Cefditoren Pivoxil Tablets

The mechanism of action of this product is to block the synthesis of bacterial cell walls. Cefditoren has a strong binding affinity with 3, 1A, and 1Bs in penicillin-binding proteins (PBPs), thus exerting a bactericidal effect. Cefditoren has antibacterial effects on both Gram-positive and Gram-negative bacteria. In particular, it has a strong antibacterial effect on Streptococcus and Pneumococcus among Gram-positive bacteria, Escherichia coli, Klebsiella, gonococci, Haemophilus influenzae, and anaerobic Peptostreptococci among Gram-negative bacteria. It has a good antibacterial effect on Serratia, indole-positive Proteus, Enterobacter, and Citrobacter, which are insensitive to previous oral cephalosporin preparations (Pioneer IV, Cefaclor, etc.). Cefditoren is stable to β-lactamases produced by various bacteria, so it is effective against strains that produce β-lactamases. There are no literature reports on the carcinogenicity and teratogenicity of Cefditoren.

The main ingredient of this product is cefditoren pivoxil. Chemical name: (6R, 7R)-7-[(Z)-2-(2-amino-4-thiazolyl)-2-(methoxyimino)acetylamino]-3-[2-(5-methyl-2H-tetrazol-2-yl)methyl]-8-oxo-5-thia-1-azabicyclo[4,2,0]oct-2-ene-2-carboxylic acid pivaloyloxymethyl ester.

This product is a film-coated tablet; it appears white or off-white after removing the coating.

The following infectious diseases caused by sensitive bacteria such as Streptococcus (except Enterococcus), Pneumococcus, Streptococcus pyogenes, Gonorrhea, Escherichia coli, Citrobacter, Klebsiella, Enterobacter, Serratia, Proteus, Haemophilus influenzae, etc.: 1. Pharyngitis (pharyngitis, laryngitis), tonsillitis (peritonsillitis, peritonsillar abscess), acute bronchitis, pneumonia, chronic bronchitis, diffuse bronchiolitis, bronchiectasis (when infected), repeated infection of chronic respiratory diseases; 2. Pyelonephritis, cystitis; 3. Gonococcal urethritis; 4. Adnexitis, endometritis, intrauterine infection, Bartholinitis, Bartholin gland abscess; 5. Otitis media, sinusitis; 6. Periodontitis, pericoronitis, palatitis.

Oral. Pharyngitis (pharyngitis, laryngitis), tonsillitis (peritonsillitis, peritonsillar abscess), acute bronchitis, pyelonephritis, cystitis, adnexitis, endometritis, intrauterine infection, Bartholinitis, Bartholin gland abscess: the regular adult dose is 50-100 mg three times a day, orally after meals. Chronic bronchitis, diffuse bronchiolitis, bronchiectasis (infection), repeated infection of chronic respiratory diseases, pneumonia, otitis media, sinusitis, gonococcal urethritis, periodontitis, pericoronitis, palatitis: the regular adult dose is 100-200 mg three times a day, orally after meals. The child dose is 9-18 mg/kg (potency) per day, orally in 3 doses. Or follow the doctor's advice. For patients with severe renal insufficiency, medication should be taken with caution and the dose and interval should be adjusted appropriately.

According to the pre-approval survey, adverse reactions (including changes in clinical examination values) occurred in 213 of 3,240 cases (6.57%); according to the usage survey in the 6 years after approval (June 1987 to June 1993), adverse reactions occurred in 104 of 13,463 cases (0.77%). At the time of re-examination, 317 cases (1.90%) out of a total of 16,703 cases had a cumulative adverse reaction of 456 cases, of which diarrhea (54 cases) (0.32%), rash (24 cases) (0.14%), loss of appetite (19 cases) (0.11%), stomach discomfort (19 cases) (0.11%), ALT (GTP) increase (81 cases) (0.48%), AST (GOT) increase (70 cases) (0.42%), eosinophilia (29 cases) (0.17%). Serious adverse reactions: 1. Because shock and rapid allergic reactions (dyspnea, etc.) (frequency unknown) have occurred, full observation should be made, and if abnormalities are found, the medication should be stopped and properly handled. 2. Because toxic epidermal necrosis syndrome (Lyell syndrome) (frequency unknown) and mucocutaneous eye (Stevens-Johnson) syndrome have occurred, full observation should be made, and if abnormalities are found, the medication should be stopped and properly handled. 3. Because of the occurrence of severe renal dysfunction such as acute renal failure (frequency unknown), regular examinations and full observation should be conducted. If abnormalities are found, the medication should be stopped and properly handled. 4. Because of the occurrence of severe colitis such as pseudomembranous colitis with blood in the stool (frequency unknown), if abdominal pain and frequent diarrhea are found, the medication should be stopped immediately and properly handled. 5. Because of the possibility of liver damage and jaundice (frequency unknown), the patient should be carefully observed. If abnormalities are found, the medication should be stopped immediately and properly handled. 6. Because of the possibility of granulocytopenia and thrombocytopenia (frequency unknown), the patient should be carefully observed. If abnormalities are found, the medication should be stopped immediately and properly handled. Similar drugs (cephalosporin antibiotics) may cause the following serious adverse reactions: 1. Hemolytic anemia. Because other cephalosporin antibiotics (cephalothin sodium, cephalothin) have been reported to cause hemolytic anemia, the patient should stop taking the medication and properly handle it if abnormalities are found. 2. Interstitial pneumonia and pulmonary interstitial edema (PIE) syndrome accompanied by fever, cough, dyspnea, abnormal chest X-ray, eosinophilia, etc. Since other cephalosporin antibiotics have been reported to cause the above symptoms, if the above symptoms are found, the medication should be stopped and measures such as taking corticosteroids should be taken for proper treatment.

Patients who are allergic to cefditoren or the ingredients of this drug.

Precautions for children: The safety of administration to premature infants, newborns, infants, and young children has not been determined. Precautions for pregnancy and lactation: The safety of administration during pregnancy has not been confirmed. Cefditoren is almost incapable of entering breast milk. For pregnant women, women who may become pregnant, and breastfeeding women, it can only be administered when the benefits of treatment outweigh the risks. Precautions for the elderly: Elderly patients may have low physiological functions or sometimes vitamin K deficiency, so they should pay attention to dosage and medication intervals and be closely observed. [Drug Interactions] Cephalosporins can inhibit intestinal flora, leading to decreased vitamin K synthesis. It is recommended that patients with malnutrition or severe conditions take vitamin K at the same time as long-term use of anticoagulants, coumarins, 13-indandione derivatives, heparin, thrombolytics and other drugs.

Cephalosporins can inhibit intestinal flora and lead to a decrease in vitamin K synthesis. It is recommended that patients with malnutrition or severe illness take vitamin K at the same time as long-term use of anticoagulants, coumarins, 13-indandione derivatives, heparin, thrombolytics and other drugs.

Keep away from light, seal tightly, and store in a cool (not exceeding 20℃) and dry place.

50mg (calculated as C16H17N9O5S2)

24 months

Qilu Antibiotics Pharmaceutical Co., Ltd.

• Founded in:

  1995-05-29

• Address:

  No. 849, Dongjia Street, Licheng District, Jinan City, Shandong Province

• Tax NO.:

  91370100614074047M

• Registered Funds:

  $86 million

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