suppression of the HPA axis in most patients. In the following patient groups, gradual discontinuation of systemic corticosteroid therapy should be considered, even after courses of 3 weeks or less:

patients who have had repeated courses of systemic corticosteroids, especially if taken for more than 3 weeks;
when prescribing a short course within 1 year after stopping long-term therapy (months or years);
patients who may have causes for adrenocortical insufficiency other than exogenous corticosteroid therapy;
patients receiving systemic corticosteroid doses exceeding 200 mg cortisone per day (or equivalent);
patients taking repeat doses in the evening.

Patients and/or caregivers should be warned that potentially severe psychiatric adverse reactions may occur with the use of systemic steroids (see Adverse Reactions section). Symptoms usually appear within a few days or weeks after starting treatment. Risks may be greater at higher doses/systemic exposure (see Drug Interactions and Other Interactions section), although dose levels do not predict the onset, type, severity, or duration of reactions. Most adverse reactions resolve after dose reduction or discontinuation of the drug, although special treatment may be required. Patients/caregivers should be advised to consult a physician if distressing psychological symptoms occur, especially if depressed mood or suicidal ideation is suspected. Patients/caregivers should also be alert to the possibility of psychiatric disturbances that may occur during or immediately following dose reduction/withdrawal of systemic steroids, although such reactions have been reported infrequently.

Particular caution is required when considering the use of systemic corticosteroids in patients with a current or history of severe mood disorders, in themselves or in first-degree relatives. These include depressive or manic-depressive illnesses and previous steroid psychosis.

Visual impairment

Visual disturbances may occur with systemic and local use of corticosteroids. If a patient develops symptoms such as blurred vision or other visual disturbances, the patient should be referred to an ophthalmologist for evaluation of possible causes, which may include cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy, which have been reported after the use of systemic and topical corticosteroids .

This medicine contains sorbitol. If the patient has an intolerance to certain sugars, you should consult your doctor before taking this drug. This medicine contains benzyl alcohol, so it should not be used in premature babies and newborns. May cause toxic and allergic reactions in infants and children under 3 years of age.

This medicinal product contains less than 1 mmol (23 mg)/dose sodium, which is essentially sodium-free.