Betason

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BETAZONE (BETAZONE)

Composition:

active substance: betamethasone;

1 g of the preparation contains micronized betamethasone valerate equivalent to 1 mg of betamethasone;

excipients: cetyl stearyl alcohol, polyethylene glycol stearate, white soft paraffin, mineral oil, anhydrous sodium dihydrogen phosphate, concentrated phosphoric acid, sodium hydroxide, chlorocresol, purified water.

Pharmaceutical form. Topical cream.

Main physico-chemical properties: white or almost white homogeneous cream.

Pharmacotherapeutic group. Corticosteroids for dermatological use. Potent corticosteroids (Group III). ATC code D07AC01.

Pharmacological properties.

Pharmacodynamics.

Betamethasone valerate is a synthetic glucocorticosteroid for topical use.

Betamethasone exhibits high glucocorticosteroid activity and only minimal mineralocorticoid effect.

Due to their anti-inflammatory, antipruritic, and vasoconstrictive actions, topical glucocorticosteroids such as betamethasone valerate should primarily be used for the treatment of dermatoses sensitive to corticosteroid therapy.

Pharmacokinetics.

After penetration into the skin, the pharmacokinetic profile of topical corticosteroids is similar to that of systemic corticosteroids.

Corticosteroids bind to plasma proteins to varying degrees. They are mainly metabolized in the liver and excreted in the urine.

Systemic absorption of topically applied corticosteroids is expected only under unfavorable conditions (prolonged treatment, occlusive dressing).

Data are available on the assessment of transdermal absorption of betamethasone valerate from a "water-in-oil" emulsion in healthy volunteers with experimentally impaired skin. After 24 hours, 68.1 ± 6.9% of the 3H-labeled 200 mg dose was detected in the skin. After 72 hours, 7.34 ± 2.74% and 4.80 ± 0.76% of the administered dose were excreted in urine and feces, respectively.

Some topical corticosteroids and their metabolites are excreted in bile.

Clinical characteristics.

Indications. For reduction of inflammatory manifestations of dermatoses sensitive to glucocorticosteroid therapy, such as: eczema (atopic, nummular), contact dermatitis, seborrheic dermatitis, neurodermatitis, solar dermatitis, exfoliative dermatitis, stasis dermatitis, radiation dermatitis, intertriginous dermatitis, psoriasis, anogenital and senile pruritus.

Contraindications. The drug is contraindicated in patients with allergic reactions to any of the components of the drug, as well as in the following cases:

• viral infections, including postvaccinal reactions and varicella;
• viral skin infections (e.g. herpes simplex, herpes zoster, varicella);
• acne vulgaris;
• rosacea-like (perioral) dermatitis;
• bacterial dermatoses, including tuberculosis and syphilis of the skin;
• fungal infections;
• ophthalmological diseases (the drug is not intended for ophthalmic use).

The use of the drug under occlusive dressings (casts, etc.) is not recommended.

Particular caution should be exercised when applying the drug to treated areas near the face. Avoid contact of the drug with eyes or mucous membranes. Prolonged treatment and/or application over large skin areas should be avoided, as systemic absorption of the active substance may occur.

The drug should not be used during the first trimester of pregnancy (see section "Use during pregnancy or breastfeeding").

Interaction with other medicinal products and other forms of interaction. Due to the presence of soft white paraffin and mineral oil, treatment with the drug in the anogenital area may damage the structure of latex condoms and reduce their safety during use while undergoing treatment.

Special precautions for use.

The drug is not intended for ophthalmic use.

Systemic absorption of topical corticosteroids generally increases with higher corticosteroid dosage, prolonged duration of treatment, and larger treated body surface area. Therefore, potent corticosteroids applied over large skin areas should be used under careful and periodic monitoring, as they may cause suppression of the hypothalamic-pituitary-adrenal (HPA) axis.

If HPA axis suppression develops, the drug should be discontinued, the frequency of application reduced, or the patient switched to a less potent corticosteroid. HPA axis function usually recovers after discontinuation of the drug. In some cases, withdrawal symptoms may occur, requiring supplementation with systemic corticosteroids.

The drug is generally well tolerated. However, treatment should be discontinued if irritation or hypersensitivity develops.

