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.

Ceftriaxone Sodium for Injection

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.

Intramuscular injection or intravenous administration. 1. Preparation of intramuscular injection solution: add 3.6ml of sterile water for injection, sodium chloride injection, 5% glucose injection or 1% lidocaine hydrochloride to 1g bottle to prepare a solution containing 250mg of ceftriaxone per 1ml. 2. Preparation of intravenous solution: add 9.6ml of the above diluent (except lidocaine) to 1g bottle to prepare a solution containing 100mg of ceftriaxone per 1ml, then dilute with 100-250ml of 5% glucose injection or sodium chloride injection and drip intravenously. The usual dose for adults is 1-2g every 24 hours or 0.5-1g every 12 hours for intramuscular or intravenous administration. The maximum dose is 4g per day. The course of treatment is 7 to 14 days. The usual dose for children is intravenous administration, 20-80mg/day based on body weight.

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.

This product is contraindicated for use in patients who are allergic to cephalosporin antibiotics. This product cannot be added to solutions containing calcium such as Hartmann's and Ringer's.

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 alcoholic drugs during the use of this product may cause disulfiram-like reactions in some patients. Therefore, drinking alcohol and taking alcoholic drugs should be avoided during the use of this product and in the following days.

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

1.0g (calculated as C18H18N8O7S3)

30 months

Shandong Runze Pharmaceuticals Co., Ltd.

• Founded in:

  2009-04-30

• Address:

  No. 999, University Road, High-tech Zone, Heze City, Shandong Province

• Tax NO.:

  91371700688283183B

• Registered Funds:

  277 million yuan

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