Sign Out
Serious colitis with bloody stool such as pseudomembranous colitis (incidence unknown): If abdominal pain or frequent diarrhea occurs, administration should be discontinued immediately and appropriate measures should be taken.
Toxic Epidermal Necrolysis (TEN), oculomucocutaneous syndrome (Stevens-Johnson syndrome) or erythema multiforme (all incidence unknown).
Interstitial pneumonia or PIE syndrome (all incidence unknown): Interstitial pneumonia or PIE syndrome, etc., with fever, cough, dyspnea, abnormal chest X-ray, eosinophilia, etc., may occur. Patients should be carefully monitored and if these symptoms occur, administration should be discontinued and appropriate measures such as administration of adrenocortical hormones should be taken.
Hepatic function disorder (incidence unknown): Hepatic function disorder with jaundice or markedly increased AST, ALT or Al-P may occur.
Serious renal disorder such as acute kidney injury (incidence unknown).
Agranulocytosis or hemolytic anemia (all incidence unknown).
Adverse Reactions (Children) (for fine granules in oral suspension): Clinically significant adverse reactions: Hypoglycemia accompanying hypocarnitinemia (incidence unknown): It has been reported that administration of antibiotics which have a pivoxil group (including this product, 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). Administration of antibiotics with a pivoxil group may cause hypoglycemia accompanying hypocarnitinemia in children (in particular, infants and small children). Therefore when symptoms of hypoglycemia such as convulsions or consciousness disorder are observed, administration should be discontinued and appropriate measures should be taken.
Other adverse reactions: See Table 6.
Click on icon to see table/diagram/imageClinical Studies: 100 mg and 200 mg tablet: Dose-ranging study in Japan (Note): Chronic bronchitis: Adverse reaction reported was 1 case (2.6%) of nausea/upper abdominal pain in the 300 mg group.
Complicated urinary tract infection: Adverse reactions reported were 1 case each (1.5%) of dizziness/coldness, stomach feeling heavy, stomach pain, and dizziness in the 300 mg group, and diarrhea in the 600 mg group.
Double-blind study in Japan (Note): Complicated urinary tract infection: Adverse reactions reported were 2 cases (1.5%) of diarrhea and 1 case each (0.7%) of stomach pain and faeces soft.
Bacterial pneumonia: Adverse reactions reported were 3 cases (3.4%) of diarrhea, 2 cases each (2.3%) of rash and queasy (nausea) and 1 case (1.1%) of stomach discomfort/diarrhea.
Chronic respiratory tract infection: Adverse reactions reported were 3 cases (3.4%) of diarrhea and 1 case each (1.0%) of rash/pruritus, fever, queasy, stomach discomfort, faeces soft and constipation.
Superficial suppurative disease: Adverse reactions reported were 2 cases (2.6%) of faeces soft and 1 case each (1.3%) of stomach feeling heavy, stomach discomfort/faeces soft, queasy/faeces soft, bloating, stomach discomfort, queasy and watery stool.
General clinical studies in Japan (Note): Adverse reactions occurred in 91 (3.95%) of 2,301 patients evaluated for the safety of the product. The main adverse reactions were digestive symptoms (87 cases; 3.78%) such as diarrhea, faeces soft, queasy and stomach discomfort and allergic symptoms (11 cases; 0.48%) such as rash. Changes in laboratory test values were observed in 6.80% (119/1,749). They included abnormal hepatic function such as LDH increased in 5.45% (3/55), ALT increased in 4.21% (69/1,638), AST increased in 3.11% (51/1,641), and abnormal hematology such as eosinophilia in 1.77% (25/1,412).
Note): This product has been confirmed to be bioequivalent to the previous formulation.
Fine granules for oral suspension: Clinical studies in Japan (granules Note) at the time of approval): Adverse reactions were reported in 19 (4.17%) of 456 cases evaluated for the safety of the product. The main adverse reactions were gastrointestinal symptoms (diarrhea only) in 17 (3.73%) and allergic symptoms (rash and redness in 1 case each) in 2 (0.44%). Changes in laboratory test values were observed in 3.60% (10/278). The main adverse reactions were abnormal hematology such as eosinophilia 1.97% (5/254), and abnormal hepatic function such as ALT increase 0.90% (2/222) and AST increase 0.45% (1/222).
Clinical studies in Japan (previous fine granules Note1) at the time of approval of additional indications): Of the total 72 patients treated, 1 (1.4%) of watery stools was reported as an adverse reaction. Abnormal changes in laboratory test values were observed with an eosinophil count increased of 6.9% (4/58).
Clinical studies in Japan (at the time of approval for a partial change in dosage and administration): Adverse reactions were reported in 36 (31.3%) of 115 cases evaluated for the safety of the product. The main adverse reactions were diarrhea/faeces soft in 28 cases (24.3%). Abnormal changes laboratory test values were observed in 7 (6.2%) of 113 cases evaluated for the safety of the product who underwent testing. The main adverse reactions were increased platelet count, etc.
Note): Bioequivalence between this product and the previous fine granule formulation, and the previous fine granule formulation and the granule formulation has been verified.
View ADR Reporting Link
Continue with Google