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Cefixime (Monograph)

Brand name: Suprax
Drug 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

Medically reviewed by Drugs.com on Sep 21, 2023. Written by ASHP.

Introduction

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

Uses for Cefixime

Acute Otitis Media (AOM)

Treatment of AOM1 2 3 5 23 43 56 61 62 63 75 138 164 165 caused by Haemophilus influenzae,1 2 23 61 62 63 Moraxella catarrhalis,1 2 23 61 62 63 or Streptococcus pyogenes (group A β-hemolytic streptococci).1 2 23 62 63

When anti-infectives indicated, AAP recommends high-dose amoxicillin or amoxicillin and clavulanate as drugs of choice for initial treatment of AOM; certain cephalosporins (cefdinir, cefpodoxime, cefuroxime, ceftriaxone) recommended as alternatives for initial treatment in penicillin-allergic patients without a history of severe and/or recent penicillin-allergic reactions.184

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 Generally effective in eradicating S. pyogenes from nasopharynx; efficacy in prevention of subsequent rheumatic fever not established to date.1

AAP, IDSA, AHA, and others recommend a penicillin regimen (10 days of oral penicillin V or oral amoxicillin or single dose of IM penicillin G benzathine) as treatment of choice for S. pyogenes pharyngitis and tonsillitis;82 86 104 152 other anti-infectives (oral cephalosporins, oral macrolides, oral clindamycin) recommended as alternatives in penicillin-allergic patients.82 86 104 152

If an oral cephalosporin used, 10-day regimen of first generation cephalosporin (cefadroxil, cephalexin) preferred instead of other cephalosporins with broader spectrums of activity (e.g., cefaclor, cefdinir, cefixime, cefpodoxime, cefuroxime).82 86 152

Respiratory Tract Infections

Treatment of acute exacerbations of chronic bronchitis caused by S. pneumoniae,1 2 23 44 70 72 103 H. influenzae,1 2 23 44 70 72 103 or M. catarrhalis† [off-label].2 44 70 72 103

Treatment of mild to moderate community-acquired pneumonia† [off-label] (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 Escherichia coli, H. parahaemolyticus, or H. parainfluenzae.2 3 44 64 75

Treatment of mild to moderate sinusitis† [off-label] 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 75 Because of variable activity against S. pneumoniae and H. influenzae, IDSA no longer recommends second or third generation oral cephalosporins for empiric monotherapy of acute bacterial sinusitis.192 Oral amoxicillin or amoxicillin and clavulanate usually recommended for empiric treatment.192 193 If an oral cephalosporin used as an alternative in children (e.g., in penicillin-allergic individuals), combination regimen that includes a third generation cephalosporin (cefixime or cefpodoxime) and clindamycin (or linezolid) recommended.192 193

Urinary Tract Infections (UTIs)

Treatment of uncomplicated UTIs1 2 5 40 51 64 74 75 182 caused by susceptible E. coli1 2 40 51 64 74 75 182 or Proteus mirabilis;1 2 40 51 74 75 182 also has been used for treatment of uncomplicated UTIs caused by susceptible Citrobacter spp.† [off-label],2 51 64 74 C. diversus† [off-label],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 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 71 106 108 109 110 111 130 197

Because of concerns related to recent reports of N. gonorrhoeae with reduced susceptibility to cephalosporins, CDC states that oral cephalosporins no longer recommended as first-line treatment for uncomplicated gonorrhea.197 For treatment of uncomplicated urogenital, anorectal, or pharyngeal gonorrhea, CDC recommends a combination regimen that includes a single dose of IM ceftriaxone and either a single dose of oral azithromycin or 7-day regimen of oral doxycycline.197

Cefixime recommended by CDC as an alternative in patients with urogenital or rectal† gonorrhea when ceftriaxone cannot be used or not available;197 used in conjunction with single dose of oral azithromycin or 7-day regimen of oral doxycycline.197

Consider that N. gonorrhoeae with reduced susceptibility to cefixime, including some treatment failures, reported in US and other countries.194 195 196 197 198 Perform test-of-cure follow-up (culture or nucleic acid amplification test [NAAT]) 1 week after cefixime treatment.197

If infection persists (treatment failure), culture relevant clinical specimens and perform in vitro susceptibility tests.197 Also consult infectious disease specialist, STD/HIV Prevention Training Center ([Web]), or CDC (404-639-8659) for treatment advice and report the case to CDC through local or state health departments within 24 hours of diagnosis.197

For all gonorrhea patients, ensure that their sex partners from preceding 60 days are evaluated promptly with culture and treated with a recommended regimen if indicated.197

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

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

Cefixime Dosage and Administration

Administration

Oral Administration

Administer orally as capsules, conventional tablets, chewable tablets, or oral suspension.1

Capsules and conventional tablets: Administer without regard to meals.1 (See Food under Pharmacokinetics.)

