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.

Adults can be injected intramuscularly or intravenously, 0.5-1g once, 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. According to the condition, it can be given once every 6 hours after surgery, and the drug should be stopped within 24 hours after surgery. For cardiac surgery, artificial joint formation, etc., preventive application can be maintained for 2 days after surgery. The maximum daily dose for adults does not exceed 12g. Children are given 50-100mg/kg of body weight per day, divided into 4 doses. Newborns within 1 week are given 20mg/kg of body weight every 12 hours; those over 1 week old are given 20mg/kg of body weight every 8 hours. Patients with renal impairment should reduce the dose appropriately. When the creatinine clearance rate is less than 10ml/min, 25ml/min, 50ml/min and 80ml/min, the doses given every 6 hours are 0.5g, 1g, 1.5g and 2g respectively. The daily maintenance dose for anuric patients is 1.5g, divided into 3 doses. Hemodialysis and peritoneal dialysis can effectively remove this product. During dialysis, 1g should be given every 6 to 12 hours to maintain effective blood drug concentration. Preparation of intramuscular injection: 1g of this product is dissolved in 4ml sterile water for injection. For intravenous injection, 1g of this product can be dissolved in 10ml sterile water for injection, 5% glucose injection or sodium chloride injection, and the prepared solution is slowly injected within 3 to 5 minutes. For intravenous drip, first dissolve 4g of this product in 20ml sterile water for injection, and then dilute it appropriately. When administered intraperitoneally, generally 60mg of cephalothin sodium is contained in each 1000ml of dialysate. The concentration of cephalothin sodium used to treat peritonitis or abdominal contamination can reach 0.1% to 4%.

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

0.5g (calculated as C16H16N2O6S2)

STAR Pharmaceutical Pte.ltd

• Founded in:

  1993-08-28

• Address:

  3rd Floor, Office Building, No. 6 Shunda Road, Jiangdong New District, Haikou City, Hainan Province

• Tax NO.:

  91469002620007633W

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  HK$50 million

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