Betamethasone cream for external use 0.05%, 30g

Skin diseases amenable to GCS therapy:

• atopic dermatitis / neurodermatitis,

• allergic contact dermatitis,

• eczema (various forms),

• contact dermatitis (including occupational) and other non-allergic dermatitis (including solar and radiation dermatitis),

• reactions to insect bites,

• psoriasis,

• bullous dermatoses,

• discoid lupus erythematosus,

• lichen planus

• exudative erythema multiforme,

• itching of various etiologies,

• erythroderma.

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

External use. The dosage regimen is individual, depending on the indications, the patient's age and the clinical situation.

Active ingredient: betamethasone dipropionate - 0.643 mg, which corresponds to the content of betamethasone - 0.5 mg

Excipients : white soft paraffin - 150 mg, cetostearyl alcohol - 72 mg, liquid paraffin - 60 mg, macrogol 20 cetostearyl ether - 22.5 mg, sodium dihydrogen phosphate dihydrate - 3.39 mg, methyl parahydroxybenzoate (methyl paraben) - 1 mg, propyl parahydroxybenzyl benzene 0.5 mg, sodium hydroxide - in the amount required to establish the pH, concentrated phosphoric acid - in the amount required to establish the pH, purified water - up to 1 g.

Х Increased sensitivity,

Х bacterial (skin tuberculosis, skin manifestations of syphilis), fungal, viral (chickenpox, herpes simplex) skin diseases,

Х post-vaccination skin reactions,

Х open wounds,

Х trophic ulcers of the leg,

Х rosacea,

Х acne vulgaris,

Х skin cancer,

Х nevus,

Х atheroma,

Х melanoma,

Х hemangioma,

Х xanthoma,

Х sarcoma,

Х children under 1 year old (cream and ointment) and up to 2 years old (spray),

Х the period of breastfeeding.

Carefully

Cataracts, diabetes mellitus, glaucoma, tuberculosis (with prolonged use or application to large areas of the body), children from 2 to 12 years old (spray).

Ointment for external use is white or almost white, translucent, homogeneous.

Composition:

Active ingredient: betamethasone dipropionate - 0.643 mg, which corresponds to the content of betamethasone - 0.5 mg

Excipients : white soft paraffin - 150 mg, cetostearyl alcohol - 72 mg, liquid paraffin - 60 mg, macrogol 20 cetostearyl ether - 22.5 mg, sodium dihydrogen phosphate dihydrate - 3.39 mg, methyl parahydroxybenzoate (methyl paraben) - 1 mg, propyl parahydroxybenzyl benzene 0.5 mg, sodium hydroxide - in the amount required to establish the pH, concentrated phosphoric acid - in the amount required to establish the pH, purified water - up to 1 g.

Pharmaco-therapeutic group: Topical glucocorticosteroid

pharmachologic effect

Betamethasone dipropionate is a synthetic corticosteroids. It has anti-inflammatory, antipruritic, anti-allergic, vasoconstrictor, anti-exudative and antiproliferative effects. When applied to the surface of the skin, it narrows blood vessels, relieves itching, reduces the release of inflammatory mediators (from eosinophils and mast cells), interleukins 1 and 2, interferon gamma (from lymphocytes and macrophages), inhibits activity and reduces the permeability of the vascular wall. Interacts with specific receptors in the cytoplasm of the cell, stimulates the synthesis of matrix ribonucleic acid, which induces the formation of proteins, including lipocortin, that mediate cellular effects. Lipocortin inhibits phospholipase A2, blocks the release of arachidonic acid and the biosynthesis of endoperoxides, prostaglandins, leukoproteins (contributing to the development of inflammation,allergies and other pathological processes).

Pharmacokinetics

When applied externally in therapeutic doses, the transdermal absorption of the active substance into the blood is very insignificant. The use of occlusive dressings, inflammation and skin diseases increase transdermal absorption, which can lead to an increased risk of systemic side effects.

Indications

Skin diseases amenable to GCS therapy:

• atopic dermatitis / neurodermatitis,

• allergic contact dermatitis,

• eczema (various forms),

• contact dermatitis (including occupational) and other non-allergic dermatitis (including solar and radiation dermatitis),

• reactions to insect bites,

• psoriasis,

• bullous dermatoses,

• discoid lupus erythematosus,

• lichen planus

• exudative erythema multiforme,

• itching of various etiologies,

• erythroderma.

Dosage regimen

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

External use. The dosage regimen is individual, depending on the indications, the patient's age and the clinical situation.

Side effect

Skin and subcutaneous tissue disorders: itching, burning, irritation, dry skin, folliculitis, hypertrichosis, striae, acne-like rashes ('steroid' acne), hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, skin atrophy, local hirsutism, telangiectasia, prickly heat, purpura.

On the part of laboratory parameters: hyperglycemia, glucosuria.

From the side of the organ of vision: blurred vision.

Others: reversible suppression of the function of the adrenal cortex, manifestation of Itsenko-Cushing's syndrome.

Contraindications for use

• Hypersensitivity

• bacterial (skin tuberculosis, skin manifestations of syphilis), fungal, viral (chickenpox, herpes simplex) skin diseases,

• post-vaccination skin reactions,

• open wounds

• trophic ulcers of the leg,

• rosacea,

• acne vulgaris,

• skin cancer,

• nevus,

• atheroma,

• melanoma,

• hemangioma,

• xanthoma,

• sarcoma,

• children under 1 year old (cream and ointment) and up to 2 years old (spray),

• period of breastfeeding.

Carefully

Cataracts, diabetes mellitus, glaucoma, tuberculosis (with prolonged use or application to large areas of the body), children from 2 to 12 years old (spray).

Application during pregnancy and lactation

Contraindicated during pregnancy and lactation (breastfeeding).

Application in children

The drug is contraindicated for use in children under 1 year old (ointment and cream) and under 2 years old (spray).

With caution when using the spray form in children from 2 to 12 years old.

special instructions

Long-term use of the drug on the face is not recommended, since rosacea, perioral dermatitis and acne may develop. The course of treatment should not exceed 5 days.

The medicinal product is not intended for use in ophthalmology. Avoid contact with eyes. If the drug gets on the mucous membranes of the eye, it is possible to develop cataracts, glaucoma, fungal infections of the eye and exacerbation of herpes infection.

With prolonged treatment, when applied to extensive skin surfaces, as well as in the armpits and groin folds, when using occlusive dressings, diapers, systemic absorption of GCS is possible.

When applied on large surfaces and / or under an occlusive dressing, it is possible to suppress the function of the hypothalamic-pituitary-adrenal system and develop symptoms of hypercortisolism, there may be a decrease in the excretion of growth hormone, an increase in intracranial pressure.

The spray form is preferable for use in the acute form of dermatosis, including those accompanied by exudation (the formation of weeping surfaces).

Use in pediatrics

Application in children aged 1-2 years is possible only under medical supervision. Children are more at risk of suppression of the function of the hypothalamic-pituitary-adrenal system due to the use of GCS for external use than adults, due to their higher ratio of body surface area and body weight and, accordingly, increased absorption of this agent. In children, this is accompanied by low plasma cortisol levels and a lack of response to ACTH stimulation. Perhaps the occurrence of Itsenko-Cushing's syndrome, impaired growth and development, a slowdown in weight gain, an increase in intracranial pressure, manifested by protrusion of the fontanelle, headaches, bilateral edema of the optic nerve head.