Chewable tablets: Must be chewed or crushed before swallowing.1

Reconstitution

Reconstitute oral suspension at the time of dispensing by adding amount of water specified on the container in 2 equal portions; shake after each addition.1 The reconstituted suspension contains 100, 200, or 500 mg/5 mL.1

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

Dosage

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

Capsules containing 400 mg of cefixime are bioequivalent to conventional 400-mg tablets when administered under fasting conditions.1

Chewable tablets are bioequivalent to oral suspension.1

Conventional tablets and oral suspension are not bioequivalent1 (see Absorption under Pharmacokinetics).

Pediatric Patients

General Pediatric Dosage
Oral

Children beyond neonatal period: AAP recommends 8 mg/kg daily in 1 or 2 equally divided doses for treatment of mild or moderate infections.82 AAP states the drug is inappropriate for treatment of severe infections.82

Children weighing 5–7.5 kg: Oral suspension containing 100 mg/5 mL is preferred preparation.1

Children weighing 7.6–10 kg: Oral suspension containing 100 or 200 mg/5 mL is preferred preparation.1

Children weighing <10 kg: Chewable tablets not recommended.1

Acute Otitis Media (AOM)
Oral

Children 6 months to 12 years of age: 8 mg/kg once daily or 4 mg/kg every 12 hours1 for 10–14 days.23 56 62 63

Children >12 years of age or weighing >45 kg: 400 mg daily1 for 10–14 days.44 64 72

Do not use capsules or conventional tablets for treatment of AOM.1

Pharyngitis and Tonsillitis
Oral

Children 6 months to 12 years of age: 8 mg/kg once daily or 4 mg/kg every 12 hours for ≥10 days.1

Children >12 years of age or weighing >45 kg: 400 mg once daily or 200 mg every 12 hours1 for ≥10 days.44 64 72

Respiratory Tract Infections
Acute Exacerbations of Chronic Bronchitis
Oral

Children 6 months to 12 years of age: 8 mg/kg once daily or 4 mg/kg every 12 hours1 for 10–14 days.44 64 72

Children >12 years of age or weighing >45 kg: 400 mg once daily or 200 mg every 12 hours1 for 10–14 days.44 64 72

Empiric Treatment of Acute Bacterial Sinusitis†
Oral

8 mg/kg daily in 2 equally divided doses for 10–14 days.192

Urinary Tract Infections (UTIs)
Uncomplicated UTIs
Oral

Children 6 months to 12 years of age: 8 mg/kg once daily or 4 mg/kg every 12 hours1 for 5–10 days.2 40 51 74

Children >12 years of age or weighing >45 kg: 400 mg once daily or 200 mg every 12 hours1 for 5–10 days.2 40 51 74

Gonorrhea and Associated Infections
Uncomplicated Urethral, Endocervical, or Rectal† Gonorrhea
Oral

Prepubertal children weighing <45 kg: 8 mg/kg (up to 400 mg) as a single dose.82

Children ≥8 years of age or weighing ≥45 kg: 400 mg as a single dose.82

Use in conjunction with single dose of oral azithromycin or 7-day regimen of oral doxycycline.82 197 Not recommended by CDC as first-line treatment.197 (See Gonorrhea and Associated Infections under Uses.)

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

Acute Otitis Media (AOM)
Oral

400 mg once daily or 200 mg every 12 hours1 for 10–14 days.23 56 62 63

Do not use capsules or conventional tablets for treatment of AOM.1

Pharyngitis and Tonsillitis
Oral

400 mg once daily or 200 mg every 12 hours for ≥10 days.1

Respiratory Tract Infections
Acute Exacerbations of Chronic Bronchitis
Oral

400 mg once daily or 200 mg every 12 hours1 for 10–14 days.44 64 72

Urinary Tract Infections (UTIs)
Uncomplicated UTIs
Oral

400 mg once daily or 200 mg every 12 hours1 for 5–10 days.40 51 74

Gonorrhea and Associated Infections
Uncomplicated Urethral, Endocervical, or Rectal† Gonorrhea
Oral

400 mg as a single dose.1 106 108 130 197 Single 800-mg dose also has been used.2 23 48 106 109 194

Use in conjunction with oral azithromycin (single 1-g dose) or oral doxycycline (100 mg twice daily for 7 days).197 Not recommended by CDC as first-line treatment.197 (See Gonorrhea and Associated Infections under Uses.)

