Страна: ЮАР
Язык: английский
Источник: South African Health Products Regulatory Authority (SAHPRA)
Lennon
CORTODERM® OINTMENT CORTODERM® CREAM SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): CORTODERM ® OINTMENT CORTODERM ® CREAM COMPOSITION: Each 5 g ointment contains 1,25 mg fluocinolone acetonide. Each 5 g cream contains 1,25 mg fluocinolone acetonide. Cortoderm Cream is preserved with 0,1% m/m chlorocresol. PHARMACOLOGICAL CLASSIFICATION: A 13.4.1 Corticosteroids with or without anti-infective agents. PHARMACOLOGICAL ACTION: Fluocinolone acetonide is a potent topical corticosteroid which exhibits anti-inflammatory, vasoconstrictive, anti- pruritic and anti-allergic properties when applied locally to the skin and mucosa. INDICATIONS: Steroid responsive dermatoses. CONTRA-INDICATIONS: Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously teratogenicity following topical application cannot be excluded. Therefore Cortoderm should not be used during pregnancy. Cortoderm is contra-indicated in the treatment of herpes simplex, vaccinia or varicella. Long- term use is contra-indicated in patients with diabetes mellitus or tuberculosis. Cortoderm should not be used on infants and young children. WARNING: FOR EXTERNAL USE ONLY. KEEP OUT OF REACH OF CHILDREN. DOSAGE AND DIRECTIONS FOR USE: Cortoderm Ointment: Apply to the affected areas 2 to 3 times daily by gentle inunction or use with occlusive dressings. Cortoderm Cream: Apply to the affected areas 2 to 3 times daily by gentle inunction. SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Local effects include atrophy of the epidermis and dermal collagen (causing atrophic striae), drying and thinning of the skin, loss of elasticity, dilatation of superficial blood vessels, telangiectasiae and ecchymoses. Increased fragility of cutaneous vessels may result in bruising and purpura. Прочитать полный документ