Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Lennon
LENOVATE OINTMENT LENOVATE CREAM SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): LENOVATE OINTMENT LENOVATE CREAM COMPOSITION Each 5 g ointment contains betamethasone valerate equivalent to 5 mg betamethasone . Each 5 g cream contains betamethasone valerate equivalent of 5 mg betamethasone. Lenovate cream is preserved with 0,1% m/m chlorocresol. PHARMACOLOGICAL CLASSIFICATION: A 13.4.1 Corticosteroids with or without anti-infective agents. PHARMACOLOGICAL ACTION: Betamethasone valerate is a potent topical corticosteroid which exhibits anti-inflammatory and anti-allergic properties when applied to the skin and mucosa. The mechanism of action is related to causing vasoconstriction, stabilizing lysosomal membranes, suppressing cell division and suppressing the immune response. INDICATIONS: Non-infected steroid responsive dermatoses. CONTRA-INDICATIONS: Betamethasone valerate 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. 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, Lenovate should not be used during pregnancy. WARNING: FOR EXTERNAL USE ONLY. KEEP OUT OF REACH OF CHILDREN. DOSAGE AND DIRECTIONS FOR USE: Lenovate Ointment: Apply to the affected areas 2 or 3 times daily by gentle inunction or use with occlusive dressings. Lenovate Cream: Apply to the affected areas 2 to 3 times daily by gently 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 vess Read the complete document