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• Bacterial infections
• Acute Bacterial Exacerbation of Chronic Bronchitis
• Community Acquired Pneumonia
• Pharyngitis
• Tonsillitis
• Uncomplicated Skin and Skin-Structure Infections

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.

Adult Dose (Oral):
Community-acquired pneumonia: 400 mg twice daily for 14 days.
Acute bacterial exacerbation of chronic bronchitis: 400 mg twice daily for 10 days.
Pharyngitis, Tonsillitis, Uncomplicated skin and skin structure infections: 200 mg twice daily for 10 days.

Child Dose: 12 years old: As in adults.

Renal Dose: Renal impairment: CrCl (ml/min) 30-49 Maximum: 200 mg twice daily; <30 Maximum: 200 mg once daily.

Hepatic Dose: No dose adjustment for mild to moderate hepatic impairment. Caution in severe liver disease.

Common Side Effects:

• Diarrhea
• Nausea
• Headache
• Abdominal pain
• Vaginal moniliasis
• Dyspepsia
• Vomiting
• Abnormal dreams
• Allergic reaction
• Anorexia
• Constipation
• Dizziness
• Dry mouth
• Fever

[SAFE IF PRESCRIBED] Cefditoren is generally considered safe to use during pregnancy. Animal studies have shown low or no adverse effects to the developing baby; however, there are limited human studies. Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Cefditoren should be used during pregnancy only if clearly needed.

• [UNSAFE] Cefditoren may decrease alertness, affect your vision or make you feel sleepy and dizzy. Do not drive if these symptoms occur.
• Your doctor has prescribed Cefditoren to cure your infection and improve your symptoms. Do not skip any doses and finish the full course of treatment even if you feel better. Stopping it early may make the infection harder to treat.
• Take it with food to avoid an upset stomach.
• Discontinue Cefditoren and inform your doctor immediately if you get a rash, itchy skin, swelling of face and mouth, or have difficulty in breathing.
• Diarrhea may occur as a side effect but should stop when your course is complete. Inform your doctor if it does not stop or if you find blood in your stools.
• Avoid consuming alcohol while taking Cefditoren as it may cause increased side effects.
• Cefditoren is not recommended when prolonged antibiotic treatment is necessary, since other pivalate-containing compounds have caused clinical manifestations of carnitine deficiency when used over a period of months.
• Prescribing Cefditoren in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

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.