Cefuroxime Sodium for Injection

This product has a broad spectrum of antibacterial activity against Gram-positive and Gram-negative bacteria, especially against Escherichia coli, Klebsiella, Haemophilus influenzae, Proteus and Bacteroides fragilis. Its mechanism of action is to show a strong affinity for penicillin-binding protein, which is the usual site of action of β-lactam antibiotics, inhibit cell wall synthesis, bind to peptidoglycan, inhibit the binding of peptidoglycan to lipoprotein to promote bacteriolysis, and show a strong bactericidal effect in a short time. This product shows antibacterial effect on bacteria during the proliferation period and the early stage of the stable period, and has a bactericidal effect at concentrations lower than the MIC, and lyses bacteria in a short time. The in vivo antibacterial effect is stronger than the prediction of the MIC. This product has no effect on the reproductive capacity of rat mothers, the development and differentiation of offspring, and the reproductive capacity when injected with 200-1600 mg/kg/day. Rabbits were injected with 400-1600 mg/kg/day for 5 days. In the group with more than 800 mg/kg/day, the nephrotoxicity was observed to be weaker than cefazolin, but slightly stronger than cephalothin. There is almost no antigenicity to mice, rats, guinea pigs and rabbits. There is no immunological cross-reactivity with cefmetazole, cefazolin, penicillin G and ampicillin, and no positive Coombs' reaction is observed.

The main ingredient of this product is cefuroxime sodium and its chemical name is: (6R,7S)-7-[(S)-2-[(2-amino-2-carboxyethyl)thio]acetylamino]-7α-methoxy-3-[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt heptahydrate.

This product is white or slightly yellowish white crystalline powder, odorless or with a slight peculiar odor, easily soluble in water, less soluble in methanol, and almost insoluble in ethanol or ether.

This product can be used to treat the following infections caused by the above-mentioned sensitive bacteria: 1. Respiratory system infections: tonsillitis, peritonsillar abscess, bronchitis, bronchiolitis, bronchiectasis (infection), secondary infection of chronic respiratory diseases, pneumonia, pulmonary suppuration. 2. Urinary system infections: pyelonephritis, cystitis. 3. Abdominal infections: cholecystitis, cholangitis, peritonitis. 4. Pelvic infections: pelvic peritonitis, adnexitis, intrauterine infection, pelvic dead cavity inflammation, parametrial tissue inflammation. 5. Sepsis.

This product is only for intravenous injection or intravenous drip. Intravenous injection: During intravenous injection, each lg (titer) of the drug can be dissolved with 20ml of water for injection, 5% glucose injection or 0.9% sodium chloride injection. Intravenous drip: During intravenous drip, each 1g (titer) of the drug can be dissolved with 100-500ml of 5% glucose injection or 0.9% sodium chloride injection, and drip for 1-2 hours. The recommended common dose is: lg (titer) for adults each time, twice a day, which can be increased or decreased appropriately with age and symptoms. For sepsis, refractory or severe infections, it can be increased to 6g (titer) per day, divided into 3-4 doses; children are measured by body weight 20mg (titer)/kg each time, 3-4 times a day.

