Indicated for

Uncomplicated Urinary Tract Infections:

• The treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli and Proteus mirabilis.

Otitis Media:

• The treatment of adults and pediatric patients six months of age or older with otitis media caused by susceptible isolates of Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes. (Efficacy for Streptococcus pyogenes in this organ system was studied in fewer than 10 infections).

Note: For patients with otitis media caused by Streptococcus pneumoniae, overall response was approximately 10% lower for cefixime than for the comparator.

Pharyngitis and Tonsillitis:

• The treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of Streptococcus pyogenes.

Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes infections. SUPRAX is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of SUPRAX in the subsequent prevention of rheumatic fever is not available.

Acute Exacerbations of Chronic Bronchitis:

• The treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of Streptococcus pneumoniae and Haemophilus influenzae.

Uncomplicated Gonorrhea (cervical/urethral):

• The treatment of adults and pediatric patients six months of age or older with uncomplicated gonorrhea (cervical/urethral) caused by susceptible isolates of Neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates).

In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of cefixime should be administered for at least 10 days.

Prescribing SUPRAX (cefixime) in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Anaphylactic/anaphylactoid reactions (including shock and fatalities) have been reported with the use of cefixime.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including SUPRAX, and may range in severity from mild diarrhea to fatal colitis.

The dose of SUPRAX should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (CAPD) and hemodialysis (HD).

Cephalosporins, including SUPRAX, may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.

Phenylalanine can be harmful to patients with phenylketonuria (PKU). SUPRAX chewable tablets contain aspartame, a source of phenylalanine.

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.

A false-positive reaction for ketones in the urine may occur with tests using nitroprusside but not with those using nitroferricyanide.

The administration of cefixime may result in a false-positive reaction for glucose in the urine
using Clinitest, Benedict’s solution, or Fehling’s solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix or TesTape) be used.A false-positive direct Coombs test has been reported during treatment with other cephalosporins; therefore, it should be recognized that a positive Coombs test may be due to the drug.

There are no adequate and well-controlled studies in pregnant women.

It is not known whether cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with this drug. 

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• Use in patients under 6 months of age. GoToSource

• Syphilis. GoToSource

• Typhoid fever. GoToSource

• Pyelonephritis. GoToSource

• Bacterial sinusitis. GoToSource

• Community-acquired pneumonia. GoToSource

• Low-risk febrile neutropenia. GoToSource

Clostridium difficile associated diarrhea. GoToSource

Coagulopathy (the ability of blood to form clots is impaired), immune-mediated hemolytic anemia (red blood cells are destroyed by body’s immune system), thrombocytopenia (low blood platelet count), seizures, hypersensitivity reactions, myoclonus (involuntary jerking of a muscle or group of muscles), encephalopathy (brain disease or damage), stevens-johnson syndrome and toxic epidermal necrolysis (severe skin disorders). GoToSource

Liver injury. GoToSource

Lawsuits filed for stevens–johnson syndrome.