Betamethasone

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BETAМETHASONE (BETAMETHASONE)

Composition:

Active substance: betamethasone;

1 g of cream contains betamethasone dipropionate* 0.64 mg;

Excipients: methylparaben (methylhydroxybenzoate) (E 218) 2 mg; imidourea 5 mg; propylene glycol; glycerol; mineral oil; white soft paraffin; dimethicone; cetylstearyl alcohol; polyethylene glycol (macrogol) cetylstearyl ether; sodium dihydrogen phosphate monohydrate; phosphoric acid diluted; purified water.

* - betamethasone dipropionate, calculated as 100% substance.

Pharmaceutical form. Cream.

Main physicochemical properties: white-colored cream.

Pharmacotherapeutic group.

Corticosteroids used in dermatology.

ATC code D07AC01.

Pharmacological properties.

Pharmacodynamics.

Betamethasone 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 should primarily be used for the treatment of dermatoses sensitive to corticosteroid action.

Pharmacokinetics.

When applied topically, betamethasone may be minimally absorbed through normal, intact skin. Systemic absorption of corticosteroids is expected only under unfavorable conditions (skin inflammation, prolonged treatment, occlusive dressing). 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.

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 and dermatitis of any type (including atopic eczema and photodermatitis), lichen planus, nodular prurigo, discoid lupus erythematosus, necrobiosis lipoidica, pretibial myxoedema, and erythroderma. May also be effective in the treatment of scalp psoriasis, plaque psoriasis on the skin areas of upper and lower limbs, excluding widespread plaque psoriasis.

Contraindications.

Betamethasone is contraindicated in patients with allergic reactions to any component of the medicinal product.

Betamethasone is contraindicated in the following cases:

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

Application of Betamethasone cream under occlusive dressings (casts, etc.) is not recommended.

Particular caution should be observed when applying Betamethasone near the face. Avoid contact of the medicinal product with eyes or mucous membranes. Prolonged treatment and/or application over large skin areas should be avoided, as systemic absorption of the active ingredient may occur.

The cream 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 Betamethasone cream in the anogenital area may damage the structure of latex condoms and reduce their safety during use while undergoing treatment.

Special precautions for use

Betamethasone is not intended for ophthalmic use.

Systemic absorption of topical corticosteroids generally increases with higher corticosteroid dosage, longer duration of treatment, and larger body surface area treated. 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 suppression occurs, the drug should be discontinued, the frequency of application reduced, or the patient switched to a corticosteroid with weaker activity.

HPA axis function usually recovers after discontinuation of the drug.

In some cases, withdrawal symptoms may develop, requiring supplementation with systemic corticosteroids.

Betamethasone cream is generally well tolerated. However, treatment should be discontinued if irritation or hypersensitivity occurs.

Betamethasone cream contains cetyl alcohol. Cetyl alcohol may cause localised skin reactions (e.g., contact dermatitis).

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

Use during pregnancy or breastfeeding

As the safety of topical corticosteroids in pregnant women has not been established, Betamethasone cream should not be used during the first trimester of pregnancy. These drugs may be used only later in pregnancy if the expected benefit to the mother outweighs the potential risk to the fetus. Drugs of this class should not be used over large areas, in large amounts, for prolonged periods, or under occlusive dressings during pregnancy.

It is not currently known whether topical corticosteroids, after systemic absorption, 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.

Effect on ability to drive or operate machinery
The drug generally does not affect the patient's reaction speed when driving or operating machinery.

Method of Administration and Dosage

Betamethasone cream should be applied in a thin layer to affected skin areas once or twice daily, depending on the severity of the condition.

Apply a sufficient amount of betamethasone cream in a thin layer to completely cover the affected skin areas and gently rub it into the skin. When clinical improvement occurs, the frequency of application may be reduced.

Prolonged use of betamethasone cream or application over large areas (more than 20% of body surface area) should be avoided. This also applies to treatment of more than 10% of body surface area for longer than one week.

After improvement of clinical symptoms, it is often recommended to switch to a weaker glucocorticosteroid.

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

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

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

Children.

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

Due to a higher skin surface area to body weight ratio in children compared to adults, percutaneous absorption of the drug is more pronounced. Children are at greater risk of hypothalamic-pituitary-adrenal (HPA) axis suppression and development of exogenous corticosteroid effects when treated with corticosteroids.

Overdose.

Excessive or prolonged use of topical corticosteroids may lead to suppression of pituitary-adrenal function, resulting in secondary adrenal insufficiency and symptoms of hypercorticism, including Cushing's syndrome. Acute symptoms of hypercorticism 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 to <1/10);

uncommon (≥1/1000 to <1/100);

rare (≥1/10000 to <1/1000);

very rare (<1/10000);

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

Skin prickling, skin induration, skin cracking, sensation of warmth, lamellar desquamation, focal desquamation, follicular eruption, erythema, telangiectasia.

When the drug is applied 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 adrenal cortex suppression, may also occur with topical application.

Shelf life. 4 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze.

Keep out of reach of children.

Packaging.

Cream 0.64 mg/g, 15 g cream in a tube, 1 tube in a carton.

Prescription status. Prescription only.

Manufacturer: JSC "Kyivmedpreparat".

Manufacturer’s location and address of business activity:

139 Saksaganskogo Street, Kyiv, 01032, Ukraine.