Cefixime

Pronunciation

Class: Third Generation Cephalosporins
Chemical Name: [6R - [6α,7β(Z)]] - 7 - [[(2 - Amino - 4 - thiazoyl)[(carboxymethoxy)imino]acetyl]amino] - 3 - ethenyl - 8 - oxo - 5 - thia - 1 - azabicyclo[4.2.0]oct - 2 - ene - 2 - carboxylic acid
CAS Number: 79350-37-1
Brands: Suprax

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Introduction

Antibacterial; β-lactam antibiotic; third generation cephalosporin.¹ ² ³ ⁴ ⁶ ⁷ ¹³ ²³ ⁴² ⁵⁷ ⁶⁰ ⁷⁵ ⁸³

Uses for Cefixime

Respiratory Tract Infections

Treatment of acute bronchitis caused by Streptococcus pneumoniae,¹ ² ²³ ⁴⁴ ⁷⁰ ⁷² ¹⁰³ ¹⁸⁷ ¹⁸⁸ Haemophilus influenzae (including β-lactamase-producing strains),¹ ² ²³ ⁴⁴ ⁷⁰ ⁷² ¹⁰³ ¹⁸⁷ ¹⁸⁸ or Moraxella catarrhalis†.² ⁴⁴ ⁷⁰ ⁷² ¹⁰³ ¹⁸⁷

Treatment of acute exacerbations of chronic bronchitis caused by S. pneumoniae,¹ ² ²³ ⁴⁴ ⁷⁰ ⁷² ¹⁰³ ¹⁸⁷ ¹⁸⁸ H. influenzae (including β-lactamase-producing strains),¹ ² ²³ ⁴⁴ ⁷⁰ ⁷² ¹⁰³ ¹⁸⁷ ¹⁸⁸ or M. catarrhalis†.² ⁴⁴ ⁷⁰ ⁷² ¹⁰³

Treatment of mild to moderate community-acquired pneumonia† (CAP) caused by S. pneumoniae,² ²³ ⁴⁴ ⁷⁰ ⁷² ¹⁰³ H. influenzae,¹ ² ²³ ⁴⁴ ⁷⁰ ⁷² ¹⁰³ M. catarrhalis,² ⁴⁴ ⁷⁰ ⁷² ¹⁰³ ¹³⁷ ¹⁶⁶ E. coli, H. parahaemolyticus, or H. parainfluenzae.² ³ ⁴⁴ ⁶⁴ ⁷⁵

Treatment of mild to moderate sinusitis† caused by S. pneumoniae,² ²³ ⁴⁴ ⁷⁰ ⁷² ¹⁰³ H. influenzae,¹ ² ²³ ⁴⁴ ⁷⁰ ⁷² ¹⁰³ M. catarrhalis,² ⁴⁴ ⁷⁰ ⁷² ¹⁰³ ¹³⁷ ¹⁶⁶ E. coli, H. parahaemolyticus, or H. parainfluenzae.² ³ ⁴⁴ ⁶⁴ ⁷⁵

Acute Otitis Media (AOM)

Treatment of AOM¹ ² ³ ⁵ ²³ ⁴³ ⁴⁹ ⁵⁶ ⁶¹ ⁶² ⁶³ ⁷⁵ ¹³⁸ ¹⁶⁴ ¹⁶⁵ ¹⁸⁷ caused by H. influenzae (including β-lactamase-producing strains),¹ ² ²³ ⁶¹ ⁶² ⁶³ ¹⁸⁷ M. catarrhalis (including β-lactamase-producing strains),¹ ² ²³ ⁶¹ ⁶² ⁶³ ¹⁸⁷ or S. pyogenes (group A β-hemolytic streptococci).¹ ² ²³ ⁶² ⁶³ ¹⁸⁷

Pharyngitis and Tonsillitis

Treatment of pharyngitis and tonsillitis caused by susceptible S. pyogenes (group A β-hemolytic streptococci).¹ ² ³ ⁵ ²³ ⁴⁴ ⁵⁶ ⁶⁴ ⁷⁵ ¹⁸⁷ ¹⁸⁸ Generally effective in eradicating S. pyogenes from the nasopharynx, but efficacy in prevention of subsequent rheumatic fever has not been established to date.¹ ¹⁸⁷ ¹⁸⁸

