Name:
Betasalicylic ointment for external use (0.5 mg + 30 mg) / 1 g in tubes 30 g in pack No. 1
Description:
White or almost white ointment. The main active ingredient Betamethasone + salicylic acid Product form ointment Dosage 30 g Pharmacological properties Combined drug with anti-inflammatory and keratolytic action for external use. Indications for use Uninfected subacute and chronic hyperkeratic and dry dermatoses sensitive to corticosteroid therapy, such as psoriasis, chronic atopic dermatitis, neurodermatitis (chronic lichen planus), lichen planus, eczema (including nummular eczema, eczema of the hands, eczematous dermatitis), dyshidrosis, seborrheic dermatitis of the scalp, ichthyosis and other ichthyotic lesions. Method of administration and doses The ointment is applied in a thin layer, gently rubbing 2 times a day – in the morning and at night, completely covering the affected areas of the skin. In some cases, a maintenance effect can be achieved by using applications once a day. The duration of the course of treatment is determined by its effectiveness, as well as the tolerability of the drug by the patient, the presence and severity of side effects. The duration of continuous treatment should not exceed 2-3 weeks. On the face, apply with caution, no more than 5 days in a row. Long-term continuous treatment should be avoided in all patients, regardless of age. Maximum daily dose: the minimum effective dose necessary to control the symptoms of the disease should be selected. The maximum weekly dose of the drug is 60 g. Use in persons with impaired liver and kidney function: it is recommended to use for a minimum period in the smallest amount that provides a therapeutic effect. In the elderly, dose adjustment is not required. Children: prescribed for children from 2 years of age, the maximum duration of continuous treatment is 5 days. The drug is prescribed with great care due to the fact that with a larger area of skin in relation to body weight and underdeveloped epidermis in children, it is possible to absorb more of both betamethasone and salicylic acid, and, consequently, the appearance of systemic reactions, manifested by suppression of the function of the hypothalamic-pituitary-adrenal system, the development of Cushing’s syndrome, growth retardation, a lag in weight gain and an increase in intracranial pressure. The use of ointment under diapers and diapers (especially plasticized ones) can lead to increased absorption, because. the diaper acts as an occlusive dressing. In case of accidental skipping of the planned time for the use of the drug, the next application of the ointment should be carried out as soon as possible. If there is a short period of time before a new planned use, the missed appointment is canceled. With the next use of the drug, there is no need to increase the amount of ointment applied. Use during pregnancy and lactation is possible only if the effect of therapy outweighs the potential risk to the fetus, but only for a short time and on small areas of the skin. During breastfeeding – only according to strict indications, but you can not apply the drug to the skin of the breast before feeding. At present, it is not clear whether corticosteroids, when applied topically as a result of systemic absorption, can penetrate into breast milk, therefore, when deciding whether to stop breastfeeding or discontinue the drug, the need for prescribing the drug should be taken into account. Precautions In cases where hypersensitivity reactions (itching, burning and redness) or excessive dryness develop during the first use of the drug, its use should be discontinued. In case of infection, appropriate etiological treatment should be prescribed. With the disappearance of dandruff or keratinization, treatment should be continued only with corticosteroids. Do not use the drug on the skin of the eyelids and periorbital area and allow it to get into the eyes. Long-term use on the skin of the face is not recommended due to the possible development of rosacea (rosacea), perioral dermatitis, acne (blackheads) and atrophy of the skin of the face. The use of the drug in the anogenital region and in areas with atrophied skin should be avoided. When using the drug in patients with impaired liver function and during long-term therapy, especially with the use of occlusive dressings, one should take into account the possible increase in the absorption of active substances and the manifestation of systemic effects of betamethasone and salicylic acid. Topical corticosteroids can be dangerous in psoriasis for a number of reasons, including the likelihood of recurrence of symptoms after tolerance develops, the risk of generalized pustular psoriasis, and local or systemic toxicity due to decreased skin barrier function. Topical corticosteroids may mask the clinical picture of an allergic reaction to any of the components of the drug. Relapse is possible when treatment is interrupted. An exacerbation of the infection may occur, and healing may also slow down. Application in pediatrics. In children, there may be more frequent occurrence of signs of depression of the hypothalamic-pituitary-adrenal system and the appearance of external corticosteroid effects under the influence of local corticosteroids than in adult patients. This is due to the higher absorption of the drug in children due to the greater ratio