Concise Prescribing Info
Cefditoren pivoxil
Acute bacterial exacerbation of chronic bronchitis. Mild to moderate community-acquired pneumonia, pulmonary suppuration, pharyngitis, tonsillitis, acute maxillary sinusitis, otitis media, scarlet fever, pertussis. Superficial secondary infection in trauma. Uncomplicated skin & skin-structure infections eg, cellulitis, infected wounds, abscesses, folliculitis, impetigo & boils, furuncle, furunculosis, carbuncle, erysipelas, phlegmon, lymphangitis (lymphadenitis), suppurative perionychia (paronychia), infectious atheroma. Pyelonephritis, cystitis.
Dosage/Direction for Use
100 mg tab Adult 100 mg tid. Severe infections 200 mg tid. Lower UTI or switch therapy of UTI following clinical response w/ IV cephalosporins 400 mg once daily. 200 mg tab Recommended dose depends on severity of infection, basal condition & potential micro-organisms involved. Adult & adolescents >12 yr Acute pharyngo-tonsillitis, acute maxillary sinusitis, uncomplicated skin & skin structure infections 200 mg every 12 hr for 10 days. Acute exacerbations of chronic bronchitis 200 mg every 12 hr for 5 days. Community-acquired pneumonia Mild cases: 200 mg every 12 hr for 14 days. Moderate cases: 400 mg every 12 hr for 14 days. Pyelonephritis, cystitis 400 mg once daily after meal. Moderate renal insufficiency (CrCl 30-50 mL/min) Max total daily dose: 200 mg every 12 hr. Severe renal insufficiency (CrCl <30 mL/min) 200 mg as a single dose once daily. Fine granules for oral soln Childn 9-18 mg/kg daily bid-tid after meals. Dose adjustment: Patients weighing >30 kg Administer adult dosage (as two 50 mg sachet or 100 mg tab) tid, >20-30 kg 80 mg tid (as one 30 mg sachet & 50 mg sachet), >16-20 kg 60 mg tid (as two 30 mg sachet), >10-16 kg 50 mg tid, >6-10 kg 30 mg tid.
Should be taken with food.
Hypersensitivity to cefditoren, cephem antibiotics & any other cephalosporin, casein (only for 200 mg tab). Previous immediate &/or severe hypersensitivity to penicillin or to any other type of β-lactam active substance. History of anaphylactic shock. Primary carnitine deficiency.
Special Precautions
History of hypersensitivity to cefditoren, penicillins, cephalosporins or other β-lactam active substance. Carefully assess patients for risk of shock. Discontinue if severe &/or bloody diarrhoea occurs during treatment & institute appropriate therapy. Personal or familial predisposition to allergic symptoms eg, bronchial asthma, exanthema or urticaria. Patients w/ poor oral food intake or who are receiving parenteral alimentation, & patients in poor general health; malnourished; on controlled Na diet. Vit K deficiency may develop. Limit the duration of administration to the min period required for the treatment to prevent drug-resistant microorganisms. Antibiotic-associated diarrhoea, colitis & pseudomembranous colitis. History of GI disease particularly colitis. Patients receiving concurrent treatment w/ nephrotoxic substances (eg, aminoglycosides) or potent diuretics (eg, furosemide). May result in overgrowth of non-susceptible organisms eg, enterococci and Candida spp. Monitor prothrombin time in patients at risk of decreased prothrombin activity eg, patients w/ renal or hepatic insufficiency or being treated w/ anticoagulant therapy. Reduce total daily dosage in patients w/ acute or chronic moderate to severe renal insufficiency. Prolong administration interval in patients w/ impaired renal function. Minor or moderate influence on the ability to drive and use machines. Pregnancy. Not recommended during lactation. Low birth-wt infants, suckling infants, infants, newborns.
Adverse Reactions
Diarrhoea. Headache; nausea, abdominal pain, dyspepsia; vag candidiasis. Exanthema; granulocytopenia, eosinophilia; increased AST, ALT & AI-P; increased BUN & serum creatinine, proteinuria; loose stools, stomach discomfort. Stevens-Johnson syndrome, toxic epidermal necrolysis.
Drug Interactions
Decreased AUC & Cmax w/ Mg- & Al hydroxide-containing antacids & IV famotidine. Increased AUC & Cmax w/ probenecid. May induce false positive in the direct Coomb's test. False-positive result for urine glucose w/ copper reduction tests but not w/ enzyme-based tests. False-negative ferricyanide test for glucose determination.
MIMS Class
ATC Classification
J01DD16 - cefditoren ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Meiact fine granules for oral soln 50 mg
120 × 1's
Meiact tab 100 mg
10 × 10's
Meiact tab 200 mg
10 × 2's
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