Beloderm

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT BЕLODERM (BELODERM®)

Composition:

Active substance: betamethasone dipropionate;

1 g of the solution contains 0.640 mg of betamethasone in the form of dipropionate, equivalent to 0.500 mg of betamethasone;

Excipients: isopropyl alcohol, carbomer 934P, sodium hydroxide, purified water.

Pharmaceutical form. 0.05% spray.

Main physicochemical characteristics: colorless, from clear to slightly opalescent, viscous solution with the odor of isopropanol.

Pharmacotherapeutic group.

Corticosteroids for dermatological use. Potent corticosteroids (Group III).

ATC code: D07AC01.

Pharmacological Properties.

Pharmacodynamics.

Betamethasone, a synthetic glucocorticoid for topical use, exhibits high glucocorticoid activity and minimal mineralocorticoid effect. It exerts a potent anti-inflammatory, antipruritic, and vasoconstrictive action. Therefore, it is used for the treatment of dermatoses sensitive to corticosteroid therapy.

Pharmacokinetics.

When applied topically, betamethasone may be minimally absorbed through intact, undamaged skin. Systemic absorption of corticosteroids is expected only under unfavorable conditions (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, are mainly metabolized in the liver, and excreted in the urine.

Some topical corticosteroids and their metabolites are excreted in bile.

Clinical characteristics.

Indications.

Local treatment of dermatoses sensitive to glucocorticosteroid therapy.

Contraindications.

Hypersensitivity to betamethasone or to other corticosteroids, or to any of the excipients. Viral infections, including postvaccinal reactions and varicella; viral skin infections (e.g., herpes simplex, herpes zoster, varicella); acne; rosacea; rosacea-like (perioral) dermatitis; bacterial dermatoses, including tuberculosis and syphilis of the skin; fungal infections; ophthalmological diseases (Beloderm is not intended for ophthalmic use). Do not use under occlusive dressings (casts). Particular caution should be exercised when applying Beloderm to facial skin. Avoid contact with eyes or mucous membranes. Do not use during pregnancy. Prolonged treatment and/or application over large skin areas should be avoided, as systemic absorption of the active ingredient may occur.

Interaction with other medicinal products and other forms of interactions.

Not established.

Special precautions for use

Beloderm is generally well tolerated; however, treatment should be discontinued if irritation or hypersensitivity occurs. If signs of hypersensitivity or skin irritation develop, the medication should be stopped immediately and appropriate therapy should be initiated. In the presence of infection, appropriate antifungal or antibacterial agents should be prescribed. If the desired effect is not rapidly achieved, corticosteroid therapy should be discontinued until signs of infection have resolved.

Beloderm is not intended for ophthalmic use. When the medication is applied to the skin near the eyes, care must be taken to avoid contact with the eyes, due to the potential risk of developing cataracts or glaucoma. In patients with facial skin lesions, the treatment course should not exceed 5 days.

Systemic absorption of topical corticosteroids generally increases with higher corticosteroid potency, longer duration of treatment, and larger treated body surface area. Therefore, potent corticosteroids applied to large skin areas should be used under careful and periodic monitoring, as they may suppress the hypothalamic-pituitary-adrenal (HPA) axis. If HPA axis suppression develops, the medication should be withdrawn, 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, which may require the addition of systemic corticosteroid therapy.

Do not apply the solution to eroded, exuding areas, skin fissures (abrasions), or ulcers. Prolonged use of the drug (more than 3–4 weeks) and high dosages (application over large areas) should be avoided.

Use of both systemic and topical corticosteroids may lead to visual disturbances.

If symptoms such as blurred vision or other visual disturbances occur, patients should consult an ophthalmologist to evaluate possible causes, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, which has been reported with both systemic and topical corticosteroid use.

Use during pregnancy or breastfeeding

There are no clinical studies on the topical use of corticosteroids in pregnant women. Topical corticosteroid therapy in pregnant women is not recommended (especially during the first trimester), except when the expected benefit outweighs the potential risk to the fetus.

It is currently unknown whether topical corticosteroids can pass into breast milk following systemic absorption. Therefore, when deciding whether to discontinue breastfeeding or discontinue the drug, the importance of the therapy to the mother and the potential risk to the infant should be carefully considered.

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.

Beloderm, topical spray, should be applied twice daily at a distance of approximately 5 cm, using one to two actuations, sprayed onto the affected area of skin or scalp, and thoroughly rubbed in. The volume of solution released per single actuation is 0.1 ml.

In treating some patients, less frequent application may be sufficient to maintain therapeutic effect.

The recommended duration of treatment should not exceed two weeks. The maximum weekly dose is 50 ml.

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

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

Careful monitoring for signs of systemic drug effects is necessary.

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

In dermatoses associated with bacterial infection, targeted antibacterial therapy should be administered. Patients with fungal dermatoses require specific treatment.

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 drug in children; therefore, its use in this age group is not recommended. It is not recommended for use in children under 12 years of age.

Since children have a larger surface area to body weight ratio compared to adults and exhibit more active absorption of the drug, they are more susceptible to 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 hypercorticism, including Cushing's syndrome. Acute symptoms of hypercorticism are usually reversible.

In case of overdose, appropriate symptomatic treatment is indicated. Electrolyte balance should be corrected if necessary. In cases of chronic toxic effects, gradual withdrawal of the corticosteroid is recommended.

Adverse Reactions

Frequency of adverse effects:

very common (≥1/10);
common (≥1/100 to <1/10);
uncommon (≥1/1,000 to <1/100);
rare (≥1/10,000 to <1/1,000);
very rare (≥1/10,000);
frequency not known (cannot be estimated from available data).

Skin and subcutaneous tissue disorders

Common – burning, itching, irritation, dry skin, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, steroid-induced acne, rosacea-like (perioral) dermatitis, skin stinging, skin induration, skin cracking, sensation of warmth, lamellar desquamation, focal desquamation, follicular eruptions, erythema, telangiectasia, skin maceration, skin atrophy, striae, allergic contact dermatitis.

Infections and infestations

Common – secondary infection, particularly under occlusive dressing.

Endocrine system disorders

Rare – adrenal cortex insufficiency.

Hypersensitivity reactions may occur in patients with individual intolerance to any component of the medicinal product.

When the medicinal product is applied over large areas or under occlusive dressing, especially for prolonged periods, systemic effects should be considered as possible.

Any adverse effects observed with systemic administration of glucocorticoids, including suppression of the adrenal cortex, may also occur with topical application of glucocorticoids.

Cases of visual disturbances have been reported with systemic use of glucocorticosteroids (frequency not known).

Shelf life

2 years.

Storage conditions

Store at a temperature not exceeding 25 °C.
Keep out of reach and sight of children.

Packaging

20 ml or 50 ml in a bottle with a mechanical pump spray. One bottle per cardboard box.

Prescription status

Prescription only.

Manufacturer

Belupo, lijekovi i kozmetika, d.d.

Manufacturer's address and place of business

Danica Street 5, 48000 Koprivnica, Croatia.