IMPORTANT SAFETY INFORMATION

FULL PRESCRIBING INFORMATION
 
 
 

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INDICATIONS
  • SUPRAX® (cefixime) is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months of age or older with the following infections when caused by susceptible isolates of the designated bacteria: Uncomplicated Urinary Tract Infections; Otitis Media; Pharyngitis and Tonsillitis; Acute Exacerbations of Chronic Bronchitis; Uncomplicated Gonorrhea (cervical/urethral).
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

  • SUPRAX (cefixime) is contraindicated in patients with known allergy to cefixime or other cephalosporins.
WARNINGS & PRECAUTIONS
  • 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.
ADVERSE REACTIONS
  • Most common adverse reactions are gastrointestinal such as diarrhea (16%), nausea (7%), loose stools (6%), abdominal pain (3%), dyspepsia (3%), and vomiting.
DRUG INTERACTIONS
  • 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.
USE IN SPECIAL POPULATIONS
  • 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.


©2017 Lupin Pharmaceuticals, Inc. Suprax is a registered trademark of Astellas Pharma Inc.
111 S. Calvert Street, Baltimore, MD 21202 All rights reserved. PP-SPX-US-0029 01/17
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