Meiact Special Precautions

Important Precautions: As a general rule, the duration of administration of this drug should be limited to the minimum period required for the treatment of the patient's condition, after susceptibility of the microorganism to the drug has been confirmed, in order to prevent the emergence of drug-resistant microorganisms.
Since shock may occur, patients should be carefully interviewed.
Since abnormal laboratory test values (AST increased, ALT increased, eosinophilia, etc.) tend to appear more frequently in patients under long-term treatment with this product, these patients should be monitored by performing periodic laboratory tests.
Patients with severe renal function disorder (Previous formulation ^Note)): The dosing interval should be prolonged. Serum concentration persists. (See Pharmacology: Pharmacokinetics under Actions.)
Note): This product has been confirmed to be bioequivalent to the previous formulation (100 mg and 200 mg tablet).
Bioequivalence between this product and the previous fine granule formulation, the previous fine granule formulation and the granule formulation, and MEIACT MS tablets and the previous tablets has been verified (fine granules for oral suspension).
Patients with Complication or History of Diseases, etc.: Cefditoren should be administered with care in the following patients: Patients with a history of hypersensitivity to cephem or penicillin antibiotics. However, do not administer to patients with a history of hypersensitivity to this product.
Patients with a personal or familial predisposition to allergic symptoms such as bronchial asthma, rash or urticaria.
Patients with poor oral food intake or who are receiving parenteral alimentation, and patients in poor general health. Patients should be observed carefully. Vitamin K deficiency symptoms may develop.
Effects on ability to drive and use machines: 100 mg tablet and fine granules for oral suspension: Not available.
200 mg tablet: MEIACT has minor or moderate influence on the ability to drive and use machines. Cefditoren pivoxil may cause dizziness and somnolence (see Adverse Reactions).
100 mg and 200 mg tablet: Important Precautions: Since hepatic function disorder may occur, periodic laboratory tests should be performed.
Since serious renal disorder such as acute renal failure may occur, periodic laboratory tests should be performed.
Since agranulocytosis or hemolytic anemia may occur, periodic laboratory tests should be performed.
Other precautions: It has been reported that administration of antibiotics which have a pivoxil group including this product (cefditoren pivoxil, cefcapene pivoxil hydrochloride hydrate, cefteram pivoxil and tebipenem pivoxil) cause serum carnitine decrease resulting from the metabolism/excretion of pivalic acid (a metabolite of antibiotics with a pivoxil group).
200 mg tablet: Hypersensitive to casein: For patients who are hypersensitive to casein, it should be noted that the medicinal product contains sodium caseinate.
Use in Children: No clinical studies have been conducted in pediatric patients (100 mg tablet and 200 mg tablet) and low birth weight infants and newborns (fine granules for oral suspension) to assess efficacy and safety.
Attention should be paid to decreased carnitine.
Do not administer this product if patients are found to have inborn errors of metabolism which may cause serum carnitine to decrease. Administration of antibiotics with a pivoxil group (pediatric formulations) may cause hypoglycemia accompanying hypocarnitinemia in children (in particular, infants and small children).
Fine granules for oral suspension: When this product is administered to children younger than 3 years in a single dose of 6 mg (potency)/kg 3 times a day, diarrhea/faeces soft may occur with high frequency. If these symptoms are observed, appropriate measures such as symptomatic treatment should be taken according to the symptoms. In a clinical study in which this product was administered to children with pneumonia, otitis media or sinusitis in a single dose of 6 mg (potency)/kg 3 times a day, the incidence of the adverse reaction of diarrhea/faeces soft was 36.2% (17/47) in children younger than 3 years and 16.2% (11/68) in children 3 years or older.
Use in the Elderly: The product should be carefully administered, paying attention to the following points, and dosage and dosing interval should be adjusted. The incidence of adverse reactions in the elderly does not differ from that in non-elderly adult patients, however in general, elderly patients often have reduced physiological function.
Since delay in excretion of this product has been observed in patients with renal hypofunction, blood concentrations may increase.
Bleeding tendency due to vitamin K deficiency has been reported after the use of other similar drugs.