Betasal (Ointment) Instructions for Use

Marketing Authorization Holder

Bosnalijek, JSC (Bosnia And Herzegovina)

ATC Code

D07XC01 (Betamethasone in combination with other drugs)

Active Substances

Salicylic acid (USP)

Betamethasone (Rec.INN)

Dosage Form

Betasal

Ointment for external use 500 mcg+30 mg/1 g: tube 30 g

Dosage Form, Packaging, and Composition

Ointment for external use white, semi-transparent, homogeneous.

Excipients: white petrolatum, liquid paraffin.

30 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with anti-inflammatory and keratolytic action for external use

Pharmacotherapeutic Group

Topical glucocorticosteroid + keratolytic agent

Pharmacological Action

A combined drug with local anti-inflammatory, antiallergic, antiproliferative, antiseptic, and keratolytic action.

Betamethasone is a glucocorticoid that has anti-inflammatory, antiallergic, anti-exudative, anti-edematous, and antipruritic effects.

It prevents or reduces the development of a local inflammatory reaction, inhibits the accumulation of leukocytes, the release of lysosomal enzymes and inflammatory mediators at the site of inflammation, suppresses phagocytosis, reduces vascular-tissue permeability, and prevents the formation of inflammatory edema.

Salicylic acid, due to its keratolytic action, softens the skin and eliminates horny layers; promotes deeper penetration of betamethasone into the skin, stabilizes the physiological acidity of the skin, preventing the development of bacterial and fungal infections.

Pharmacokinetics

Betamethasone easily penetrates the skin through the stratum corneum. It does not undergo biotransformation in the skin and penetrates through it into the body.

The absorption of betamethasone through the skin increases when applied to delicate skin in the fold areas, when applied to skin with damaged epidermis or skin damaged by an inflammatory process. Furthermore, absorption increases with frequent application of the drug or after application to a large body surface area.

Betamethasone is biotransformed mainly in the liver. Betamethasone is excreted primarily by the kidneys and to a lesser extent in bile, mainly as glucuronic acid conjugates and in small amounts unchanged.

Indications

• Subacute and chronic dermatoses sensitive to local glucocorticoid therapy, accompanied by hyperkeratosis and scaling;
• Psoriasis;
• Acute and chronic eczema;
• Neurodermatitis;
• Lichen planus;
• Atopic dermatitis;
• Dyshidrosis;
• Seborrheic dermatitis of the scalp;
• Ichthyosis and ichthyosiform changes.

ICD codes

Dosage Regimen

Externally. Betasal is applied in a thin layer to the affected area of the skin, rubbing gently, 2 times/day – in the morning and in the evening.

In mild cases, the ointment is usually sufficient to apply once a day; for more severe lesions, more frequent application may be necessary. A different frequency of application may be established by the doctor, based on the severity of the disease.

Adverse Reactions

With topical application of glucocorticosteroids, the following may occur: burning, irritation, dry skin, skin itching, folliculitis, acne-like eruptions, hypopigmentation, allergic contact dermatitis, hypertrichosis.

With long-term use, as well as the use of occlusive dressings – skin maceration, secondary infection, skin atrophy, miliaria, purpura.

When applied to large body surface areas, mainly in children, systemic side effects of glucocorticosteroids and salicylates may occur.

Contraindications

• Skin manifestations of syphilis;
• Chickenpox;
• Perioral dermatitis;
• Skin tuberculosis;
• Skin tumors;
• Skin post-vaccination reactions;
• Open wounds;
• Trophic ulcers due to chronic venous insufficiency;
• Rosacea;
• Acne vulgaris;
• Childhood (under 1 year);
• Hypersensitivity to any component of the drug.

With caution: hepatic insufficiency, long-term therapy, especially with the use of occlusive dressings, application to large areas of the skin.

Use in Pregnancy and Lactation

There is insufficient clinical experience with the use of the drug during pregnancy. The use of Betasal during pregnancy is possible only in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus.

In such cases, the use of the drug should be short-term and limited to small areas of the skin.

During lactation, the use of Betasal is possible for strict indications, but the issue of discontinuing breastfeeding should be considered.

Use in Hepatic Impairment

With caution: hepatic insufficiency.

Pediatric Use

For children from 1 year of age, the drug is prescribed only for strict indications and under medical supervision, as the development of systemic side effects associated with betamethasone is possible.

The drug is contraindicated in children under 1 year of age.

Special Precautions

The drug Betasal is intended for external use only. The drug is not intended for use in ophthalmology.

Avoid getting the drug into the eyes, do not apply to the skin near the eyes and on the mucous membranes.

If signs of hypersensitivity or skin irritation associated with the use of the drug are noted, treatment should be discontinued and adequate therapy should be selected for the patient.

For children from 1 year of age, the drug is prescribed only for strict indications and under medical supervision, as the development of systemic side effects associated with betamethasone is possible.

When applying the drug to large surfaces and/or under an occlusive dressing, suppression of the hypothalamic-pituitary-adrenal system function and the development of symptoms of hypercorticism are possible, decreased excretion of growth hormone, increased intracranial pressure may be observed.

With long-term use of the drug, its withdrawal should be carried out gradually.

Atrophic changes may appear on the facial skin more often than on other body surfaces after long-term treatment with topical glucocorticosteroids; the course of treatment in this case should not exceed 5 days.

Overdose

Acute overdose is unlikely. With long-term continuous use, chronic overdose is possible.

Symptoms: hyperglycemia, glucosuria, reversible suppression of the adrenal cortex, appearance of Cushing’s syndrome.

Treatment: gradual withdrawal of the drug and symptomatic therapy.

Drug Interactions

Increased irritation and dryness of the skin may occur with simultaneous use with resorcinol and tretinoin.

No cases of clinically significant interaction of the drug Betasal with other drugs have been described.

Storage Conditions

The drug should be stored at a temperature not exceeding 25°C (77°F), in a place inaccessible to children.

Shelf Life

Shelf life – 3 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.