of surface area to body weight. In children treated with topical corticosteroids, depression of the function of the hypothalamic-pituitary-adrenal system, Cushing’s syndrome, linear growth retardation, lag in weight gain, and increased intracranial pressure may be observed. Manifestations of adrenal suppression in children: low plasma cortisol levels and lack of response to ACTH stimulation. An increase in intracranial pressure is manifested by bulging of the fontanel, headache, bilateral edema of the optic discs. Interaction with other drugs Salicylic acid may enhance the penetration of other topical drugs. Therefore, the treatment of skin areas with the drug should not be combined with other drugs or cosmetics. Light oxidizing agents and strong alkaline compounds lead to the degradation of corticosteroids. Salicylic acid is incompatible with phenols and zinc oxide. Contraindications Hypersensitivity to betamethasone, salicylic acid or other components of the drug; bacterial (including tuberculosis and syphilis) and fungal infections of the skin without proper etiological treatment; viral infections (for example, chicken pox, herpes simplex, herpes zoster, molluscum contagiosum); skin reactions after vaccination, widespread plaque psoriasis, acne, rosacea, perioral dermatitis, skin itching (including perianal and genital), diaper dermatitis; wounds and ulcerative lesions of the skin and mucous membranes; children under 2 years of age. Do not use in ophthalmology, around the eyes and under occlusive bandages. Composition 1 g of ointment contains as active ingredients 0.5 mg of betamethasone (in the form of betamethasone dipropionate) and 30 mg of salicylic acid. Excipients: liquid paraffin, soft white paraffin. OverdoseSymptoms: when applying the drug to large areas of affected skin for a long period (more than 3 weeks), especially when using occlusive dressings, or with prolonged use in children, it is possible to increase the absorption of active ingredients into the systemic circulation and increase systemic side effects associated with the action betamethasone (growth retardation, Itsenko-Cushing syndrome, benign increase in intracranial pressure after the end of treatment, hyperglycemia (increased blood glucose), glucosuria, hypokalemia (decrease in blood potassium levels), increased blood pressure) and salicylic acid (pallor, fatigue , drowsiness, hyperventilation against the background of rapid breathing, nausea, vomiting, hearing impairment, confusion). Treatment: Appropriate symptomatic treatment is indicated. Acute symptoms of hypercortisolism are usually reversible. If necessary, correction of electrolyte imbalance is indicated. In case of chronic toxic effects, slow withdrawal of corticosteroids is recommended. Treatment of salicylism is symptomatic. Measures are taken to more quickly remove salicylates from the body. Orally, sodium bicarbonate is used to alkalinize urine and increase diuresis. Side effect At the beginning of treatment: Immune system: hypersensitivity reactions. Skin: skin irritation, burning, itching, dryness. Longer-term use: Skin: skin atrophy, telangiectasias (risk is high especially on the face), skin hemorrhages, striae, acne, onset or exacerbation of rosacea, perioral dermatitis, hypertrichosis, depigmentation, purulent rash. Topical corticosteroids can cause delayed wound healing, pressure sores, and leg ulcers. When used on large surfaces and / or with prolonged use under an occlusive dressing: Infections: infections. Endocrine system: suppression of the synthesis of endogenous corticosteroids, hypercortisolism with edema. Metabolism: diabetes mellitus (manifestation of a latent disease). Skin: stretch marks. Musculoskeletal system: osteoporosis, growth retardation in children. General disorders and reactions at the site of application: edema. With prolonged or excessive use of local glucocorticosteroids, it is possible to suppress the pituitary-adrenal function with the development of secondary adrenal insufficiency and the appearance of symptoms of hypercorticism, including Cushing’s disease. Prolonged or excessive use of topical corticosteroids with salicylic acid may result in symptoms of salicycism. Prolonged use of salicylic acid preparations can cause dermatitis. Reporting adverse reactions If you experience any adverse reactions, it is recommended that you consult your doctor. This recommendation applies to any possible adverse reactions, including those not listed in the package insert for the use of the medicinal product. You can report adverse reactions directly to the information database on adverse drug reactions (in the Republic of Belarus: UE Center for Expertise and Testing in Healthcare of the Ministry of Health of the Republic of Belarus, site rceth.by). By reporting adverse reactions, you help to get more information about the safety of the medicine. You can also report the ineffectiveness of the drug. Storage conditionsStore at a temperature not exceeding 25°C. Keep out of the reach of children. Buy Betasalicylic ointment (0.5mg + 30.0mg) / 1g 30g No. 1 5mg+30.0mg)/1g 30g №1
INN | BETAMETHASONE+SALICYLIC ACID |
---|---|
The code | 73 677 |
Barcode | 4 810 183 006 081 |
Dosage | (0.5mg+30mg)/1g 30g |
Active substance | Betamethasone, salicylic acid |
Manufacturer | Pharmtekhnologiya LLC, Belarus |
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