CDC, AAP, IDSA, AHA, and others recommend oral penicillin V or IM penicillin G benzathine as treatments of choice;⁵ ⁸² ⁸⁶ ¹⁰⁴ ¹⁵¹ ¹⁵² oral cephalosporins and oral macrolides considered alternatives.⁵ ⁸² ¹⁵² Amoxicillin sometimes used instead of penicillin V, especially for young children.¹⁵²

Urinary Tract Infections (UTIs)

Treatment of uncomplicated UTIs¹ ² ⁵ ⁴⁰ ⁴² ⁵¹ ⁶⁴ ⁷⁴ ⁷⁵ ¹⁸² ¹⁸⁷ ¹⁸⁸ caused by susceptible Escherichia coli¹ ² ⁴⁰ ⁵¹ ⁶⁴ ⁷⁴ ⁷⁵ ¹⁸² ¹⁸⁷ ¹⁸⁸ or Proteus mirabilis;¹ ² ⁴⁰ ⁵¹ ⁷⁴ ⁷⁵ ¹⁸² ¹⁸⁷ ¹⁸⁸ also has been used for treatment of uncomplicated UTIs caused by susceptible Citrobacter spp.†,² ⁵¹ ⁶⁴ ⁷⁴ C. diversus†,² ⁷⁴ C. freundii†,² ⁷⁴ Enterobacter spp.†,² ⁴⁰ ⁵¹ E. aerogenes†,² ⁴⁰ ⁷⁴ E. agglomerans†,² ⁶⁴ Klebsiella spp.†,² ⁴⁰ ⁵¹ ¹⁸² K. pneumoniae†,² ⁶⁴ ⁷⁴ Morganella morganii†,² Proteus spp.†,² ⁵¹ ⁶⁴ or Serratia†² ⁵¹ ⁷⁴ .

Has been used for treatment of uncomplicated UTIs¹ ² ⁵ ⁴⁰ ⁴² ⁵¹ ⁶⁴ ⁷⁴ ⁷⁵ ¹⁸² caused by susceptible gram-positive bacteria, including Staphylococcus epidermidis†,² Staphylococcus spp.†,² ⁵¹ Streptococcus agalactiae†,² ⁴⁰ nonhemolytic streptococci†,² ⁴⁰ ⁵¹ or Enterococcus faecalis†.² ⁴⁰ Consider that treatment failures have been reported and gram-positive bacteria (e.g., staphylococci, S. agalactiae, enterococci) have been isolated in urine during or after cefixime treatment and usually are resistant to cefixime.² ⁵¹ ⁷⁴

Treatment of pyelonephritis† and other complicated UTIs†² ²³ ⁴⁰ ⁷⁵ caused by susceptible Enterobacteriaceae, including E. coli.² ²³

Gonorrhea and Associated Infections

Treatment of uncomplicated urethral, endocervical, or rectal infections† caused by susceptible Neisseria gonorrhoeae.¹ ² ²³ ⁴⁸ ⁷¹ ¹⁰⁵ ¹⁰⁶ ¹⁰⁸ ¹⁰⁹ ¹¹⁰ ¹¹¹ ¹³⁰ ¹⁸⁶ ¹⁸⁷ ¹⁸⁸ CDC recommends ceftriaxone or cefixime as drug of choice for uncomplicated cervical, urethral, or rectal gonorrhea in adults and adolescents;¹³⁰ ¹⁸⁶ ceftriaxone is recommended for pharyngeal gonorrhea.¹³⁰ ¹⁸⁶

Follow-up treatment of disseminated gonococcal infections† after an initial parenteral regimen (ceftriaxone or, alternatively, cefotaxime, or spectinomycin [not currently commercially available in the US]); CDC recommends cefixime or cefpodoxime as drug of choice for follow-up treatment.¹³⁰ ¹⁸⁶

Salmonella and Shigella Infections

Has been used for treatment of typhoid fever (enteric fever) or septicemia caused by multidrug-resistant Salmonella typhi†.¹⁴¹ ¹⁴² ¹⁸⁹ ¹⁹⁰ ¹⁹¹

Has been used for treatment of shigellosis† caused by susceptible Shigella.¹³⁹ ¹⁴⁸

Lyme Disease

Has been used for treatment of disseminated Lyme disease†.¹⁸¹ Other cephalosporins (cefotaxime, ceftriaxone, cefuroxime axetil) usually recommended by IDSA and others when a cephalosporin is used in the treatment of Lyme disease.¹⁰⁴ ¹⁸⁵

