Χώρα: Μαλαισία
Γλώσσα: Αγγλικά
Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BETAMETHASONE; NEOMYCIN SULPHATE
HOVID BERHAD
BETAMETHASONE; NEOMYCIN SULPHATE
15 gm mcg/mL
HOVID BERHAD
Consumer Medication Information Leaflet (RiMUP) NEO BETASONE CREAM (Betamethasone (as 17-valerate) 0.1% w/w, Neomycin (as Sulphate) 0.5% w/w) 1 WHAT IS IN THIS LEAFLET 1. What Neo Betasone Cream is used for 2. How Neo Betasone Cream works 3. Before you use Neo Betasone Cream 4. How to use Neo Betasone Cream 5. While you are using Neo Betasone Cream 6. Side effects 7. Storage and disposal of Neo Betasone Cream 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT NEO BETASONE CREAM IS USED FOR Neo Betasone is useful in treating infective acute or chronic inflammatory dermatoses such as: Localized neurodermatitis (itchy patch of skin) Psoriasis (raised, red, scaly patches to appear on the skin) Atopic or seborrheoic dermatitis (dry, itchy rash skin) Inflammatory phase of xerosis (dry skin) Anogenital pruritus (itching, acute or chronic, affecting the anal, perianal, perineal and genital skin) Discoid lupus erythematosus (recurring scaly rash) Lichen planus (chronic itchy skin of unknown origin) Granuloma annulare (raised reddish or skin-colored bumps (lesions) in a ring pattern) Psoriatic plaques (dry, raised, red skin lesions) Allergic contact dermatitis or irritant dermatitis HOW NEO BETASONE WORKS This cream contains topical corticosteroids. Topical corticosteroids are used to help reduce inflammation in the affected area which helps to reduce redness and itchiness caused by the skin disease. It also contains other ingredient to help prevent or clear up some bacterial infections of the skin. BEFORE YOU USE NEO BETASONE_ _ _ _ _When you must not use it _ Do not use if you are allergic to corticosteroids, neomycin or any other ingredients contained in this medicine as listed at the end of this leaflet. Do not use on deep or puncture wounds, serious burns or raw areas unless directed by your doctor. If you are not sure whether you should start using this medicine, talk to your doctor or pharmacist. _Before you start Διαβάστε το πλήρες έγγραφο
DESCRIPTION White opaque cream. COMPOSITION Betamethasone (as 17-valerate) 0.1% w/w Neomycin Sulphate 0.5% w/w ACTIONS AND PHARMACOLOGY • PHARMACODYNAMICS - _BETAMETHASONE - 17 - VALERATE:_ Betamethasone - 17- valerate is a corticosteroid. Its action is similar to that of cortisone. Betamethasone diffuse across cell membranes and complex with specific cytoplasmic receptors. These complexes then enter the cell nucleus, bind to DNA (chromatin) and stimulate transcription of messenger RNA (mRNA) and subsequent protein synthesis of various enzymes thought to be ultimately responsible for anti-inflammatory effects of tropical application of betamethasone. - _NEOMYCIN:_ Neomycin, an aminoglycoside effective against most aerobic gram-negative bacilli, is actively transported across the bacterial cell membrane. It then binds to a specific receptor protein on the 30s subunit of bacterial ribosomes. This interferes with an initiation complex between mRNA (messenger RNA) and the 30s subunit, inhibiting protein synthesis. DNA may be misread, thus producing non-functional proteins. Polyribosomes are split apart and are unable to synthesize protein. Propagation of bacteria controlled. • PHARMACOKINETICS - _ABSORPTION: _ After topical application, small amounts of the vale rate may be absorbed systematically during prolonged usage. Topical neomycin is readily absorbed from large denuded, burned or granulating areas. - _HALF-LIFE:_ Biological half-life of neomycin is about 2 hours. - _DISTRIBUTION:_ Neomycin may enter the cerebrospinal fluid and may accumulate in renal function impairment. - _PROTEIN BINDING:_ About 60 to 65% of Betamethasone- 17-Valerate is bound to plasma proteins. - _EXCRETION:_ Absorbed neomycin and betamethasone is excreted through the urine. INDICATIONS For treatment of infective acute or chronic inflammatory dermatoses such as: • Localized neurodermatitis • Psoriasis • Atopic or seborrhoeic dermatitis • Inflammatory phase of xerosis • Anogenital pruritus • Discoid lupus erythematosus • L Διαβάστε το πλήρες έγγραφο