Dosing & Uses
Dosage Forms & Strengths
capsule
- 400mg
tablet, chewable
- 100mg
- 200mg
oral suspension
- 100mg/5mL
- 200mg/5mL
- 500mg/5mL
Acute Exacerbations of Chronic Bronchitis
Indicated in the treatment of acute exacerbations of chronic bronchitis caused by susceptible isolates of Streptococcus pneumoniae and Haemophilus influenzae
400 mg/day PO in single daily dose or divided q12hr
Otitis Media
Indicated in the treatment of otitis media caused by susceptible isolates of Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes
400 mg/day PO in single daily dose or divided q12hr
Pharyngitis/Tonsillitis
Indicated in the treatment of pharyngitis and tonsillitis caused by susceptible isolates of Streptococcus pyogenes
400 mg/day PO in single daily dose or divided q12hr
Uncomplicated Gonorrhea
Alternative treatment of uncomplicated urogenital, anorectal, or pharyngeal gonorrhea if ceftriaxone unavailable; no longer indicated as first-line treatment, per CDC guidelines
400 mg PO once plus azithromycin 1 g PO once (preferred) or alternatively doxycycline 100 mg PO q12hr for 7 days
CDC STD guidelines: MMWR Recomm Rep. June 5, 2015:64(RR3);1-137
Uncomplicated Urinary Tract Infections
Indicated in the treatment of uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli and Proteus mirabilis
400 mg/day PO in single daily dose or divided q12hr
Typhoid Fever (Off-label)
15-20 mg/kg/day PO divided q12hr for 7-14 days
Dosing Modifications
Renal impairment
- CrCl >60 mL/min: No dosage adjustment necessary
- CrCl 21-60 mL/min: 260 mg/day PO
- CrCl ≤20 mL/min or continuous peritoneal dialysis : 200 mg/day PO
Dosing Considerations
Treatment of infections due to Streptococcus pyogenes, cefixime should be administered for at least 10 days
Susceptible organisms
- Escherichia coli, Haemophilus influenzae, Neisseria gonorrhoeae, Proteus mirabilis, Streptococcus pneumoniae, Streptococcus pyogenes, Enterobacteriaceae, Salmonella spp, Serratia spp, Shigella spp
Dosage Forms & Strengths
capsule
- 400mg
tablet, chewable
- 100mg
- 200mg
oral suspension
- 100mg/5mL
- 200mg/5mL
- 500mg/5mL
Acute Bronchitis & Acute Exacerbations of Chronic Bronchitis
<6 months: Safety and efficacy not established
6 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 q12hr
Otitis Media
<6 months: Safety and efficacy not established
6 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 q12hr
Pharyngitis/Tonsillitis
<6 months: Safety and efficacy not established
6 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 q12hr
Uncomplicated Gonorrhea
Cervical or urethral gonorrhea
<6 months: Safety and efficacy not established
6 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 days
Uncomplicated Urinary Tract Infections
<6 months: Safety and efficacy not established
6 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 q12hr
Typhoid Fever (Off-label)
15-20 mg/kg/day PO divided q12hr for 7-14 days; not to exceed 400 mg/day
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Diarrhea (16%)
Frequency Not Defined
Abdominal pain
Candidiasis
Dizziness
Dyspepsia
Elevated transaminases
Eosinophilia
Erythema multiforme
Fever
Flatulence
Headache
Increased blood urea nitrogen (BUN)
Increased creatinine
Leukopenia
Nausea
Prolonged prothrombin time (PT)
Pruritus
Pseudomembranous colitis
Rash
Serum sickness-like reaction
Stevens-Johnson syndrome
Thrombocytopenia
Urticaria
Vaginitis
Vomiting
Warnings
Contraindications
Documented hypersensitivity
Cautions
Limited activity against anaerobes
Dosage 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 therapy
Use with caution in patients with history of penicillin allergy
Bacterial or fungal overgrowth of nonsusceptible organisms may occur with prolonged or repeated therapy
Immune-mediated hemolytic anemia reported; monitor hematologic parameters during and for 2 to 3 weeks after therapy; discontinue therapy if hemolytic anemia occurs during treatment
Phenylalanine 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 tablets
Use caution in patients with history of gastrointestinal disease
Clostridium 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 indicated
Immune-mediated hemolytic anemia reported; monitor hematologic parameters during and for 2 to 3 weeks after therapy; discontinue therapy if hemolytic anemia occurs during treatment
Cephalosporins 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 indicated
May cause acute renal failure including tubulointerstitial nephritis; discontinue therapy if renal failure occurs and initiate supportive therapy
Severe 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 occurs
Drug interactions overview
- Concomitant use with cefixime and carbamazepine may elevate carbamazepine levels reported in postmarketing experience
- Administration of cefixime may result in a false-positive reaction for glucose in the urine using Clinitest®, Benedict’s solution, or Fehling’s solution; use glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix® or TesTape®) be used
- A false-positive direct Coombs test reported during treatment with other cephalosporins; therefore, it should be recognized that a positive Coombs test may be due to the drug
Pregnancy & Lactation
Pregnancy
There are no adequate and well-controlled studies in pregnant women
Cefixime has not been studied for use during labor and delivery
Treatment should only be given if clearly needed
Lactation
Unknown whether cefixime is excreted in human milk
Consider discontinuing nursing temporarily during treatment
Pregnancy Categories
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Mechanism of Action
Third-generation oral cephalosporin with broad activity against gram-negative bacteria; by binding to 1 or more penicillin-binding proteins, it arrests bacterial cell-wall synthesis and inhibits bacterial growth
Absorption
Bioavailability: 40-50%
Average peak plasma concentration: ~2 mcg/mL (single 200 mg-tablet); ~3.7 mcg/mL (single 400 mg-tablet)
Peak plasma time: 2-6 hr (single 200mg, 400 mg–tablet or 400mg suspension); 2-5 hr (single 200 mg-suspension); 3-8 hr (single 400 mg-capsule)
Food reduces absorption following administration of the capsule by ~15% based on AUC and 25% based on peak plasma concentrations
Distribution
Distributed widely throughout body and reaches therapeutic concentration in most tissues and body fluids, including synovial, pericardial, pleural, and peritoneal; bile, sputum, and urine; bone, myocardium, gallbladder, skin, and soft tissue
Protein bound: 65%
Elimination
Half-life: 3-4 hr
Excretion: Urine (50% as unchanged drug), feces (10%)
Administration
Oral Suspension Preparation
Tap bottle several times to loosen powder contents prior to reconstitution
Add ~1/2 of the total amount of water for reconstitution and shake well (refer to prescribing information for specific volumes)
Add remainder of water and shake well
Oral Administration
Administer orally once or twice daily depending on indication
Do not substitute tablet or capsule for the chewable tablets or suspension in the treatment of otitis media
Chewable tablets must be chewed or crushed before swallowing
Storage
Capsules, chewable tablets, or tablets: Store at 20-25°C (68-77°F)
Unused suspension: Store at 20-25°C (68-77°F)
Reconstituted suspension
- Store at room temperature, or under refrigeration, without significant loss of potency for up to 14 days
- Keep tightly closed
- Shake well before using
- Discard unused portion after 14 days
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Patient Handout
Formulary
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