Cefditor 200 mg tablet: Each tablet contains Cefditoren INN 200 mg.
Cefditor Tablets are indicated in 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 Exacerbations of Chronic Bronchitis (ABECB) caused by Haemophilus influenzae (including beta-lactamase-producing strains), Haemophilus parainfluenzae (including beta-lactamase-producing strains),Streptococcus pneumoniae (penicillin-susceptible strains only), or Moraxella catarrhalis (including beta-lactamase-producing strains).
Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcusaureus (including beta-lactamase-producing strains) or Streptococcus pyogenes.
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).
Dosage & Administration
ABECB: 400mg bid for 10 days. Pharyngitis/Tonsillitis/SSSI: 200mg bid for 10 days.
CAP: 400mg bid for 14 days. Take with meals.
Pediatrics: 12 yrs:
ABECB: 400mg bid for 10 days.
Pharyngitis/Tonsillitis/SSSI: 200mg bid for 10 days.
CAP: 400mg bid for 14 days.
Most adverse events are mild and self-limiting. No deaths or permanent disabilities have been attributed to cefditoren.
Other adverse events reported are abnormal dreams, allergic reaction, anorexia, asthenia, asthma, coagulation time increased, constipation, dizziness, dry mouth, eructation, face edema, fever, flatulence, fungal infection, gastrointestinaldisorder, hyperglycemia, increased appetite, insomnia, leukopenia, leukorrhea, liver function test abnormal, myalgia, nervousness, oral moniliasis, pain, peripheral edema, pharyngitis, pseudomembranous colitis, pruritus, rash, rhinitis, sinusitis, somnolence, stomatitis, sweating, taste perversion, thirst, thrombocythemia, urticaria, and vaginitis. Pseudomembranous colitis symptoms may begin during or after antibiotic treatment.The overall incidence of adverse events, particularly diarrhea, increased with the higher recommended dose of cefditoren.
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)
Pregnancy Category B: There are, however, no adequate and well-controlled studies in pregnant women. Cefditoren is to be used during pregnancy only if clearly needed.
Use in Children: Safety and efficacy in children below the age of 12 years have not been studied.
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.
Cefditor 200 mg tablet: Each box contains 4 blister strips of 5 tablets.