Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BETAMETHASONE VALERATE; FUSIDIC ACID
HOVID BERHAD
BETAMETHASONE VALERATE; FUSIDIC ACID
15gm mcg/mL
HOVID BERHAD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ DISUF-B CREAM Fusidic Acid / Betamethasone valerate (2.0% w/w / 0.1% w/w) 1 WHAT IS IN THIS LEAFLET 1. What Disuf-B Cream is used for 2. How Disuf-B Cream works 3. Before you use Disuf-B Cream 4. How to use Disuf-B Cream 5. While you are using it 6. Side effects 7. Storage and Disposal of Disuf- B Cream 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT DISUF-B CREAM IS USED FOR Disuf-B Cream is used to treat bacterial skin infection and inflammation. HOW DISUF-B CREAM WORKS Disuf-B Cream contains two active ingredients which are fusidic acid, an antibiotic and betamethasone valerate from steroid group. Fusidic acid works by killing the bacteria that cause infections and betamethasone help to reduce any swelling, redness or itchiness of your skin. BEFORE YOU USE DISUF-B CREAM _-_ _ _ _ When you must not use it _ Do not use this medicine if: • You are allergic (hypersensitive) to fusidic acid or betamethasone valerate or any other ingredients of this medicine (listed in Product Description). • You have red spotty rash around your mouth or chin. • You have viral or fungal skin infection. • You have acne-like breakouts on face. • You have tuberculosis of the skin (skin infection). • You have skin ulceration. _-_ _ _ _Before you start to use it _ _Pregnancy and lactation _ • Please consult your doctor or pharmacist if you are pregnant, planning for pregnancy or breast-feeding before using any medicine. • Disuf-B must only be used during pregnancy if the benefits is more than the risks to the fetus. However, topical steroid should not be used extensively in pregnancy. _-_ _ _ _Taking other medicines _ • Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. HOW TO USE DISUF-B CREAM _-_ _ _ _How much to use _ • Wash your hands before and after using this cream • Apply sparingly to the affe Baca dokumen lengkap
DESCRIPTION White, opaque cream COMPOSITION Fusidic Acid (Micronised) 2.0% w/w Betamethasone valerate equivalent to Betamethasone 0.1% w/w ACTIONS AND PHARMACOLOGY Fusidic acid is an antibiotic with a bacteriostatic or bactericidal activity, mainly against Gram positive bacteria. Fusidic acid inhibits bacterial protein synthesis although, in contrast to drugs such as the macrolides or tetracyclines, it does not bind to the bacterial ribosomes, but inhibits a factor necessary for translocation of peptide subunits and elongation of the peptide chain. Betamethasone valerate is a topical steroid with rapid effect in inflammatory dermatoses. Even refractory conditions can often be treated successfully. PHARMACOKINETICS _In vitro_ studies show that fusidic acid can penetrate intact human skin. The degree of penetration depends on factors such as the duration of exposure to fusidic acid and the condition of the skin. Betamethasone can be absorbed when given locally. INDICATIONS Disuf-B Cream is indicated in inflammatory dermatoses where bacterial infection is present or likely to occur. Inflammatory dermatoses include atopic eczema, discoid eczema, stasis eczema, seborrhoeic dermatitis, contact dermatitis, lichen simplex chronicus, psoriasis, discoid lupus erythematosus. CONTRAINDICATIONS • Topical corticosteroids are contraindicated in viral, tuberculous and fungal skin infections, perioral dermatitis, acne rosacea and ulcerative condition. • Patients with hypersensitivity to any of the ingredients. WARNING / PRECAUTIONS • Long term continuous should be avoided. • Caution should be exercised when the product is used near the eye, since topical steroid may cause glaucoma if the preparation gets into the eye. • Steroid antibiotic combination should not be used for more than 7 days in the absence of any clinical improvement. PREGNANCY AND LACTATION Topical steroids should not be used extensively in pregnancy as fetal abnormalities have been observed in animals due to systemic absorption. DISUF-B CREAM 523 FRONT Baca dokumen lengkap