Products

Ceftizoxime Sodium for Injection

Instructions for Ceftizoxime Sodium for Injection
Please read the instructions carefully and use under the guidance of a physician

[Name of the drug]
Generic name: Ceftizoxime Sodium for Injection
Product name: Ceftizoxime Sodium for Injection
Hanyu Pinyin: Zhusheyong Toubaozuowona
[Ingredients]
The active ingredient of this product is cefazoloxime sodium.
Chemical name: (6 R R,7 R )-7-[2-(2-aminothiazol-4-yl)-2-(methoxyimino)acetylamino]-8-oxo-5-thio-1-azabicyclic [4.2.0]octane-2-en-2-carboxylate sodium salt
Chemical structural formula:
 
Molecular formula:C ₁₃ H ₁₂ N ₅ NaO ₅ S ₂
Molecular weight: 405.38
Excipients: There are no excipients in the prescription of this product.
[Characteristics]
This product is a white to yellowish crystalline, crystalline or granular powder.
[Indications]
Lower respiratory tract infections, urinary tract infections, abdominal infections, pelvic infections, sepsis, skin and soft tissue infections, bone and joint infections, meningitis caused by Streptococcus pneumoniae or Haemophilus influenzae, and simple gonorrhea caused by bacteria.
[Specifications]
As C _1: p.m. ₁₃ N ₅ O ₅ S ₂ 计(1)0.5g (2)1.0g (3)2.0g
[Usage and dosage]
1. Common dosage for adults: 1~2g at a time, once every 8~12 hours; The dose for seriously infected patients can be increased to 3~4g once every 8 hours. When treating uncomplicated urinary tract infections, 0.5g once every 12 hours.
2. Infants and children aged 6 months and above: 50mg/kg once every 6~8 hours according to body weight.
3. Patients with renal impairment: Patients with renal impairment need to adjust the dose according to the degree of damage. After the first loading dose of 0.5~1g, the usual dose for patients with mild renal impairment (endogenous creatinine clearance Clcr is 50~79ml/min) is 0.5g once every 8 hours, and for severe infection, the usual dose is 0.5g once every 8 hours, and in patients with moderate renal impairment (Clcr is 5~49ml/ minutes) The usual dose is 0.25~0.5g once every 12 hours, 0.5~1g once every 12 hours in case of severe infection; The usual dose for patients with severe renal impairment (Clcr is 0~4ml/minute) is 0.5g once every 48 hours, or 0.25g once every 24 hours, 0.5~1g once every 48 hours in severe infection, or 0.5g once every 48 hours, or 0.5g once every 24 hours. Hemodialysis patients can not add additional doses after dialysis, but they need to be administered at the end of dialysis according to the above dosage and time.
This product can be dissolved in water for injection, sodium chloride injection, 5% glucose injection and slowly injected intravenously, or it can be added to 10% glucose injection, electrolyte injection or amino acid injection for intravenous infusion for 30 minutes ~ 2 hours.
This product should be used as soon as possible after being prepared into a solution, and the state of the solution should be observed before use, and if there is visible particulate matter precipitation, it should be discarded.
[Adverse reaction]
Cefazoxime sodium for injection is generally well tolerated. The most common adverse reactions (greater than 1%, but less than 5%) are:
Rash, pruritus and allergic reactions such as drug fever, mild increase in alkaline phosphatase, serum aminotransferase. 
Burning sensation at the injection site, cellulitis, phlebitis (in intravenous injectors), pain, hardening and paresthesia, etc.
Less common adverse reactions (less than 1%) were:
Allergies – occasionally headache, numbness, vertigo, vitamin K and B deficiencies, anaphylactic shock.
Liver – Elevated bilirubin is rarely reported. 
Renal – occasionally elevated urea nitrogen and creatinine are observed. 
Hematologic-anemia, including occasionally fatal hemolytic anemia, leukopenia, neutropenia, and thrombocytopenia are rarely reported.
Genitourinary system – vaginitis rarely occurs.
Very few patients can develop mucosal candidiasis.
Gastrointestinal – occasionally diarrhea, nausea, vomiting, loss of appetite have been reported.
Symptoms of pseudomembranous colitis may occur during or after antibiotic therapy (see precautions).
In addition to the adverse effects described above, the following adverse reactions of cephalosporin antibiotics and changes in laboratory tests have been reported in patients treated with cefazoloxime sodium:
Stevenson syndrome, erythema multiforme, toxic epidermal necrolysis, syncope-like reactions, toxic nephropathy, aplastic anemia, bleeding, prolonged prothrombin time, elevated lactate dehydrogenase, pancytopenia, and agranulocytosis.
Several cephalosporins have been associated with seizure triggering, especially in patients with impaired renal function, and the dose has not been reduced. If seizures related to medication occur, the drug should be discontinued. If clinically indicated, anticonvulsant therapy may be considered.
[Contraindication]
1. It is prohibited for those who are allergic to this product and other cephalosporins.
2. Use with caution if you are allergic to penicillin.
3. Use with caution if you or your parents and siblings are prone to allergies such as bronchial asthma, rash, and hives.
4. Patients with severe renal impairment, patients with difficulty eating, or non-oral nutrition, patients with low general status, and elderly patients should use it with caution.
[Precautions]
