Note: Unless otherwise specified, any dosage form may be used. Oral suspension is available in multiple concentrations; use caution.
General dosing; susceptible infection (mild to moderate): Infants, Children, and Adolescents: Oral: 8 mg/kg/day once daily or in divided doses every 12 hours; maximum daily dose: 400 mg/day (Ref).
Febrile neutropenia (low-risk): Limited data available: Infants, Children, and Adolescents: Oral: 8 mg/kg/day once daily or in divided doses every 12 hours; in most trials, cefixime therapy was initiated as step-down therapy after 48 to 72 hours of empiric parenteral antibiotic therapy with first cefixime dose administered at the end of the last IV infusion (Ref). Note: In clinical trials, doses were repeated if patient vomited within 2 hours.
Gonococcal infection, uncomplicated infections of the cervix, urethra, or rectum (alternative agent): Children ≥45 kg and Adolescents: Oral: 800 mg as a single dose. If chlamydial infection has not been excluded, give as part of an appropriate combination regimen (Ref). Note: Cefixime should only be used if ceftriaxone is unavailable (Ref).
Irinotecan-associated diarrhea, prophylaxis: Limited data available: Infants, Children, and Adolescents: Oral: 8 mg/kg once daily; begin 5 days before oral irinotecan therapy and continue throughout course (Ref).
Otitis media, acute (alternative agent): Oral suspension or chewable tablets: Infants, Children, and Adolescents: Oral: 8 mg/kg/day once daily or in divided doses every 12 hours; maximum daily dose: 400 mg/day. Note: Not preferred therapy; may be considered in combination with clindamycin in certain scenarios after failure of first-line agents (Ref).
Rhinosinusitis, acute bacterial (alternative agent): Infants, Children, and Adolescents: Oral: 8 mg/kg/day once daily or in divided doses every 12 hours with concomitant clindamycin for 10 to 14 days; maximum daily dose: 400 mg/day (Ref). Note: Not first-line therapy; may be considered after failure of initial therapy or in patients with non-type I penicillin allergy (Ref).
Streptococcus, group A; pharyngitis/tonsillitis (alternative agent for nonanaphylactic penicillin allergy): Note: Narrow-spectrum cephalosporins (eg, cephalexin) are preferred over broad-spectrum cephalosporins such as cefixime (Ref).
Infants, Children, and Adolescents: Oral: 8 mg/kg/day once daily or in divided doses every 12 hours for 10 days; maximum daily dose: 400 mg/day (Ref).
Urinary tract infection, acute: Infants ≥2 months, Children, and Adolescents: Limited data available in infants <6 months: Oral: 8 mg/kg/day once daily or in divided doses every 12 hours for 7 to 14 days (Ref). Note: Shorter courses (1 to 3 days) have been shown to be inferior to longer durations of therapy (Ref).
Infants ≥6 months, Children, and Adolescents: Very limited data available; some clinicians have suggested the following (Ref):
Mild to moderate impairment: No adjustment recommended
Severe impairment (eg, GFR ≤10 to 20 mL/minute/1.73 m2): Reduce dose by 50%
Anuric: Reduce dose by 50%
Hemodialysis, peritoneal dialysis: Not significantly removed
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Cefixime: Drug information")
Usual dosage range: Oral: 400 mg/day divided every 12 or 24 hours.
Gonococcal infection, uncomplicated (infection of the cervix, rectum [off-label use], or urethra) (alternative agent):
Note: Use cefixime only if ceftriaxone cannot be used because cefixime is not as effective (Ref).
Oral: 800 mg as a single dose; give in combination with treatment for chlamydia if it has not been excluded (Ref). When treatment failure is suspected (eg, detection of N. gonorrhoeae after treatment without additional sexual exposure), consult an infectious diseases specialist. Report failures to the CDC through state and local health departments (Ref).
