Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
Roxithromycin
Southern Cross Pharma Pty Ltd
Medicine Registered
C:Products/Roxi/CMI 17feb12 scp 17/2/12 Page 1 of 4 ROXITHROMYCIN SCP ROXITHROMYCIN CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor and pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking roxithromycin against the benefits they expect it will have for you. If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again. WHAT ROXITHROMYCIN IS USED FOR Roxithromycin is used to treat infections in different parts of the body caused by bacteria. For example: acute pharyngitis (sore throat and discomfort when swallowing) tonsillitis sinusitis acute bronchitis (infection of the bronchi causing coughing) pneumonia (lung infection characterised by fever, malaise, headache) skin and soft tissue infections non gonoccocal urethritis impetigo (bacterial infection causing sores on the skin) Roxithromycin is an antibiotic that belongs to a group of medicines called macrolides. These antibiotics work by killing or stopping the growth of the bacteria that are causing your infection. Roxithromycin, like other antibiotics, does not work against viral infections such as the flu. YOUR DOCTOR MAY HAVE PRESCRIBED ROXITHROMYCIN FOR ANOTHER REASON. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. Roxithromycin is not addictive. BEFORE YOU TAKE ROXITHROMYCIN _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ROXITHROMYCIN IF: 1. you have an allergy to: Прочетете целия документ
C:Products/Roxi/PI 17feb12 scp 17/2/12 Page 1 of 9 PRODUCT INFORMATION ROXITHROMYCIN SCP NAME OF THE MEDICINE ACTIVE INGREDIENT: Roxithromycin CHEMICAL NAMES:_ _ (3_R_, 4_S_, 5_S_, 6_R_, 7_R_, 9_R_, 11_S_, 12_R_, 13_S_, 14_R_)-4-[(2,6-dideoxy-3-_C_-methyl-3-O- methyl-α- L -_ribo_-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-10-[(_E_)-[(2- methoxyethoxy)-methoxy]imino]-3,5,7,9,11,13,-hexamethyl-6-[(3,4,6-trideoxy-3- (dimethylamino)-β- D -_xylo_-hexopyranosyl)oxy]-oxacyclotetradecan-2-one. STRUCTURAL FORMULA: _ _ MOLECULAR FORMULA: C 41 H 76 N 2 O 15 . MOLECULAR WEIGHT: 837.07 CAS REGISTRY NUMBER : 80214-83-1 _ _ DESCRIPTION Roxithromycin is a semi-synthetic macrolide antibiotic. Each Roxithromycin film- coated tablet contains either 150 mg or 300 mg of roxithromycin as the active ingredient. ROXITHROMYCIN SCP tablets also contain the following inactive ingredients: maize starch, hydroxypropylcellulose, silica – colloidal anhydrous, sodium starch glycollate, poloxamer, povidone, magnesium stearate, talc – purified, propylene glycol, glucose, titanium dioxide and hypromellose. C:Products/Roxi/PI 17feb12 scp 17/2/12 Page 2 of 9 PHARMACOLOGY MICROBIOLOGY: Roxithromycin is bacteriostatic at low concentrations and bactericidal at high concentrations. It binds to the 50S subunit of the 70S ribosome, thereby disrupting bacterial protein synthesis. A prolonged postantibiotic effect has been observed with roxithromycin. Whilst the clinical significance of this remains uncertain, it supports the rationale for once daily dosing. Although clinical data have demonstrated the efficacy and safety of once daily dosing in adults, these have not been demonstrated in children. At plasma concentrations achieved with the recommended therapeutic doses, roxithromycin has been demonstrated to have _in vitro_ and clinical activity against the following mi Прочетете целия документ