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 23, 2024. Written by ASHP.

Introduction

Antibacterial; β-lactam antibiotic; third generation cephalosporin.

Uses for Cefixime

Acute Otitis Media (AOM)

Treatment of AOM caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pyogenes (group A β-hemolytic streptococci).

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.

Pharyngitis and Tonsillitis

Treatment of pharyngitis and tonsillitis caused by susceptible S. pyogenes (group A β-hemolytic streptococci). Generally effective in eradicating S. pyogenes from nasopharynx; efficacy in prevention of subsequent rheumatic fever not established to date.

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; other anti-infectives (oral cephalosporins, oral macrolides, oral clindamycin) recommended as alternatives in penicillin-allergic patients.

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).

Respiratory Tract Infections

Treatment of acute exacerbations of chronic bronchitis caused by S. pneumoniae, H. influenzae, or M. catarrhalis^{† [off-label]}.

Treatment of mild to moderate community-acquired pneumonia^{† [off-label]} (CAP) caused by S. pneumoniae, H. influenzae, M. catarrhalis, Escherichia coli, H. parahaemolyticus, or H. parainfluenzae.

Treatment of mild to moderate sinusitis^{† [off-label]} caused by S. pneumoniae, H. influenzae, M. catarrhalis, E. coli, H. parahaemolyticus, or H. parainfluenzae. 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. Oral amoxicillin or amoxicillin and clavulanate usually recommended for empiric treatment. 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.

Urinary Tract Infections (UTIs)

Treatment of uncomplicated UTIs caused by susceptible E. coli or Proteus mirabilis; also has been used for treatment of uncomplicated UTIs caused by susceptible Citrobacter spp.^{† [off-label]}, C. diversus^{† [off-label]}, C. freundii^†, Enterobacter spp.^†, E. aerogenes^†, E. agglomerans^†, Klebsiella spp.^†, K. pneumoniae^†, Morganella morganii^†, Proteus spp.^†, or Serratia^†.

Has been used for treatment of uncomplicated UTIs caused by susceptible gram-positive bacteria, including Staphylococcus epidermidis^†, Staphylococcus spp.^†, Streptococcus agalactiae^†, nonhemolytic streptococci^†, or Enterococcus faecalis^†. 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.

Treatment of pyelonephritis^† and other complicated UTIs^† caused by susceptible Enterobacteriaceae, including E. coli.

Gonorrhea and Associated Infections

Treatment of uncomplicated urethral, endocervical, or rectal infections^† caused by susceptible Neisseria gonorrhoeae.

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. 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.

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

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

If infection persists (treatment failure), culture relevant clinical specimens and perform in vitro susceptibility tests. 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.

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.

Lyme Disease

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

Salmonella and Shigella Infections

Has been used for treatment of typhoid fever (enteric fever) or septicemia caused by multidrug-resistant Salmonella typhi^†.

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

Cefixime Dosage and Administration

Administration

Oral Administration

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

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

Chewable tablets: Must be chewed or crushed before swallowing.

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. The reconstituted suspension contains 100, 200, or 500 mg/5 mL.

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

Dosage

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

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

Chewable tablets are bioequivalent to oral suspension.

Conventional tablets and oral suspension are not bioequivalent (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. AAP states the drug is inappropriate for treatment of severe infections.

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

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

Children weighing <10 kg: Chewable tablets not recommended.

Acute Otitis Media (AOM)

Oral

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

Children >12 years of age or weighing >45 kg: 400 mg daily for 10–14 days.

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

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.

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

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 hours for 10–14 days.

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

Empiric Treatment of Acute Bacterial Sinusitis†

Oral

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

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 hours for 5–10 days.

Children >12 years of age or weighing >45 kg: 400 mg once daily or 200 mg every 12 hours for 5–10 days.

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.

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

Use in conjunction with single dose of oral azithromycin or 7-day regimen of oral doxycycline. Not recommended by CDC as first-line treatment. (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. Usually given for 14 days; high rate of treatment failure occurred when given for only 7 days.

Shigellosis†

Oral

8 mg/kg daily for 5 days.

Adults

Acute Otitis Media (AOM)

Oral

400 mg once daily or 200 mg every 12 hours for 10–14 days.

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

Pharyngitis and Tonsillitis

Oral

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

Respiratory Tract Infections

Acute Exacerbations of Chronic Bronchitis

Oral

400 mg once daily or 200 mg every 12 hours for 10–14 days.