Gonococcal infection, expedited partner therapy (off-label use): Oral: 800 mg as a single dose; give in combination with treatment for chlamydia if it has not been excluded (Ref). Note: Expedited partner therapy (EPT) involves the delivery of medication and educational materials directly to a sex partner by the patient or collaborating pharmacy. Only use EPT if public health strategies are impractical/unavailable and there is concern that the partner will not otherwise get prompt evaluation and treatment. Use EPT with caution in men who have sex with men because of uncertain efficacy and lost opportunities for sexually transmitted infection/HIV risk assessment (Ref).
Rhinosinusitis, acute bacterial (alternative agent for patients with penicillin allergy who are able to tolerate cephalosporins) (off-label use):
Note: In uncomplicated acute bacterial rhinosinusitis, initial observation and symptom management without antibiotic therapy is appropriate in most patients. Reserve antibiotic therapy for poor follow-up or lack of improvement over the observation period (Ref).
Oral: 400 mg once daily with clindamycin for 5 to 7 days (Ref); some experts use as monotherapy when the risk of drug-resistant S. pneumoniae is low (eg, <65 years of age, low endemic resistance, few comorbidities, no recent hospitalization or antibiotic use) (Ref).
Streptococcal pharyngitis, group A (alternative agent for mild, nonanaphylactic penicillin allergy):
Note: Cephalosporin selection depends on the type of hypersensitivity reaction to penicillin. To avoid the development of resistance, narrower spectrum cephalosporins (eg, cephalexin or cefadroxil) are preferred when possible (Ref).
Oral: 400 mg once daily for 10 days (Ref).
Typhoid fever (off-label use): Oral: 100 to 200 mg twice daily for 7 to 14 days (Ref).
Urinary tract infection (alternative agent): Note: Use only when preferred agents cannot be used; limited evidence suggests inferior efficacy of oral beta-lactams (Ref).
Cystitis, acute uncomplicated or acute simple cystitis (infection limited to the bladder without signs/symptoms of upper tract, prostate, or systemic infection): Oral: 400 mg once daily for 7 days (Ref).
Urinary tract infection, complicated (including pyelonephritis): Oral: 400 mg once daily for 10 to 14 days (Ref); for patients with symptomatic improvement within the first 48 to 72 hours of therapy, some experts recommend shorter courses of 7 to 10 days (Ref). Note: Oral therapy should follow appropriate parenteral therapy (Ref).
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Note: Single-dose regimens (eg, 800 mg as a single dose) do not need to be dose adjusted for any degree of kidney dysfunction or type of renal replacement therapy. Renally adjusted dose recommendations are based on doses of 400 mg/day. Use only chewable tablets or oral suspension for patients with kidney dysfunction since unable to achieve recommended doses using capsules. Recommendations below are expert opinion derived from Dhib 1991, Guay 1986, and manufacturer's labeling.
Altered kidney function:
CrCl ≥60 mL/minute: No dosage adjustment necessary.
CrCl >20 to <60 mL/minute: 300 mg once daily.
CrCl ≤20 mL/minute: 200 mg once daily.
Hemodialysis, intermittent (thrice weekly): Limited dialyzability (Ref): 300 mg once daily.
Peritoneal dialysis: Minimally dialyzed (Ref): 200 mg once daily.
CRRT: No data available; use of an alternative agent is recommended (Ref).
PIRRT (eg, sustained, low-efficiency diafiltration): No data available; use of an alternative agent is recommended (Ref).
No dosage adjustment provided in manufacturer’s labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Gastrointestinal: Diarrhea (16%)
2% to 10%: Gastrointestinal: Abdominal pain, nausea, dyspepsia, flatulence, loose stools
<2%: Acute renal failure, anaphylactoid reaction, anaphylaxis, angioedema, candidiasis, dizziness, drug fever, eosinophilia, erythema multiforme, facial edema, fever, headache, hepatitis, hyperbilirubinemia, increased blood urea nitrogen, increased serum creatinine, increased serum transaminases, jaundice, leukopenia, neutropenia, prolonged prothrombin time, pruritus, pseudomembranous colitis, seizure, serum sickness-like reaction, skin rash, Stevens-Johnson syndrome, thrombocytopenia, toxic epidermal necrolysis, urticaria, vaginitis, vomiting
Hypersensitivity to cefixime, other cephalosporins, or any component of the formulation.
