Cefixime Capsules

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 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 effect was 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, and its chemical name is (6R,7R)-7-[[(Z)-2-(2-amino-4-thiazolyl)-2-[(carboxymethyloxy)imino]acetyl]amino]-3-vinyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid trihydrate.

The content of this product is white to light yellow powder.

It is effective for the following infections caused by cefixime-sensitive bacteria among 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.

Oral. Dosage for adults and children weighing more than 30 kg: Oral, 100 mg each time, twice a day; for adults with severe infection, the dose can be increased to 200 mg each time, twice a day. Children: Oral, 1.5-3.0 mg per kg each time, twice a day. Or follow the doctor's advice.

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 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 discomfort, abnormal sensation in the mouth, asthma, dizziness, constipation, 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 fever, headache, joint pain, skin or mucosal erythema, blisters, skin tension, burning sensation, pain, etc. occur, the drug should be stopped ④ Blood disorders: There is a possibility of agranulocytosis (<0.1%, early symptoms: fever, sore throat, headache, fatigue), 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., and if abnormalities occur, 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 abnormalities occur, 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% respectively) 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.

Patients who are allergic to this product or other cephalosporin antibiotics; patients with a history of penicillin anaphylactic shock should avoid using this product.

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. This drug should only be used when it is really necessary. It is not clear whether this drug is secreted from breast milk. If it is necessary to use it, breastfeeding should be suspended. Precautions for the elderly: The dosage of the drug should be reduced 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 (not exceeding 20℃).

0.1g

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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