Ceftriaxone Sodium for Injection

This product is a first-generation cephalosporin with a broad antibacterial spectrum and strong activity against Gram-positive bacteria. Penicillinase-producing and non-penicillinase-producing Staphylococcus aureus, coagulase-negative Staphylococcus, Streptococcus pyogenes, Streptococcus pneumoniae, Group B hemolytic Streptococcus, Streptococcus viridans, Staphylococcus epidermidis, Corynebacterium diphtheriae, and Bacillus anthracis are all quite sensitive to this product. Enterococci, methicillin-resistant Staphylococcus, Listeria, and Nocardia are resistant. Haemophilus influenzae, Neisseria meningitidis, Moraxella catarrhalis, and Neisseria gonorrhoeae are highly sensitive to this product. Some strains of Escherichia coli, Klebsiella, Salmonella, Shigella, and Proteus are moderately sensitive to this product, while most of the other Gram-negative rods are resistant. Gram-positive anaerobic bacteria are sensitive to this product, and Bacteroides fragilis is resistant to this product. This product mainly inhibits the synthesis of bacterial cell walls.

The main ingredient of this product is ceftriaxone sodium, and its chemical name is (6R,7R)-3-[(acetyloxy)methyl]-7-[2-(2-thienyl)acetylamino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt.

This product is white or off-white crystalline powder.

This product is suitable for respiratory tract infections, soft tissue infections, urinary tract infections, sepsis, etc. caused by penicillin-resistant Staphylococcus aureus (except methicillin-resistant ones) and sensitive Gram-negative bacilli. In severe cases, it can be used in combination with aminoglycoside antibiotics, but caution should be exercised as it may aggravate renal toxicity. This product should not be used in patients with bacterial meningitis.

For adults, intramuscular or intravenous injection, 0.5-1g per time, once every 6 hours. The daily dose for patients with severe infection can be increased to 6-8g. To prevent postoperative infection, 1-2g can be used 0.5-1 hour before surgery. If the operation time exceeds 3 hours, 1-2g can be given during the operation. Depending on the condition, it can be given once every 6 hours after surgery, and the drug should be stopped within 24 hours after surgery. For heart surgery, artificial joint repair, etc., preventive use can be maintained for 2 days after surgery. The maximum daily dose for adults does not exceed 12g. Children can take 50-100mg/kg of body weight per day, divided into 4 doses. For newborns under 1 week old, it is 20mg/kg of body weight every 12 hours; for those over 1 week old, it is 20mg/kg of body weight every 8 hours. Patients with impaired renal function should reduce the dose appropriately. Creatinine clearance is low

1. Local pain is more common after intramuscular injection, and there may be lumps, tenderness, and temperature rise. The incidence of thrombophlebitis after high-dose or long-term intravenous infusion of ceftriaxone can be as high as 20%. 2. The more common adverse reactions are rash, eosinophilia, drug fever, serum sickness-like reactions and other allergic reactions. Anaphylactic shock rarely occurs. 3. Granulocytopenia and hemolytic anemia may occur occasionally. 4. Convulsions and other central nervous system symptoms may occur at high doses, especially in patients with renal impairment. 5. Gastrointestinal adverse reactions such as nausea and vomiting are rare. 6. Diarrhea and pseudomembranous colitis caused by Clostridium difficile may occur. 7. Encephalopathy may occur when this product is used in large doses.

It is contraindicated in patients with a history of cephalosporin allergy and penicillin anaphylactic shock.

1. It is contraindicated with the following drugs: amikacin sulfate, gentamicin, kanamycin, tobramycin, neomycin, chlortetracycline hydrochloride, tetracycline hydrochloride, oxytetracycline hydrochloride, colistin sodium methanesulfonate, polymyxin B sulfate, erythromycin gluconate, erythromycin lactobionate, lincomycin, sulfisoxazole, aminophylline, soluble barbiturates, calcium chloride, calcium gluconate, diphenhydramine hydrochloride and other antihistamines, lidocaine, norepinephrine, metahydroxylamine, methylphenidate, succinylcholine, etc. It may also be contraindicated with the following drugs: penicillin, methicillin, hydrocortisone sodium succinate, phenytoin sodium, prochlorperazine, vitamin B group and vitamin C, hydrolyzed protein. 2. The combined use of strong diuretics such as furosemide, ethacrynic acid, bumetanide, anti-tumor drugs such as carmustine, streptozocin, and aminoglycoside antibiotics with this product may increase nephrotoxicity. 3. Clavulanic acid can enhance the antibacterial activity of this product against certain Gram-negative bacteria that are resistant to it due to the production of β-lactamase.

Sealed, stored in a cool, dark and dry place. Validity period: 24 months

1.0g (calculated as C16H16N2O6S2)

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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