Betliben - instructions for use, dose, side effects, contraindications

It inhibits the accumulation of leukocytes, the release of lysosomal enzymes and anti-inflammatory mediators in the inflammatory focus, inhibits phagocytosis, reduces vascular-tissue permeability, prevents the formation of inflammatory edema.

Pharmacokinetics:

Betamethasone is absorbed from the skin surface, depending on the amount (dose) of the drug applied and the presence of damage to the stratum corneum. It is assumed that no more than 5% of the applied amount (dose) of the drug is absorbed.

Absorbed betamethasone It is metabolized in the liver by hydrolysis and oxidation and is excreted through the kidneys. Penetration and absorption of the drug is higher in case of damaged, mucus-covered skin (with inflammatory and / or other skin diseases).

The drug binds to plasma proteins in an amount of about 64%.

The half-life is 6.5 hours. Less than 5% of the concentration of betamethasone in serum is excreted unchanged in the urine.Much of the drug is absorbed in the case of occlusive dressing, which is caused by a local increase in temperature and humidity.

Indications:

Allergic skin diseases (including acute, subacute and chronic contact dermatitis, occupational dermatitis, seborrheic dermatitis, atopic dermatitis, sun dermatitis, neurodermatitis, skin itching, dyshidrotic dermatitis, eczema), acute and chronic forms of non-allergic dermatitis; psoriasis.

Contraindications:

- Tuberculosis of the skin;

- cutaneous manifestations of syphilis;

- chickenpox;

- viral, bacterial and fungal skin infections;

- skin postvaccinal reactions;

- open wounds;

- trophic ulcers;

- rosacea;

- Acne vulgaris;

- tumors of the skin and subcutaneous structures;

- Children's age up to 1 year;

- hypersensitivity to betamethasone or to any of the auxiliary components of the drug:

Carefully:

This drug should be used with caution in pregnancy.

With prolonged use or application to large surfaces, care should be taken with the following diseases: cataract, diabetes mellitus, glaucoma, tuberculosis.

Pregnancy and lactation:

Pregnant women are not recommended to use Betliben in large quantities, on large areas of the body or for a long time. The use of betamethasone during pregnancy should only be carried out when the potential benefit exceeds the potential risk to the fetus.

Lactation

When using large amounts of Betliben ointment, breast-feeding is not recommended.

Dosing and Administration:

The drug is intended for external use only.

Ointment for external use is applied to the affected area of the skin with a thin layer 1 or 2 times a day, lightly rubbing. On sites with more dense skin (for example, elbows / palms and feet), as well as places from which the drug is easily erased, the drug can be applied more often.

The duration of continuous treatment is usually not more than 4 weeks. For the prevention of relapse in the treatment of chronic diseases, therapy should continue for some time after the disappearance of all symptoms.

During the year, repeated courses of therapy are possible.

Ointment for external use is intended for therapy of subacute and chronic dermatoses, incl.dry, lichenized and flaky lesions, or in cases where the occlusive effect of the ointment is necessary.

Side effects:

When topical application of glucocorticosteroids can occur: burning, irritation, dry skin, folliculitis, hypertrichosis, acne-like rashes, itching, striae, sweating, hypopigmentation, perioral dermatitis.

With prolonged use, as well as the use of occlusive dressings, skin maceration, secondary infection, skin atrophy, sweating, purpura, local hirsutism, telangiectasia.

When applied to extensive body surfaces, especially in children, there may be systemic side effects of glucocorticosteroids (gastritis, ulceration of the gastrointestinal mucosa, hyperglycemia, glucosuria, reversible suppression of adrenal cortex function, manifestation of Itenko-Cushing syndrome).

If adverse reactions are not described in the instructions, you should consult your doctor.

Overdose:

For prolonged continuous use of the drug, especially in children, on extensive skin surfaces, when applied to the skin with impaired integrity or when used under an occlusive dressing,it is possible to develop side effects associated with suppression and insufficiency of the function of the adrenal cortex.

Treatment: it is recommended to cancel the drug and, if necessary, prescribe symptomatic therapy.

Interaction:The interaction of Betlyben ointment with other drugs is unknown.

Special instructions:

If there are signs of hypersensitivity or skin irritations associated with the use of the drug, you should stop treatment.

With prolonged treatment, when applying the drug on the vast surface of the skin, with the use of occlusive dressings, as well as in children, a systemic absorption of glucocorticosteroids is possible.

Children from 1 year of the drug is prescribed only for strict indications and under medical supervision, as it is possible to develop systemic side effects associated with betamethasone.

When using the drug on extensive surfaces and / or under occlusive dressing, it is possible to increase absorption of betamethasone and manifest systemic side effects associated with the suppression of hypothalamic-pituitary-adrenal system and the development of symptoms of hypercorticism.

When using the drug on the face skin treatment should not exceed 5 days, since with prolonged use of topical glucocorticosteroids, the probability of developing atrophic skin changes increases.

The drug is not intended for use in ophthalmology.

Avoid getting ointment in the eyes.

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

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

The drug does not affect the ability to drive a car or to management of complex mechanisms.

Form release / dosage:

Ointment for external use, 0,05%.

Packaging:

For 25 g of the drug in an aluminum tube, coated twice with a protective varnish, with a sealed hole, a protective membrane and a plastic cap, equipped with a cone-shaped device for puncturing the protective membrane.

The tube together with the instruction for use is placed in a cardboard box.

Storage conditions:

At a temperature not higher than 25 ° C, out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001654

Date of registration:16.04.2012

Expiration Date:16.04.2017

The owner of the registration certificate:Yadran Galensky Laboratories a.o.Yadran Galensky Laboratories a.o. Croatia

Manufacturer: & nbsp

JADRAN Galenski Laboratorij, d.d. Croatia

Representation: & nbspYadran Galen Laboratory as.Yadran Galen Laboratory as.Croatia

Information update date: & nbsp25.01.2017

Illustrated instructions

Instructions

Betliben (Betliben)