Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Beclometasone dipropionate
TENANG PHARMA SDN. BHD.
Beclometasone dipropionate
1 (200 actuations) Units
TENANG PHARMA SDN. BHD.
_Consumer Medication Information Leaflet (RiMUP) _ BECLOTEN ® INHALER 100MCG _Beclometasone dipropionate (100mcg/actuation) _ _______________________________________________________________________________________________________________ _ _ WHAT IS IN THIS LEAFLET 1) What Becloten ® Inhaler is used for 2) How Becloten ® Inhaler works 3) Before you use Becloten ® Inhaler 4) How to use Becloten ® Inhaler 5) While you are using it 6) Side Effects 7) Storage and Disposal of Becloten ® Inhaler 8) Product Description 9) Manufacturer and Product Registration Holder 10) Date of Revision WHAT BECLOTEN ® INHALER IS USED FOR Becloten ® Inhaler contains _beclometasone _ _dipropionate,_ which is one of a group of medicines known as glucocorticoid. Becloten ® Inhaler is used in the prophylactic management of asthma. HOW BECLOTEN ® INHALER WORKS The anti-inflammatory effect of _beclometasone _ _dipropionate_ plays an important role in the efficacy of _beclometasone _ _dipropionate_ in controlling symptoms and improving lung function in asthma. It is a pressurised metered-dose spray is for oral inhalation use only. Becloten ® inhaler is not indicated for the immediate relief of asthma attacks. BEFORE YOU USE BECLOTEN ® INHALER - _When you must not use it _ Do not use Becloten ® Inhaler if you are allergic (hypersensitive) to: a) _Beclometasone dipropionate_ b) any of the other ingredients of Becloten ® Inhaler. Do not use Becloten ® Inhaler if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before using Becloten ® Inhaler. _- Before you start to use it _ Check with your doctor, nurse or pharmacist before taking your medicine if: a) you are suffering from active or latent pulmonary tuberculosis. b) your asthma seems to be getting worse. Perhaps you are feeling wheezy and short of breath than usual, your ‘reliever’ inhaler seems to be less effective, you require more puffs from your ‘reliever’ inhaler than usual, or you do not seem to be getting better. Your doc Perskaitykite visą dokumentą
_ _ _For Medical Professional Use Only _ _ _ BECLOTEN ® INHALER 100MCG _Beclometasone dipropionate _ _pressurised metered-dose inhaler/solution _ DESCRIPTION A pressurised metered-dose inhaler containing not less than 200 actuations of _beclometasone dipropionate_ clear solution filled in a 19 ml aluminium canister fitted with a 50-microliter plastic and elastomeric metering valve with a white polypropylene actuator and a light brown polypropylene dust cap and packed into individual printed carton. Each actuation delivers 100 microgram _ beclometasone dipropionate. _ PHARMACODYNAMICS _Beclometasone dipropionate_ is a pro-drug with weak glucocorticoid receptor binding affinity. It is hydrolyzed via esterase enzymes to an active metabolite _beclometasone-17-monopropionate_ which has higher topical anti-inflammatory activity compared with _beclometasone dipropionate_ . The _in vitro_ study shows that, _beclometasone 17-monopropionate _ exhibits affinity for the human glucocorticoid receptor is 13 times that of _dexamethasone_ , 6 times that of _triamcinolone _ _acetonite,_ 1.5 times that of _budesonide_ , and 25 times that of parent compound. Inflammation is an important component in the pathogenesis of asthma. The wide range of inhibitory activities against multiple cell types (mast cells, eosinophils, neutrophils, macrophages and lymphocytes) and mediators (histamine, eicosanoids, leukotrienes and cytokines) involved in allergic and non- allergic-mediated inflammation may contribute to their efficacy in asthma. PHARMACOKINETICS _Absorption:_ Following inhalation, systemic absorption of _beclomethasone dipropionate_ occurs through the lung with negligible oral absorption of the swallowed dose. Prior to absorption within the lung, there is an extensive conversion of _beclometasone propionate,_ to its active metabolite, _beclometasone 17-monopropionate._ The systemic absorption of _beclometasone 17-monopropionate_ arises from lung deposition and oral absorption is 36 and 26% respectively. Following inhalation of the Perskaitykite visą dokumentą