Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MOMETASONE FUROATE
MERCK SHARP & DOHME (MALAYSIA) SDN BHD
MOMETASONE FUROATE
001Units Units
MSD International GmbH (Singapore Branch)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ ASMANEX ® TWISTHALER ® Mometasone furoate (200mcg, 400mcg for oral inhalation) 1 WHAT IS IN THIS LEAFLET 1. What ASMANEX is used for 2. How ASMANEX works 3. Before you use ASMANEX 4. How to use ASMANEX 5. While you are using it 6. Side effects 7. Storage and Disposal of ASMANEX 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT ASMANEX IS USED FOR ASMANEX is used as preventive treatment in people with persistent asthma. HOW ASMANEX WORKS ASMANEX contains the active substance mometasone furoate which is a steroid. ASMANEX works by their anti- inflammatory effects (reduce swelling and irritation in the walls of the small air passages in the lungs), easing breathing problems. BEFORE YOU USE ASMANEX _- When you must not use it _ Do not take ASMANEX: If you are allergic (hypersensitive) to mometasone furoate or to lactose (which contains trace amount of milk proteins). _ _ _- Pregnancy and lactation _ Ask your doctor for advice if you are pregnant, planning to become pregnant, or if you are breastfeeding. _ _ - _Before you start using it _ Tell your doctor or pharmacist if you: Have an infection (fungal, bacterial or viral) or tuberculosis infection of the respiratory tract. _ASMANEX CONTAINS LACTOSE. _ _This medicine contains a small amount _ _of lactose (4.64mg per day is the _ _maximum recommended daily dose). This _ _amount does not normally cause _ _problems in lactose intolerant people. _ - _Taking other medicines _ Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. Medicines that may interact with ASMANEX include: Antifungal medication (ketoconazole, itraconazole) Anti-HIV or other antiviral medication (ritonavir, cobicistat- containing products) Antibiotics medication (clarithromycin) It is also important to tell your doctor before you start to use ASMANEX if you are taking other steroids Baca dokumen lengkap
1 LPC -MK0887 -PwIH -082017 AS MANEX® TW IST HALER ® Brand of mometasone furoa te FOR ORAL INH AL ATION DES CR IPTION: Ea ch inha lation contains either 200 micrograms or 400 mi crograms of mometasone furoate anh ydrou s. Inactive ingredients: Lac tose (which contain s trace amount of milk proteins). ACTIONS: Mometason e furoate is a top ical glucocorticos teroid with local anti-inflammatory prop erties. It is likely that much of the mechani sm for the anti-allergic and anti-inflammatory effec ts of mometasone furoa te lies in its ability to inhibit the relea se of mediators of the inflammatory cascade. In vitro, mometason e furoate sign ificantly inhibits the release of leu ko triene s from leukocytes of allergic pa tients. In cell culture, mometasone furoate demons trated hig h potency in inh ibition of synthesis and release of IL-1, IL-5, IL-6, an d TNF a; it is also a potent inh ibitor of LT prod uc tion and in addition it is an extremely potent inhibitor of the production of the Th 2 cytokines, IL-4 and IL-5, from human CD4+ T- cells. Mometasone furoate has been sho wn in vitro to exh ibit a bind ing a ffinity for the hu man glucoco rtico id rece ptor, which is app rox imately 12 times that of dex amethasone, 7 times that of triamcino lone ac eton ide, 5 times that of budeson ide, and 1.5 times that of fluticasone. Doub le-blind placeb o-con trolled trials of 12- weeks du ration have sho wn that treatment wi th AS MANE X at de live red doses wi thin the range of 20 0-800 microg rams per day resu lted in improved lung func tion as meas ured by FEV 1 and peak exp iratory flow, improved as thma sy mptom co ntrol, and de creas ed need for inha led be ta-2 agon ist. Improved lung func tion was obse rved wi thin 24 hou rs of the start of treatm ent in so me pa tients, although max imum bene fit was not ach ieved be fore 1 to 2 weeks or longe r. Im proved lung func tion was maintained for the duration of treatment. Cli nical trials in hea lthy vo lun tee rs de monstrated a low rate of sys temic bioava ilab ility Baca dokumen lengkap