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Indications/Uses
Used in the treatment of susceptible infections including gonorrhea, otitis media, pharyngitis, lower respiratory tract infections such as bronchitis, and urinary tract infections.
Dosage/Direction for Use
Adults: The recommended dose of Cefixime is 400 mg daily. This may be given as 400 mg once daily or as 200 mg every 12 hours.
Children: The recommended dose is 8 mg/kg/day. This may be administered as a single daily dose or may be given in two divided doses, as 4 mg/kg every 12 hours.
Children weighing 37.5 kg: 300 mg/day or 3 capsules/day; 31.25 kg: 250 mg/day or 2½ capsules/day; 25 kg: 200 mg/day or 2 capsules/day; 18.75 kg: 150 mg/day or 1½ capsule/day; 12.5 kg: 100 mg/day or 1 capsule/day; 6.25 kg: 50 mg/day or ½ capsule/day.
Children weighing more than 50 kg or older than 12 years should not be treated with the recommended adult dose.
Children: The recommended dose is 8 mg/kg/day. This may be administered as a single daily dose or may be given in two divided doses, as 4 mg/kg every 12 hours.
Children weighing 37.5 kg: 300 mg/day or 3 capsules/day; 31.25 kg: 250 mg/day or 2½ capsules/day; 25 kg: 200 mg/day or 2 capsules/day; 18.75 kg: 150 mg/day or 1½ capsule/day; 12.5 kg: 100 mg/day or 1 capsule/day; 6.25 kg: 50 mg/day or ½ capsule/day.
Children weighing more than 50 kg or older than 12 years should not be treated with the recommended adult dose.
Overdosage
There is no experience with overdoses with Cefixime. Gastric lavage may be indicated in over dosage. No specific antidote exists. Cefixime is not removed from the circulation in significant quantities by dialysis.
Administration
May be taken with or without food: May be taken w/ food or milk to reduce GI discomfort.
Contraindications
Hypersensitivity to Cefixime, other cephalosporin antibiotics or to any of the excipients. Previous, immediate and/or severe hypersensitivity reaction to penicillin or any beta-lactam antibiotic.
Special Precautions
Superinfection/Clostridium difficile-associated Diarrhea and Colitis: Possible emergence and overgrowth of nonsusceptible bacteria or fungi, especially Enterobacter, Pseudomonas, Enterococci, Staphylococci, or Candida. Careful observation of the patient is essential.
History of GI Disease: Use Cefixime with caution in patients with a history of GI disease, particularly colitis.
Hypersensitivity Reactions: Hypersensitivity reactions such as anaphylaxis (including shock and fatalities), angioedema, serum sickness-like reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported. The use of cefixime should be discontinued immediately and appropriate emergency measures should be initiated. Decreased Prothrombin Activity: Prolonged PT and prolonged partial thromboplastin time reported.
Renal Insufficiency: Cefixime should be administered with caution in adult patients with creatinine clearance <20 ml / min.
Use in Pregnancy: Cefixime should not be used in pregnant mothers unless considered essential by the physician.
Use in Lactation: It is unknown whether cefixime is excreted in human breast milk. Cefixime should not be prescribed to breastfeeding mothers.
Pediatric Use: Safety and efficacy not established in children <6 months of age.
History of GI Disease: Use Cefixime with caution in patients with a history of GI disease, particularly colitis.
Hypersensitivity Reactions: Hypersensitivity reactions such as anaphylaxis (including shock and fatalities), angioedema, serum sickness-like reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported. The use of cefixime should be discontinued immediately and appropriate emergency measures should be initiated. Decreased Prothrombin Activity: Prolonged PT and prolonged partial thromboplastin time reported.
Renal Insufficiency: Cefixime should be administered with caution in adult patients with creatinine clearance <20 ml / min.
Use in Pregnancy: Cefixime should not be used in pregnant mothers unless considered essential by the physician.
Use in Lactation: It is unknown whether cefixime is excreted in human breast milk. Cefixime should not be prescribed to breastfeeding mothers.
Pediatric Use: Safety and efficacy not established in children <6 months of age.