The following adverse reactions have been observed after this product was put on the market: Incidence: Occasionally: less than 0.1%, sometimes: 0.1-5%, common: more than 5% or unknown frequency. (1) Serious side effects: ① Shock Occasionally shock occurs, so you should observe carefully. If you experience discomfort, foreign body sensation in the mouth, wheezing, dizziness, urge to defecate, tinnitus, sweating, etc., you should stop the drug and deal with it appropriately. ② Pancytopenia Occasionally pancytopenia occurs, so you should check regularly and observe carefully. If abnormalities occur, you should stop the drug and deal with it appropriately. ③ Pseudomembranous colitis Occasionally severe colitis such as pseudomembranous colitis accompanied by bloody stools occurs, so you should observe carefully. If you experience abdominal pain or frequent diarrhea, you should stop the drug and deal with it appropriately. (2) Serious side effects observed with similar drugs: ① Skin mucosal eye syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome) Other cephem antibiotics have occasional reports of skin mucosal eye syndrome (Stevens-Johnson syndrome) and toxic epidermal necrolysis (Lyell syndrome). Careful observation should be made. If abnormalities occur, the drug should be discontinued and appropriate treatment should be given. ② Acute renal failure Other cephem antibiotics have occasional reports of severe renal damage such as acute renal failure. If abnormalities occur, the drug should be discontinued and appropriate treatment should be given. ③ Hemolytic anemia Other cephem antibiotics have reports of hemolytic anemia. Regular inspections and careful observation should be made. If abnormalities occur, the drug should be discontinued and appropriate treatment should be given. ④ Interstitial pneumonia, PIE syndrome Other cephem antibiotics have occasionally been reported to cause interstitial pneumonia, PIE syndrome, etc. accompanied by fever, cough, dyspnea, abnormal chest X-ray, eosinophilia, etc. If such symptoms occur, the drug should be discontinued and appropriate treatment should be given with adrenocortical hormone preparations. (3) Other side effects: ① Allergic reactions may sometimes cause rashes, and occasionally skin redness, itching, fever, etc. If such symptoms occur, the drug should be discontinued and appropriate treatment should be given. ② Kidney damage may occasionally occur, such as increased BUN, increased blood creatinine, oliguria, and proteinuria. Therefore, regular examinations should be performed and careful observation should be observed. If oliguria, hematuria, urine protein, increased BUN, and increased blood creatinine occur, the drug should be discontinued and appropriate treatment should be given. ③ Blood may sometimes show granulocytopenia, eosinophilia, and occasionally erythropenia, decreased hematocrit, decreased hemoglobin, thrombocytopenia, prolonged prothrombin time, etc., so regular inspections should be carried out and observations should be observed. If abnormalities are found, the drug should be discontinued and appropriate treatment should be given. ④ Liver may sometimes show increased GOT, GPT, and AL-P, and occasionally increased γ-GTP, LAP, LDH, and bilirubin, as well as jaundice, so observations should be observed. If abnormalities are found, the drug should be discontinued and appropriate treatment should be given. ⑤ Digestive tract may sometimes show diarrhea, and occasionally nausea, vomiting, and loss of appetite, so observations should be observed. If abnormalities are found, the drug should be discontinued and appropriate treatment should be given. ⑥ Stomatitis and candidiasis may occasionally occur in alternating flora. ⑦ Vitamin deficiency may occasionally show symptoms of vitamin K deficiency (hypoprothrombinemia, bleeding tendency, etc.) and vitamin B deficiency (glossitis, stomatitis, loss of appetite, neuritis, etc.). ⑧ Others may occasionally show general fatigue.

It is contraindicated in patients with a history of allergic reactions to cefuroxime or cephem antibiotics.

This product cannot be used in combination with aminophylline or pyridoxal phosphate because it will reduce potency or color. It should not be used in combination with fursultiamine, lipoic acid, hydrocortisone sodium succinate and adenosylcobalamin because it will change color after a while. It should be used as soon as possible after combination. It may increase renal toxicity when used in combination with diuretics (such as furanilamide). Animal experiments have confirmed that this product affects alcohol metabolism, increases blood acetaldehyde concentration, and shows a disulfiram-like effect. Therefore, alcohol should be avoided during or after medication.

Keep away from light, tightly closed, in a cool and dry place.

0.5g (calculated as C16H21N7O7S3)

ShenZhen Lijian Pharmaceutical Co., Ltd.

• Founded in:

  2001-04-28

• Address:

  1st Floor, Building B2, No. 1 Yuanfu Road, Shanghenglang Community, Dalang Street, Longhua District, Shenzhen

• Tax NO.:

  91440300728555703C

• Registered Funds:

  40 million yuan

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