Beloderm

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BELADERM (BELODERM®)

Composition:

Active substance: betamethasone;

1 g of cream contains 0.640 mg of betamethasone dipropionate, equivalent to 0.500 mg of betamethasone;

Excipients: mineral oil, white soft paraffin, macrogol cetylstearyl ether, chlorocresol, sodium dihydrogen phosphate monohydrate, cetylstearyl alcohol, phosphoric acid, sodium hydroxide, purified water.

Pharmaceutical form. Topical cream.

Main physico-chemical characteristics: white homogeneous cream, free from mechanical inclusions.

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 produces only minimal mineralocorticoid effect. It exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. Therefore, it is used for the treatment of dermatoses responsive to corticosteroids.

Pharmacokinetics.

When applied topically, betamethasone is minimally absorbed through intact, normal 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.

Treatment of dermatoses sensitive to potent glucocorticosteroid therapy, such as psoriasis; initial treatment of severe atopic eczema.

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

Due to the presence of white soft paraffin and mineral oil as excipients, treatment with this product in the anogenital area may damage the structure of latex condoms and reduce their safety during use while undergoing treatment.

Special precautions for use.

Beloderm, cream, is generally well tolerated; however, treatment should be discontinued if irritation or hypersensitivity occurs. If a hypersensitivity reaction or skin irritation develops, application of the medicinal product must be stopped immediately and appropriate therapy should be initiated for the patient. In the presence of infection or fungal skin lesions, appropriate antifungal or antibacterial agents should be prescribed. If the desired effect is not rapidly achieved under these conditions, corticosteroid use should be discontinued until signs of infection have resolved.

Beloderm, cream, is not intended for ophthalmic use. Avoid contact of the preparation with mucous membranes. Beloderm must not be applied to the eyes or periorbital area due to the risk of developing cataracts, glaucoma, fungal eye infections, or herpes simplex exacerbation.

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 over large skin areas should be used under careful and periodic monitoring, as they may suppress the hypothalamic-pituitary-adrenal (HPA) axis. If suppression occurs, the medicinal product 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.

Local and systemic toxicity may occur, especially after prolonged use of betamethasone on large skin areas, damaged skin, skin folds, or under occlusive dressings. Certain body areas, such as the groin, axillae, and perianal region, where natural occlusion exists, are more susceptible to the development of striae during betamethasone therapy. Application to these areas should be strictly limited.

Prolonged use of the cream on the face is not recommended due to the possible development of rosacea-like dermatitis, perioral dermatitis, and acne.

Do not use in the treatment of leg varicose ulcers (trophic dermatomycoses).

The use of topical corticosteroids may be hazardous in psoriasis for several reasons, including the risk of relapses due to development of tolerance, the risk of generalized pustular psoriasis, and local or systemic toxicity resulting from impaired barrier function.

Use of 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, which may include cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, which has been reported with the use of systemic and topical corticosteroids.

Use during pregnancy or breastfeeding.

The drug should not be used during the first trimester of pregnancy, as the safety of topical corticosteroids in pregnant women has not been established. These drugs may be used only in later stages of pregnancy and only if the expected benefit to the mother clearly outweighs the potential risk to the fetus. Medicinal products of this group should not be applied over large skin areas, in large quantities, for prolonged periods, or under occlusive dressings during pregnancy.

It is currently unknown whether topical corticosteroids can pass into breast milk following systemic absorption. Therefore, when deciding whether to discontinue breastfeeding or discontinue drug use, the importance of the treatment for the mother must be taken into account.

Ability to influence reaction speed while driving or operating machinery.

The product generally does not affect the patient's reaction speed while driving or operating machinery.

Method of Administration and Dosage

Beloderm cream should be applied as a thin layer to the affected skin area 1–2 times daily, depending on the severity of the condition.

Method of Administration

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

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

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

A so-called tandem therapy approach is often recommended, involving once-daily application of Beloderm, followed 12 hours later by a suitable topical preparation that does not contain an active ingredient.

Intermittent therapy may also be appropriate, consisting of alternating application of Beloderm cream and a non-active topical preparation throughout the week.

Close monitoring for signs and symptoms of systemic drug effects is necessary.

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

Beloderm cream is the preferred dosage form for dry, scaly, and thickened skin in chronic and subacute stages of 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 drug's adverse effects.

Children

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

Because children have a higher surface-area-to-body-weight ratio than adults and exhibit increased drug absorption, they are more susceptible to hypothalamic-pituitary-adrenal (HPA) axis suppression and the 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. If necessary, correction of electrolyte imbalance should be performed. 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 (≥1/1000 to <1/100);

rare (≥1/10000 to <1/1000);

very rare (≥1/10000);

frequency unknown (frequency cannot be determined from available data).

Skin prickling, skin induration, skin cracking, sensation of warmth, lamellar desquamation, focal skin desquamation, follicular eruptions, erythema, telangiectasias, ecchymoses, allergic contact dermatitis, skin hyperpigmentation, hair depigmentation.

When the drug is applied over large areas or under occlusive dressing, especially for 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 effects observed with systemic administration of glucocorticoids, including suppression of the adrenal cortex, may also occur with topical application of glucocorticoids.

Cases of visual clouding have been reported with systemic use of glucocorticosteroids (frequency unknown).

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

Shelf life.

4 years.

Storage conditions.

Store at a temperature not exceeding 25 °C.
Keep out of reach of children. Do not freeze.

Packaging.

15 or 30 g in a tube; 1 tube 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.