IBN SINA PHARMACEUTICALS LTD.
Cefditoren is indicated for the treatment of mild to moderate infections in adults and adolescents (12 years of age or older) which are caused by susceptible strains of the designated microorganisms in the conditions listed below: Acute Bacterial Exacerbation of Chronic Bronchitis Community Acquired Pneumonia Pharyngitis Tonsillitis Uncomplicated Skin and Skin-Structure Infections
Third generation Cephalosporins
Cefditoren inhibits the synthesis of bacterial cell wall. It has high affinity to penicillin-binding proteins (PBPs) in various bacteria, showing a bactericidal effect.
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. Cefditoren should be taken after meals.
Co-administration of a single dose of an antacid and H2 receptor antagonists may reduce the oral absorption of cefditoren pivoxil. As with other beta-lactam antibiotics, co-administration of probenecid with cefditoren pivoxil resulted in an increase in the plasma exposure of cefditoren.
Contraindicated in patients hypersensitive to drug or other cephalosporins. Also contraindicated in patients with carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency. Because cefditoren tablets contain sodium caseinate, a milk protein, don't give to patients hypersensitive to milk protein (as distinct from those with lactose intolerance).
The most common side effects of Cefditoren are diarrhea, nausea, headache, abdominal pain, vaginal moniliasis, dyspepsia, vomiting, abnormal dreams, allergic reaction, anorexia, constipation, dizziness, dry mouth and fever.
Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. Cefditoren should be used during pregnancy only if clearly needed. Lactation: Animal studies show that Cefditoren excreted in breast milk. Caution should be exercised when Cefditoren is administered to nursing women.
Information on Cefditoren overdosage in humans is not available. However, with other 8-lactam antibiotics, adverse effects following overdosage have included nausea, vomiting, epigastric distress, diarrhea, and convulsions. Hemodialysis may aid in the removal of Cefditoren from the body, particularly if renal function is compromised.
Cefditor should be prescribed with caution in individuals with a history of gastrointestinal diseases, particularly colitis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance< 30 ml/min)
Store in a cool (below 258 C) and dry place protected from light.