Ceftriaxone Sodium for Injection

Ceftriaxone is a long-acting, broad-spectrum cephalosporin that produces antibacterial effects by inhibiting the synthesis of cell walls. It has a strong bactericidal effect on both Gram-positive and Gram-negative bacteria. It is highly stable to beta-lactamase (including penicillinase and cephalosporinase). In vitro and clinical trials have shown that ceftriaxone sodium has high antibacterial activity against the following Gram-negative bacilli: Escherichia coli, Klebsiella, Proteus mirabilis, indole-positive Proteus, Salmonella, Shigella and other r/Enterobacteriaceae and Haemophilus influenzae; it also has good antibacterial effects on Gram-negative cocci such as meningococci and gonococci; Gram-positive cocci such as pneumococci, Streptococcus pyogenes, Streptococcus viridans, and Streptococcus bovis are all sensitive to this product; it also has a certain antibacterial effect on Staphylococcus aureus, but the antibacterial effect is poorer than that of the above-mentioned Gram-positive cocci. Pseudomonas aeruginosa and Acinetobacter are less sensitive to this product. It also has antibacterial activity against some anaerobic bacteria such as Bacteroides fragilis, Clostridium, and Peptococcus.

The main ingredient of this product is ceftriaxone sodium, without any excipients.

Infections caused by pathogens sensitive to Rocephin, such as: sepsis, meningitis, disseminated Lyme disease (early and late stages), abdominal infections (peritonitis, biliary and gastrointestinal infections), bone, joint, soft tissue, skin and wound infections, infections in immunocompromised patients, kidney and urinary tract infections, respiratory tract infections, especially pneumonia, ear, nose and throat infections, reproductive system infections, including gonorrhea, and preoperative prevention of infection.

1. Adults and children under 12 years old, children weighing more than 50 kg should use the adult dose, usually 1-2g, once a day. For critically ill patients or infections caused by moderately sensitive bacteria, the dose can be increased to 4g, once a day. 2. For newborns, infants and children under 12 years old, the following doses are recommended for use once a day: The daily dose for newborns (under 14 days old) is 0-50mg/kg based on body weight. Not exceeding 50mg/kg, no need to distinguish between premature infants and full-term infants. The daily dose for infants and children (15 days to 12 years old) is 20-80mg/kg based on body weight. 3. Intramuscular injection: 1.0g of this product is dissolved in 3.5ml of 1% lidocaine hydrochloride for intramuscular injection. It is better to inject it into a relatively large muscle. It is not recommended to inject more than 1g into the muscle. Lidocaine solution must not be used for intravenous injection. Intravenous injection: 1.0g of this product is dissolved in 10ml of sterile water for injection for intravenous injection. The injection time cannot be less than 2-4 minutes. Intravenous drip: 2g of this product is dissolved in 40ml 0.9% sodium chloride solution or 5% glucose injection, and then diluted with the same solvent to 100-250ml for intravenous drip. When the intravenous dose is 50 mg/kg or more, the infusion time should be at least 30 minutes. Due to the possibility of drug incompatibility, this product cannot be mixed with other drugs. When combined medication is required, it should be used separately. The newly prepared solution should be used immediately. 4. Course of treatment The course of treatment depends on the course of the disease, usually 4 to 14 days, and can be appropriately extended for severe complicated infections. As with general antibacterial drug treatment regimens, this product should be continued for at least 48 to 72 hours after the fever subsides or evidence of bacterial elimination is obtained. 5. Special medication guidance Meningitis: For bacterial meningitis in infants and children, the initial treatment dose is 100 mg per kilogram of body weight (not more than 4g), once a day. Once the pathogenic bacteria and drug sensitivity test results are confirmed, the dose can be reduced as appropriate. Acute otitis media: 50 mg/kg for children and adults, with a maximum dose of no more than 1 g. Gonorrhea: The recommended dosage for the treatment of gonorrhea (penicillinase-producing and non-penicillinase-producing strains) is a single dose of 250 mg intramuscularly. Preoperative prophylaxis: To prevent infection after contaminated or uncontaminated surgery, a single dose of 1 to 2 g of this product is recommended 30 to 90 minutes before surgery, depending on the risk of infection. It has been proven to be effective for colorectal surgery patients to use this product alone or in combination with 5-nitroimidazole (such as ornidazole) (but used separately). Hepatic and renal insufficiency: For patients with renal insufficiency, if their liver function is not damaged, there is no need to reduce the dosage of this product. For patients with severe renal failure (creatinine clearance (10ml/min), the daily dosage of this product should not exceed 2g. For patients with impaired liver function, if their renal function is intact, there is no need to reduce the dosage. Patients with severe liver and kidney dysfunction should check the blood concentration of this product regularly. Patients who are receiving dialysis treatment do not need to increase the dose after dialysis. Since the drug clearance rate of such patients may be reduced, the blood concentration should be monitored to determine whether the dose needs to be adjusted.

1. This product has good tolerance, and adverse reactions are rare, about 5-7%, manifested as mild allergic reactions, such as rash, pruritus, urticaria, edema, erythema multiforme, fever, bronchospasm; digestive tract reactions, such as nausea, vomiting, abdominal pain, abdominal distension, soft stools, diarrhea, glossitis, gastritis, colitis, taste abnormalities, jaundice, etc.; nervous system reactions, such as headache and dizziness. Occasionally, hematological changes such as eosinophilia, leukopenia, thrombocytopenia, hemolytic anemia, transient serum transaminase elevation, alkaline phosphatase elevation, bilirubin elevation, blood urea nitrogen and blood creatinine increase and other adverse reactions are seen. Most of these reactions can be reversed by themselves, or disappear after stopping the drug. Long-term use of this product will cause overgrowth of insensitive bacteria, which can cause secondary infections such as candidiasis, vaginitis, rare pseudomembranous enterocolitis and coagulopathy. 2. Local side effects: Local application may cause pain and induration at the injection site. In rare cases, phlebitis may occur after intravenous administration. These phenomena can be reduced by slowing down the intravenous injection rate (the injection time should be greater than 2 to 4 minutes). Intramuscular injection may cause pain if lidocaine is not added.

This product 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. So far, no cases of renal insufficiency caused by the simultaneous use of large doses of this product and diuretics (such as furosemide) have been found. This product has not been found to increase the renal toxicity of aminoglycoside antibiotics. 2. No alcohol withdrawal-like side effects have been found in those who use this product after drinking, but drinking and taking alcoholic beverages at the same time should still be avoided. 3. Ceftriaxone does not contain N-methylthiotetrazole, which is related to the bleeding symptoms of some cephalosporin antibiotics. 4. The clearance of this product is not affected by probenecid. 5. In vitro tests have found that the combination of chloramphenicol and ceftriaxone will produce antagonistic effects. Adding erythromycin, tetracycline, amphotericin B, vasoactive drugs (hydroxylamine, norepinephrine, etc.), phenytoin sodium, chlorpromazine, isopropyl alcohol, vitamin B group, and vitamin C to the intravenous infusion of cephalosporins may cause turbidity. Since this product has many contraindications, it should be administered alone.

Keep away from light, tightly closed, in a cool (not exceeding 20℃) and dry place.

Calculated as C18H18N8O7S3 0.5g

30 months

KPC Pharmaceuticals, Inc.

• Founded in:

  1995-12-14

• Address:

  No. 166, Keyi Road, High-tech Industrial Development Zone, Kunming, Yunnan Province

• Tax NO.:

  91530000216562280W

• Registered Funds:

  757.986969 yuan

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