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 (1a, 1b, 1c) and PBP3 among penicillin-binding proteins (PBP). This product has a strong stability against β-lactamases produced by various bacteria.

The main ingredient of this product is cefixime, and its chemical name is (6R, 7R)-7-[(Z)-2-(2-amino-4-thiazolyl)-2-(carboxymethyloxyimino)acetamido-3-ethylene-8-oxo-5-thia-1-azabicyclo[4,2,0]oct-2-ene-2-carboxylic acid trihydrate].

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

It is effective for the following infections caused by cefixime-sensitive bacteria in Streptococcus (except enterococci), Pneumococcus, Neisseria gonorrhoeae, Branhamella catarrhalis, Escherichia coli, Klebsiella, Serratia, Proteus, and Haemophilus influenzae. ●Acute exacerbation of chronic bronchitis, bacterial infection complicated by acute bronchitis, bronchiectasis complicated by infection, pneumonia; ●Pyelonephritis, cystitis, gonococcal urethritis; ●Acute bacterial infection of the biliary system (cholecystitis, cholangitis); ●Scarlet fever; ●Otitis media, sinusitis.

Adults and children weighing more than 30 kg: Oral administration, 0.1 g (one tablet) each time, twice a day. In addition, the dosage can be appropriately increased or decreased according to age, weight, and symptoms. For severe patients, 0.2 g (two tablets) can be taken orally each time, twice a day.

Of the total 12,879 cases, adverse reactions including abnormal clinical examination values were found in 294 cases (2.58%). These adverse reactions included digestive tract symptoms such as diarrhea in 112 cases (0.87%), skin symptoms such as rash in 29 cases (0.23%), and abnormal clinical examination values including increased GPT in 78 cases (0.61%), increased GOT in 58 cases (0.45%), and increased eosinophilia in 26 cases (0.20%). (1) Serious adverse reactions: ① Shock: Due to the possibility of shock (0.1%), the patient should be closely observed. If any 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%) and toxic epidermal necrolysis (Lyell syndrome, 0.1%). The patient should be closely observed. If any symptoms such as fever, headache, joint pain, skin or mucosal erythema, blisters, skin tension, burning sensation, pain, etc. occur, the drug should be stopped. Take appropriate measures; 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 should be made, such as regular examinations, etc. 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 examinations, etc. If any abnormality occurs, the drug should be stopped and appropriate measures should be taken; ⑥ Colitis: It may cause severe colitis with bloody stools, such as pseudomembranous colitis (0.1%). If abdominal pain or recurrent diarrhea occurs, medication 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 fever, cough, dyspnea, abnormal chest X-ray, eosinophilia and other symptoms. If the above symptoms occur, medication 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 at less than 0.1%. Allergies: common rash, urticaria, erythema, rare itching, fever, edema; blood: common (0.1-5%) eosinophilia, rare granulocytopenia; liver: common increase of alanine aminotransferase (ALP/GPT), increase of aspartate aminotransferase (AST/GOT), rare jaundice; kidney: rare increase of urea nitrogen (BUN); digestive system: common diarrhea, stomach discomfort, rare nausea, vomiting, abdominal pain, burning sensation in the chest, loss of appetite, abdominal fullness, constipation; dysbacteriosis: rare stomatitis, oral candidiasis; vitamin deficiency: rare vitamin K deficiency (hypoprothrombinemia, bleeding tendency, etc.), vitamin B deficiency (glossitis, stomatitis, loss of appetite, neuritis, etc.); others: headache, dizziness.

Those who are allergic to this product or other cephalosporin antibiotics

Precautions for children: The safety and effectiveness of cefotaxime for children under 6 months of age have not been established. Precautions for pregnancy and lactation: Use with caution in pregnant and lactating women. Precautions for the elderly: Use with caution in 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.

Keep in a dark, sealed container, and stored in a cool, dark (no more than 20°C) dry place.

50mg (calculated as C16H15N5O7S2)

24 months

Shandong Lukang Pharmaceutical Co., Ltd.

• Founded in:

  1993-02-15

• Address:

  No. 88, Deyuan Road, Jining High-tech Zone, Shandong Province

• Tax NO.:

  913700001659297311

• Registered Funds:

  880.229735 yuan

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