CEFTIN Tablets and CEFTIN for Oral Suspension contain cefuroxime as cefuroxime axetil. CEFTIN is a semisynthetic, broad-spectrum cephalosporin antibiotic for oral administration. Chemically, cefuroxime axetil, the 1-(acetyloxy) ethyl ester of cefuroxime, is ( RS )-1- Cefuroxime is classified as FDA pregnancy risk category B. Animal data show that there are no teratogenic effects of cefuroxime. There are, however, no adequate and well-controlled studies in pregnant women, Because animal reproduction studies are not always predictive of human response, cefuroxime should be used during pregnancy only if clearly needed. Rx ONLY. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefuroxime for Injection and other antibacterial drugs, Cefuroxime for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Drug information on Cefuroxime Axetil for health care professionals. Table 4. Dosage of Cefuroxime for Injection in Adults With Reduced Renal Function * Since Cefuroxime for Injection is dialyzable, patients on hemodialysis should be given a further dose at the end of the dialysis. Cefuroxime: Package Insert and Label Information. West-Ward Pharmaceutical Corp 27 April 2015. CEFUROXIME- cefuroxime sodium injection, powder, for solution West-Ward Pharmaceutical Corp. Rx Only. PHARMACY BULK PACKAGE — Not for Direct Infusion: To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefuroxime for Injection and other antibacterial drugs. Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Cefuroxime is a cephalosporin (SEF a low spor in) antibiotic. It works by fighting bacteria in your body. Cefuroxime is used to treat many kinds of bacterial infections, including severe or life-threatening forms. Table 1. Adult Patients and Pediatric Patients Dosage Guidelines for Cefuroxime Axetil Tablets * The safety and effectiveness of Cefuroxime Axetil administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established. The FDA has approved revisions to the safety labeling for cefuroxime for injection plus dextrose injection, simvastatin (Zocor), and clozapine (Clozaril).