The drug contains cetostearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).

The drug contains chlorocresol, which may cause allergic reactions.

If skin irritation or signs of hypersensitivity occur during treatment, therapy should be discontinued and appropriate alternative treatment initiated. In the presence of infection, appropriate antifungal or antibacterial agents should be administered. If the desired therapeutic effect is not rapidly achieved, corticosteroid treatment should be discontinued until signs of infection have resolved.

Use during pregnancy or breastfeeding. Since the safety of topical corticosteroids in pregnancy has not been established, the drug should not be used during the first trimester of pregnancy. Use of these drugs may be considered during later stages of pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus. These drugs should not be used over large areas of skin, in large quantities, for prolonged periods, or under occlusive dressings in pregnant women.

It is currently unknown whether the drug, due to systemic absorption following topical corticosteroid application, can pass into breast milk. Therefore, when deciding whether to discontinue breastfeeding or to discontinue the drug, the importance of the therapy to the mother should be taken into account.

Ability to affect reaction speed while driving or operating machinery. The drug usually does not affect the patient's reaction speed while driving or operating machinery.

Method of Administration and Dosage

The drug should be applied in a thin layer to affected skin areas 1–3 times daily, depending on the severity of the condition.

Apply a sufficient amount of the drug in a thin layer to completely cover the affected skin areas and gently rub into the skin. As the condition improves, the frequency of application may be reduced.

Prolonged use of the drug (more than 3 months) or application over large body surface areas (more than 20% of body surface) should be avoided. This also applies to treatment of more than 10% of body surface for longer than 1 week.

After improvement of the clinical picture, switching to a weaker glucocorticosteroid is often recommended.

Intermittent therapy, consisting of alternating application of the active drug and a topical preparation without the active ingredient throughout the week, may also be appropriate.

Careful monitoring for signs and symptoms of systemic drug effects is recommended.

The method of administration should be adapted according to skin type and disease stage.

The ointment is the preferred dosage form for oily skin, increased sebaceous gland activity, weeping lesions, and acute stages of the disease.

Patients with fungal dermatoses require specific treatment.

Do not use under occlusive dressings, as this may enhance the drug's adverse effects.

Children. There are no clinical data on the use of this drug in children; therefore, its use in this age group is not recommended.

Since children have a higher surface area to body weight ratio compared to adults, systemic absorption of the drug is more pronounced, making children more susceptible to the risk of hypothalamic-pituitary-adrenal (HPA) axis suppression and development of exogenous corticosteroid effects.

Overdose. Excessive or prolonged use of topical corticosteroids may lead to suppression of pituitary-adrenal function, resulting in secondary adrenal insufficiency and symptoms of hypercortisolism, including Cushing's syndrome. Acute symptoms of hypercortisolism are usually reversible.

In case of overdose, appropriate symptomatic treatment is indicated. If necessary, correction of electrolyte imbalance should be performed. In cases of chronic toxic effects, gradual withdrawal of the corticosteroid is recommended.

Adverse reactions.

The frequency of adverse effects is based on the following categories:

very common (≥1/10);

common (≥ 1/100 - < 1/10);

uncommon (≥ 1/1000 - < 1/100);

rare (≥ 1/10000 - < 1/1000);

very rare (< 1/10000);

unknown (frequency cannot be estimated from the available data).

Skin tingling, skin hardening, skin cracking, sensation of warmth, lamellar desquamation, focal desquamation, follicular rash, erythema, telangiectasia.

When applying the drug to large areas or under occlusive dressing, especially over prolonged periods, the possibility of systemic effects should be considered.

Hypersensitivity reactions may occur in individuals with known hypersensitivity to any component of the drug.

Any adverse reactions associated with systemic use of glucocorticoids, including suppression of the adrenal cortex, may also occur with topical application.

Shelf life. 3 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 15 g or 30 g in a tube in a carton.

Prescription status. Prescription only.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's address and place of business. Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenka Street, 22.

(all manufacturing stages, quality control, batch release)

Ukraine, 08301, Kyiv region, city of Boryspil, Shevchenka Street, 100, building B-II (corpus 4).

(all manufacturing stages, batch release)