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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.
Patient Profiles*
Discover why Suprax® may be the right option for your patients

UTI

 
Patient 1 is a 24-year-old sexually-active female who experiences uncomplicated UTI a few times a year. Her physician typically prescribes ciprofloxacin because it's his go-to treatment for uncomplicated UTI.1 However, an FDA safety alert regarding fluoroquinolones has led the physician to seek another option with a more favorable safety profile and simpler dosing.2

 
Patient 2 is an elderly woman who experiences uncomplicated UTI every few months. She's taken TMP-SMX with good results, but has recently had to go on hydrochlorothiazide for her blood pressure. Because TMP-SMX interacts with thiazides3, her physician is looking for an option that won't interact with her blood pressure medication and is suitable for geriatric patients without dose adjustment.

P/T

 
Patient 3 presents with a sore throat, paired with difficulty swallowing and swollen lymph nodes in the neck. His throat culture is positive for GABHS but he is allergic to penicillin. His physician needs a treatment option that will be easy for this young patient to remember and will provide β-lactamase stability.

 
Patient 4 is a mother of 3 whose children were recently diagnosed with P/T. After complaining of a sore throat, she tested positive for GABHS pharyngitis and received a full course of treatment with amoxicillin. Despite adhering perfectly to the regimen, the infection did not resolve. Her physician suspects that penicillin-resistant pathogens may be present and needs a β-lactamase stable drug with efficacy against these co-pathogens.

AECB

 
Patient 5 has suffered from COPD for several years. Her previous AECB was severe and was resolved with the help of aggressive therapy, but her physician hesitates to prescribe amoxicillin-clavulanate or fluoroquinolones for the current AECB because it's not severe. The physician needs a drug without a black box warning that can be used safely at a standard dosage in the elderly.

 
Patient 6 is a longtime smoker who has chronic bronchitis. He experiences non-severe AECB on a fairly regular basis and his physician has treated those episodes with clarithromycin. He recently began statin treatment for his cholesterol and can no longer take clarithromycin.4 He needs a clinically effective alternative for AECB that will not interfere with his medication.



*Not actual patients.

References:
1. Cipro® (ciprofloxacin) [package insert]. Whippany, NJ: Bayer Healthcare. 2016. 2. 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. 3. Bactrim® (sulfamethoxazole and trimethoprim) [package insert]. Cranbury, NJ: Sun Pharmaceuticals. 2017. 4. Biaxin® (clarithromycin) [package insert]. Barceloneta, PR: AbbVie Ltd. 2016.

Bactrim® is a registered trademark of Sun Pharmaceutical Industries, Inc.
Cipro® is a registered trademark of Bayer Healthcare
Biaxin® is a registered trademark of AbbVie Ltd.

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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.