Cefixime Dosage and Administration

Administration

Oral Administration

Administer orally.¹ ¹⁸⁷ ¹⁸⁸

Reconstitution

Reconstitute oral suspension at the time of dispensing by adding the amount of water specified on the container in 2 portions; invert bottle and shake after each addition.¹ ¹⁸⁷ The reconstituted suspension contains 100 or 200 mg/5 mL.¹ ¹⁸⁷

Shake oral suspension well just prior to administration of each dose.¹ ¹⁸⁷

Dosage

Available as cefixime trihydrate; dosage expressed in terms of cefixime.¹ ¹⁸⁷ ¹⁸⁸

Pediatric Patients

Respiratory Tract Infections

Acute Bronchitis

Oral

Oral suspension in children 6 months to 12 years of age: 8 mg/kg once daily or 4 mg/kg every 12 hours¹ ¹⁸⁷ ¹⁸⁸ for 10–14 days.⁴⁴ ⁶⁴ ⁷²

Oral suspension or tablet in children >12 years of age or weighing >50 kg: 400 mg once daily or 200 mg every 12 hours¹ ¹⁸⁷ ¹⁸⁸ for 10–14 days.⁴⁴ ⁶⁴ ⁷²

Acute Exacerbations of Chronic Bronchitis

Oral

Oral suspension in children 6 months to 12 years of age: 8 mg/kg once daily or 4 mg/kg every 12 hours¹ ¹⁸⁷ ¹⁸⁸ for 10–14 days.⁴⁴ ⁶⁴ ⁷²

Oral suspension or tablet in children >12 years of age or weighing >50 kg: 400 mg once daily or 200 mg every 12 hours¹ ¹⁸⁷ ¹⁸⁸ for 10–14 days.⁴⁴ ⁶⁴ ⁷²

Acute Otitis Media (AOM)

Oral

Oral suspension in children 6 months to 12 years of age: 8 mg/kg once daily or 4 mg/kg every 12 hours¹ ¹⁸⁷ for 10–14 days.²³ ⁴⁷ ⁴⁹ ⁵⁵ ⁵⁶ ⁶² ⁶³

Oral suspension in children >12 years of age or weighing >50 kg: 400 mg daily¹ ¹⁸⁷ for 10–14 days.⁴⁴ ⁶⁴ ⁷²

Do not use tablets for treatment of AOM.¹ ¹⁸⁷ ¹⁸⁸

Pharyngitis and Tonsillitis

Oral

Oral suspension in children 6 months to 12 years of age: 8 mg/kg once daily¹ ⁵ ²³ ⁴³ ⁴⁹ ⁵⁶ ⁶¹ ⁶² ⁶³ ⁶⁴ ⁷⁵ ¹⁸⁷ or 4 mg/kg every 12 hours¹ ⁵ ²³ ⁶¹ ⁶² ¹⁸⁷ for ≥10 days.¹

Oral suspension or tablet in children >12 years of age or weighing >50 kg: 400 mg once daily or 200 mg every 12 hours¹ ¹⁸⁷ ¹⁸⁸ for ≥10 days.⁴⁴ ⁶⁴ ⁷² ¹⁸⁸

Urinary Tract Infections (UTIs)

Uncomplicated UTIs

Oral

Oral suspension in children 6 months to 12 years of age: 8 mg/kg once daily¹ ⁵ ²³ ⁴³ ⁴⁹ ⁵⁶ ⁶¹ ⁶² ⁶³ ⁶⁴ ⁷⁵ ¹⁸⁷ or 4 mg/kg every 12 hours¹ ⁵ ²³ ⁶¹ ⁶² ¹⁸⁷ for 5–10 days.² ⁴⁰ ⁵¹ ⁷⁴

Oral suspension or tablet in children >12 years of age or weighing >50 kg: 400 mg once daily or 200 mg every 12 hours¹ ¹⁸⁷ ¹⁸⁸ for 5–10 days.² ⁴⁰ ⁵¹ ⁷⁴

Gonorrhea and Associated Infections

Uncomplicated Urethral, Endocervical, or Rectal† Gonorrhea

Oral

Oral suspension (200 mg/5 mL) or tablet in adolescents: 400 mg as a single dose.¹³⁰ ¹⁸⁶ ¹⁸⁷ ¹⁸⁸

