Class: Antibiotic, Cephalosporin
- Oral suspension 100 mg per 5 mL
- Oral suspension 200 mg per 5 mL
Inhibits mucopeptide synthesis in bacterial cell wall.
About 40% to 50% is absorbed. C max following 200 and 400 mg doses of oral suspension are 3 and 4.6 mcg/mL, respectively. T max occurs between 2 and 6 h following administration of 400 mg and between 2 and 5 h after a 200 mg dose.
Protein binding is about 65%.
About 50% of absorbed dose is excreted unchanged in the urine in 24 h. Serum t ½ averages 3 to 4 h, but may be as long as 9 h in some healthy subjects.
Special PopulationsRenal Function Impairment
Moderate impairment (CrCl 20 to 40 mL/min), the t ½ prolonged to 6.4 h; severe impairment (CrCl 5 to 20 mL/min), the t ½ increased to 11.5 h.Elderly
Average AUCs at steady state in elderly patients are approximately 40% higher than average AUCs in healthy adults.
Indications and Usage
Treatment of uncomplicated UTIs, otitis media, pharyngitis, tonsillitis, acute bronchitis, acute exacerbations of chronic bronchitis, and uncomplicated gonorrhea caused by susceptible strains of specific organisms.
Allergy to cephalosporin group of antibiotics.
Dosage and AdministrationInfection
Adults and Children (weighing more than 50 kg or older than 12 yr of age)
PO 400 mg daily.Children 6 mo to 12 yr of age
PO 8 mg/kg/day as a once-daily dose or in 2 divided doses of 4 mg/kg every 12 h.Uncomplicated Gonorrhea
PO 400 mg as a single dose.Dose Adjustment for Renal Function Impairment
CrCl between 21 and 60 mL/min or on hemodialysis, give 75% of dose (300 mg/day). CrCl less than 20 mL/min or on continuous peritoneal dialysis, give 50% of dose (200 mg/day).
- Administer prescribed dose without regard to meals, but administer with food if GI upset occurs.
- Shake suspension well before measuring dose. Measure and administer prescribed dose of suspension using dosing syringe, dosing spoon, or medicine cup.
Store powder at 68° to 77°F. After reconstitution, store at room temperature or under refrigeration for up to 14 days. Keep tightly closed. Shake well before using. Discard unused portion after 14 days.
Plasma concentrations may be elevated by cefixime, increasing the risk of adverse reactions.Warfarin
Increased PT, with and without bleeding, may occur.
Laboratory Test Interactions
May cause false-positive urine glucose test results with Benedict solution, Fehling solution, or Clinitest tablets, but not with enzyme-based tests (eg, Clinistix , Tes-tape ); false-positive test results for ketones in the urine may occur with tests using nitroprusside but not nitroferricyanide; false-positive direct Coombs test.
Dizziness, headache, seizure (less than 2%).
Erythema multiforme, facial edema, pruritus, skin rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria (less than 2%).
Diarrhea (16%); nausea (7%); loose or frequent stools (6%); flatulence (4%); abdominal pain, dyspepsia (3%); vomiting (less than 2%); pseudomembranous colitis.
Acute renal failure, candidiasis, genital pruritus, transient elevations in BUN or creatinine, vaginitis (less than 2%).
Eosinophilia, leukopenia, neutropenia, prolongation in PT, transient thrombocytopenia (less than 2%); agranulocytosis, pancytopenia.
Hepatitis, jaundice, transient elevations in alkaline phosphatase, ALT, and AST (less than 2%).
Anaphylactic/anaphylactoid reactions (including shock and death), angioedema, drug fever, serum sickness–like reactions (less than 2%).
Hyperbilirubinemia (less than 2%).
Monitor PT and patient's response to therapy.Adverse reactions
Monitor patient for GI, CNS, general body adverse reactions, and signs of superinfection.
Category B .
Safety and efficacy not established in children younger than 6 mo of age.
If administered to penicillin-allergic patients, use with caution because cross-sensitivity has been documented and may occur in up to 10% of patients with penicillin allergy.
Use with caution in patients with renal function impairment. Dosage adjustment based on renal function may be required. Ensure that reduced dose is administered to patient with renal function impairment (CrCl less than 60 mL/min) following manufacturer's guidelines.
May result in bacterial or fungal overgrowth of nonsusceptible microorganisms.
Use with caution, especially for colitis.
A fall in prothrombin activity may occur; patients at risk include patients with renal or hepatic function impairment, poor nutritional status, patients receiving protracted antimicrobial therapy, and patients previously stabilized on anticoagulant therapy.
Consider possibility if diarrhea develops.
- Review dosing schedule and prescribed length of therapy with patient.
- Instruct patient or caregiver to shake well before measuring dose, and to measure and administer prescribed dose using dosing spoon, dosing syringe, or medicine cup.
- Advise patient to take without regard to meals but to take with food if GI upset occurs.
- Instruct patient to complete entire course of therapy even if symptoms of infection have disappeared.
- Advise patient to discontinue therapy and contact health care provider immediately if skin rash, hives, itching, or shortness of breath occur.
- Advise patient to report the following signs of superinfection to health care provider: black “furry” tongue, foul-smelling stools, vaginal itching or discharge, white patches in mouth.
- Instruct patient to notify health care provider if infection does not appear to improve or worsens.
- Instruct patient to immediately report severe diarrhea, diarrhea containing blood or pus, or severe abdominal cramping.
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