Lyme Disease†
Oral

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

Special Populations

Renal Impairment

Dosage adjustments necessary in patients with Clcr <60 mL/minute.1 2 Adults with Clcr 21–59 mL/minute: 260 mg daily as oral suspension, preferably as oral suspension containing 200 or 500 mg/5 mL; conventional tablets and chewable tablets not recommended.1

Adults with Clcr ≤20 mL/minute: 200 mg daily as conventional tablets or chewable tablets, 172 mg daily as oral suspension containing 100 mg/5 mL, 176 mg daily as oral suspension containing 200 mg/5 mL, or 180 mg daily as oral suspension containing 500 mg/5 mL.1

Adults undergoing hemodialysis: 260 mg daily as oral suspension, preferably as oral suspension containing 200 or 500 mg/5 mL; conventional tablets and chewable tablets not recommended.1

Adults undergoing continuous peritoneal dialysis: 200 mg daily as conventional tablets or chewable tablets, 172 mg daily as oral suspension containing 100 mg/5 mL, 176 mg daily as oral suspension containing 200 mg/5 mL, or 180 mg daily as oral suspension containing 500 mg/5 mL.1

Geriatric Patients

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

Detailed Cefixime dosage information

Cautions for Cefixime

Contraindications

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 Careful observation of the patient is essential.1 Institute appropriate therapy if superinfection occurs.1

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.1 42 177 178 C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all anti-infectives, including cefixime, and may range in severity from mild diarrhea to fatal colitis.1 42 177 178 C. difficile produces toxins A and B which contribute to development of CDAD;1 40 42 hypertoxin-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.1

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.1 42 177 178 Obtain careful medical history since CDAD may occur as late as 2 months or longer after anti-infective therapy is discontinued.42

If CDAD is suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible.42 177 178 Initiate appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.1 42 177 178

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

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

Cross-hypersensitivity

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

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs.1 Cefixime is contraindicated in individuals hypersensitive to cephalosporins.1 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

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

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

Phenylketonuria

Chewable tablets containing 100, 150, and 200 mg of cefixime contain aspartame (NutraSweet), which is metabolized in the GI tract to provide 3.3, 5, and 6.7 mg of phenylalanine, respectively.1

Coombs’ Test Results

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

Decreased Prothrombin Activity

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

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

Specific Populations

Pregnancy

Category B.1

Lactation

Distributed into milk in rats;36 not known whether distributed into milk in humans.1 Discontinue nursing or the drug.1

Pediatric Use

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

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.1

Possible increased oral bioavailability;1 35 37 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 Dosage adjustments necessary if Clcr <60 mL/minute.1 2 33 35 37 (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 loose or frequent stools,1 abdominal pain,1 2 23 40 41 44 51 56 64 67 75 nausea,1 2 23 40 41 44 51 63 64 74 75 dyspepsia,1 2 23 40 41 44 51 75 flatulence).1 2 40 41 75

Drug Interactions

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

Carbamazepine

Increased carbamazepine concentrations1

Monitor carbamazepine concentrations1

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

Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix, Tes-Tape)1

Tests for ketones

Possible false-positive reaction for ketones in urine if nitroprusside tests used; not reported with tests using nitroferricyanide1
Cefixime drug interactions (more detail)

Cefixime Pharmacokinetics

Absorption

Bioavailability

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

Capsules containing 400 mg of cefixime are bioequivalent to conventional tablets containing 400 mg of the drug when administered under fasting conditions.1

Chewable tablets are bioequivalent to the oral suspension.1

Conventional tablets and oral suspension are not bioequivalent;1 studies in adults indicate oral suspension results in peak serum concentrations 25–50% higher than concentrations attained with tablets.1

Food

Conventional tablets and oral suspension: Food decreases rate1 but not extent of absorption.1 2 3 26

Capsules: Food decreases absorption by about 15% (based on AUC) or 25% (based on peak serum concentrations).1

Distribution

Extent

Distributed into bile,1 2 5 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

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

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

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

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

Half-life

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

Special Populations

Adults with moderate renal impairment (Clcr 20–40 mL/minute): Serum half-life averages 6.4 hours.1

Adults with severe renal impairment (Clcr 5–20 mL/minute): Serum half-life averages 11.5 hours.1

Stability

Storage

Oral

Capsules, Conventional Tablets, Chewable Tablets

20–25°C.1

For Suspension

20–25°C.1 After reconstitution, store suspension in tight container at room temperature or in the refrigerator; discard after 14 days.1

Actions and Spectrum

Advice to Patients

Preparations

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

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Cefixime (Trihydrate)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

400 mg (of cefixime)

Suprax

Lupin

For suspension

100 mg (of cefixime) per 5 mL

Suprax

Lupin

200 mg (of cefixime) per 5 mL

Suprax

Lupin

500 mg (of cefixime) per 5 mL

Suprax

Lupin

Tablets, chewable

100 mg (of cefixime)

Suprax

Lupin

150 mg (of cefixime)

Suprax

Lupin

200 mg (of cefixime)

Suprax

Lupin

Tablets, film-coated

400 mg (of cefixime)

Suprax (scored)

Lupin

AHFS DI Essentials™. © Copyright 2024, Selected Revisions October 1, 2013. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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

References

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