Concerns related to adverse effects:
• Dermatologic reactions: Severe cutaneous reactions (eg, toxic epidermal necrolysis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms [DRESS]) have been reported. If a reaction occurs, discontinue and institute supportive therapy.
• Hemolytic anemia: Immune-mediated hemolytic anemia (including fatalities) has been reported. Monitor patient (including hematologic parameters and drug-induced antibody testing when clinically appropriate) during and for 2 to 3 weeks after therapy. If hemolytic anemia occurs during therapy, discontinue use.
• Hypersensitivity: Hypersensitivity and anaphylaxis have been reported in patients receiving beta-lactam drugs. Use caution in patients with a history of hypersensitivity to cephalosporins, penicillins, or other beta-lactams. If administered to penicillin-sensitive patients, use with caution and discontinue use if allergic reaction occurs.
• Renal failure: May cause acute renal failure, including tubulointerstitial nephritis. If renal failure occurs, discontinue and initiate appropriate supportive therapy.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile–associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Renal impairment: Use with caution in patients with renal impairment; may increase the risk of seizures if dosage not reduced.
• Gastrointestinal disease: Use with caution in patients with a history of GI disease.
• Hemolytic anemia: Do not administer to patients with a history of cephalosporin-associated hemolytic anemia; recurrence of hemolysis is more severe.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggest that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.
• Phenylalanine: Chewable tablets contain phenylalanine; avoid use or use with caution in patients with phenylketonuria (PKU).
May cause diarrhea; reported incidence (~16%) similar in children receiving oral suspension and adults receiving tablet dosage form. Use caution when interchanging product formulations; oral suspension and chewable tablets are bioequivalent but oral immediate release tablets are not bioequivalent; for some infections (eg, otitis media), dosing recommendations are product specific.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule, Oral:
Suprax: 400 mg [DSC]
Generic: 400 mg
Suspension Reconstituted, Oral:
Suprax: 100 mg/5 mL (50 mL [DSC]) [strawberry flavor]
Suprax: 200 mg/5 mL (50 mL [DSC], 75 mL [DSC]); 500 mg/5 mL (10 mL [DSC], 20 mL [DSC]) [contains sodium benzoate; strawberry flavor]
Generic: 100 mg/5 mL (50 mL); 200 mg/5 mL (50 mL, 75 mL)
Tablet Chewable, Oral:
Suprax: 100 mg [DSC], 200 mg [DSC] [contains aspartame, fd&c red #40(allura red ac)aluminum lake; tutti-frutti flavor]
May be product dependent
Capsules (Cefixime Oral)
400 mg (per each): $23.53 - $24.91
Suspension (reconstituted) (Cefixime Oral)
100 mg/5 mL (per mL): $4.45
200 mg/5 mL (per mL): $8.91
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension Reconstituted, Oral:
Suprax: 100 mg/5 mL (50 mL) [contains sodium benzoate]
Generic: 100 mg/5 mL (50 mL, 100 mL)
Tablet, Oral:
Suprax: 400 mg
Generic: 400 mg
Oral: May be administered with or without food; administer with food to decrease GI distress.
Oral suspension: Shake suspension well before use. Oral suspension is available in multiple concentrations; use precaution.
Tablets, chewable: Must be chewed or crushed before swallowing.
May be administered with or without food. Shake oral suspension well before use. Chewable tablets must be chewed or crushed before swallowing.
Capsule, chewable tablet: Store at 20°C to 25°C (68°F to 77°F).
Powder for suspension: Prior to reconstitution, store at 20°C to 25°C (68°F to 77°F). After reconstitution, suspension may be stored for 14 days at room temperature or under refrigeration.
Treatment of urinary tract infections, otitis media, acute exacerbations of chronic bronchitis; treatment of pharyngitis and tonsillitis due to Streptococcus pyogenes; treatment of uncomplicated cervical/urethral gonorrhea due to Neisseria gonorrhoeae (All indications: FDA approved in ages ≥6 months and adults); has also been used for treatment of acute bacterial rhinosinusitis, management of irinotecan-associated diarrhea, and management of low-risk febrile neutropenia.
