Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Hydrocortisone Acetate (Micronised); Fusidic Acid (Micronised)
Noripharma Sdn. Bhd.
Hydrocortisone Acetate (Micronised); Fusidic Acid (Micronised)
15 gm; 5 gm
Noripharma Sdn. Bhd.
_Consumer Medication Information Leaflet (RiMUP)_ FUSATE H CREAM Fusidic acid 20mg and Hydrocortisone acetate 10mg 1 | P a g e WHAT IS IN THIS LEAFLET 1. What FUSATE H CREAM used for 2. How FUSATE H CREAM works 3. Before you use FUSATE H CREAM How to use Ferrous Fumarate 4. While you are using it 5. Side effects 6. Storage and Disposal of FUSATE H CREAM 7. Product Description 8. Manufacturer and Product Registration Holder 9. Date of Revision. WHAT FUSATE H CREAM USED FOR FUSATE H CREAM combines the antibacterial action of fusidic acid (antibiotic) with the anti-inflammatory effect of hydrocortisone acetate (corticoid). It is used for the topical treatment of infected atopic dermatitis (commonly known as eczema, a skin disease accompanied by inflammation, reddening, exudation or scabs and itching, frequently of an allergic origin). Because of its hydrocortisone content, Fusate-H Cream is particularly appropriate in cases where a milder corticosteroid (a group of steroid hormones that are produced in the adrenal cortex of vertebrates, and the synthetic substances with like properties. )it is indicated, including milder inflammatory dermatoses on the face and children`s skin. Fusate- H Cream is cosmetically acceptable for use on the face and hands and convenient for use in the line of join,and armpits area. HOW FUSATE H CREAM WORKS The Fusidic acid killing germs (bacteria) mainly gram positive organisms that causes infections. The corticosteroid reducing any swelling, redness or itchiness of your skin. It is used to treat Conditions where the skin is inflamed (eczema or dermatitis) and infected, or might become infected, by germs (bacteria). BEFORE YOU USE FUSATE H CREAM _When you must not use it_ -if you are allergic (Hypersensitive) to fusidic acid/sodium fusidate or hydrocortisone acetate AS THIS MEDICINE CONTAINS A STEROID DO NOT USE • To treat skin infections caused by a fungus, such as athlete’s foot or ringworm. • To treat skin conditions caused by a virus, such as cold sores or chicken pox. • To tre Read the complete document
FUSATE H CREAM COMPOSITION: Each gram of cream contains: Fusidic acid 20mg or 2.0% w/w Hydrocortisone Acetate 10mg or 10.0% w/w Preservative: Potassium sorbate 2.7mg or 0.27% w/w DESCRIPTION : A white to off white, smooth cream. PHARMACODYNAMIC: Hydrocortisone is a corticosteroid that has anti-inflammatory, antipruritic and vasoconstrictive effects. Fusidic acid has antibacterial action that results from the inhibition of bacterial protein synthesis; it is mainly active towards the gram- positive organisms especially _Staph aureus_. FUSATE H CREAM combines the potent antibacterial action of fusidic acid with the anti-inflammatory effect of hydrocortisone acetate. FUSATE H CREAM s effective against staphylococci, streptococci, corynebacteria, Neisseria and certain Clostridia and Bacteroides when topically applied. PHARMACOKINETIC 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. Fusidic acid is excreted mainly in the bile with little excreted in the urine. Hydrocortisone is absorbed following topical administration. The degree of absorption is dependent on various factors including skin condition and site of application. Absorbed hydrocortisone is extensively metabolised and rapidly eliminated in the urine. INDICATION: Indicated for the treatment of dermatitis, including atopic dermatitis and contact dermatitis, where infection with bacteria sensitive to fusidic acid is suspected or confirmed. Because of its hydrocortisone content, Fusate-H Cream is particularly appropriate in cases where a milder corticosteroid is indicated, including milder inflammatory dermatoses on the face and children`s skin. Fusate-H Cream is cosmetically acceptable for use on the face and hands and convenient for use in the groin area and armpits. RECOMMENDED DOSAGE: Fusate-H Cream should be applied 2-3 times daily on uncovered lesions. For covered lesions, less frequent application may be adequate. CONTRAINDICATION: Hyp Read the complete document