Betaderm ointment 0.05% + 0.1% 15g
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Active ingredients
Betamethasone + Gentamicin
Release form
Ointment
Composition
Betamethasone (in the form of dipropionate) 500 mcg, salicylic acid 30 mg. Auxiliary substances: liquid paraffin - 100 mg, vaseline - up to 1 g.
Pharmacological effect
Combined preparation for external use. Betamethasone is a synthetic corticosteroids, has a strong anti-inflammatory, antipruritic, anti-allergic and vasoconstrictor action. It reduces inflammation by inhibiting the production of prostaglandins and leukotrienes due to the inhibition of phospholipase A2 activity and reducing the release of arachidonic acid from phospholipids of cell membranes, and also has antiallergic effect. Due to the local vasoconstrictor action reduces exudative reactions. Accelerates the biotransformation of protein in the skin and weakens proliferative processes. Salicylic acid - NSAIDs, shows moderate keratolytic properties, contributes to the penetration of betamethasone into the skin.
Pharmacokinetics
Absorption and distribution As a result of keratolytic action of salicylic acid, betamethasone easily penetrates into the stratum corneum of the epidermis, where it accumulates. In small amounts can penetrate into the systemic circulation when used externally and have a systemic effect. After a slight absorption into the body, it is metabolized mainly in the liver. It is excreted by the kidneys and, to a lesser extent, with bile in the form of compounds with glucuronic acid, and also in small quantities in unchanged form.
Indications
Inflammatory skin diseases (dermatoses) sensitive to the treatment of GCS with keratosis and peeling: - urticaria; - exudative erythema multiforme; - chronic atopic dermatitis; - simple and allergic dermatitis; - simple chronic lichen; - red warty lichen, red flat lichen; - eczema (including monet-like eczema, hand eczema, eczematous dermatitis); - psoriasis; - dyshidrosis; - ichthyosis and other ichthyoso similar states.
Contraindications
- pink and juvenile acne; - perioral dermatitis; - bacterial, viral or fungal infection of the skin (pyoderma, syphilis, chicken pox, skin tuberculosis, infections caused by Herpes simplex, Varicella zoster, actinomycosis, blastomycosis, sporotrichosis); - trophic ulcers on the background chronic venous insufficiency; - skin tumors (skin cancer, nevus, atheroma, epithelioma, melanoma, hemangioma, xanthoma, sarcoma); - post-vaccination skin reactions; - children's age up to 2 years; - pregnancy; - lactation (breastfeeding) period; - heightened sensitive components to be preparata.S caution should be used drug in the presence of atrophic skin changes in patients with hepatic insufficiency, continuous treatment, if necessary with the application to extensive areas of skin using occlusive dressings; in children aged 2 years and older, in elderly patients.
Precautionary measures
Application for violations of liver functionWith caution should be used in patients with hepatic insufficiency.Application in childrenIt is contraindicated for use in children under 2 years old. Due to the fact that in children the area of the skin in relation to body weight is larger, and the epidermis is not sufficiently developed In case of external use of the drug, absorption of a proportionally larger amount of active substances is possible and, therefore, there is a greater risk of developing systemic side effects. Use the drug in children should be as short as possible and with all precautions. Use in elderly patientsWith caution should be used in elderly patients.
Use during pregnancy and lactation
The drug is contraindicated in pregnancy and lactation (breastfeeding). At the time of treatment, it is recommended to stop breastfeeding.
Dosage and administration
The drug is used externally. A small amount of ointment is applied with a thin layer on the affected skin surface 2 times a day - in the morning and at night, completely covering the affected skin. In some patients, a supportive effect can be achieved with less frequent applications. If necessary, impose occlusive dressings, which change every 24 hours. The duration of treatment depends on the effectiveness and tolerability of therapy and is usually no more than 3-4 weeks. If necessary, a longer course of therapy is recommended to use the drug less often, for example, every other day.In the treatment of chronic diseases, treatment should continue for some time after the disappearance of all symptoms in order to avoid recurrence of the disease. For children aged 2 to 12 years, the ointment should be applied to a small area of skin 1-2 times / day for no more than 1 week.
Side effects
Local reactions: burning sensation, irritation, dry skin, folliculitis, hypertrichosis, acne-like rashes, hypopigmentation, perioral dermatitis, allergic contact dermatitis are possible. With prolonged use, as well as with the use of occlusive dressings - maceration of the skin, secondary infection, atrophy of the skin, prickly heat, purpura. Systemic reactions: with prolonged use and application to vast body surfaces (mainly in children) - hypoglycemia, glycosuria, reversible inhibition of function Adrenal cortex, manifestation of Itsenko-Cushing syndrome. The patient should be warned about the need to inform the doctor if any of the side effects indicated in the instructions are aggravated, or the patient has noticed any other adverse effects. Effects not listed in the instructions.
Overdose
Overdose is very rare. However, prolonged use and use of local corticosteroids on the extensive surface of the skin may suppress adrenal function with the development of secondary adrenal insufficiency and symptoms of hypercorticism, including Cushing syndrome. Prolonged use of preparations containing salicylic acid on the extensive surface of the skin can lead to salicylic acid poisoning. Treatment: symptomatic therapy. The acute symptoms of hypercorticism are usually reversible. If necessary, carry out the correction of the electrolyte balance. With an overdose of salicylates, the treatment is also symptomatic. Measures should be taken for the early removal of salicylates from the body, for example, ingestion of sodium bicarbonate (for urine alkalization) and conducting forced diuresis.
Interaction with other drugs
Drug interaction Betaderm; And with other drugs have not been studied.
special instructions
Do not put the drug on the skin due to the possibility of telangiectasia even after a short application. Do not allow the drug to get into the eyes and on the periorbital area. Some areas of the body (inguinal folds, underarms and perianal area) are more at risk of developing stretch marks.Therefore, the duration of use of the drug in these areas should be limited. Do not use in the anogenital area, as well as in areas of extensive skin lesions, especially with a violation of the integrity of the skin, for example, burns. Avoid contact with the mucous membranes. If there are signs of allergic reactions or local irritation treatment should be discontinued. With long-term use of the drug, its withdrawal should be carried out gradually. If there is an urgent need to apply a bandage, then you should apply an air-tight dressing and do not use a sealing, oilcloth dressing. In cases of joining the infection, appropriate therapy should be prescribed. Use in pediatrics The drug should be used in children aged 2 years and older only under strict indications and under medical supervision. Due to the fact that children, the skin area in relation to body weight is larger, and the epidermis is also underdeveloped, with external use of the drug it is possible to absorb proportionally more active substances and, trace Well, there is a greater risk of systemic side effects. Use the drug in children as soon as possible and in compliance with all precautions. Effects on the ability to drive vehicles and control mechanisms There are no data on the adverse effects of the drug on the ability to drive vehicles and mechanisms.