Disseminated Gonococcal Infections†

Oral

Oral suspension (200 mg/5 mL) or tablet in adolescents: 400 mg twice daily recommended by CDC; given to complete ≥1 week of treatment after an initial parenteral regimen of ceftriaxone or, alternatively, cefotaxime or spectinomycin (not currently commercially available in the US).¹³⁰ ¹⁸⁶

Salmonella and Shigella Infections†

Typhoid Fever†

Oral

Children 6 months to 16 years of age: 5–10 mg/kg twice daily.¹⁴¹ ¹⁴² ¹⁸⁹ ¹⁹⁰ ¹⁹¹ Usually given for 14 days;¹⁴¹ ¹⁴² ¹⁸⁹ high rate of treatment failure occurred when given for only 7 days.¹⁹⁰

Shigellosis†

Oral

8 mg/kg daily for 5 days.¹³⁹ ¹⁴⁸

Adults

Respiratory Tract Infections

Acute Bronchitis

Oral

Oral suspension or tablet: 400 mg once daily¹ ³ ⁵ ²³ ⁴⁰ ⁴⁴ ⁵¹ ⁷⁰ ⁷² ⁷⁴ ⁷⁵ ¹⁸⁷ ¹⁸⁸ or 200 mg every 12 hours¹ ² ³ ²³ ⁴⁴ ¹⁸⁷ ¹⁸⁸ for 10–14 days.⁴⁴ ⁶⁴ ⁷²

Acute Exacerbations of Chronic Bronchitis

Oral

Oral suspension or tablet: 400 mg once daily¹ ³ ⁵ ²³ ⁴⁰ ⁴⁴ ⁵¹ ⁷⁰ ⁷² ⁷⁴ ⁷⁵ ¹⁸⁷ ¹⁸⁸ or 200 mg every 12 hours¹ ³ ⁵ ²³ ⁴⁴ ⁵¹ ¹⁸⁷ ¹⁸⁸ for 10–14 days.⁴⁴ ⁶⁴ ⁷²

Acute Otitis Media (AOM)

Oral

Oral suspension: 400 mg once daily¹ ² ³ ⁵ ²³ ⁴⁰ ⁴⁴ ⁵¹ ⁷⁰ ⁷² ⁷⁴ ⁷⁵ ¹⁸⁷ or 200 mg every 12 hours¹ ² ³ ²³ ¹⁸⁷ for 10–14 days.²³ ⁴⁷ ⁴⁹ ⁵⁵ ⁵⁶ ⁶² ⁶³

Do not use tablets for treatment of AOM.¹ ¹⁸⁷ ¹⁸⁸

Pharyngitis and Tonsillitis

Oral

Oral suspension or tablet: 400 mg once daily¹ ³ ⁵ ²³ ⁴⁰ ⁴⁴ ⁵¹ ⁷⁰ ⁷² ⁷⁴ ⁷⁵ ¹⁸⁷ ¹⁸⁸ or 200 mg every 12 hours¹ ³ ⁵ ²³ ⁴⁴ ¹⁸⁷ ¹⁸⁸ for ≥10 days.¹ ¹⁸⁷ ¹⁸⁸

Urinary Tract Infections (UTIs)

Uncomplicated UTIs

Oral

Oral suspension or tablet: 400 mg once daily¹ ³ ⁵ ²³ ⁴⁰ ⁴⁴ ⁵¹ ⁷⁰ ⁷² ⁷⁴ ⁷⁵ ¹⁸⁷ ¹⁸⁸ or 200 mg every 12 hours¹ ³ ⁵ ²³ ⁵¹ ¹⁸⁷ ¹⁸⁸ for 5–10 days.⁴⁰ ⁵¹ ⁷⁴

Gonorrhea and Associated Infections

Uncomplicated Urethral, Endocervical, or Rectal† Gonorrhea

Oral

Oral suspension (200 mg/5 mL) or tablet: 400 mg as a single dose.¹ ¹⁰⁰ ¹⁰⁵ ¹⁰⁶ ¹⁰⁸ ¹³⁰ ¹⁸⁶ ¹⁸⁷

Disseminated Gonococcal Infections†

Oral

Oral suspension (200 mg/5 mL) or tablet: 400 mg twice daily recommended by CDC; given to complete ≥1 week of treatment after an initial parenteral regimen of ceftriaxone or, alternatively, cefotaxime or spectinomycin (not currently commercially available in the US).¹³⁰ ¹⁸⁶

