Locoid ointment 0.1% 30g №1

Name:
Locoid. Release form Ointment for external use. Dosage 0.1% 30 g. Pack quantity: 1 pc. Manufacturer Astellas Pharma Inc. INN Hydrocortisone. FTGglucocorticosteroid for local use. Composition 1 g of ointment contains: Active substance: hydrocortisone 17-butyrate -1.0 mg, Excipients: polyethylene ointment base (Vaseline oil 95%, polyethylene 5%) – up to 1.0 g.
Description:
Translucent, from light gray to almost white, homogeneous, soft, greasy ointment. Pharmacotherapeutic group Corticosteroids for use in dermatology. ATX code: D07AB02. Pharmacological properties Pharmacodynamics Hydrocortisone butyrate is an active synthetic non-halogenated glucocorticosteroid for topical use. It has a rapidly advancing anti-inflammatory, anti-edematous, anti-allergic effect. The anti-inflammatory effect of hydrocortisone butyrate is more powerful than hydrocortisone acetate, its effectiveness is comparable to that of halogenated steroids. Pharmacokinetics Absorption After application, the active substance accumulates in the epidermis, mainly in the granular layer, systemic absorption is negligible. A small amount of hydrocortisone 17-butyrate is absorbed into the systemic circulation unchanged. Metabolism Most of the hydrocortisone 17-butyrate is metabolized to hydrocortisone and other metabolites directly in the epidermis and subsequently in the liver. Withdrawal Metabolites and a small part of unchanged hydrocortisone 17-butyrate are excreted by the kidneys and through the intestines. Indications for use Superficial, uninfected skin diseases sensitive to local glucocorticosteroids: dermatitis, including atopic, contact, seborrheic; eczema; psoriasis. Topical corticosteroids are not usually indicated for psoriasis, but they can sometimes be used, except in the common plaque form, in which they are not recommended. Contraindications Hypersensitivity to hydrocortisone or auxiliary components of the drug. bacterial infections of the skin (strepto- and staphyloderma, gram-negative folliculitis, etc.); viral skin infections (herpes simplex, chickenpox, shingles, etc.) fungal skin infections; tuberculous and syphilitic lesions of the skin; parasitic infections of the skin; neoplastic skin changes (benign and malignant tumors); acne, rosacea, perioral dermatitis; post-vaccination period; violation of the integrity of the skin (wounds, ulcers); With caution: pregnancy, lactation. Pregnancy and lactation The safety of corticosteroids during pregnancy has not been established. Topical application of corticosteroids to animals during pregnancy may cause fetal abnormalities, including non-closure of the hard palate and intrauterine growth retardation. There is a small risk of such effects when using the drug in humans. Theoretically, there is a possibility of a violation of the function of the adrenal glands of a child with systemic absorption of corticosteroids in the mother’s body. There is no data on the amount of hydrocortisone excreted in breast milk. Prescribing a drug to women during lactation is possible only in cases where the potential benefit from the use outweighs the possible risk to the child. It is recommended to take special care when prescribing the drug to women during lactation. Women who are breastfeeding should not apply the cream to the mammary gland. Method of administration and doses For topical application. Lokoid in the form of an ointment is used in subacute and chronic processes, especially in the presence of lichenification, infiltration, dryness. A small amount of the drug is evenly applied with massaging movements to the affected skin no more than twice a day. The frequency of application of the drug and the duration of therapy is determined by the doctor. With positive dynamics, the frequency of use of the drug can be reduced to 2-3 times a week. Under occlusive dressings, the drug can only be applied to small areas in the case of a resistant course of the disease, for example, with the localization of dense psoriatic plaques on the elbows and knees. The dose of the drug used during the week should not exceed 30-60 g. Adjustment of the dose and dosing regimen in the elderly is not required. Children. In children, the drug should be prescribed for the shortest possible time. In young children, the total duration of treatment should not exceed 7 days. Side effects Side effects are indicated by frequency of occurrence: rarely (> 1: 10,000, < 1: 1,000); very rare (<1:10,000, including isolated cases). From the endocrine system: rarely - inhibition of the function of the adrenal cortex. On the part of the organs of vision: very rarely - increased intraocular pressure, increased risk of cataracts when applied to the periorbital region. On the part of the skin and subcutaneous tissue: rarely - allergic contact dermatitis, skin atrophy (often irreversible, with thinning of the skin), telangiectasia, purpura, striae, depigmentation, rosacea-like and perioral dermatitis, which may be accompanied by skin atrophy, "rebound syndrome", which can lead to steroid addiction, slowing down of reparative processes, hypertrichosis, pustular acne. From the immune system - hypersensitivity reactions (frequency unknown). Systemic side effects from topical glucocorticoid use in adults are rare but can be serious. In the case of long-term treatment, inhibition of the