IMPORTANT SAFETY INFORMATION
WARNINGS & PRECAUTIONS
- SUPRAX (cefixime) is contraindicated in patients with known allergy to cefixime or other cephalosporins.
- Hypersensitivity reactions: including shock and fatalities have been reported with cefixime. Before therapy with SUPRAX is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. Discontinue use if a reaction occurs.
- Clostridium difficile associated diarrhea: Evaluate if diarrhea occurs.
- Dose Adjustment in Renal Impairment: The dose of SUPRAX should be adjusted in patients with renal impairment and those undergoing continuous ambulatory peritoneal dialysis and hemodialysis.
- Coagulation Effects: Cephalosporins, including SUPRAX, may be associated with a fall in prothrombin activity. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.
- Phenylketonurics: SUPRAX Chewable Tablets contain aspartame, a source of phenylalanine.
- Most common adverse reactions are gastrointestinal such as diarrhea (16%), nausea (7%), loose stools (6%), abdominal pain (3%), dyspepsia (3%), and vomiting.
USE IN SPECIAL POPULATIONS
- Elevated carbamazepine levels have been reported in postmarketing experience when cefixime is administered concomitantly.
- Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly with warfarin and anticoagulants.
- Efficacy and safety in infants aged less than six months have not been established.
- Cefixime should be used during pregnancy only if clearly needed.
- Consideration should be given to discontinuing nursing temporarily during treatment with cefixime.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088, or contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561.
Please note that this information is not comprehensive. Please see full Prescribing Information.