Properties
What is it?
Trade name: Novosalick International Nonproprietary Name: Betamethasone + Salicylic Acid Dosage form: Ointment for external use Composition: One gram contains: Betamethasone dipropionate, equivalent to betamethasone 0.5 mg; salicylic acid 30 mg. Pharmacotherapeutic group: Topical glucocorticosteroid + keratolytic agent ATC code: D07ХC01. Pharmacological properties: Combined preparation, whose action is determined by its components; has anti-inflammatory, anti-edema, anti-allergic, vasoconstrictive, antiproliferative, immunosuppressive, keratolytic, antimicrobial, antifungal, and local hypothermic effects. It inhibits the release of inflammatory mediators, prevents marginal accumulation of neutrophils, reduces inflammatory exudate and cytokine production, lowers macrophage migration, and leads to a reduction in infiltration and granulation processes. The presence of salicylic acid softens the skin, removes horny deposits, and promotes deeper penetration of GCS. The ointment has a water-repellent effect and forms a protective film that protects the skin from external moisture; it has a deep emollient action, making it more suitable for treating patients with dry and thin skin. Indications: - Psoriasis, eczema (especially chronic), ichthyosis, circumscribed lichen simplex with marked lichenification, atopic dermatitis, diffuse neurodermatitis; - Simple and allergic dermatitis; - Urticaria, erythema multiforme exudativum; - Simple chronic lichen (organic neurodermatitis); - Dermatoses not amenable to treatment with other GCS (especially red pityriasis lichenoides), lichen planus, dyshidrosis of the skin. Contraindications: Hypersensitivity to betamethasone, salicylic acid, or any excipient of the preparation. Tuberculosis of the skin, cutaneous manifestations of syphilis, chickenpox, viral infections of the skin, post-vaccination skin reactions, open wounds, trophic ulcers, rosacea, acne vulgaris, children under 6 months of age. Pregnancy and lactation: In pregnant women, topical use of Novosalick is permissible when the potential benefit to the mother outweighs the risk to the fetus. In such cases, the preparation should be used for a short duration and limited to small areas of the skin. During lactation, Novosalick can be used under strict indications, but the preparation should not be applied to the skin of the mammary gland before feeding the baby. Dosage and administration: For external use only. Novosalick ointment for external use is intended for application on smooth skin. Novosalick ointment is applied twice a day. A small amount of ointment is evenly distributed over the skin surface and gently rubbed in. In mild cases, once daily application is sufficient. The duration of continuous treatment is usually limited to 3-4 weeks. If longer therapy is necessary, it is recommended to use the preparation less frequently, e.g., every other day. For the treatment of chronic diseases, it is necessary to continue treatment for some time after the disappearance of all symptoms, under the supervision of a doctor, to prevent recurrence of the disease. Therapy can be repeated several times a year. Side effects: Side effects are usually mild. Hypersensitivity reactions (itching, burning, or redness) may develop. Rarely, as with other glucocorticosteroids, acne-like changes, hypopigmentation, striae, skin atrophy, hypertrichosis, telangiectasias, secondary skin infections may develop. Prolonged, continuous use of betamethasone over large areas of skin may cause systemic side effects associated with suppression of adrenal cortex function. In case of hypersensitivity reactions or side effects, discontinue therapy and consult a doctor. Overdose: With prolonged and continuous use of the combination of betamethasone and salicylic acid, especially in children, on large skin surfaces, on damaged skin, or under occlusive dressings, enhanced absorption of active components and systemic effects cannot be ruled out. In this case, discontinuation of the preparation and symptomatic therapy are recommended. Use in pediatrics: The use of Novosalick (ointment for external use) in children should be as short as possible, with strict adherence to precautions, as there is a risk of proportionally large systemic absorption of active substances in children due to the excess of skin surface area relative to body mass and insufficient epidermal maturity. In children, the preparation should not be used under dressings, especially under plastic diapers, which can increase the risk of adverse events. Interactions with other drugs: No clinically significant interactions with other drugs have been identified. Simultaneous use of cosmetic and dermatological products for acne therapy, products containing ethanol or strongly drying medical soaps, etc., may in some cases cause skin irritation. Special instructions: Novosalick ointment is intended for external use on the skin and/or scalp only. Avoid contact with eyes and mucous membranes. Prolonged use of the ointment on facial skin is not recommended due to the risk of developing dermatitis of the rosacea type, perioral dermatitis, skin atrophy, and acne. Avoid using the preparation in the anogenital area. It is not recommended to use the preparation under occlusive dressings, except when necessary. If fungal or bacterial microflora develops on the skin, additional antibacterial or antifungal agents must be used. Effect on ability to drive and operate machinery: No data on the adverse effects of Novosalick on the ability to drive and operate machinery are available. Form of release: Ointment for external use in a 30 g tube. One tube with instructions for use is placed in a cardboard box. Storage conditions: Store in a dry, protected from light place, at a temperature not exceeding 25°C. Keep out of reach of children! Do not freeze. Shelf life: Indicated on the packaging. Do not use after the expiry date. Dispensing conditions: Available without a prescription. Trademark and registration certificate holder: VEGAPHARM LLP., London, Great Britain. Manufactured by: Replex Pharm Ltd., Skopje, Republic of Macedonia.