Note: Due to concerns of resistance, the CDC no longer recommends use of cefixime as a first-line regimen in the treatment of uncomplicated gonorrhea in the US; ceftriaxone is the preferred cephalosporin in combination with azithromycin (CDC 2012; CDC [Workowski 2015]).
Cefixime may be confused with cefepime
Suprax may be confused with Sporanox
Cefiton: Brand name for cefixime [Portugal] may be confused with Ceftim brand name for ceftazidime [Portugal]; Ceftime brand name for ceftazidime [Thailand]; Ceftin brand name for cefuroxime [US, Canada]
Substrate of OAT1/3
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
Aminoglycosides: Cephalosporins may enhance the nephrotoxic effect of Aminoglycosides. Cephalosporins may decrease the serum concentration of Aminoglycosides. Risk C: Monitor therapy
Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination
Furosemide: May enhance the nephrotoxic effect of Cephalosporins. Risk C: Monitor therapy
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy
Mycophenolate: Antibiotics may decrease serum concentrations of the active metabolite(s) of Mycophenolate. Specifically, concentrations of mycophenolic acid (MPA) may be reduced. Risk C: Monitor therapy
Probenecid: May increase the serum concentration of Cephalosporins. Risk C: Monitor therapy
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
Food delays cefixime absorption. Management: May administer with or without food.
Chewable tablets contain phenylalanine; avoid use or use with caution in patients with phenylketonuria (PKU).
Cefixime crosses the placenta and can be detected in the amniotic fluid (Ozyüncü 2010).
An increased risk of major birth defects or other adverse fetal or maternal outcomes has generally not been observed following use of cephalosporin antibiotics.
With prolonged therapy, monitor renal and hepatic function periodically; number and type of stools/day for diarrhea. Observe for signs and symptoms of anaphylaxis during first dose.
Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs); which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.
Note: Chewable tablets and oral suspension are bioequivalent. However, oral suspension and capsule formulation are not considered bioequivalent.
Absorption: 40% to 50%; Note: Capsule AUC reduced by ~15% and Cmax by ~25% when taken with food.
Distribution: Widely throughout the body and reaches therapeutic concentration in most tissues and body fluids, including synovial, pericardial, pleural, peritoneal; bile, sputum, and urine; bone, myocardium, gallbladder, and skin and soft tissue
Protein binding: 65%
Half-life elimination: Normal renal function: 3 to 4 hours; Moderate impairment (CrCl 20 to 40 mL/minute): 6.4 hours; Renal failure: Up to 11.5 hours
Time to peak, serum: Suspension: 2 to 6 hours; Capsule: 3 to 8 hours; Delayed with food
Excretion: Urine (50% of absorbed dose as active drug); feces (10%)
Older adult: Average AUCs at steady state in elderly patients are ~40% higher than average AUCs in healthy adults.
Anti-infective considerations:
Parameters associated with efficacy: Time dependent; associated with time free drug concentration (fT) > minimum inhibitory concentration (MIC): Goal: ≥40% to 50% (fT) > MIC (bacteriostatic), ≥60% to 70% (fT) > MIC (bactericidal) (Craig 1996; Craig 1998; Owens 2001; Turnidge 1998).
Expected drug exposure in normal renal function:
Pediatric patients, Cmax (peak): Single dose: Oral: 8 mg/kg:
Infants ≥2 months of age and children ≤2 years of age: 3.1 ± 1.8 mg/L (Nahata 1993).
Children ≥6 years of age and adolescents ≤13 years of age: 4.04 ± 1.51 mg/L (Mamzoridi 1996).
Adults, Cmax (peak):
Single dose: 400 mg: 3.85 to 4.4 mg/L (Brittain 1985; Faulkner 1988).
Steady state: 400 mg once daily: 4.74 ± 1.43 mg/L.
Postantibiotic effect: Generally <1 hour; varies based on organism (Craig 1991; Craig 1998; Dubois 2000).
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