Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLOBETASONE BUTYRATE
HOE PHARMACEUTICALS SDN. BHD.
CLOBETASONE BUTYRATE
100 gm; 15 gm
HOE PHARMACEUTICALS SDN. BHD.
Please refer to section E12 Baca dokumen lengkap
U-CLOSONE CREAM & OINTMENT Est. 1979 NAME AND STRENGTH OF ACTIVE SUBSTANCE: Clobetasone Butyrate 0.05% w/w. PRODUCT DESCRIPTION: Cream: A white cream. Ointment: White ointment. Other ingredients for cream are Sodium Citrate. Chlorocresol, Glyceryl Monostearate, Glycerin, Cetostearyl Alcohol, Glyceryl Monostearate (and) PEG-100 Stearate, Dimethicone and Purified Water. Other ingredients for ointment are Liquid Paraffin and White Soft Paraffin. PHARMACODYNAMICS: Clobetasone Butyrate is a topically active fluorinated corticosteroid which has anti-inflammatory, anti-pruritic and vasoconstrictive actions. PHARMACOKINETICS: Topical corticosteroids have anti-inflammatory, anti-pruritic and vasoconstrictive actions. When administered topically, particularly under occlusive dressings or when the skin is broken, sufficient corticosteroid may be absorbed to give systemic effects. Corticosteroids are extensively bound to plasmaproteins. Only unbound corticosteroids have pharmacological effects or are metabolised. They are metabolised mainly in the liver, also in the kidney, and are excreted in the urine. INDICATIONS: All types of eczema and dermatitis, including atopic eczema, photodermatitis, otitis externa, primary irritant and allergic dermatitis, prurigo nodularis, seborrhoeic dermatitis and insect bite reactions. Maintenance between courses of more potent topical steroids in more resistant dermatoses. CONTRAINDICATIONS: Hypersensitivity to Clobetasone Butyrate, to other corticosteroids or to any ingredient in this preparation, rosacea, acne vulgaris, peri-oral dermatitis, primary cutaneous viral infections (eg. herpessimplex, chicken pox). The use of U-Closone is not indicated in the treatment of primarily infected skin lesions caused by infection with fungi or yeasts (eg. candidiasis, tinea), or bacteria (eg. impetigo), peri-anal and genital pruritus. DRUG INTERACTIONS: Unknown. ADVERSE EFFECTS: Reported local adverse reactions are burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions Baca dokumen lengkap