It (cefditoren pivoxil) 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 caused by Haemophilus influenzae (including ?-lactamase-producing strains),Haemophilus parainfluenzae (including ?-lactamase producing strains),Streptococcus pneumoniae (penicillin susceptible strains only),or Moraxella catarrhalis (including ?-lactamase-producing strains). Community-Acquired Pneumonia caused by Haemophilus influenzae (including ?-lactamase-producing strains),Haemophilus parainfluenzae (including ?-lactamase-producing strains),Streptococcus pneumoniae (penicillin-susceptible strains only),or Moraxella catarrhalis (including ?-lactamase producing strains). Pharyngitis/Tonsillitis caused by Streptococcus pyogenes. NOTE: It is effective in the eradication of Streptococcus pyogenes from the oropharynx. It has not been studied for the prevention of rheumatic fever following Streptococcus pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including ?-lactamase-producing strains) or Streptococcus pyogenes.
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.
It is contraindicated in patients with known allergy to the cephalosporin class of antibiotics or any of its components. It is contraindicated in patients with carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency,because use of It causes renal excretion of carnitine. (See PRECAUTIONS, General.) It tablets contain sodium caseinate,a milk protein. Patients with milk protein hypersensitivity (not lactose intolerance) should not be administered It
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.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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