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INDICATION

  • 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

SUPRAX should only be used to treat infections that are proven or strongly suspected to be caused by bacteria.

CONTRAINDICATIONS

  • SUPRAX (cefixime) is contraindicated in patients with known allergy to cefixime or other cephalosporins.
Pharyngitis/Tonsillitis
(P/T)
Coaggregation and β-Lactam antibiotic failure

When Group A Streptococcus (GAS) coaggregates with β-lactamase producing M. catarrhalis, penicillin failure can occur. 1,2


Suprax® delivers β-lactamase* stability for the treatment of pharyngitis/tonsillitis3
  • Because penicillin failure is a rising concern1,4
  • Penicillin has been associated with failure rates >20% in P/T1
  • Efficacy of amoxicillin also appears to be waning1
  • A strong consideration of β-lactamase stability is key1
  • Copathogen and coaggregation mechanisms are likely the major explanation for treatment failure with β-lactam drugs1

* Cefixime may have limited efficacy against Enterobacteriaceae producing extended spectrum beta-lactamases (ESBLs). See Package Insert for additional information about resistance.




Clinical efficacy against P/T caused by GABHS 4
Surpassed Penicillin for the Treatment of P/T Caused by GABHS 4



Note: Suprax is generally effective in the eradication of S. pyogenes from the nasopharynx; however, data establishing the efficacy of Suprax in the subsequent prevention of rheumatic fever are not available.

 
Susceptibility * of isolates from patients with P/T 5†


Study conducted at Children's Mercy Hospital
* In vitro susceptibility does not imply in vivo efficacy
Pathogens were isolated from pediatric patients
Reported as 100% in study

 

References:
1. Pichichero ME. Pathogen shifts and changing cure rates for otitis media and tonsillopharyngitis. Clin Pediatr. 2006;45(6):493-502. 2. Brook I. Penicillin Failure in the treatment of group A streptococcal pharyngo-tonsillitis: Causes and solutions. J Ped Infect Dis. 2013;8:59-69. 3. Suprax® Prescribing Information. 4. Casey JR, Pichichero ME. Meta-analysis of cephalosporin vs. penicillin treatment of group A streptococcal tonsillopharyngitis in children. Pediatrics. 2004;113(4):866-882. 5. Harrison, CG, Woods C, Stout G, et al. Susceptibilities of Haemophilus influenzae, Streptococcus pneumoniae, including serotype 19A, Moraxella catarrhalis paediatric isolates from 2005 to 2007 to commonly used antibiotics. Antimicrob Chemotherapy. 2009;63:511-519.

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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

SUPRAX should only be used to treat infections that are proven or strongly suspected to be caused by bacteria.

CONTRAINDICATIONS

  • SUPRAX (cefixime) is contraindicated in patients with known allergy to cefixime or other cephalosporins.

WARNINGS AND PRECAUTIONS

  • Hypersensitivity reaction: Anaphylactic/anaphylactoid reactions (including shock and fatalities) have been reported with the use of 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%), loose or frequent stools (6%), abdominal pain (3%), nausea (7%), dyspepsia (3%), and flatulence (4%).
  • Adverse reactions during postmarketing experience occurred at rates of less than 2%. Some serious adverse reactions included: pseudomembranous colitis, hypersensitivity reactions including Stevens-Johnson syndrome and serum sickness, acute renal failure, seizures, agranulocytosis, and toxic epidermal necrolysis.

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.
  • A false positive reaction for ketones and glucose in urine may occur with certain test kits. A false positive direct Coombs test has also been reported.

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.

Please note this information is not comprehensive. Please visit www.supraxrx.com for full Prescribing Information.

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.