Cefixime Tablets

This product is an oral third-generation cephalosporin with a broad antibacterial spectrum. It has antibacterial activity against some Gram-positive and Gram-negative bacteria, especially against Streptococcus (except Enterococcus) and Pneumococcus among Gram-positive bacteria, and gonococci, Branhamella, Escherichia coli, Klebsiella, Serratia, Proteus, and influenza bacilli among Gram-negative bacteria. Its mechanism of action is to prevent the synthesis of bacterial cell walls. Its action point varies with the type of bacteria. It has a high affinity with PBP1 (la, lb, lc) and PBP3 among penicillin-binding proteins (PBP). This product has strong stability against β-lactamases produced by various bacteria. Toxicological studies on reproductive toxicity: SD rats were orally administered 100-1000 mg/kg before pregnancy and in early pregnancy, and 320-3200 mg/kg during organogenesis, perinatal period, and lactation. There was no effect on the fertility of the rats, no teratogenic effects were found, and no abnormalities were found in the growth, development, and reproductive ability of the newborn rats.

The main ingredient of this product is cefixime.

This product is an off-white tablet or film-coated tablet, which appears off-white or light yellow after removing the film coating.

This product is suitable for the following infectious diseases caused by Streptococcus (except Enterococcus), Pneumococcus, Neisseria gonorrhoeae, Branhamella catarrhalis, Escherichia coli, Klebsiella, Serratia, Proteus and Haemophilus influenzae: (1) bronchitis, bronchiectasis (when infected), secondary infection of chronic respiratory system infections, pneumonia; (2) pyelonephritis, cystitis, gonococcal urethritis; (3) acute bacterial infection of the biliary system (cholecystitis, cholangitis); (4) scarlet fever; (5) otitis media, sinusitis.

Adults and children weighing more than 30 kg: Oral, 0.5 to 1 tablet each time, twice a day. In addition, it can be appropriately increased or decreased according to age, weight, and symptoms. For severe patients, 2 tablets can be taken orally each time, twice a day. For children, oral, 1.5 to 3.0 mg per kilogram each time, twice a day. Or follow the doctor's advice.

Clinical research data show that the main adverse reactions of this product include gastrointestinal symptoms such as diarrhea in 112 cases (0.87%), skin symptoms such as rash in 29 cases (0.23%), in addition, abnormal clinical examination values include increased GPT in 78 cases (0.61%), increased GOT in 58 cases (0.45%), eosinophilia in 26 cases (0.20%), etc. (1) Serious adverse reactions: ① Shock: Due to the possibility of shock (0.1%), the patient should be closely observed. If discomfort, abnormal sensation in the mouth, asthma, dizziness, urge to defecate, tinnitus, sweating, etc. occur, the drug should be stopped and appropriate measures should be taken; ② Allergic symptoms: There is a possibility of allergic symptoms (including dyspnea, systemic flushing, angioedema, urticaria, etc.) (0.1%). The patient should be closely observed. If any abnormality occurs, the drug should be stopped and appropriate measures should be taken; ③ Skin lesions: There is a possibility of skin mucosal eye syndrome (Stevens-Johnson syndrome, (0.1%), toxic epidermal necrolysis (Lyell syndrome, 0.1%), the patient should be closely observed. If fever, headache, etc. occur, the patient should be stopped and appropriate measures should be taken. ④ Blood disorders: There is a possibility of agranulocytosis (0.1%, early symptoms: fever, sore throat, headache, fatigue, etc.), hemolytic anemia (0.1%, early symptoms: fever, hemoglobinuria, anemia, etc.), thrombocytopenia (0.1%, early symptoms: punctate hemorrhage, purpura, etc.), and there are reports of other cephalosporin antibiotics causing pancytopenia, so close observation, such as regular examinations, etc., should be made, and if any abnormality occurs, the drug should be stopped and appropriate measures should be taken; ⑤ Renal dysfunction: Due to the possibility of causing severe renal dysfunction such as acute renal insufficiency (0.1%), Close observation should be made, such as regular check-ups, etc. If any abnormality occurs, the drug should be stopped and appropriate measures should be taken; ⑥ Colitis: It may cause severe colitis accompanied by bloody stools, such as pseudomembranous colitis (0.1%). If abdominal pain or recurrent diarrhea occurs, the drug should be stopped immediately and appropriate measures should be taken; ⑦ Interstitial pneumonia, PIE syndrome: There is a possibility of interstitial pneumonia and PIE syndrome (0.1% each) accompanied by symptoms such as fever, cough, dyspnea, abnormal chest X-ray, and eosinophilia. If the above symptoms occur, the drug should be stopped and appropriate measures such as glucocorticoids should be taken; (2) Other adverse reactions The incidence of adverse reactions is common at 0.1-5%, and rare below 0.1%. Allergies: Common Rash, urticaria, erythema; rarely itching, fever, edema; blood: common (0.1-5%) eosinophilia; rare neutropenia; liver: common elevated alanine aminotransferase (ALT/GPT) and aspartate aminotransferase (AST/GOT); rare jaundice; kidney: rare elevated urea nitrogen (BUN); digestive system: common diarrhea and stomach discomfort; rarely nausea, vomiting, abdominal pain, burning sensation in the chest, loss of appetite, abdominal fullness, and constipation; dysbacteriosis: rare stomatitis and oral candidiasis; vitamin deficiency: rare vitamin K deficiency (hypoprothrombinemia, bleeding tendency, etc.) and vitamin B deficiency (glossitis, stomatitis, loss of appetite, neuritis, etc.); others: headache and dizziness.

It is contraindicated for patients who are allergic to this product, its ingredients or other cephalosporin antibiotics.

Precautions for children: The safety of the drug for premature infants and newborns has not been established (no experience). Precautions for pregnancy and lactation: The safety and effectiveness of this drug for pregnant women have not been established. Use this drug only when it is really necessary. It is not clear whether this drug is secreted from breast milk. Breastfeeding should be suspended when it is necessary. Precautions for the elderly: Reduce the dosage for elderly patients.

Carbamazepine: When used in combination with this product, it may cause an increase in carbamazepine levels. When used in combination, the plasma carbamazepine concentration should be monitored. Warfarin and anticoagulants: When used in combination with this product, prothrombin time may be increased.

Protect from light, seal tightly and store in a cool place.

0.1g (based on cefixime)

24 months

Harbin Brightway Pharm. Co., Ltd.

• Founded in:

  1998-09-09

• Address:

  Beijing Road, Limin Development Zone, Hulan District, Harbin City, Heilongjiang Province

• Tax NO.:

  91230111702846756T

• Registered Funds:

  84.87 million yuan

• Email:

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