Lyme Disease†

Oral

200 mg daily for 100 days (administered with oral probenecid).¹⁸¹

Special Populations

Renal Impairment

Dosage adjustments necessary in patients with Cl_cr <60 mL/minute.¹ ² ¹⁸⁷ ¹⁸⁸

Dosage in Adults with Renal Impairment
Cl_cr (mL/min)	Dosage
21–60	75% of the usual dose given at usual intervals¹ ¹⁸⁷ ¹⁸⁸
<20	50% of the usual dose given at the usual intervals¹ ¹⁸⁷ ¹⁸⁸
Hemodialysis Patients	75% of the usual dose given at usual intervals;¹ ¹⁸⁷ ¹⁸⁸ supplemental doses not necessary during or after hemodialysis³³ ⁷⁵
CAPD Patients	50% of the usual dose given at the usual intervals¹ ²³ ³⁷ ⁷⁵ ¹⁸⁷ ¹⁸⁸ or the usual dose given at twice the usual dosing interval;³³ supplemental doses not necessary during or after CAPD³³ ⁷⁵

Geriatric Patients

No dosage adjustments except those related to renal impairment.² ³⁵ ³⁷ (See Renal Impairment under Dosage and Administration.)

Cautions for Cefixime

Contraindications

Known hypersensitivity to cefixime or other cephalosporins.¹ ¹⁸⁷ ¹⁸⁸

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Diarrhea and Colitis

Possible emergence and overgrowth of nonsusceptible bacteria or fungi, especially Enterobacter, Pseudomonas, enterococci, staphylococci, or Candida.¹ ⁵ ¹⁸⁷ ¹⁸⁸ Careful observation of the patient is essential.¹ ¹⁸⁷ ¹⁸⁸ Institute appropriate therapy if superinfection occurs.¹ ¹⁸⁷ ¹⁸⁸

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.¹ ¹⁷⁵ ¹⁷⁶ ¹⁷⁷ ¹⁷⁸ ¹⁷⁹ ¹⁸⁷ ¹⁸⁸ C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including cefixime, and may range in severity from mild diarrhea to fatal colitis.¹ ¹⁷⁵ ¹⁷⁶ ¹⁷⁷ ¹⁷⁸ ¹⁷⁹ ¹⁸⁷ ¹⁸⁸ Hyper toxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.¹ ¹⁷⁵ ¹⁷⁶ ¹⁷⁷ ¹⁷⁸ ¹⁷⁹ ¹⁸⁷ ¹⁸⁸ Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.

If CDAD is suspected or confirmed, the anti-infective may need to be discontinued.¹⁷⁵ ¹⁷⁶ ¹⁷⁷ ¹⁷⁸ ¹⁷⁹ Some mild cases may respond to discontinuance alone.¹ ¹⁷⁵ ¹⁷⁶ ¹⁷⁷ ¹⁷⁸ ¹⁷⁹ ¹⁸⁷ ¹⁸⁸ Manage moderate to severe cases with fluid, electrolyte, and protein supplementation; anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin); and surgical evaluation when clinically indicated.¹ ¹⁷⁵ ¹⁷⁶ ¹⁷⁷ ¹⁷⁸ ¹⁷⁹

Sensitivity Reactions

Hypersensitivity Reactions

Hypersensitivity reactions such as anaphylaxis (including shock and fatalities), angioedema, serum sickness-like reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported.¹ ⁵ ⁴⁰ ⁴¹ ⁴³ ⁵⁶ ⁶⁴ ⁷⁵ ¹⁸⁷ ¹⁸⁸

If an allergic reaction occurs, discontinue cefixime and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).¹ ¹⁸⁷ ¹⁸⁸

Cross-hypersensitivity

Partial cross-allergenicity among cephalosporins and other β-lactam antibiotics, including penicillins and cephamycins.¹ ¹⁷² ¹⁷³ ¹⁸⁷ ¹⁸⁸ Use caution.¹ ¹⁸⁷ ¹⁸⁸

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs.¹ ¹⁸⁷ ¹⁸⁸ Cefixime is contraindicated in individuals hypersensitive to cephalosporins.¹ ¹⁸⁷ ¹⁸⁸ Avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction and administer with caution in those who have had a delayed-type (e.g., rash, fever, eosinophilia) reaction.¹⁷³

General Precautions

History of GI Disease

Use cefixime with caution in patients with a history of GI disease, particularly colitis.¹ ¹⁸⁷ ¹⁸⁸ (See Superinfection/Clostridium difficile-associated Diarrhea and Colitis under Cautions.)

