Cefditoren is indicated for the treatment of mild to moderate infections in adults and adolescents (12 years of age or older) caused by susceptible microorganisms, including the following conditions:

• Acute bacterial exacerbation of chronic bronchitis
• Community-acquired pneumonia
• Pharyngitis
• Tonsillitis
• Uncomplicated skin and skin-structure infections

Cefditoren is administered as cefditoren pivoxil, a broad-spectrum third-generation cephalosporin antibiotic. It is a prodrug that is converted to its active form, cefditoren, by esterases during absorption and then distributed in the bloodstream. Cefditoren exhibits antibacterial activity against both gram-positive and gram-negative organisms. Its bactericidal effect is achieved by inhibiting bacterial cell wall synthesis through binding to penicillin-binding proteins (PBPs). It remains stable in the presence of various β-lactamases, including penicillinases and some cephalosporinases.

Cefditoren should be taken after meals.

Community-Acquired Pneumonia: 400 mg twice daily for 14 days.
Acute Exacerbation of Chronic Bronchitis: 400 mg twice daily for 10 days.
Pharyngotonsillitis and Acute Sinusitis: 200 mg twice daily for 10 days.
Uncomplicated Skin and Soft Structure Infections: 200 mg twice daily for 10 days.

Antacids and intravenous famotidine reduce the oral absorption of cefditoren. Similar to other β-lactam antibiotics, co-administration with probenecid increases the plasma concentration of cefditoren. Repeated dosing of cefditoren does not affect the pharmacokinetics of ethinyl estradiol, the estrogen component of most oral contraceptives.

Cefditoren is contraindicated in patients with known hypersensitivity to cephalosporin antibiotics or any component of the formulation. It contains sodium caseinate (a milk protein); therefore, it should not be used in patients with milk protein hypersensitivity (not lactose intolerance).

Common adverse effects of cefditoren include diarrhea, nausea, headache, abdominal pain, vaginal moniliasis, dyspepsia, vomiting, abnormal dreams, allergic reactions, anorexia, constipation, dizziness, dry mouth, and fever.

Cefditoren is classified as pregnancy category B. There are no adequate and well-controlled studies in pregnant women, so it should be used only if clearly necessary. Animal studies indicate that cefditoren is excreted in breast milk; therefore, caution should be exercised when administered to nursing mothers.

Cefditoren is not recommended for prolonged antibiotic therapy, as pivoxil-containing compounds may lead to carnitine deficiency when used for extended periods. Use of cefditoren without a confirmed or strongly suspected bacterial infection or as prophylaxis is unlikely to benefit the patient and may increase the risk of developing drug-resistant bacteria.

Children: Cefditoren is not recommended for use in patients below 12 years of age, as safety and efficacy, including the effects on carnitine levels, have not been established.

Geriatric: No dosage adjustment is required in elderly patients with normal renal function.

Patients with renal insufficiency: No dose adjustment is necessary in mild renal impairment (CICr: 50–80 mL/min/1.73 m²). In moderate impairment (CICr: 30–49 mL/min/1.73 m²), the dose should not exceed 200 mg twice daily, and in severe impairment (CICr: <30 mL/min/1.73 m²), 200 mg once daily is recommended. Appropriate dosing in end-stage renal disease has not been established.

Patients with hepatic disease: No dosage adjustment is required in mild to moderate hepatic impairment.

Information regarding cefditoren overdose in humans is limited. However, as with other β-lactam antibiotics, overdose may result in nausea, vomiting, epigastric discomfort, diarrhea, and convulsions. Hemodialysis may help remove cefditoren from the body, particularly in patients with impaired renal function.

Third generation Cephalosporins

Store below 25°C, protected from light and moisture. Keep out of reach of children.