Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
roxithromycin
Sanofi-Aventis Australia Pty Ltd
Roxithromycin
Registered
ROXITHROMYCIN GH 130703 V 2.0 1 ROXITHROMYCIN GH _Roxithromycin _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Roxithromycin GH. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you taking this medicine 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 GH IS USED FOR Roxithromycin GH 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) • exacerbation of chronic bronchitis • pneumonia (lung infection characterised by fever, malaise, headache) • skin and soft tissue infections • non gonococcal urethritis • impetigo (bacterial infection causing sores on the skin). Roxithromycin GH 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 GH, like other antibiotics, does not work against viral infections such as the flu. Your doctor, however, may prescribe Roxithromycin GH for another purpose. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. This medicine is not addictive. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ROXITHROMYCIN GH IF YOU HAVE SEVERE LIVER PROBLEMS. DO NOT TAKE ROXITHROMYCIN GH IF YOU HAVE AN ALLERGY TO: • roxithromycin or any other macrolide antibiotic eg azithromycin, clarithromycin or erythromycin • any of the ingredients listed at the Lue koko asiakirja
roxithromycin-ccdsv7-piv5-26sep17 _ _ _ _ _ _ _Page 1_ PRODUCT INFORMATION ROXITHROMYCIN GH NAME OF THE MEDICINE Roxithromycin GH Tablets NON-PROPRIETARY NAME Roxithromycin CHEMICAL STRUCTURE Roxithromycin has the following structural formula: The empirical formula for roxithromycin is C 41 H 76 N 2 O 15 . Its molecular weight is 837.07. CAS NUMBER Chemical Abstracts Number: [80214–83-1] DESCRIPTION Roxithromycin is a semi-synthetic macrolide antibiotic. It is a white crystalline powder. Roxithromycin is very slightly soluble in water, freely soluble in acetone, in alcohol and in methylene chloride. It is slightly soluble in dilute hydrochloric acid. roxithromycin-ccdsv7-piv5-26sep17 _ _ _ _ _ _ _Page 2_ Roxithromycin GH tablets contain 150 mg or 300 mg of roxithromycin. Roxithromycin GH tablets also contain hyprolose, poloxamer, povidone, colloidal anhydrous silica, magnesium stearate (470), purified talc (553), maize starch, hypromellose, glucose, titanium dioxide (171) and propylene glycol (1520). PHARMACOLOGY PHARMACOKINETICS Absorption Roxithromycin is absorbed after oral administration with an absolute bioavailability of approximately 50%. Peak plasma concentrations following administration of 150 mg and 300 mg film-coated tablets are achieved in young and elderly adult patients approximately 1 to 2 hours post-dose. As food intake decreases absorption, Roxithromycin GH should be administered at least 15 minutes before food or, alternatively, on an empty stomach (_i.e._ more than 3 hours after a meal). Absorption is not linear; with increasing doses in the range 150 mg to 300 mg, peak plasma levels and AUC do not increase in proportion to the dose. After repeated administration of 2.5 mg/kg every 12 hours to children, the average peak plasma concentration at steady state was 9 mg/L and the AUC was 61 mg.h/L. Following administration of a single oral dose of Roxithromycin GH 150 mg to healthy young adults, the mean peak plasma concentration was 6.6 mg/L and the AUC was 69 mg.h/L. At steady state following d Lue koko asiakirja