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 is a preparation of Cefditoren Pivoxil which is a broad spectrum third generation cephalosporin antibiotic. Cefditoren is a prodrug which is hydrolyzed by esterases during absorption, and the drug is distributed in the circulating blood as active Cefditoren. Cefditoren has antibacterial activity against gram-positive and gram-negative pathogens. The bactericidal activity of Cefditoren results from the inhibition of cell wall synthesis via affinity for penicillin- binding proteins (PBPs). Cefditoren is stable in the presence of a variety of ß-lactamases, including penicillinases and some cephalosporinases.
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 Famotidine (intravenous administration) reduced the oral absorption of Cefditoren. As with other ß-lactam antibiotics, co-administration of probenecid with Cefditoren Pivoxil resulted in an increase in the plasma exposure of Cefditoren. Multiple doses of Cefditoren had no effect on the pharmacokinetics of ethinyl estradiol, the estrogenic component in most oral contraceptives.
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). 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).
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 ß-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.
Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.
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