100 mg tablet and Fine granules for oral susp: Careful administration (MEIACT should be administered with care in the following patients): Patients with a history of hypersensitivity to penicillins.
Patients with a personal or familial predisposition to allergic symptoms such as bronchial asthma, exanthema or urticaria.
Patients with severely impaired renal function [Serum concentration persists. (See Pharmacology: Pharmacokinetics under Actions.)]
Patients with poor oral food intake or who are receiving parenteral alimentation, and patients in poor general health (Patients should be observed carefully because vitamin K deficiency may develop).
100 mg tablet: 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.
In patients with severely impaired renal function, the administration interval should be prolonged (see "careful administration" as previously mentioned and Pharmacology: Pharmacokinetics under Actions).
100 mg tablet and Fine granules for oral susp: Important Precautions: The patient should be carefully interviewed to assess the risk of shock.
Effects on Laboratory Tests: False-positive results may occur in urine glucose tests with Benedict's solution, Fehling's solution and Clinitest, but not with Tes-Tape.
Positive results may occur in the direct Coombs' test. Caution is required.
Other Precautions: 100 mg tablet: It has been reported that this product decreases serum carnitine.
Fine granules for oral susp: Since this product has been reported to reduce serum carnitine level, it is recommended to use the product in children for not more than 2 weeks.
200 mg tablet: Before therapy with cefditoren is instituted, careful inquiry should be made to determine whether the patient has had any previous hypersensitivity reactions to cefditoren, cephalosporins, penicillins, or other beta-lactam active substances.
Cefditoren should be given with caution to patients who have had any other type of hypersensitivity reaction to a penicillin or any other beta-lactam active substance.
Antibiotic-associated diarrhoea, colitis and pseudomembranous colitis have all been reported with the use of cefditoren. These diagnoses should be considered in any patient who develops diarrhoea during or shortly after treatment.
Cefditoren should be discontinued if severe, and/or bloody diarrhoea occurs during treatment and appropriate therapy instituted.
Cefditoren should be used with caution in individuals with a previous history of gastrointestinal disease, particularly colitis.
In patients with moderate to severe renal impairment the rate and extent of exposure to cefditoren is increased (see Pharmacology: Pharmacokinetics under Actions). For this reason, the total daily dosage should be reduced when cefditoren is administered to patients with acute or chronic moderate to severe renal insufficiency in order to avoid potential clinical consequences, such as seizures (see Dosage & Administration).
Cephalosporin antibiotics should be given with caution to patients receiving concurrent treatment with nephrotoxic active substances such as aminoglycoside antibiotics or potent diuretics (such as furosemide) as these combinations may have undesirable effects on renal function and have been associated with ototoxicity.
Prolonged use of cefditoren may result in the overgrowth of non-susceptible organisms, such as Enterococci and Candida spp.
During treatment with cephalosporins, a decrease in prothrombin activity may occur. Therefore, the prothrombin time should be monitored in patients at risk, such as patients with renal or hepatic insufficiency or patients being treated with anticoagulant therapy.
Administration of pivalate prodrugs has been associated with decreases in plasma carnitine concentrations. However, clinical studies concluded that no clinical effects of carnitine decrease were associated with the administration of cefditoren pivoxil.
Effects on ability to drive and use machines: 200 mg tablet only: MEIACT has minor or moderate influence on the ability to drive and use machines. Cefditoren pivoxil may cause dizziness and somnolence (see Adverse Reactions).
Use in Children: 100 mg tablet: The safety of this product in low birth-weight infants, newborns, suckling infants, infants and children has not been established (few clinical experience).
Fine granules for oral susp: The safety of this product in low birth-weight infants and newborns has not been established.
Use in the Elderly: 100 mg tablet: The incidence of adverse reactions in the elderly does not differ from that in non-elderly adult patients. However, since the physiological functions are generally reduced in the elderly, the product should be administered carefully, paying attention to the following two points: dose and dose intervals should be adjusted according to the patient's condition.
Delay in excretion has been observed in patients with renal hypofunction. Therefore, high serum levels of the product may persist for a longer period of time in the elderly.
As for other analogous drugs, bleeding tendency due to vitamin K deficiency has been reported to occur in the elderly.