|Suprax is generally well tolerated|
|1.||SUPRAX® [package insert]. Baltimore, MD: Lupin Pharmaceuticals, Inc|
|Suprax® is contraindicated in patients with known allergy to the Cephalosporin class of antibiotics.|
|IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS HYPERSENSITIVITY AMONG Ŗ-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UPTO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY.|
|The dose of Suprax® should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (CAPD) and hemodialysis (HD). Patients on dialysis should be monitored carefully. (See DOSAGE AND ADMINISTRATION)|
|Suprax® should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.|
Carbamazepine: Elevated carbamazepine levels have been reported in postmarketing experience when cefixime is administered concomitantly. Drug monitoring may be of assistance in detecting alterations in carbamazepine plasma concentrations.
Warfarin and Anticoagulants: Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly.
|Drug/Laboratory Test Interactions|
A false-positive reaction for ketones in the urine may occur with tests using nitroprusside but not with those using nitroferricyanide.
The administration of cefixime may result in a false-positive reaction for glucose in the urine using Clinitest ® **, Benedictís solution, or Fehlingís solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix ® ** or TesTape ® **) be used.
A false-positive direct Coombs test has been reported during treatment with other cephalosporin antibiotics; therefore, it should be recognized that a positive Coombs test may be due to the drug.
|Carcinogenesis, Mutagenesis, Impairment of Fertility|
|Lifetime studies in animals to evaluate carcinogenic potential have not been conducted. Cefixime did not cause point mutations in bacteria or mammalian cells, DNA damage, or chromosome damage in vitro and did not exhibit clastogenic potential in vivo in the mouse micronucleus test. In rats, fertility and reproductive performance were not affected by cefixime at doses up to 125 times the adult therapeutic dose.|
|Usage in Pregnancy|
|Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 400 times the human dose and have revealed no evidence of harm to the fetus due to cefixime. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.|
|Labor and Delivery|
|Cefixime has not been studied for use during labor and delivery. Treatment should only be given if clearly needed.|
|It is not known whether cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with this drug.|
|Safety and effectiveness of cefixime in children aged less than six months old have not been established.|
|Information for Patients|
|Patients should be counseled that antibacterial drugs, including Suprax®, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Suprax® is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may decrease the effectiveness of the immediate treatment and increase the likelihood that bacteria will develop resistance and will not be treatable by Suprax® or other antibacterial drugs in the future.|
|Please view Package insert for more information about side effects and safe use of Suprax®|