Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Moxifloxacin
Bayer Australia Ltd
Medicine Registered
AVELOX ® TABLETS CMI 1 AVELOX ® TABLETS (AV·E·LOX) _moxifloxacin hydrochloride _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Avelox tablets. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Avelox 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 AVELOX IS USED FOR Avelox tablets are used in adults for the treatment of infections of the lungs, airways and sinuses. In certain infections, you may require treatment with Avelox IV injection followed by a course of Avelox tablets e.g. severe and complicated skin and skin structure infections. Even if you have read the Consumer Medicine Information for Avelox IV, you should read this leaflet as well as it contains information specific to the tablets. Avelox tablets contain the active ingredient, moxifloxacin, which is an antibiotic belonging to a group of medicines called quinolones. These antibiotics work by killing the bacteria that are causing your infection. Avelox tablets will not work against infections caused by viruses such as colds or the flu. Avelox tablets are available by prescription only. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. BEFORE YOU TAKE AVELOX _WHEN YOU MUST NOT TAKE IT _ DO NOT TA Read the complete document
111013 Avelox PI Page 1 of 22 PRODUCT INFORMATION AVELOX ® (MOXIFLOXACIN HYDROCHLORIDE, BAYER) NAME OF THE MEDICINE Moxifloxacin hydrochloride (CAS number: 186826-86-8). Its empirical formula is C 21 H 23 FN 3 O 4 * HCl and has a molecular weight of 437.9. Moxifloxacin, a fluoroquinolone, differs from other quinolones in that it has a methoxy function at the 8-position and an _S,S_ configurated diazabicyclononyl ring moiety at the 7-position. Its chemical name is 1-cyclopropyl-7-{(_S,S_)-2,8- diaza-bicyclo[4.3.0]non-8-yl}-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid hydrochloride. It is a pale yellow substance. The substance shows no melting point but it decomposes above 250°C. It is sparingly soluble in water and methanol, slightly soluble in HCl and ethanol, and practicably insoluble in acetone and toluene. It has the following chemical structure: DESCRIPTION Avelox (moxifloxacin hydrochloride) is a synthetic broad spectrum antibacterial agent and is available as Avelox tablets for oral administration, and as Avelox IV infusion solution for intravenous administration. Avelox tablets are available as a 400 mg film-coated tablet. Besides the active ingredient, Avelox tablets also contain the following excipients: microcrystalline cellulose, croscarmellose sodium, lactose, magnesium stearate, ferric oxide, hypromellose, macrogol 4000, and titanium dioxide. Avelox IV is available in ready-to-use 250 mL (containing 400 mg of moxifloxacin) flexibags or glass infusion bottles, as a sterile, preservative free aqueous solution of moxifloxacin hyd Read the complete document