function of the adrenal cortex may be of particular importance. The risk of systemic side effects is greatest when: applied under conditions of occlusion (synthetic dressing, skin folds) applied to large surfaces long-term treatment used in children (thin skin and relatively large surface) presence of components or excipients that increase penetration through the stratum corneum (propylene glycol) or enhance the effect of the active component of the drug. The likelihood of developing local adverse reactions increases in proportion to the increase in the concentration of the active substance and the duration of therapy. Applying the drug under occlusive conditions (synthetic dressing, skin folds) increases this risk. The skin of the face, the skin with hairline and the skin of the genitals are most sensitive to local influences. If the drug is used incorrectly, the manifestations of bacterial, parasitic, fungal and viral infections can be either erased or intensified. Overdose When applied to large areas of the skin and / or long-term use, as well as when used under occlusive dressings, symptoms of hypercortisolism and suppression of the function of the adrenal cortex may develop. If symptoms of an overdose appear, the drug should be discontinued. Interaction with other drugs There are no data on drug interactions of Lokoid. During the period of treatment is not recommended to vaccinate. Precautions Do not apply Lokoid® to the periorbital area due to the risk of developing glaucoma. With systematic contact with the conjunctiva, there is a risk of increasing intraocular pressure. It is not advisable to use any glucocorticosteroids for external use in the form of an ointment on the scalp, as well as in acute inflammation (especially exudative). For the treatment of steroid-sensitive skin lesions localized in the face, folds, genitals, as well as in areas of skin with abundant hair, it is preferable to use other dosage forms of Lokoid (cream, crelo). The drug is not advisable to use in the presence of atrophic skin changes. The risk of local and systemic side effects increases when applied to large lesions, prolonged use, the use of occlusion and in childhood. If within 7 days of continuous treatment there is no effect or the condition worsens, it is recommended to consult a doctor. As with the use of any glucocorticosteroid drug, it is desirable to limit the duration of use and the course dose to the minimum sufficient to stop the skin process. As a result of topical application of hydrocortisone butyrate, the secretion of adrenocorticotropic hormone (ACTH) by the pituitary gland may decrease due to the inhibition of the pituitary-adrenal gland system, the level of cortisol in the blood will decrease and iatrogenic Cushing's syndrome may occur, which disappears after discontinuation of the drug. It is recommended to periodically monitor the function of the adrenal cortex by determining cortisol in the blood and in the urine after stimulation of the adrenal glands with ACTH. In the event of an infection at the site of application of the drug, antibacterial or antifungal treatment should be applied. If the symptoms do not disappear, the drug should be discontinued until the infection is cured. On the skin of the face, as well as on the skin of the axillary and inguinal regions, use the drug only in extremely necessary cases due to increased absorption and the high possibility of side effects (telangiectasia, perioral dermatitis), even after short-term use. Topical corticosteroids can be dangerous in psoriasis for a number of reasons, including relapse after tolerance develops, risk of generalized pustular psoriasis, and local systemic toxicity due to decreased skin barrier function. Steroids can be used for scalp psoriasis and chronic plaque psoriasis vulgaris of the hands and feet with careful medical supervision. Application in pediatrics The drug is used in children from 6 months of age. Do not use in children under 10 years of age without medical advice. When used in children, the area of the treated skin area should not exceed 20% of the body surface area. In children, the drug should be prescribed for the shortest possible time. In young children, the total duration of treatment should not exceed 7 days. Eliminate measures that increase the absorption of corticosteroids (warming, fixing and occlusive dressings). In childhood, suppression of the function of the adrenal cortex with the use of topical corticosteroids may develop faster. In addition, there may be a decrease in the production of growth hormone. When using the drug for a long time, it is necessary to monitor body weight, height, plasma cortisol levels. Influence on the ability to drive vehicles and work with mechanisms There are no data on the effect of Lokoid on the ability to drive vehicles and work with mechanisms. Release formOintment for external use 0.1%. 30 g of the ointment is placed in an aluminum tube with an aluminum membrane and a screw cap made of high density polyethylene. 1 tube along with instructions for use in a cardboard box. Storage conditionsAt temperature not higher than 25°C. In a place inaccessible to children. Shelf life 5 years. Do not use after the expiration date. Conditions for dispensing from pharmacies By prescription. Buy Lokoid ointment 0.1% 30g No. 1 Price for Lokoid ointment 0.1% 30g No. 1