+

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.
Urinary Tract Infection (UTI)
When choosing an antibiotic agent for uncomplicated UTI,
check the math:

Patient Adherence + Clinical Efficacy = Greater Probability of Treatment Success1



How do patient preferences factor in to your choice of treatment?
Watch the video to hear perspectives from real women.
With FDA advisories, drug-drug interactions, contraindications, and boxed warnings to account for, selecting an antimicrobial option for your patients can be complex.


*Not actual patients, based on uncomplicated UTI risk factors7


Suprax® delivers versatility for the treatment of uncomplicated UTI 6
See why Suprax may be suitable for a wider range of patients:


Clinical efficacy against UTI 8*
With high clinical success rates in adult patients
 

Clinical success was defined as alleviation of fever without a recurrence during treatment and a negative urine culture after 72 hours of treatment.
*Cefixime may have limited efficacy against Enterobacteriaceae producing extended spectrum beta-lactamases (ESBLs). See Package Insert for additional information about resistance.



Proven in vitro activity against UTI-causing pathogens 6
With a low MIC90 for key microbes 9

* In vitro susceptibility does not imply in vivo efficacy


Susceptibility of isolates from patients with UTI10a*


a The two resistant organisms in the Suprax group were enterococci
* Pathogens were isolated from pediatric patients


References:
1. Kardas P, Bishai WR. Compliance in Anti-Infective Medicine. Adv Stud Med. 2006;6(7C):S652-S658. 2. Cipro® (ciprofloxacin) [package insert]. Whippany, NJ: Bayer Healthcare. 2016. 3. FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone taken by mouth or by injection. Available at: www.fda.gov/Drugs/Drug Safety/ucm511530.htm. 4. Macrobid® (nitrofurantoin macrocrystals) [package insert]. Pine Brook, NJ: Almatica Pharma, Inc. 2013. 5. Bactrim® (sulfamethoxazole and trimethoprim) [package insert]. Cranbury, NJ: Sun Pharmaceuticals. 2017. 6. Suprax® Prescribing Information 7. Brusch JL, Bavaro MF, Cunha BA, Tessier JM. Urinary Tract Infection (UTI) and Cystitis (Bladder Infection) in Females Overview – Epidemiology. Medscape eMedicine. Updated 19 Jul 2018. Available at: https://emedicine.medscape.com/article/233101-overview#a5. 8. Ludwig E. Cefixime in the treatment of respiratory and urinary tract infections. Chemotherapy. 1998;44(suppl 1):31-34. 9. Knapp CC, Sierra-Madero J, Washington JA. Antibacterial activities of cefpodoxime, cefixime, and ceftriaxone. Antimicrob Agent Chemother. 1988;32(12):1896-1898 10. Dagan R, Einhorn M, Lang R, et al. Once daily cefixime compared to twice-daily trimethoprim / sulfamethoxazole for treatment of urinary tract infections in infants and children. Pediatr Infect Dis J.1992;11(3):198-203.

Macrobid® is a registered trademark of Almatica Pharma, Inc.
Bactrim® is a registered trademark of Sun Pharmaceutical Industries, Inc.
Cipro® is a registered trademark of Bayer Healthcare

-


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.