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Product Name
:
CEFIXIME-ELSaad (tab)
Chemical Name
:
Cefixime
Therapeutic Category
:
Antimicrobial
Pharmacologic Category
:
Antibiotic, Cephalosporin (Third Generation)
Pharmaceutical Form
:
Tablets
Composition
:
Cefixime 200mg, 400mg
Monitoring Parameters
Dosing
 
Dosing: Adult
Susceptible infections: Oral: 400 mg/day divided every 12-24 hours
S. pyogenes infections: Treat for 10 days
Typhoid fever (unlabeled use): Oral: 20-30 mg/kg/day in 2 divided doses for 7-14 days after I.V. therapy
Uncomplicated cervical/urethral gonorrhea due to N. gonorrhoeae: Oral: 400 mg as a single dose.

Dosing: Pediatric
Susceptible infections: Oral:
Children ≥6 months: 8 mg/kg/day divided every 12-24 hours
Children >50 kg or >12 years: Refer to adult dosing.
S. pyogenes infections: Treat for 10 days
Typhoid fever (unlabeled use): Oral: 20 mg/kg/day for 10-14 days; maximum 400 mg/day.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

Clcr 21-60 mL/minute: Administer 75% of the standard dose.
Clcr <20 mL/minute: Administer 50% of the standard dose.
10% removed by hemodialysis
Use
 
Treatment of urinary tract infections, otitis media, respiratory infections due to susceptible organisms including S. pneumoniae and S. pyogenes, H. influenzae, and many Enterobacteriaceae; uncomplicated cervical/urethral gonorrhea due to N. gonorrhoeae
Adverse Reactions
 
>10%: Gastrointestinal: Diarrhea (16%)
2% to 10%: Gastrointestinal: Abdominal pain, nausea, dyspepsia, flatulence, loose stools
<2% (Limited to important or life-threatening): Acute renal failure, anaphylactic/anaphylactoid reactions, angioedema, BUN increased, candidiasis, creatinine increased, dizziness, drug fever, eosinophilia, erythema multiforme, facial edema, fever, headache, hepatitis, hyperbilirubinemia, jaundice, leukopenia, neutropenia, pruritus, pseudomembranous colitis, PT prolonged, rash, seizure, serum sickness-like reaction, Stevens-Johnson syndrome, thrombocytopenia, toxic epidermal necrolysis, transaminases increased, urticaria, vaginitis, vomiting
Reactions reported with other cephalosporins: Agranulocytosis, aplastic anemia, colitis, hemolytic anemia, hemorrhage, interstitial nephritis, pancytopenia, superinfection
Contraindications
 
Hypersensitivity to cefixime, any component of the formulation, or other cephalosporins
Warnings / Precautions Drug
 
Concerns related to adverse effects:
• Penicillin allergy: Use with caution in patients with a history of penicillin allergy, especially IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria).
• 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; modify dosage.
Interactions
 
BCG: Antibiotics may diminish the therapeutic effect of BCG. Risk X: Avoid combination
Probenecid: May increase the serum concentration of Cephalosporins. Risk C: Monitor therapy
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 24 hours after cessation of antibacterial agents. Risk D: Consider therapy modification
Ethanol/Nutrition/Herb Interactions
Food: Delays cefixime absorption.
Pregnancy
 
B
Pregnancy Implications
Teratogenic effects were not observed in animal studies; therefore cefixime is classified as pregnancy category B. It is not known if cefixime crosses the human placenta; other cephalosporins cross the placenta and are considered safe in pregnancy. Congenital anomalies have not been associated with cefixime use during pregnancy (limited data). Cefixime is recommended for use in pregnant women for the treatment of gonococcal infections.
Lactation
 
Excretion in breast milk unknown
Mechanism of Action
 
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.
Pharmacodynamics / Kinetics
 
Absorption: 40% to 50%
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: 3-4 hours; Renal failure: Up to 11.5 hours
Time to peak, serum: 2-6 hours; delayed with food
Excretion: Urine (50% of absorbed dose as active drug); feces (10%)
 
   
 
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