Betaderm A - instructions for use, dose, side effects, contraindications

Betamethasone - synthetic glucocorticosteroid (GCS), has a strong anti-inflammatory, antipruritic, anti-allergic and vasoconstrictive.Reduces inflammatory processes by inhibiting the production of prostaglandins and leukotrienes due to oppression of phospholipase activity A₂ and reduce the release of arachidonic acid from the phospholipids of cell membranes, and also has an antiallergic effect. Due to local vasoconstrictive action reduces exudative reactions. Accelerates biotransformation of protein in the skin and weakens proliferative processes.

Salicylic acid - a non-steroidal anti-inflammatory drug (NSAID), exhibits a moderate keratolytic property, promotes the penetration of betamethasone into the skin.

Pharmacokinetics:

Due to keratolytic action of salicylic acid betamethasone easily penetrates into the stratum corneum of the epidermis, where cumulates. Betamethasone practically not metabolized in the skin. In a small amount can enter the systemic circulation with external application and have a systemic effect. After a slight absorption in the body is metabolized mainly in the liver. It is excreted through the kidneys, and to a lesser extent, with bile in the form of compounds with glucuronic acid, and also in small amounts in unchanged form.

Indications:

Inflammatory skin diseases (dermatoses) sensitive to GKS therapy, which occur with keratosis and desquamation:

- urticaria, multiforme exudative erythema;

- chronic atopic dermatitis;

- simple and allergic dermatitis;

- limited pruritus with severe lichenification;

- seborrheic dermatitis of the scalp;

- simple chronic lichen;

- red warty lichen, red flat lichen;

- Eczema (including coin-like eczema, eczema of hands, eczematous dermatitis);

- psoriasis;

- dyshidrosis;

- ichthyosis and other ichthyosis-like conditions.

Contraindications:

- Pincreased sensitivity to betamethasone, salicylic acid and other components of the drug;

- pink and youthful acne;

- perioral dermatitis;

- bacterial, viral or fungal skin infection (pyoderma, syphilis, chicken pox, skin tuberculosis, Herpes simplex, Herpes zoster, actinomycosis, blastomycosis, sporotrichosis);

- trophic ulcers on the background of chronic venous insufficiency;

- skin tumors (skin cancer, nevus, atheroma, epithelioma, melanoma, hemangioma, xanthoma, sarcoma);

- postvaccinal skin reactions;

- children under 2 years;

- pregnancy;

- lactation period.

Carefully:

- Child age from 2 years;

- elderly age;

- Persons with atrophic skin changes;

- liver failure;

- long-term treatment, use on large areas of the skin, the use of occlusive dressings.

Pregnancy and lactation:

Do not use in pregnant women.

It is recommended to stop breastfeeding for the duration of treatment.

Dosing and Administration:

Outwardly. Apply a small amount of the drug in a thin layer on the affected surface of the skin 2 times a day - in the morning and at night, completely covering the affected areas of the skin. In some patients, the supporting effect can be achieved by less frequent applica- tions. If necessary, impose occlusive dressings, which are changed every 24 hours.

The duration of treatment depends on the effectiveness and tolerability of therapy and is, as a rule, no more than 3-4 weeks. If a longer course of therapy is required, the drug should be used less frequently, for example every other day. In the treatment of chronic diseases, treatment should continue for some time after the disappearance of all symptoms to avoid relapse of the disease.

Children aged 2 to 12 years - Apply a thin layer on a small area of the skin 1 or 2 times a day for no more than 1 week.

Side effects:

With topical application of glucocorticosteroids can be observed: burning sensation, irritation, dry skin, folliculitis, hypertrichosis, acne-like rashes, hypopigmentation, perioral dermatitis, allergic contact dermatitis.

With prolonged use and application to extensive body surfaces, mainly in children, there may be systemic side effects of glucocorticosteroids (hypoglycemia, glucosuria, reversible suppression of adrenal cortex function, manifestation of Itenko-Cushing syndrome).

With prolonged use, as well as with the use of occlusive dressings: maceration of the skin, secondary infection, skin atrophy, sweating, purpura.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

Overdose is very rare. However, with long-term use and the use of local glucocorticosteroids on the vast surface of the skin, suppression of adrenal function with the development of secondaryadrenal insufficiency and symptoms of hypercorticism, including Itenko-Cushing syndrome. Long-term use on the vast surface of the skin preparations containing salicylic acid, can lead to poisoning with salicylic acid.

Treatment: symptomatic. Acute symptoms of hypercorticoidism are usually reversible. If necessary, correct the electrolyte balance. In overdose of salicylates, treatment is also symptomatic. It is necessary to take measures for the early removal of salicylates from the body, for example, ingestion of sodium bicarbonate (for urine alkalinization) and forcing diuresis.

Interaction:

Not studied.

Special instructions:

Do not apply the product to the skin due to the possibility of telangiectasis even after a short application.

Avoid contact with eyes and periorbital area.

Some areas of the body (inguinal folds, axillary cavities and perianal region) are more susceptible to the risk of striae. Therefore, the duration of application of the drug in these areas should be limited.

Do not use in the anogenital area, as well as in areas of extensive skin damage, especially with a breach of the integrity of the skin, for example, with burns.

Avoid getting the drug on the mucous membranes.

When there are signs of allergic reactions or local irritation, treatment should be stopped.

With prolonged use of the drug, it should be canceled gradually.

If there is an extreme need for dressing, then a bandage that allows air to be applied and not to use a sealing, glue bandage should be applied.

In cases of infection, appropriate therapy should be prescribed.

Children. Children are allowed to prescribe the drug from two years only on strict indications and under the supervision of a doctor.

Due to the fact that in children the area of the skin with respect to the body weight is greater, as well as the epidermis is not sufficiently developed, with external application of the drug it is possible to absorb proportionally more active substances and, consequently, there is a greater risk of development of systemic side effects. Use the drug in children should be as short as possible and with all precautions.

Effect on the ability to drive transp. cf.and fur:

Data on the adverse effects of the drug on the ability to control vehicles and mechanisms are not available.

Form release / dosage:

Ointment for external use, 0.05% + 3%.

Packaging:

For 15 grams of ointments in aluminum tubes with a varnished inner surface.

The tube is placed in a cardboard box with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001626

Date of registration:06.04.2012 / 23.12.2013

Expiration Date:06.04.2017

The owner of the registration certificate:VALEANT, LLC VALEANT, LLC Russia

Manufacturer: & nbsp

PHARMACEUTICAL WORKS JELFA, S.A. Poland

Representation: & nbspVALEANT LLC VALEANT LLC Russia

Information update date: & nbsp24.01.2017

Illustrated instructions

Instructions

Betaderm® A (Betaderm® A)