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Pharmacology: Pharmacodynamics: Antibacterial Activity: Cefixime has a broad-spectrum activity against Gram-positive and Gram-negative microorganisms. In comparison with the other oral cephalosporins, this product has a particular potent activity against such gram-positive organisms as Streptococcus sp., Streptococcus pneumoniae, and such gram-negatives as Neisseria gonorrhoeae, Branhamella catarrhalis, Escherichia coli, Klebsiella sp., Serratia sp., Proteus sp., and Haemophilus influenzae. Its mechanism of action is bactericidal.
It is extremely stable to β-lactamase produced by many organisms, and has good activity against β-lactamase producing organisms.
Mechanism of Action: Cefixime acts by inhibiting the cell wall synthesis. It has high affinity for penicillin binding proteins (PBP)1 (1a, 1b, and 1c) and 3, with the site of activity varying according to organism.
Pharmacokinetics: Serum concentration: Following a single-oral dose of 50, 100 or 200 mg (potency) of Cefixime in healthy, fasted adults, maximum serum concentrations at 4 hours were 0.69, 1.13, and 1.95 mcg/mL, respectively. The serum half-life was 2.3-2.5 hours. Following a single oral dose of 1.5, 3.0 or 6.0 mg (potency)/kg of Cefixime in pediatric patients with normal renal function, maximum serum concentrations at 3-4 hours were 1.14, 2.01, and 3.97 mcg/mL, respectively. The serum half-life was 3.2-3.7 hours.
Diffusion and tissue penetration: Penetration into sputum, tonsils, maxillary sinus, mucosal tissue, otorrhea, biliary fluid and gallbladder tissue is good.
Metabolism: No antibacterially active metabolites are found in the human serum or urine.
Excretion: Cefixime is primarily renally excreted. The extent of urinary excretion (up to 12 hours) after oral administration of 50, 100 or 200 mg (potency) in healthy, fasted adults was about 20-25%. Maximum urine concentrations were 42.9, 62.2, and 82.7 mcg/mL at 4-6 hours. The extent of urinary excretion (up to 12 hours) after oral administration of 1.5, 3.0, or 6.0 mg (potency)/kg in pediatric patients with normal renal function was about 13-20%.
