Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BETAMETHASONE; FUSIDIC ACID
PHARMANIAGA MANUFACTURING BERHAD
BETAMETHASONE; FUSIDIC ACID
5 gm
PHARMANIAGA MANUFACTURING BERHAD
PHARMANIAGA GERMACORT CREAM Betamethasone/ Fusidic Acid (0.1% w/w/ 2%w/w) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Pharmaniaga Germacort Cream is used for 2. How Pharmaniaga Germacort Cream works 3. Before you use Pharmaniaga Germacort Cream 4. How to use Pharmaniaga Germacort Cream 5. While you are using it 6. Side effects 7. Storage and disposal of Pharmaniaga Germacort Cream 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT PHARMANIAGA GERMACORT CREAM IS USED FOR Pharmaniaga Germacort Cream is used to treat condition where the skin is inflamed e.g. eczema, discoid eczema (affected areas usually have a red well- defined edge with small blisters or scales on top of it), seborrhoeic dermatitis (skin inflammatory causes bad dandruff and rashes on the face), lichen simplex chronicus (thickened scaling skin as a result of repetitive scratching), psoriasis (immune- mediated disease that affects the skin), discoid lupus erythematosus (chronic dermatological disease that can lead to scarring, hair loss, and hyperpigmentation changes in skin) due to bacterial infection. HOW PHARMANIAGA GERMACORT CREAM WORKS Pharmaniaga Germacort Cream contains two different types of medicine. One medicine is called fusidic acid. It is an antibiotic medicine used to treat infections with bacteria. The other medicine is called betamethasone valerate. It is a type of corticosteroid (steroid). These two medicines work at the same time in different ways. Pharmaniaga Germacort Cream works by: • The antibiotic killing germs (bacteria) that cause infections. • It works by entering bacterial cells and interfere the production of proteins that the bacteria need to divide and multiply. It does not directly kill the bacteria but leaves them unable to increase in numbers. The bacteria eventually die or are destroyed by the immune system. • The betamethasone works by acting inside the cells to decrease the release of inflammatory substances. • The cortic Baca dokumen lengkap
PHARMACODYNAMICS PREGNANCY XXX XXXXXXXXXX Fusidic acid: No effects during pregnancy are anticipated, since systemic exposure to fusidic acid is negligible. Studies in animals have not shown teratogenic effects with fusidic acid. Limited studies in animals have shown negligible systemic absorption of topical fusidic acid. PHARMACOKINETICS pregnant women. Studies in animals have shown reproductive toxicity/foetal abnormalities. Germacort should not be used during pregnancy unless clearly necessary. LACTATION Germacort can be used during breast-feeding but should not be applied on the breasts to avoid accidental ingestion by the infant. 28th February 2019 30 Fusidic acid is potent topical antibacterial agent. Fusidic acid is very active against staphylococci, notably _S.aureus_ and _S.epidermis_. _Nocardia_ _osteroides_ and many clostridial strains are also highly susceptible. Most Gram-negative bacteria are intrinsically resistant but fusidic acid is active against _Neisseria spp._ and _Bacteroids fragilis._ It has some activity against strains of _Mycobacterium tuberculosis_ is highly active against _M. leprae._ Betamethasone valerate is an anti-inflammatory and anti-pruritic agent. Betamethasone valerate: There are no or limited amount of data from the use of topical betamethasone valerate in EFFECTS ON ABILITY TO DRIVE AND USE MACHINE Germacort cream has no or negligible influence on the ability to drive or to use machines. Baca dokumen lengkap