Cefixime Dispersible 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 characteristics vary depending on 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.

This product is off-white tablets.

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

Oral administration: can be taken directly with water, or add this product to an appropriate amount of warm boiled water and wait for dispersion and dissolution (can be stirred) before taking. 1. Adults and children weighing more than 30 kg: 50-100 mg (titer) each time, twice a day. In addition, it can be appropriately increased or decreased according to age, weight, and symptoms. For critically ill patients, 200 mg (titer) can be taken orally each time, twice a day. 2. Children: 1.5-3 mg (titer)/kg (body weight) each time, twice a day. In addition, it can be appropriately increased or decreased according to symptoms. For critically ill patients, 6 mg (titer)/kg (body weight) 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 112 cases (0.87%) of gastrointestinal symptoms such as diarrhea, 29 cases (0.23%) of skin symptoms such as rash, and abnormal clinical examination values including 78 cases (0.61%) of increased GPT, 58 cases (0.45%) of increased GOT, and 26 cases (0.20%) of increased eosinophils. (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 with 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% respectively) 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 increase of alanine aminotransferase (ALP/GPT), increase of alanine aminotransferase (ALP/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 determined. Precautions for pregnancy and lactation: Reproduction studies in mice and rats at doses up to 400 times the human dose showed no evidence of damage to fetal mice. The safety of the drug during pregnancy has not been determined, so when using the drug for pregnant women or women who may become pregnant, the pros and cons must be weighed, and the drug can only be used when the benefits outweigh the cons. The effect of cefotaxime on delivery has not been studied, and it can only be used when it is clearly needed. It is unclear whether cefotaxime is excreted in human milk. When using this product, you should consider suspending breastfeeding. Precautions for the elderly: The peak blood concentration and AUC of this product in the elderly can be 26% and 20% higher than that in young people, respectively, and elderly patients can use this product.

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.

Light-shielding and sealed.

50 mg (calculated as cefixime)

24 months

Zhejiang Shapuaisi Pharmaceutical Co., Ltd.

• Founded in:

  2000-07-17

• Address:

  No. 1588, Xinming Road, Economic Development Zone, Pinghu City, Zhejiang Province

• Tax NO.:

  91330000146644116H

• Registered Funds:

  375.925005 yuan

• Website:

  Log in to view

• Email:

  Log in to view