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 strong affinity for penicillin-binding protein, which is the usual action point of β-lactam antibiotics, inhibit cell wall synthesis, bind to peptidoglycan, inhibit the binding of peptidoglycan to lipoprotein to promote bacteriolysis, and show strong bactericidal power 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 power is stronger than the prediction of 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 ingredients and chemical names of this product are: (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 [Molecular formula] C16H20N7NaO7S3·7H2O [Molecular weight] 667.67

This product is white or slightly yellow 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 1g (titer) of the drug can be dissolved with 20ml of water for injection, 5%-10% 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%-10% glucose injection or 0.9% sodium chloride injection, and drip for 1-2 hours. The recommended common dose is: 1g (titer) each time for adults, twice a day, which can be increased or decreased appropriately according to 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 weight 20mg (titer)/kg each time, 3-4 times a day. This product should be prepared when it is used and used as soon as possible after dissolution.

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 pay attention to observation. 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 pay attention to observation. 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 pay attention to observation. 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 occasionally reported cases of skin mucosal eye syndrome (Stevens-Johnson syndrome) and toxic epidermal necrolysis (Lyell syndrome). Therefore, pay attention to observation. If abnormalities occur, the drug should be discontinued and appropriate treatment should be given. ② Acute renal failure Other cephem antibiotics have occasionally reported cases of severe renal damage such as acute renal failure. Therefore, the drug should be discontinued and appropriate treatment should be given if abnormalities occur. ③ Hemolytic anemia Other cephem antibiotics have reported cases of hemolytic anemia. Therefore, regular examinations should be performed and attention should be paid. If abnormalities occur, the drug should be discontinued and appropriate treatment should be given. ④ Interstitial pneumonia, PIE syndrome Other cephem antibiotics have occasionally reported cases of 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 adrenocortical hormone preparations should be given for appropriate treatment. (3) Other side effects ① Allergic reactions may cause skin rashes, and occasionally skin redness, itching, fever, etc. If such symptoms occur, the drug should be discontinued and appropriate measures should be taken. ② Kidney damage may occasionally cause increased BUN, increased blood creatinine, oliguria, proteinuria, etc., so regular examinations should be conducted and observations should be made. If oliguria, hematuria, urine protein, increased BUN, increased blood creatinine, etc. are found, the drug should be discontinued and appropriate measures should be taken. ③ Blood may sometimes cause granulocytopenia and eosinophilia, and occasionally erythropenia, decreased hematocrit, decreased hemoglobin, thrombocytopenia, prolonged prothrombin time, etc., so regular examinations should be conducted and observations should be made. If abnormalities are found, the drug should be discontinued and appropriate measures should be taken. ④ Liver may sometimes cause increased GOT, GPT, and AL-P, and occasionally increased γ-GTP, LAP, LDH, bilirubin, etc., and jaundice, so observations should be made. If abnormalities are found, the drug should be discontinued and appropriate measures should be taken. ⑤ Sometimes diarrhea occurs in the digestive tract, and nausea, vomiting, loss of appetite, etc. occur occasionally, so pay attention to observation. If abnormalities occur, the drug should be discontinued and appropriate treatment should be given. ⑥ Occasionally, stomatitis and candidiasis occur in alternating flora. ⑦ Occasionally, symptoms of vitamin K deficiency (hypoprothrombinemia, bleeding tendency, etc.) and vitamin B deficiency (glossitis, stomatitis, loss of appetite, neuritis, etc.) occur in vitamin deficiency. ⑧ Others Occasionally, a feeling of general fatigue occurs.

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 will change color after a while when used with fursultiamine, lipoic acid, hydrocortisone sodium succinate and adenosylcobalamin. It should be used as soon as possible after the 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 in a dark and airtight place in a cool and dry place. Validity period: two years

1.0g (calculated as C16H21N7O7S3)

NCPC Hebei HUAMIN Pharmaceutical Co., Ltd.

• Founded in:

  2010-04-28

• Address:

  No. 98, Hainan Road, Shijiazhuang Economic and Technological Development Zone

• Tax NO.:

  91130182554463533P

• Registered Funds:

  1.450139 million yuan

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