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Meiact

Meiact

cefditoren

Manufacturer:

Meiji

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Cefditoren pivoxil
Indications/Uses
Folliculitis, pyelonephritis, cystitis. 100 mg tab & fine granules for oral susp: Pharyngolaryngitis (throat abscess), acute bronchitis, tonsillitis (peritonsillitis, peritonsillar abscess), pneumonia; otitis media, sinusitis; superficial secondary infection in trauma, surgical wound; UTI; furuncle, furunculosis, carbuncle, impetigo contagiosa, erysipelas, phlegmon, lymphangitis (lymphadenitis), suppurative perionychia (paronychia), SC abscess, infectious atheroma. 100 mg tab: Chronic bronchitis, bronchiectasis w/ infection, secondary infection in chronic resp disease, pulmonary suppuration. 200 mg tab: Acute pharyngo-tonsillitis; acute maxillary sinusitis; acute exacerbations of chronic bronchitis; mild-moderate community-acquired pneumonia; uncomplicated skin & skin structure infections eg, cellulitis, infected wounds, abscesses, impetigo & boils. Fine granules for oral susp: Scarlet fever, pertussis.
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 microorganisms involved. Adult & adolescent >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 (lower UTI or switch therapy of UTI following clinical response w/ IV cephalosporins) 400 mg once daily. 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 single dose once daily. Fine granules for oral susp Childn 9-18 mg/kg daily bid-tid. Dose adjustment: Patient weighing >30 kg Adult dose (two 50 mg sachet) tid, >20-30 kg 80 mg tid (one 30 mg sachet & one 50 mg sachet), >16-20 kg 60 mg tid (two 30 mg sachet), >10-16 kg 50 mg tid, >6-10 kg 30 mg tid.
Administration
Should be taken with food.
Contraindications
History of or known hypersensitivity.
Special Precautions
Severe allergic reaction in penicillin-allergic patients. Not to be used in patients w/ history of hypersensitivity to cephem or penicillin antibiotics. Patients w/ personal or familial predisposition to allergic reactions eg, bronchial asthma, rash or urticaria. Discontinue treatment if fever, rashes, blisters, skin peeling, stomatitis, pharyngitis, rhinitis, conjunctivitis, genital inflammation occur; any abnormalities eg, feeling unwell, oral cavity discomfort, stridor, vertigo, defecation desire, tinnitus or diaphoresis are observed; abdominal pain or frequent diarrhea occurs; interstitial pneumonia or pulmonary interstitial emphysema syndrome w/ fever, cough, dyspnea, abnormal chest X-ray, eosinophilia occurs. Carefully observe patients w/ poor oral food intake or who are receiving parenteral alimentation, & in poor general health. Monitor patients w/ abnormal lab test values (increased AST & ALT, eosinophilia) in patients under long-term treatment by performing periodic lab tests. Vit K deficiency may develop. Shock. Limit duration of treatment to min period to prevent emergence of drug-resistant microorganisms. Prolong dosing interval in patients w/ severe renal function disorder. Hypocarnitinemia in women taking antibiotics containing pivoxil group during last trimester of pregnancy, as well as in neonates born to them. Not to be administered in ped patients found to have inborn errors of metabolism which may cause serum carnitine to decrease. Hypoglycemia accompanying hypocarnitinemia in childn particularly infants & small childn. Blood conc may increase in elderly patients w/ renal hypofunction. Bleeding tendency due to vit K deficiency in the elderly. 100 & 200 mg tab: Agranulocytosis or hemolytic anemia. Hepatic function disorder; serious renal disorder eg, acute renal failure. 200 mg tab: Patients who are hypersensitive to casein. Minor or moderate influence on ability to drive & use machines. Not recommended during lactation.
Adverse Reactions
Rash; granulocytopenia, eosinophilia; increased ALT, AST & alkaline phosphatase; increased BUN, proteinuria; diarrhea, soft faeces, queasy, stomach discomfort, abdominal pain. TEN, SJS, erythema multiforme.
Drug Interactions
Reduced absorption w/ antacids. Reduced urinary excretion rate w/ probenecid. False +ve result in urine glucose tests w/ Benedict's soln & Fehling's soln & Clinitest except w/ Tes-Tape. +ve results w/ direct Coombs test. 100 & 200 mg tab: Decreased Cmax & AUC w/ IV famotidine.
MIMS Class
Cephalosporins
ATC Classification
J01DD16 - cefditoren ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Form
Meiact fine granules for oral susp 50 mg
Packing/Price
120 × 1's
Form
Meiact tab 100 mg
Packing/Price
10 × 10's
Form
Meiact tab 200 mg
Packing/Price
10 × 2's
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