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, B. blahamella, Escherichia coli, Klebsiella, Serratia, Proteus, and Haemophilus influenzae 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 beta-lactamase 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-thiazolin-4-yl)-2-(carboxymethoxyamino)acetamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid trihydrate.

This product is a capsule, and the contents are off-white to light yellow powder.

It is effective for the following infections caused by cefixime-sensitive bacteria among Streptococcus (except Enterococcus), Pneumococcus, Neisseria gonorrhoeae, Branhamella catarrhalis, Escherichia coli, Klebsiella, Serratia, Proteus, and Haemophilus influenzae.

Adults and children weighing more than 30 kg: Orally take 0.1g (one tablet) at a time, twice a day. In addition, the dosage can be appropriately increased or decreased according to age, weight, and symptoms. For severe patients, 0.2g (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 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 GOP, 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%) and toxic epidermal necrolysis (Lye11 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 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 bleeding, purpura, etc.), and there are reports of other cephalosporin antibiotics causing pancytopenia. Therefore, 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: Severe colitis with bloody stools, such as pseudomembranous colitis, may be caused (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) with 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 at less than 0.1%. Allergies: common rash, urticaria, erythema, rare itching, fever, edema; blood: common (0.1-5%) eosinophilia, rare neutropenia; 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 efficacy of cefixime for children under 6 months of age have not been determined. Precautions for pregnancy and lactation: Reproductive 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 cefixime on delivery has not been studied, and it can only be used when it is clearly needed. It is unclear whether cefixime is excreted in human milk. When using this product, consider suspending breastfeeding. Precautions for the elderly: 1. The peak blood concentration and AUC of this product in the elderly can be 26% and 20% higher than those in young people, respectively, and the elderly can use this product. 2. Patients with renal insufficiency should adjust the dosage, and patients with a creatinine clearance of ge; 60ml/min can use it according to the normal dose and course of treatment. Patients with a creatinine clearance of 21~60ml/min or hemodialysis can be given at 75% of the standard dose (standard dosing interval). Patients with creatinine clearance of 20 ml/min or long-term bedridden peritoneal dialysis can be given half the standard dose (standard dosing interval).

Carbamazepine: When used in combination with this product, the level of carbamazepine may increase. If co-use is necessary, the plasma concentration of carbamazepine should be monitored.

Keep in a dark and dry place, sealed and protected from light. Valid for 2 years.

0.1 g

24 months

Shanghai Haihong Industry (Group) Chaohu Jinchen Pharmaceutical Co., Ltd.

• Founded in:

  2002-11-26

• Address:

  No. 18, Yicheng Road, Chaohu City, Anhui Province

• Tax NO.:

  91340181744869155N

• Registered Funds:

  31 million yuan

• Website:

  Log in to view

• Email:

  Log in to view