Cefixime capsules for treating bacterial infections in adults and children

Cefixime capsules are an oral antibiotic used to treat various bacterial infections in adults and children aged six months and older. They target specific infections like urinary tract infections, throat infections, bronchitis exacerbations, and uncomplicated gonorrhea caused by susceptible bacteria.

• Treatment of uncomplicated urinary tract infections in adults and pediatric patients six months and older caused by Escherichia coli and Proteus mirabilis.
• Treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes in adults and pediatric patients six months and older. (Note: Penicillin is the usual drug of choice for Streptococcus pyogenes; cefixime effectively eradicates bacteria from the nasopharynx but has no established data on preventing rheumatic fever.)
• Treatment of acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae in adults and pediatric patients six months and older.
• Treatment of uncomplicated cervical or urethral gonorrhea caused by susceptible Neisseria gonorrhoeae isolates, including penicillinase-producing strains, in adults and pediatric patients six months and older.

Cefixime

Cefixime is a cephalosporin antibiotic that works by interfering with the bacterial cell wall synthesis, leading to the destruction of susceptible bacteria responsible for the infection.

Adults:

• 400 mg orally once daily. For uncomplicated gonorrhea (cervical/urethral), a single 400 mg oral dose is recommended.
• For Streptococcus pyogenes infections, treatment should continue for at least 10 days.

Pediatric patients (6 months and older):

• 8 mg/kg/day divided as appropriate; patients weighing over 45 kg or older than 12 years can be treated using adult dosing.
• Do not substitute cefixime capsules for Suprax chewable tablets or suspension when treating otitis media, as these forms achieve higher blood levels.
• Treatment duration for Streptococcus pyogenes infections is at least 10 days.

Renal impairment:

• Normal dosing can be used in patients with creatinine clearance ≥60 mL/min.
• Dose adjustment and careful monitoring are required for patients with renal impairment or undergoing dialysis.
• Hemodialysis and peritoneal dialysis do not significantly remove cefixime from the body.

Administration:

• The capsule may be taken with or without food.

Known allergy to cefixime or other cephalosporin antibiotics.

Serious hypersensitivity reactions:

Anaphylaxis and anaphylactoid reactions, including shock and fatalities, have occurred. Treatment should be discontinued immediately if such reactions develop. Caution is advised in patients with a history of penicillin allergy due to possible cross-reactivity.

Clostridioides difficile-associated diarrhea (CDAD):

CDAD ranging from mild diarrhea to fatal colitis has been reported during or after treatment with cefixime. Consider this diagnosis in any patient developing diarrhea after antibiotic use, even up to two months later. Early diagnosis and appropriate management including stopping cefixime if possible, fluid and electrolyte replacement, and specific treatment for C. difficile are critical.

Coagulation abnormalities:

Cefixime can reduce prothrombin activity, especially in patients with renal or hepatic impairment, poor nutrition, those on long courses of antibiotics, or stabilized on anticoagulants. Monitor prothrombin time and administer vitamin K as needed.

Use only for bacterial infections:

To prevent antibiotic resistance, cefixime should be prescribed only for infections confirmed or strongly suspected to be caused by susceptible bacteria.

Common adverse effects:

• Gastrointestinal symptoms including diarrhea (16%), nausea (7%), loose stools (6%), abdominal pain (3%), dyspepsia (3%), flatulence (4%), and vomiting.

Serious and less common adverse effects (less than 2% incidence):

• Pseudomembranous colitis.
• Hypersensitivity reactions: skin rashes, urticaria, drug fever, pruritus, angioedema, facial edema, erythema multiforme, Stevens-Johnson syndrome, serum sickness-like reactions.
• Hepatic: transient elevations in liver enzymes, hepatitis, jaundice.
• Renal: transient elevations in BUN or creatinine, acute renal failure.
• Central Nervous System: headaches, dizziness, seizures.
• Hematologic: thrombocytopenia, leukopenia, neutropenia, prolongation of prothrombin time, agranulocytosis, pancytopenia, eosinophilia.
• Other: genital pruritus, vaginitis, candidiasis, toxic epidermal necrolysis.

Seizures may occur, particularly in patients with renal impairment without dose adjustment.

• Carbamazepine: Elevated carbamazepine levels have been reported. Drug monitoring is recommended when used together.
• Warfarin and other anticoagulants: Increased prothrombin time and bleeding risk have been reported; monitor coagulation parameters.
• Laboratory test interference: Cefixime may cause false-positive urine ketone tests (using nitroprusside), false-positive urine glucose tests (using Benedict’s or Fehling’s solutions), and false-positive direct Coombs test results.

Pregnancy:

Available data from observational studies and animal studies have not shown an increased risk of major birth defects, miscarriage, or adverse outcomes. However, data are limited and have methodological limitations.

Breastfeeding:

No human data on cefixime levels in breast milk or effects on breastfed infants are available. Cefixime is present in animal milk, suggesting likely presence in human milk; benefits of breastfeeding should be balanced with potential risks.

Pediatric use:

Safe and effective in patients aged 6 months and older. Safety in children younger than 6 months has not been established.

Geriatric use:

No significant differences in response were identified compared to younger adults; however, renal function should be monitored.

Overdose may lead to seizures, especially in patients with renal impairment when dosage is not adjusted. Discontinue the drug and provide anticonvulsant therapy if seizures occur.