Urinary Tract Infections (UTIs)

Uncomplicated UTIs

Oral

400 mg once daily or 200 mg every 12 hours for 5–10 days.

Gonorrhea and Associated Infections

Uncomplicated Urethral, Endocervical, or Rectal† Gonorrhea

Oral

400 mg as a single dose. Single 800-mg dose also has been used.

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

Lyme Disease†

Oral

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

Special Populations

Renal Impairment

Dosage adjustments necessary in patients with Cl_cr <60 mL/minute. Adults with Cl_cr 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.

Adults with Cl_cr ≤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.

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.

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.

Geriatric Patients

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

Cautions for Cefixime

Contraindications

• Known hypersensitivity to cefixime or other cephalosporins.

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

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile. 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. C. difficile produces toxins A and B which contribute to development of CDAD; 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.

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

If CDAD is suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible. 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.

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.

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).

Cross-hypersensitivity

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

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

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.

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

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.

Coombs’ Test Results

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

Decreased Prothrombin Activity

Prolonged PT and prolonged partial thromboplastin time reported rarely.

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

Specific Populations

Pregnancy

Category B.

Lactation

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

Pediatric Use

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

Geriatric Use

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

Possible increased oral bioavailability; not considered clinically important.

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

Renal Impairment

Increased serum half-life. Dosage adjustments necessary if Cl_cr <60 mL/minute. (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

GI effects (diarrhea, loose or frequent stools, abdominal pain, nausea, dyspepsia, flatulence).

Drug Interactions

Specific Drugs and Laboratory Tests

Cefixime Pharmacokinetics

Absorption

Bioavailability

30–50% of a single oral dose absorbed; peak serum concentrations attained within 2–6 hours.

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

Chewable tablets are bioequivalent to the oral suspension.

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

Food

Conventional tablets and oral suspension: Food decreases rate but not extent of absorption.

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

Distribution

Extent

Distributed into bile, sputum, tonsils, maxillary sinus mucosa, middle ear discharge, blister fluid, and prostatic fluid.

Distribution into CSF unknown.

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

Plasma Protein Binding

65–70%.

Elimination

Metabolism

Does not appear to be metabolized; no biologically active metabolites detected in serum or urine.

Elimination Route

Eliminated by renal and nonrenal mechanisms.

7–50% of a dose excreted unchanged in urine within 24 hours. In animal studies, >10% of a dose may be excreted unchanged in bile.

Not substantially removed by hemodialysis or peritoneal dialysis.

Half-life

Adults with normal renal function: 2.4–4 hours.

Special Populations

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

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

Stability

Storage

Oral

Capsules, Conventional Tablets, Chewable Tablets

20–25°C.

For Suspension

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

Actions and Spectrum

• Based on spectrum of activity, classified as a third generation cephalosporin. Expanded spectrum of activity against gram-negative bacteria compared with first and second generation cephalosporins; less active against Enterobacteriaceae than some other third-generation cephalosporins.

• Usually bactericidal.

• Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.

• Spectrum of activity includes many gram-positive and gram-negative aerobic bacteria; inactive against most anaerobic bacteria. Inactive against chlamydia, fungi, and viruses.

• Gram-positive aerobes: Active in vitro against Streptococcus pneumoniae and Streptococcus pyogenes (group A β-hemolytic streptococci). Also active in vitro against S. agalactiae (group B streptococci) and groups C, F, and G streptococci. Most staphylococci, enterococci, and Listeria monocytogenes are resistant.

• Strains of staphylococci resistant to penicillinase-resistant penicillins (methicillin-resistant [oxacillin-resistant] staphylococci) should be considered resistant to cefixime, although results of in vitro susceptibility tests may indicate susceptibility.

• Gram-negative aerobes: Active in vitro against Neisseria gonorrhoeae, Haemophilus influenzae (including β-lactamase-producing strains), Moraxella catarrhalis (including β-lactamase-producing strains), Escherichia coli, and Proteus mirabilis. Also active in vitro against H. parainfluenzae, Klebsiella, Pasteurella multocida, P. vulgaris, Providencia, Salmonella, Shigella, and Serratia. Most Enterobacter and Pseudomonas are resistant.

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).

• Importance of completing full course of therapy, even if feeling better after a few days.

• 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.

• 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.

• Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.

• Importance of informing patients of other important precautionary information. (See Cautions.)

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.

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Frequently asked questions

• Is there a gonorrhea treatment available over the counter?

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