Each gram of Betamethasone cream for topical use contains:

active ingredient: betamethasone [as valerate] – 1 mg;

excipients: ceteareth-12, ceteareth-20, cetostearyl alcohol, liquid paraffin, propylene glycol, dimethicone, methylparaben, propylparaben,ethanol 96%, water purified.

Glucocorticosteroid for topical use. ATC code – D07AC01.

Betamethasone – glucocorticosteroid, anti-inflammatory, antiallergic, antiexudative and antipruritic effect. Characterized by a high degree of glucocorticoid activity with a slight mineralocorticoid effect.Eliminates edema, hyperemia, itching at the site of application. Decreased formation, release and activity of chemical mediators of inflammation (kinins, histamine, lysosomal enzymes and prostaglandins), reduces the vasodilation and increased vascular permeability, inhibits cell migration to the site of inflammation, which prevents the formation of edema. Inhibits III and IV types hypersensitivity reactions by blocking the effect of the complexes “antigen-antibody”, which concentrate on the walls of blood vessels, and inhibiting the action of lymphokines, target cells, and macrophages. In addition, it prevents access of sensitized T lymphocytes and macrophages to target cells.

When applied to a healthy, undamaged skin betamethasone absorbed to a small extent. Skin lesions, inflammatory processes and application with occlusive dressing may increase absorption. Systemic absorption after topical application is 12-14%. Plasma protein binding is about 64%.

Betamethasone biotransformes in liver. Metabolites are excreted primarily in the urine and in small amounts – with bile.

Adminsitration

Betamethasone cream is applied topically. Topical Betamethasone0.1% cream usually is applied sparingly in thin films and are rubbed gently into the affected area 1–3 times daily. However, once- or twice-daily administration of these preparations often is effective. Some patients supporting effect can be achieved with less frequent application of the formulation.

When using the preparation in patients with lesions of the face treatment should not exceed 5 days.

In the absence of effect of the preparation for 14 days is necessary to consult with a specialist in order to clarify the diagnosis.

Local reactions: burning sensation, itching, irritation, folliculitis, hypertrichosis, acne, depigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, joining secondary infection, skin atrophy, striae, miliaria, cracked skin.

In continuous and prolonged use of the preparation and the application of occlusive dressings may suppress the pituitary gland and the adrenal cortex.

Betamethasone creamshould be terminated in nursing women.

• Hypersensitivity to the preparation’s ingredients.
• The use of occlusive dressings.
• TB skin.
• Fungal and viral skin lesions.

• Betamethasone cream is not intended for ophthalmic use. Avoid contact with eyes, mouth, and nose.
• If irritation or sensitization occurs following topical application of Betamethasone cream, the drug should be discontinued.

General

• Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.
• Conditions which augment systemic absorption include use over large surface areas, prolonged use, and use under occlusive dressings. Patients applying Betamethasone cream to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid.
• Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids.
• Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios.
• If irritation develops, Betamethasone cream should be discontinued and appropriate therapy instituted.
• Cream contains propylenglycol as excipient which may cause skin irritation.
• Cream contains cetostearyl alcoholas excipient which may cause local skin reactions (e.g. contact dermatitis).
• Cream contains propylparaben (E216) and methylhydroxybenzoate (E218) as excipient which may cause may cause allergic reactions (possibly delayed), and exceptionally, bronchospasm.

Pediatric Use

• Use of the preparation in children should be as short as possible, subject to safeguards, on strict conditions and under medical supervision, because there is a risk of systemic absorption of betamethasone proportionally more of the prevalence of the area of the skin over the body weight and lack of maturity of the epidermis for childrenParents should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, since such garments may constitute occlusive dressings. It is possible to suppress the hypothalamic-pituitary-adrenal system and the development of symptoms of Cushing, there may be a reduction in the excretion of growth hormone, increased intracranial pressure.

None well documented.

Symptoms: with prolonged use of glucocorticoids in high doses symptoms of Cushing may develop.

Treatment: appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms are usually reversible. Treat electrolyte imbalance, if necessary. In case of chronic toxicity, slow withdrawal of corticosteroids is advised. Perhaps the appointment of sodium bicarbonate inside for alkalinization of urine and forcing diuresis.

White homogenous odorless cream.

15 g of cream is filled into aluminum tubeswhich are packed and inserted with the leaflet into cardboard boxes.

3 years. Do not use after the expiration date.

Store in a cool and dry place, out of the reach of children. Protect from light.

To be dispensed with prescription.