Betamethasone

General characteristics. Structure:

Acting veshchestvo:betamethasone;

1 g of cream contains Dipropionas betamethasone in terms of 100% substance of 0,64 mg;

excipients: methylparaben (methylparahydroxybenzoate) (Е 218) 2 mg, imidourea of 5 mg, propylene glycol, glycerin, oil mineral, paraffin white soft, диметикон 350, cetostearyl alcohol, a macrogoal the 20th cetostearyl ether, sodium dihydrophosphate monohydrate, the phosphoric acid divorced the water purified.

Pharmacological properties:

Pharmacodynamics. Anti-inflammatory, antiallergic and antipruritic drug. Betamethasone slows down migration of leukocytes, release of lizosomalny enzymes and antiinflammatory mediators in the inflammation center, phagocytosis oppresses, reduces vascular and fabric permeability, interferes with formation of inflammatory hypostasis.

Pharmacokinetics. At topical administration of cream in therapeutic doses transdermalny absorption of betamethasone in blood insignificant – 12-14%. Linkng with blood proteins makes 64%. Метаболизируетсяв liver. Removal happens in the form of metabolites preferential kidneys, an insignificant part – to bile. Existence of inflammatory process, injuries of skin and use of occlusive bandages can strengthen betamethasone absorption.

Pharmaceutical characteristics.

Main physical and chemical properties: cream of white color.

Indications to use:

For reduction of inflammatory manifestations of a dermatosis sensitive to glucocorticoid therapy, such, as: eczema and dermatitis of any types, including atopichny eczema, a photodermatitis, red flat deprive, neurodermatitis, nodal пруриго, a diskoidny lupus erythematosus, a lipoid necrobiosis, a pretibialny myxedema and an erythrosis. Besides, it is also effective at treatment of psoriasis of a pilar part of the head and other forms of psoriasis, except for extensive blyashkovy.

Route of administration and doses:

Cream is applied locally. The drug dose is established individually as it depends on the area of an affected area. Cream needs to be applied on an affected area with a thin layer 2 times a day, carefully rubbing in skin; after achievement of clinical improvement the frequency of use of medicine can be reduced to 1 time a day. Duration of treatment is defined by the speed of elimination of inflammatory process, the termination of an itch, clarification of skin; duration of a course of treatment depends on a look and weight of a course of a disease, is defined by the doctor and usually makes 1-2 weeks, but no more than 3 weeks; between repeated courses the break is necessary not less than 20 days. The course of treatment for children and patients with damage of a face has to make no more than 5 days. It is not applied in ophthalmologic practice.

Features of use:

Do not use drug in ophthalmologic practice. It is impossible to allow hits of medicine in eyes, and also it is not necessary to apply cream on skin around eyes as at the same time development of glaucoma, cataract, fungal infections of eyes and an aggravation of a herpes infection is possible.

At emergence of irritation of skin, or manifestations of hypersensitivity in connection with cream use treatment the patient should stop and pick up adequate therapy. Use of cream under occlusive bandages and prolonged use of medicine on face skin as strengthening of side effect is possible is not recommended. Cream is not applied to treatment of varicose ulcers.

In case of prolonged use of medicine when using occlusive bandages, at treatment of a big body surface, especially at children, system side reactions from endocrine system are possible. These side reactions develop exclusively seldom, have reversible character and disappear at once after medicine phase-out. Regular control of function гипоталамо - pituitary and adrenal system is necessary for such patients during use of cream. At emergence of symptoms of suppression of function гипоталамо - pituitary and adrenal system it is necessary to cancel medicine or to increase intervals between cream applications.

At patients with psoriasis corticosteroids for topical administration can worsen its current, including resuming of symptoms with the subsequent development of tolerance, risk of developing of pustulyarny psoriasis and local systematic toxicity owing to decrease in protective function of skin.

Some body parts, such as axillary hollows, inguinal folds (where there is natural occlusion), are more subject to risk of emergence of striya. Therefore use of medicine on these sites has to be short. In case of development of fungal or bacterial superinfection of skin additional use of antifungal or antibacterial agent is necessary.

Use of cream on a pilar part of the head is not recommended.

Ability to influence speed of response at control of motor transport or work with other mechanisms. Usually drug does not influence the speed of response of the patient at control of motor transport or work with other mechanisms.

Side effects:

From skin: at long therapy in the place of application emergence of a burning sensation, an itch, irritation, dryness, a folliculitis, a hypertrichosis, an acne, hypopigmentation, a hyperpegmentation, perioral dermatitis, allergic contact dermatitis, maceration of skin, consecutive infection, a heat rash is possible. At prolonged continuous use development of an atrophy of skin, striya and telangiectasias is possible, especially at use on a face.

System manifestations: at certain patients development of system side effects is possible: oppression of function of bark of adrenal glands, decrease in tolerance to carbohydrates, an Icenco-Cushing syndrome; at children oppression of function of bark of adrenal glands can arise more often and it is shown by a growth inhibition, increase in intracranial pressure, a body degrowth, decrease in level of cortisol in a blood plasma and urine, lack of the response to stimulation by adrenocorticotropic hormone, displays of intracranial hypertensia (protrusion of a fontanel, a headache and bilateral hypostasis of an optic nerve).

Interaction with other medicines:

Interaction with other medicines is not described.

Contraindications:

Medicine should not be applied at primary viral, fungal and bacterial damages of skin, a tuberculosis cutis, skin displays of syphilis, skin reactions after vaccination, at acne rash, perioral dermatitis, a perianal and genital itch, a rozatsea, extensive blyashkovy psoriasis, a varicosity, and also at individual hypersensitivity to betamethasone or to other components of medicine.

Use during pregnancy or feeding by a breast. Because safety of use of local glucocorticosteroids for pregnant women was not established, prescription of medicines of this group during pregnancy is possible only in that case when the potential advantage for mother exceeds potential risk for a fruit. During pregnancy medicines of this group should not be applied in high doses and long time. For today it is not studied whether leads topical administration of glucocorticosteroids to the system adsorption sufficient for definition in breast milk. During feeding by a breast use of medicine is possible only according to strict indications and after ratio assessment advantage risk, but at the same time cream cannot be applied on skin of a mammary gland.

Children. Use is not recommended to children up to 2 years. Use is possible only in that case when the expected advantage exceeds potential risk of development of side reactions.

In case of drug use children need to consider possibility of signs of oppression гипоталамо - pituitary and adrenal system which arise at children more often than at adult patients that is connected with bigger adsorption of drug at children because of bigger value of a ratio of surface area of skin to body weight.

At children who received corticosteroids for topical administration, oppression of function of adrenal glands, an Icenco-Cushing syndrome, a growth inhibition, insufficient increase in body weight, increase in intracranial pressure was noted.

Overdose:

Excessive and prolonged use of medicine on the big surface of skin can lead to manifestation of the system side effects inherent to glucocorticosteroids, in particular to oppression гипоталамо - pituitary and adrenal system with development of secondary insufficiency of epinephral glands and to emergence of symptoms of a hypercorticoidism, including an Icenco-Cushing syndrome (especially at children).

Treatment. Symptomatic therapy. If necessary carry out correction of electrolytic balance. Gradual drug withdrawal is recommended.

Storage conditions:

Period of validity 3 years. To store in original packaging at a temperature not above 25 °C. Not to freeze. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

On 15 g of cream in a tuba, 1 tuba in a pack.