Ceftriaxone Sodium for Injection

[Pharmacology and Toxicology] 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 have poor sensitivity 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. [Pharmacokinetics] After intramuscular injection of 0.5g and 1g of this product, the peak blood concentration (Cmax) is reached about 2 hours later, which is 43mg/L and 80mg/L respectively. The blood concentration 24 hours after intramuscular injection of 0.5g is 6.0mg/L, and the blood elimination half-life (t1/2b) is 7.1 hours. After intravenous injection of 0.5g within 1 minute, the immediate peak blood concentration (Cmax) is 150.9mg/L, and the blood concentration after 24 hours is 9.9mg/L, and the blood elimination half-life (t1/2b) is 7.87 hours. After intravenous infusion of 1g of this product within 30 minutes, the immediate peak blood concentration (Cmax) at the end of the infusion is 150.7mg/L, and the blood concentration after 24 hours is 9.3mg/L. Give patients with purulent meningitis 15-20mg intramuscular injection daily /kg, the average cerebrospinal fluid concentration was 5.16mg/L at 6 hours and 2.3mg/L at 12 hours. The concentration in bile was 1600mg/L and 13.5mg/L at 5 hours and 14 hours after intravenous infusion of 1g of this product, respectively. The protein binding rate is 95%. Ceftriaxone is not metabolized in the human body, about 40% of the drug is excreted in the bile duct and intestines in its original form, and 60% is excreted in the urine. Probenecid cannot increase the blood concentration of this product or prolong its half-life.

The main ingredient of this product is 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 make 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 make a solution containing 100mg of ceftriaxone per 1ml, and then dilute with 100-250ml of 5% glucose injection or sodium chloride injection and drip intravenously. The common 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 7-14 days. The common dose for children is intravenous administration, 20-80mg per day according to 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.

It is contraindicated for 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 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 away from light, tightly closed, in a cool and dry place.

1.0g (calculated as C18H18N8O7S3)

30 months

Haikou Pharmaceutical Factory Co., Ltd.

• Founded in:

  1990-03-09

• Address:

  No. 192, Nanhai Avenue, Xiuying District, Haikou City, Hainan Province

• Tax NO.:

  91460100984090386D

• Registered Funds:

  562.352031 yuan

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