Ciprofloxacin is a broad-spectrum antimicrobial carboxyfluoroquinoline. The bactericidal action of ciprofloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, strand supercoiling repair, and recombination. Ciprofloxacin Bayer and associated names is an antibiotic, indicated for the treatment of uncomplicated and complicated infections, including severe infections, caused by ciprofloxacin susceptible pathogens. It is available as immediate release film coated tablets, modified release film coated tablets, granules and solutions for oral suspension, solutions for infusion in bags, solutions for infusion in bottles and sachets. On 22 June 2007, France presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Ciprofloxacin Bayer and associated names. The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Ciprofloxacin Bayer and associated names approved across EU Member States, with respect to the indications, the posology, the contra-indications and the special warnings and precautions for use. This medicinal product belongs to the list of products identified in 2007 for SPC harmonisation. The Marketing Authorisation Holder provided supplementary information on 23 November 2007 and 22 April 2008. During its July 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet was acceptable and that they should be amended. The CHMP gave a positive opinion on 24 July 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Ciprofloxacin Bayer and associated names.
Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here. Ciprofloxacin is an effective antibiotic that treats a wide variety of infections; however, it should not be given to children aged less than 18 and in adults it should be reserved for infections that are not treated by other antibiotics. Bayer Health Care Pharmaceuticals Inc https:// Tablets [Package Insert]. Aurobindo Pharma Limited https:// KJ, Kerns RJ, Osheroff N. Side effects include tendinitis and tendon rupture. Is a registered trademark of Bayer Health Care Pharmaceuticals Inc. This information has been designed as a quick reference. It is intended as a reference source only and not for prescribing or dispensing product. The appropriate approved prescribing information should be consulted. Images viewed herein may appear different than they do when viewing them live because of computer and/or photographic distortion. In addition, over time, some images and information for a particular product may change. For the most up-to-date product information, please contact your pharmacist or physician.
Drug. After a 250 mg oral dose, urine concentrations of ciprofloxacin usually. package insert for CIPRO ciprofloxacin hydrochloride Tablets and CIPRO. CIPRO ® ciprofloxacin hydrochloride tablet, for oral use. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL. Cipro 250 mg 100 Tablets. NDC 50419-758-01. Cipro®