1. Before using this product, the patient must be asked in detail if there is a history of previous allergy to this product, other cephalosporins, penicillins, or other drugs, as cross-allergic reactions have been demonstrated between β lactam antibiotics such as penicillins and cephalosporins. In patients with penicillin antibiotic allergy, about 5%~10% can have cross-allergic reactions to cephalosporins. Therefore, patients with a history of penicillin allergy must fully weigh the pros and cons and use it with caution under close observation when indicating the use of this product. If patients who have had penicillin shock in the past, this product should not be used again. If an allergic reaction occurs when using this product, the drug should be stopped immediately. If anaphylactic shock occurs, emergency measures such as adrenaline, airway patency, oxygen inhalation, glucocorticoids and antihistamines are given immediately.
2. Interference with diagnosis: A positive antiglobulin (Coombs) test can occur. Urine glucose test with Bendict, Fehling and Clinitest reagents can be false positive. Serum alkaline phosphatase, blood urea nitrogen, alanine aminotransferase, aspartate aminotransferase, or serum lactate dehydrogenase values may be increased.
3. Almost all antibiotics can cause pseudomembranous colitis, including cefazoloxime sodium. If antibiotic-associated enteritis occurs during application, the drug must be stopped immediately and corresponding measures must be taken. Mild cases of pseudomembranous colitis only need to be stopped. For moderate to severe pseudomembranous colitis, infusions and electrolyte and protein supplementation should be considered and treated with clinically effective antimicrobials against Clostridium difficile colitis.
4. People with a history of gastrointestinal diseases, especially patients with colitis, should use it with caution. Use with caution for those who are prone to bronchial asthma, rash, urticaria and other allergic constitutions. Patients who cannot eat well or take nutrition out of mouth, the elderly, and patients with cachexia should use it with caution because of vitamin K deficiency. Antimicrobial therapy can alter the normal flora of the colon and may lead to overgrowth of Clostridium. Studies have shown that toxins produced by Clostridium difficile are the main cause of antibiotic-associated colitis.
5. Although this product has not shown any effect on kidney function, attention should still be paid to kidney function when using this product, especially in those critically ill patients receiving high-dose therapy.
6. Similar to other antibiotics, excessive use of this product may lead to excessive reproduction of insensitive microorganisms, which requires close observation and corresponding measures should be taken in case of double infection.
7. A large dose of intravenous injection can cause vascular pain and thrombophlebitis, and the injection speed should be slowed down as much as possible to prevent their occurrence.
8. This product should not be placed at room temperature for more than 7 hours after dissolution, and should not be placed in the refrigerator for more than 48 hours.
9. Cephalosporins may be associated with a decrease in prothrombin activity and are dangerous in patients including renal or hepatic impairment, or in patients with poor nutritional status, as well as in patients on long-term antibiotic therapy and stable on prior anticoagulation therapy. In these patients, prothrombin time should be monitored and exogenous vitamin K should be given as directed.
10. Administration of Ceftizoxime Sodium for Injection in the absence of a proven or highly suspected bacterial infection or prophylactic indication is unlikely to provide a benefit to the patient and carries the risk of increased bacterial resistance.
[Medication for pregnant and lactating women]
No damage to fertility and fetus has been found in animal experiments, but the safety of the drug during pregnancy and childbirth is unknown, and pregnant women should only use it when there are clear indications.
A small amount of this product can be secreted into milk, and breastfeeding women should suspend breastfeeding when using this product.
[Children's medication]
The safety and efficacy of this product for use in children under 6 months of age have not been established. Ceftizoxime Sodium for Injection is given to children 6 months of age and older with transient eosinophils, aspartate aminotransferase, alanine aminotransferase, and creatine phosphokinase levels are elevated. Elevated creatine phosphokinase may be associated with intramuscular administration.
[Medication for the elderly]
Clinical studies of cefazoloxime sodium did not include a sufficient number of subjects aged 65 years and older to determine if their response was different from that of younger subjects. Other reported clinical experiences have not found a difference in response between older and younger patients. In general, the choice of dose should be cautious in the elderly due to reduced liver, kidney, or heart function, as well as concomitant diseases or other drug therapy, usually starting from a low dose range.
[Drug Interactions]
Combined with coumarins, it has the possibility of enhancing the effect of coumarins; Nephrotoxicity occurs when used in combination with diuretics such as furanophenynine and other cephalosporins and aminoglycoside antibiotics.
[Drug overdose]
It is not clear.
[Clinical Pharmacology]
Pharmacokinetics
The following table shows the concentration and duration of the drug in serum after intramuscular injection of cefazoloxime sodium 0.5g and 1g in healthy volunteers.
Serum concentration (mg/ml) after intramuscular injection