Adverse Reactions
Gastrointestinal Disturbances: The most frequent side effects seen with Cefixime are diarrhea and stool changes. Moderate to severe diarrhea has been reported. Other gastrointestinal side effects seen less frequently are nausea, abdominal pain, dyspepsia, vomiting and flatulence. Pseudomembranous colitis has been reported.
Central Nervous System: Headache and dizziness.
Hypersensitivity Reactions: Allergies in the form of rash, pruritus urticaria, drug fever and arthralgia have been observed. These reactions usually subsided upon discontinuation of therapy.
Haematological and Clinical Chemistry: Thrombocytopenia, leukopenia and eosinophilia have been reported. Miscellaneous: Other possible reactions include genital pruritus and vaginitis.
Central Nervous System: Headache and dizziness.
Hypersensitivity Reactions: Allergies in the form of rash, pruritus urticaria, drug fever and arthralgia have been observed. These reactions usually subsided upon discontinuation of therapy.
Haematological and Clinical Chemistry: Thrombocytopenia, leukopenia and eosinophilia have been reported. Miscellaneous: Other possible reactions include genital pruritus and vaginitis.
Drug Interactions
A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper sulphate test tablets, but not with tests based on enzymatic glucose oxidase reactions. A false positive direct Coombs' test has been reported during treatment with cephalosporin antibiotics; Carbamazepine; Nifedipine, Probenecid; Anticoagulants, oral (warfarin).
Storage
Store at temperatures not exceeding 30°C. Protect from light and moisture.
Action
Pharmacology: Cefixime is an antibacterial agent of the cephalosporin class. Like other cephalosporins, Cefixime inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs); which in turn inhibit 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.
Pharmacokinetics: Absorption: The absolute oral bioavailability of Cefixime is in the range of 22-54%. Absorption is not significantly modified by the presence of food. Cefixime may therefore be given without regard to meals.
Distribution: The mean volume of distribution of Cefixime is 0.1 L/kg. Penetration into tissue fluid is slow (mean tmax=6.7h) but peak concentration similar to those of plasma has been achieved. Lower levels are found in palatine tonsil, maxillary sinus mucosa, sputum and middle ear discharge. Very high concentrations occur in bile. After single oral dose of 100 mg, mean biliary concentrations is 135 mg/ml. Cefixime is almost exclusively bound to the albumin fraction, the mean free fraction being approximately 30%. Protein binding of Cefixime is only concentration dependent in human serum at very high concentrations which are not seen following clinical dosing.
Elimination: Cefixime is predominantly eliminated as unchanged drug in the urine. Glomerular filtration is considered the predominant mechanism. Metabolites of Cefixime have not been isolated from human serum or urine.
Half life: Half life of Cefixime in adults with normal renal function is 2.4-4 hours. In patients with renal impairment, half-life averages 6-11.5 hours.
Pharmacokinetics: Absorption: The absolute oral bioavailability of Cefixime is in the range of 22-54%. Absorption is not significantly modified by the presence of food. Cefixime may therefore be given without regard to meals.
Distribution: The mean volume of distribution of Cefixime is 0.1 L/kg. Penetration into tissue fluid is slow (mean tmax=6.7h) but peak concentration similar to those of plasma has been achieved. Lower levels are found in palatine tonsil, maxillary sinus mucosa, sputum and middle ear discharge. Very high concentrations occur in bile. After single oral dose of 100 mg, mean biliary concentrations is 135 mg/ml. Cefixime is almost exclusively bound to the albumin fraction, the mean free fraction being approximately 30%. Protein binding of Cefixime is only concentration dependent in human serum at very high concentrations which are not seen following clinical dosing.
Elimination: Cefixime is predominantly eliminated as unchanged drug in the urine. Glomerular filtration is considered the predominant mechanism. Metabolites of Cefixime have not been isolated from human serum or urine.
Half life: Half life of Cefixime in adults with normal renal function is 2.4-4 hours. In patients with renal impairment, half-life averages 6-11.5 hours.
MedsGo Class
Cephalosporins
Features
Brand
Bacticef
Full Details
Dosage Strength
200mg
Drug Ingredients
- Cefixime
Drug Packaging
Capsule 1's
Generic Name
Cefixime Trihydrate
Dosage Form
Capsule
Registration Number
DRP-6904
Drug Classification
Prescription Drug (RX)