Acute Otitis Media (AOM) Treatment | Suprax AOM Indications

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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.
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Acute Otitis Media (AOM)
Bacteria causing AOM in North America in 20121,a

A 2012 study found H. influenzae and M. catarrhalis were more prevalent than S. pneumoniae in children with AOM1



a Data from cases of Legacy Pediatrics, Rochester, New York, for the 2011-2012 respiratory season.
b 20% amoxicillin-resistant.
c 50% amoxicillin-resistant.
d 100% amoxicillin-resistant.


American Academy of Pediatrics (AAP) Guidelines

The American Academy of Pediatrics (AAP) guidelines support immediate antibiotic treatment for very young children presenting with bilateral AOM2

When to consider antibiotics with additional β-lactamase coverage2

Cephalosporin antibiotics like SUPRAX® are recommended when the child:

Has received amoxicillin within the last 30 days
or
Has a history of AOM unresponsive to amoxicillin
or
Has concurrent purulent conjunctivitis


Also consider an antibiotic like SUPRAX® when other antibiotic drugs aren't improving the patient's condition. H. flu and M. cat may be present.2


Efficacy

SUPRAX® delivers efficacy in acute otitis media (AOM)

Because ear infections often follow upper respiratory infections in young children1


Rapidly penetrates into middle ear fluid3


Rapid and effective penetration into the middle ear fluid (MEF)

– Achieves peak concentrations within 4 hours3
– MIC90 in MEF achieved for at least 12 hours
    for H. flu, M. cat and S. pneum.


Active* against M. cat and H. flu4
PK/PD Susceptibility (Pediatric Respiratory Isolates; 2005-2007)4
 
   Amoxicillin             Cefprozil             Cefdinir

*In vitro susceptibility does not imply in vivo efficacy.
a Reported as 100% in study.
Study conducted at Children's Mercy Hospital, Kansas City. Cefzil (cefprozil) is a registered trademark of Bristol Myers Squibb. Omnicef (cefdinir) is a registered trademark of Warner-Lambert Company.

1. Pichichero ME. Urgent care management of acute otitis media in children. J Urgent Care Med. 2016; January. 23-31. 2. Lieberthal AS, Carroll AE, Chonmaitree T, Ganiats TG, et al. Clinical practice guideline: The diagnosis and management of acute otitis media. Pediatrics. 2013;131(3):e964-e999. 3. Pichichero ME. Pathogen shifts and changing cure rates for otitis media and tonsillopharyngitis. Clin Pediatr. 2006;45(6):493-502. 4. Harrison CJ, Woods C, Stout G, et al. Susceptibilities of Haemophilus influenzae, Streptococcus pneumoniae, including serotype 19A, and Moraxella catarrhalis paediatric isolates from 2005 to 2007 to commonly used antibiotics. J Antimicrob Chemotherapy. 2009;63:511-519.



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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.

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.