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of cefixime and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.¹ ¹⁸⁷ ¹⁸⁸

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.¹ ¹⁸⁷ ¹⁸⁸ In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.¹ ¹⁸⁷ ¹⁸⁸

Coombs’ Test Results

Positive direct Coombs’ test results reported with cephalosporins.¹ ¹⁸⁷ ¹⁸⁸ ^b This may interfere with certain hematologic studies or transfusion cross-matching procedures.^b

Decreased Prothrombin Activity

Prolonged PT¹ ² ¹⁸⁷ ¹⁸⁸ and prolonged partial thromboplastin time² ³³ ⁴¹ reported rarely.¹ ² ⁴¹ ¹⁸⁷ ¹⁸⁸

Patients with renal or hepatic impairment, poor nutritional status, prolonged anti-infective therapy, and previous anticoagulant therapy (stabilized) appear to be at risk.¹ ¹⁸⁷ ¹⁸⁸ Monitor PT in such patients and administer exogenous vitamin K as indicated.¹ ¹⁸⁷ ¹⁸⁸

Specific Populations

Pregnancy

Category B.¹ ¹⁸⁷ ¹⁸⁸

Lactation

Discontinue nursing or the drug.¹ ¹⁸⁷ ¹⁸⁸

Pediatric Use

Safety and efficacy not established in children <6 months of age.¹ ¹⁸⁷ ¹⁸⁸ Frequency of adverse GI effects (e.g., diarrhea, loose stools) similar to that in adults.¹ ¹⁸⁷ ¹⁸⁸

Geriatric Use

Possible increased oral bioavailability;¹ ³⁵ ³⁷ ¹⁸⁷ ¹⁸⁸ not considered clinically important.³⁵ ³⁷

Consider age-related decreases in renal function when selecting dosage and adjust dosage if necessary.² ³⁵ ³⁷ (See Renal Impairment under Dosage and Administration.)

Renal Impairment

Increased serum half-life.¹ ² ²³ ³³ ³⁷ ⁷⁵ ¹⁸⁷ ¹⁸⁸ Dosage adjustments necessary if Cl_cr <60 mL/minute.¹ ² ³³ ³⁵ ³⁷ ¹⁸⁷ ¹⁸⁸ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

GI effects (diarrhea,¹ ² ³³ ⁴⁰ ⁴¹ ⁴³ ⁴⁴ ⁵¹ ⁵⁶ ⁶³ ⁶⁴ ⁶⁷ ⁷⁵ ¹⁰³ ¹⁸⁷ ¹⁸⁸ loose or frequent stools,¹ ¹⁸⁷ ¹⁸⁸ abdominal pain,¹ ² ²³ ⁴⁰ ⁴¹ ⁴⁴ ⁵¹ ⁵⁶ ⁶⁴ ⁶⁷ ⁷⁵ ¹⁸⁷ ¹⁸⁸ nausea,¹ ² ²³ ⁴⁰ ⁴¹ ⁴⁴ ⁵¹ ⁶³ ⁶⁴ ⁷⁴ ⁷⁵ ¹⁸⁷ ¹⁸⁸ dyspepsia,¹ ² ²³ ⁴⁰ ⁴¹ ⁴⁴ ⁵¹ ⁷⁵ ¹⁸⁷ ¹⁸⁸ flatulence).¹ ² ⁴⁰ ⁴¹ ⁷⁵ ¹⁸⁷ ¹⁸⁸

Interactions for Cefixime

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
Antacids (aluminum- or magnesium-containing)	No clinically important effect on cefixime pharmacokinetics ³²
Anticoagulants, oral (warfarin)	Possible increased PT (with or without bleeding)¹ ¹⁸⁷ ¹⁸⁸
Carbamazepine	Increased carbamazepine concentrations¹ ¹⁸⁷ ¹⁸⁸	Monitor carbamazepine concentrations¹ ¹⁸⁷ ¹⁸⁸
Nifedipine	Possible increased plasma concentrations and AUC of cefixime¹⁴³
Probenecid	Increased cefixime plasma concentrations and AUC²
Salicylates	Possible decreased plasma concentrations and AUC of cefixime² ²⁵	Clinical importance unclear² ¹⁰²
Tests for glucose	Possible false-positive reactions in urine glucose tests using Clinitest, Benedict’s solution, or Fehling’s solution¹ ¹⁸⁷ ¹⁸⁸	Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix, Tes-Tape)¹ ¹⁸⁷ ¹⁸⁸
Tests for ketones	Possible false-positive reaction for ketones in urine if nitroprusside tests used; not reported with tests using nitroferricyanide¹ ¹⁸⁷ ¹⁸⁸

