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Fine granules: Incidences of adverse reactions by MEIACT Granules, that have been confirmed to be bioequivalent to MEIACT fine granules, were as follows.
Adverse reactions occurred in 19 (4.17%) of the 456 patients evaluated for the safety of the product. Principal symptoms observed were diarrhea in 17 (3.73%) patients and allergic symptoms (1 patient each with exanthema and redness) in 2 (0.44%) patients. Changes in laboratory test values were observed in 3.60% (10/278). They included abnormal hepatic function such as increased AST (GOT) in 0.45% (1/222) and increased ALT (GPT) in 0.90% (2/222), and abnormal hematology, such as eosinophilia, in 1.97% (5/254) (at the time of approval of MEIACT granules).
100 mg tablet and Fine granules for oral susp: Clinically significant adverse reactions: Shock, anaphylactoid reaction (<0.1%) may occur. Therefore, patients should be monitored thoroughly and if any anaphylactic shock-related signs or symptoms such as discomfort, oral cavity discomfort, stridor, vertigo, defecation desire, tinnitus or diaphoresis develop, the administration should be discontinued and suitable measures should be taken.
Serious colitis with bloody stool such as pseudomembranous colitis (<0.1%) may occur. Therefore, the patient should be monitored thoroughly and if abdominal pain or frequent diarrhea occurs, the administration should be discontinued immediately and suitable measures should be taken.
Muco-cutaneo-ocular syndrome (Stevens Johnson syndrome) or toxic epidermal necrolysis (Lyell syndrome) (<0.1%) may occur. Therefore, the patients should be thoroughly monitored and if any abnormality occurs, the administration should be discontinued and suitable measures should be taken.
Interstitial pneumonia, PIE syndromes (<0.1%) etc., accompanied with fever, coughing, dyspnea, abnormal chest X-ray images, eosinophilia, etc., may occur. Therefore, the patients should be monitored thoroughly and if these symptoms occur, the administration should be discontinued and suitable measures such as the administration of corticosteroid should be taken.
Hepatic function disorders (<0.1%) associated with jaundice and markedly increased AST (GOT), ALT (GPT) and Al-P may occur. Therefore, periodical clinical examinations should be carried out to thoroughly monitor patients and if any abnormality occurs, the administration should be discontinued and suitable measures should be taken.
Serious renal dysfunction (<0.1%) such as acute renal failure may occur. Therefore, periodical clinical examinations should be carried out to thoroughly monitor patients and if any abnormality occurs, the administration should be discontinued and suitable measures should be taken.
Agranulocytosis (<0.1%) and hemolytic anemia (<0.1%) may occur. Therefore, periodical clinical examinations should be carried out to thoroughly monitor patients and if any abnormality occurs, the administration should be discontinued and suitable measures should be taken.
Other adverse reactions: (See Table 6.)
Click on icon to see table/diagram/image200 mg tablet: Approximately 6000 patients received cefditoren at either 200 mg or 400 mg twice daily for up to 14 days in clinical trials. About 24% of patients reported at least one adverse reaction. Treatment discontinuation as a consequence of adverse reactions occurred in 2.6% of the patients.
The most commonly occurring adverse reactions were gastrointestinal events. In most studies, diarrhoea occurred in more than 10% of all patients and was more common with 400 mg than with 200 mg twice daily. The observed adverse reactions, reported either during clinical trials or post-marketing experience, are described as follows: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See Table 7.)
Click on icon to see table/diagram/imageThe following adverse reactions could appear as they have been observed with other cephalosporins: cholestasis and aplastic anemia.
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