Country: Armenia
Bahasa: Inggeris
Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
betamethasone (betamethasone dipropionate), salicylic acid
Arpimed LLC
D07XC01
betamethasone (betamethasone dipropionate), salicylic acid
0,5mg/g+ 30mg/g
ointment for topical use
15g aluminium tube
Prescription
Registered
2018-10-09
SUMMARY PRODUCT CHARACTERISTIC (SPC) BETACID ® OINTMENT 1.1 BRAND NAME – BETACID 1.2 INTERNATIONAL NON-PROPERTY NAME – - BETAMETHASONE / SALICYLIC ACID 2. QUALITATIVE AND QUANTITATIVE COMPOSITION EACH GRAM CONTAINS: _ACTIVE INGREDIENTS: _betamethasone - 0.5 mg (as dipropionate), salicylic acid - 30 mg; _ _ _FOR A FULL LIST OF EXCIPIENTS, SEE SECTION 6.1 _ 3. PHARMACEUTICAL FORM White to yellowish white odorless ointment. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Betamethasone Dipropionate is a synthetic fluorinated corticosteroid. It is active topically and produces a rapid and sustained response in those inflammatory dermatoses that are normally responsive to topical corticosteroid therapy, and it is also effective in the less responsive conditions, such as psoriasis of the scalp, chronic plaque psoriasis of the hands and feet, but excluding widespread plaque psoriasis. Topical salicylic acid softens keratin, loosens cornified epithelium and desquamates the epidermis. Betacid presentations are therefore indicated for the treatment of hyperkeratotic and dry corticosteroid-responsive dermatoses where the cornified epithelium may resist penetration of the steroid. The salicylic acid constituent of Betacid preparations, as a result of its descaling action, allows access of the dermis more rapidly than by applying steroid alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Once to twice daily. In most cases a thin film should be applied to cover the affected area twice daily. For some patients adequate maintenance therapy may be achieved with less frequent application. It is recommended that Betacid preparations are prescribed for two weeks, and that treatment is reviewed at that time. The maximum weekly dose should not exceed 60g. Children: Dosage in children should be limited to 5 days. 4.3 CONTRAINDICATIONS Rosacea, acne, perioral dermatitis, perianal and genital pruritus. Hypersensitivity to any of the ingredients of the Betacid presentations contra-indicates their use as does tuberculous and Baca dokumen lengkap