Ceftriaxone Sodium for Injection

This product is a third-generation cephalosporin antibiotic. It has strong activity against Enterobacteriaceae. The MIC90 for Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Citrobacter fluorescens, indole-positive Proteus, Providencia and Serratia is between 0.12 and 0.25 mg/L. Enterobacter cloacae, Acinetobacter and Pseudomonas aeruginosa are poorly sensitive to this product. It has a strong antibacterial effect on Haemophilus influenzae, Neisseria gonorrhoeae and Neisseria meningitidis, and also has a good effect on hemolytic streptococci and pneumococci. The MIC for Staphylococcus aureus is 2 to 4 mg/L. Methicillin-resistant Staphylococci and enterococci are resistant to this product. Most Bacteroides fragilis are resistant to this product.

The main ingredient of this product is ceftriaxone sodium. Its chemical name is [6R[6alpha;,7beta;(Z)]]-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazine-3-yl)thio]methyl]-7-[[(2-amino-4-thiazolyl](methoxyimino)acetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid disodium salt triplicate hemihydrate.

This product is white or off-white crystalline powder.

It is used for lower respiratory tract infections, urinary tract infections, biliary tract infections, abdominal infections, pelvic infections, skin and soft tissue infections, bone and joint infections, sepsis, meningitis, etc. caused by sensitive pathogens, as well as the prevention of surgical infections. A single dose of this product can treat simple gonorrhea.

Adults: 1-2g daily, intramuscular, intravenous or intravenous infusion. In severe infections, the dose can be increased to 4g/day. Children: 20-80mg/kg body weight/day. Infusion should be at least 30 minutes. Newborns: 20-50mg/kg body weight/day. The duration of treatment should vary depending on the course of the disease, usually for at least 48-72 hours after the patient has no fever or there are signs of bacterial eradication. Infants and children with meningitis: 100mg/kg body weight/day, not exceeding 4g/day. Once the pathogenic microorganism is identified and the sensitivity is determined, the dose can be reduced accordingly. Course of treatment: Neisseria meningitidis - 4 days, Haemophilus influenzae - 6 days, pneumococcus - 7 days, sensitive intestinal bacteria - 10-14 days. Gonorrhea: single dose 250mg. To prevent infection, use a single dose of 1-2g 30-90 minutes before surgical surgery. Use ceftriaxone sodium and 5-nitroimidazole in combination for colon and rectal surgery. For patients with severe renal failure (creatinine clearance < 10mL/min), the dose of this product should not exceed 2g/day. For patients who require dialysis, there is no need to increase the dose after dialysis. However, it is necessary to monitor the blood concentration to determine whether the dose needs to be adjusted, because the elimination rate of such patients may be reduced.

Adverse reactions are related to the dosage and course of treatment. Local reactions include phlebitis (1.86%), in addition to allergic reactions such as rash, itching, fever, bronchospasm and serum sickness (2.77%), headache or dizziness (0.27%), diarrhea, nausea, vomiting, abdominal pain, colitis, jaundice, flatulence, taste disorders and indigestion and other digestive tract reactions (3.45%). About 19% of laboratory tests were abnormal, of which 14% were abnormal in hematological tests, including eosinophilia, thrombocytosis or thrombocytopenia and leukopenia. Abnormal liver and kidney function was 5% and 1.4% respectively.

It is contraindicated in patients who are allergic to cephalosporin antibiotics.

Precautions for children: Ceftriaxone can displace bilirubin from serum albumin. Newborns with hyperbilirubinemia (especially premature infants) may develop kernicterus. This product should be used with caution or avoided. Precautions for pregnancy and lactation: Reproductive toxicity tests on mice and rats using 20 times the human dose did not show embryotoxicity and teratogenicity. Adequately well-controlled clinical trials have not been conducted in pregnant women. Because animal test results cannot fully reflect human toxicity, pregnant and lactating women should use it only when it is really necessary. Precautions for the elderly: Unless the elderly patient is weak, malnourished, or has severe renal impairment, the recommended adult dose is generally administered without change.

1. When erythromycin, tetracycline, amphotericin B, vasoactive drugs (meta-hydroxylamine, norepinephrine, etc.), phenytoin sodium, chlorpromazine, isopropyl alcohol, vitamin B group, vitamin C, etc. are added to the intravenous infusion of cephalosporins, turbidity will occur. Since this product has many contraindications, it should be administered alone. 2. Drinking alcohol or taking alcohol-containing drugs during the use of this product may cause disulfiram-like reactions in some patients. Therefore, drinking alcohol and taking alcohol-containing drugs should be avoided during the use of this product and in the following days.

Keep in a dark place, tightly sealed, and dry and cool place. The validity period is 2 and a half years.

3.0 g (calculated as C18H18N8O7S3)

30 months

Guangdong Bozhou Pharmaceutical Co., Ltd.

• Founded in:

  2000-12-07

• Address:

  Green Industrial Park, Jiedong Economic Development Zone, Jieyang City

• Tax NO.:

  9144520372599310X7

• Registered Funds:

  20 million yuan

• Email:

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