Adverse Reactions Reported for Cephalosporin-class DrugsPharmacokinetic Parameters (mean ± SD) for Cefixime in Both Young & Elderly SubjectsWe comply with the HONcode standard for trustworthy health information -
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Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Diseases & Conditions
Indicated in the treatment of acute exacerbations of chronic bronchitis caused by susceptible isolates of Streptococcus pneumoniae and Haemophilus influenzae400 mg/day PO in single daily dose or divided q12hrIndicated in the treatment of otitis media caused by susceptible isolates of Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes400 mg/day PO in single daily dose or divided q12hrIndicated in the treatment of pharyngitis and tonsillitis caused by susceptible isolates of Streptococcus pyogenes400 mg/day PO in single daily dose or divided q12hrAlternative treatment of uncomplicated urogenital, anorectal, or pharyngeal gonorrhea if ceftriaxone unavailable; no longer indicated as first-line treatment, per CDC guidelines400 mg PO once plus azithromycin 1 g PO once (preferred) or alternatively doxycycline 100 mg PO q12hr for 7 daysCDC STD guidelines: MMWR Recomm Rep. June 5, 2015:64(RR3);1-137Indicated in the treatment of uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli and Proteus mirabilis400 mg/day PO in single daily dose or divided q12hrTreatment of infections due to Streptococcus pyogenes, cefixime should be administered for at least 10 days6 months-12 years, ≤45 kg: 8 mg/kg/day PO in single daily dose or divided q12hr >12 years, >45 kg: 400 mg/day PO in single daily dose or divided q12hr6 months-12 years, ≤45 kg: 8 mg/kg/day PO in single daily dose or divided q12hr >12 years, >45 kg: 400 mg/day PO in single daily dose or divided q12hr6 months-12 years, ≤45 kg: 8 mg/kg/day PO in single daily dose or divided q12hr >12 years, >45 kg: 400 mg/day PO in single daily dose or divided q12hr6 months-12 years, ≤45 kg: 8 mg/kg/day PO in single daily dose or divided q12hr >12 years, >45 kg: 400 mg PO once plus azithromycin 1 g in single dose or doxycycline 100 mg PO q12hr for 7 days6 months-12 years, ≤45 kg: 8 mg/kg/day PO in single daily dose or divided q12hr >12 years, >45 kg: 400 mg/day PO in single daily dose or divided q12hr15-20 mg/kg/day PO divided q12hr for 7-14 days; not to exceed 400 mg/dayDosage must be adjusted in severe renal insufficiency (high doses may cause CNS toxicity, including seizures); superinfections and promotion of nonsusceptible organisms may occur with prolonged use or repeated therapyUse with caution in patients with history of penicillin allergyBacterial or fungal overgrowth of nonsusceptible organisms may occur with prolonged or repeated therapyImmune-mediated hemolytic anemia reported; monitor hematologic parameters during and for 2 to 3 weeks after therapy; discontinue therapy if hemolytic anemia occurs during treatmentPhenylalanine can be harmful to patients with phenylketonuria (PKU); chewable tablets contain aspartame, a source of phenylalanine; before prescribing, consider combined daily amount of phenylalanine from all sources, including chewable tabletsUse caution in patients with history of gastrointestinal diseaseClostridium difficile associated diarrhea (CDAD) reported with use of nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis; if CDAD is suspected or confirmed, discontinue ongoing antibacterial drug use not directed against C. difficile; institute appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile, and surgical evaluation as clinically indicatedImmune-mediated hemolytic anemia reported; monitor hematologic parameters during and for 2 to 3 weeks after therapy; discontinue therapy if hemolytic anemia occurs during treatmentCephalosporins may be associated with a fall in prothrombin activity; patients with renal or hepatic impairment, or poor nutritional state, patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy; monitor prothrombin time in patients at risk and exogenous vitamin K administered as indicatedMay cause acute renal failure including tubulointerstitial nephritis; discontinue therapy if renal failure occurs and initiate supportive therapySevere cutaneous reactions, including Stevens-Johnson syndrome, epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS) reported; discontinue therapy and implement supportive therapy if reaction occursAvailable data from published observational studies, case series, and case reports over several decades with cephalosporin use, including cefixime, in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomesMaternal gonorrhea may be associated with preterm birth, low neonatal birth weight, chorioamnionitis, intrauterine growth restriction, small for gestational age and premature rupture of membranes; perinatal transmission of gonorrhea to offspring can result in infant blindness, joint infections, and bloodstream infectionsThere are no available data on presence of drug in human milk, effects on breastfed infant, or on milk production; drug is present in animal milk; when a drug is present in animal milk, it is likely the drug will be present in human milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from mother’s underlying conditionA: Generally acceptable.
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– 200 mg tablet – 100 mg/5 ml powder for oral suspension, to be reconstituted with filtered water.
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. Unlicensed use.
The recommended dose of cefixime is 400 mg daily. A single 200 mg tablet of cefixime produces an average peak serum concentration of approximately 2 mcg/mL (range 1 to 4 mcg/mL); a single 400 mg tablet produces an average peak concentration of approximately 3.7 mcg/mL (range 1.3 to 7.7 mcg/mL).
If an allergic reaction to cefixime occurs, discontinue the drug.If CDAD is suspected or confirmed, ongoing antibacterial use not directed against The dose of cefixime should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (CAPD) and hemodialysis (HD).
Five percent (5%) of patients in the U.S. clinical trials discontinued therapy because of drug-related adverse reactions.