Cefixime Pharmacokinetics

Absorption

Bioavailability

30–50% of a single oral dose absorbed;¹ ² ⁵ ⁷⁵ ¹⁰⁰ ¹⁸⁸ peak serum concentrations attained within 2–6 hours.¹ ² ²⁶ ³⁰ ³¹ ³⁵ ³⁷ ¹⁰⁰ ¹⁸⁸

Tablets and oral suspension are not bioequivalent;¹ ¹⁸⁸ oral suspension results in peak plasma concentrations 14–50% higher than concentrations attained with tablets.¹ ⁵ ¹⁰⁰ ¹⁸⁸

Food

Food decreases the rate¹ but not the extent of absorption.¹ ² ³ ²⁶ ¹⁸⁷ ¹⁸⁸

Distribution

Extent

Distributed into bile,¹ ² ⁵ ¹⁸⁷ ¹⁸⁸ sputum,² ²³ tonsils,²³ maxillary sinus mucosa,²³ middle ear discharge,²³ blister fluid,² ⁷⁵ and prostatic fluid.²

Distribution into CSF unknown.¹ ¹⁸⁷ ¹⁸⁸

Crosses the placenta.² ²³ Not detected in human milk following a single 100-mg oral dose.²

Plasma Protein Binding

65–70%.¹ ² ²³ ²⁷ ³³ ³⁷ ⁷⁵ ¹⁸⁷ ¹⁸⁸

Elimination

Metabolism

Does not appear to be metabolized; no biologically active metabolites detected in serum or urine.¹ ² ⁵ ²³ ³⁰

Elimination Route

Eliminated by renal and nonrenal mechanisms.¹ ² ²³ ²⁴ ²⁶ ²⁷ ²⁹ ³⁰ ³¹ ³⁷ ⁵² ⁷⁵ ¹⁸⁷ ¹⁸⁸

7–50% of a dose excreted unchanged in urine within 24 hours.¹ ² ²³ ²⁴ ²⁶ ²⁷ ²⁹ ³¹ ³⁷ ⁷⁵ ¹⁰⁰ ¹⁸⁷ ¹⁸⁸ In animal studies, >10% of a dose may be excreted unchanged in bile.¹ ² ⁵² ¹⁸⁷ ¹⁸⁸

Not substantially removed by hemodialysis or peritoneal dialysis.¹ ² ³³ ³⁷ ⁷⁵ ¹⁸⁷ ¹⁸⁸

Half-life

Adults with normal renal function: 2.4–4 hours.¹ ² ⁵ ²³ ²⁴ ²⁶ ²⁷ ²⁹ ³¹ ³³ ³⁷ ⁷⁵ ¹⁰⁰ ¹⁸⁷ ¹⁸⁸

Special Populations

In patients with renal impairment, half-life averages 6–11.5 hours.¹ ³³ ¹ ³³ ¹⁸⁷ ¹⁸⁸

Stability

Storage

Oral

For Suspension

20–25°C.¹ ¹⁸⁷

After reconstitution, store in tight container at room temperature or in the refrigerator.¹ ¹⁸⁷ Discard any unused suspension after 14 days.¹ ¹⁸⁷