The table below shows the drug concentrations in serum after intravenous administration of cefazoloxime sodium 1g, 2g and 3g in healthy volunteers.
Serum concentration after intravenous injection (mg/ml).

ND indicates no acquisition
The serum half-life after intravenous or intramuscular injection of cefazoloxime sodium was about 1.7 h, and the protein binding rate was 30%.
Cefazoxime sodium is not metabolized in the body and is excreted through the kidneys in its original form within about 24 hours, so the concentration of cefazoloxime sodium in the urine is high, and the urine concentration > 6000 μ/mL 2 hours after intravenous injection of cefazoloxime sodium 1g. Probenecid can slow down the secretion of renal tubules, increase the concentration of this product in the serum, and prolong the duration of this product in the body.
Cefazoxime sodium is widely distributed in various tissues and body fluids throughout the body, including cerebrospinal fluid (in patients with human meningitis), bile, fluid from surgical wounds, pleural effusion, aqueous humor, ascites, abdominal fluid, prostate fluid, saliva, heart, gallbladder, bone tissue, peritoneum, prostate, and uterus.
[Pharmacology and Toxicology]
This product is a third-generation cephalosporin, which has a broad spectrum of antibacterial effects and is stable to broad-spectrum lactamases (including penicillinase and cephalosporinase) produced by a variety β of gram-positive and gram-negative bacteria. This product has a strong antibacterial effect on Enterobacteriaceae bacteria such as Escherichia coli, Klebsiella pneumoniae, and Proteus miraculous, and Pseudomonas aeruginosa and Acinetobacter are poorly sensitive to this product. Cefazoxime has a good antibacterial effect on Haemophilus influenzae and Neisseria gonorrhoeae. The effect of this product on Staphylococcus aureus and Staphylococcus epidermidis is worse than that of the first and second generation cephalosporins, methicillin-resistant Staphylococcus aureus and enterococcus are resistant to this product, and various streptococci are highly sensitive to this product. Anaerobic bacteria such as peptococcus, streptococcus and some Bacteroides are mostly sensitive to this product, and Clostridium difficile is resistant to this product.
The mechanism of action of this product is that this product achieves bactericidal effect by inhibiting the biosynthesis of bacterial cell wall mucopeptides.
[Storage]
Keep away from light, airtight, and store no more than 25°C.
[Packaging]
Medium borosilicate glass control injection bottles, ethylene tetrafluoroethylene copolymer film for sterile powder for injection, butyl chloride butyl rubber stoppers and antibiotic bottles for aluminum-plastic combination cap packaging, 1 bottle/box, 10 bottles/box.
Validity: 24 months
【Implementation Standards】 National Medical Products Administration Standard YBH11472025
[Approval number]
(1) 0.5g: Sinopharm quasi-character H20254291
(1) 1.0g: Sinopharm quasi-word H20254292
(1) 2.0g: Sinopharm quasi-word H20254298
[Marketing authorization holder ]
Name: Guangdong Jincheng Jinsu Pharmaceutical Co., Ltd
Registered address: No. 10, Shennong Road, Torch Development Zone, Zhongshan City, Guangdong Province
Postal code: 528437
Phone number: 0760-22830525
Fax number: 0760-22578279
Website: www.gdjcjs.com
[Manufacturer]
Company name: Guangdong Jincheng Jinsu Pharmaceutical Co., Ltd
Production address: No. 10, Shennong Road, Torch Development Zone, Zhongshan City, Guangdong Province
Postal code: 528437
Phone number: 0760-22830525
Fax number: 0760-22578279
Website: www.gdjcjs.com