Tablets

20–25°C.¹⁸⁸

Actions and Spectrum

Based on spectrum of activity, classified as a third generation cephalosporin.³ ¹³ ¹⁵ ⁴² ⁵⁰ ⁶⁹ ⁷⁵ Expanded spectrum of activity against gram-negative bacteria compared with first and second generation cephalosporins;² ³ ⁵ ¹⁴ ²³ ⁵⁹ ⁶⁰ ⁷⁵ less active against Enterobacteriaceae than some other third-generation cephalosporins.¹⁵ ⁷⁵ ¹⁰¹
Usually bactericidal.¹ ² ¹⁴ ³⁴ ⁶⁵ ⁶⁹ ⁷⁸ ¹⁸⁷ ¹⁸⁸
Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.¹ ² ⁷⁵ ¹⁸⁷ ¹⁸⁸
Spectrum of activity includes many gram-positive and gram-negative aerobic bacteria;¹ ¹⁸⁷ ¹⁸⁸ inactive against most anaerobic bacteria.² ¹⁴ ²³ ⁵⁹ ⁶⁰ ⁷⁵ Inactive against chlamydia, fungi, and viruses.¹ ² ^b
Gram-positive aerobes: Active in vitro and in clinical infections against Streptococcus pneumoniae¹ and Streptococcus pyogenes (group A β-hemolytic streptococci).¹ ² ³ ¹³ ¹⁴ ²⁰ ²³ ⁵⁰ ⁵⁹ ⁶⁰ ⁶⁶ ⁷⁷ ⁷⁸ ⁷⁹ Also active in vitro against S. agalactiae (group B streptococci)¹ ² ¹³ ¹⁵ ¹⁸ ²³ ⁵⁰ ⁵⁹ ⁶⁰ ⁶⁶ ⁷⁵ and groups C, F, and G streptococci.¹³ ²³ ⁵⁹ ⁶⁰ ⁶⁶ Most staphylococci, enterococci, and Listeria monocytogenes are resistant.¹ ² ³ ¹³ ¹⁴ ¹⁸ ²⁰ ²³ ⁵⁹ ⁶⁰ ⁶⁶ ⁶⁹ ⁷⁵ ⁷⁸ ¹⁰¹
Strains of staphylococci resistant to penicillinase-resistant penicillins (oxacillin-resistant [methicillin-resistant] staphylococci) should be considered resistant to cefixime, although results of in vitro susceptibility tests may indicate susceptibility.¹³²
Gram-negative aerobes: Active in vitro and in clinical infections against Neisseria gonorrhoeae,¹ ² ³ ⁵ ¹¹ ¹⁴ ²³ ⁵⁹ ⁶⁰ ⁷⁵ Haemophilus influenzae (including β-lactamase-producing strains),¹ ² ³ ⁵ ⁸ ¹⁰ ¹³ ¹⁴ ¹⁸ ²⁰ ²³ ⁵⁰ ⁵⁹ ⁶⁵ ⁶⁶ ⁶⁸ ⁷⁵ ⁷⁶ ⁷⁷ ⁷⁸ Moraxella catarrhalis (including β-lactamase-producing strains),¹ ² ³ ⁵ ¹³ ²⁰ ²³ ⁵⁸ ⁵⁹ ⁶⁶ ⁷⁵ ⁷⁷ ⁷⁸ Escherichia coli,¹ and Proteus mirabilis.¹ ¹⁵ ²¹ ²³ ⁵⁹ ⁶⁰ ⁷⁵ Also active in vitro against H. parainfluenzae,¹ ² ⁸ ¹³ Klebsiella,¹ Pasteurella multocida,¹ P. vulgaris,¹ Providencia,¹ Salmonella,¹ Shigella,¹ and Serratia.¹ Most Enterobacter⁵ ⁶⁰ ⁷⁵ and Pseudomonas are resistant.² ⁵ ¹³ ¹⁴ ¹⁵ ²⁰ ²³ ⁵⁹ ⁶⁰ ⁶⁶ ⁷⁵ ¹⁰¹

Advice to Patients

Advise patients that antibacterials (including cefixime) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).¹ ¹⁸⁷ ¹⁸⁸
Importance of completing full course of therapy, even if feeling better after a few days.¹ ¹⁸⁷ ¹⁸⁸
Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with cefixime or other antibacterials in the future.¹ ¹⁸⁷ ¹⁸⁸
Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued. Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.
Importance of discontinuing cefixime and informing clinician if an allergic reaction occurs.¹ ¹⁸⁷ ¹⁸⁸
Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.¹ ¹⁸⁷ ¹⁸⁸
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹ ¹⁸⁷ ¹⁸⁸
Importance of informing patients of other important precautionary information.¹ ¹⁸⁷ ¹⁸⁸ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Cefixime (Trihydrate)
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	For suspension	100 mg/5 mL (of cefixime)	Suprax	Lupin
		200 mg/5 mL (of cefixime)	Suprax	Lupin
	Tablets	400 mg (of cefixime)	Suprax	Lupin

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2013. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Suprax 100MG/5ML Suspension (LUPIN PHARMACEUTICALS): 100/$293.93 or 300/$850.38

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions November 1, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

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