Products

Cefuroxime Sodium for Injection

Instructions for Cefuroxime Sodium for Injection
Please read the instructions carefully and use under the guidance of a physician or pharmacist.

[Name of the drug]
Generic name: Cefuroxime Sodium for Injection
Product name: Cefuroxime Sodium for Injection
Hanyu Pinyin: Zhusheyong Toubaofuxinna
[Ingredients]
The main ingredient of this product is cefuroxime sodium.
Chemical name: (6 R R,7 R )-7-[2-(furan-2-yl)-2-(methoxyimino)acetylamino]-3-carbamateoxymethyl-8-oxo-5-thio-1-azabiabicycl[4.2.0]octane-2-en-2-carbamate sodium salt.
Chemical structural formula:
 
Molecular formula:C ₁₆ H ₁₅ N ₄ NaO ₈ S
Molecular weight: 446.37
【Properties】 This product is white or white-like powder.
[Indications]
This product is suitable for the treatment of infections caused by specific microbial-sensitive strains in the following diseases:
1. Respiratory infections: caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., methicillin-sensitive Staphylococcus aureus (penicillinase-producing and non-penicillinase-producing strains), Streptococcus pyogenes, and Escherichia coli. For example: acute and chronic bronchitis, infectious bronchiectasis, bacterial pneumonia, lung cysts, and chest infections after surgery.
2. Ear, nose and throat infections: caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase strains), Moraxella catarrhalis (including β-lactamase strains), and Streptococcus pyogenes sensitive strains. For example: sinusitis, tonsillitis, pharyngitis and otitis media.
3. Urinary tract infections: caused by bacteria of the genus Escherichia coli and Klebsiella. For example: acute and chronic pyelonephritis, cystitis, and asymptomatic bacteriuria.
4. Skin and soft tissue infections: Caused by methicillin-sensitive Staphylococcus aureus (penicillinase and non-penicillinase strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacteriaceae bacteria. For example: cellulitis, erysipelas, peritonitis and wound infection.
5. Sepsis: Caused by methicillin-sensitive Staphylococcus aureus (penicillinase-producing and non-penicillinase-producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (ampicillin-resistant strains), and bacteria of the genus Klebsiella.
6. Meningitis: Caused by Streptococcus pneumoniae, Haemophilus influenzae (ampicillin-resistant strains), Neisseria meningitidis, and methicillin-sensitive Staphylococcus aureus (penicillinase-producing and non-penicillinase-producing strains).
7. Gonorrhea: Non-comorbid and disseminated gonococcal infections in men and women caused by Neisseria gonorrhoeae (penicillinase-producing and non-penicillinase-producing strains), especially those who are not suitable for penicillin treatment.
8. Bone and joint infections: Caused by Staphylococcus aureus (penicillinase-producing and non-penicillinase-producing strains). For example: osteomyelitis and septic arthritis.
9. Puerperal and gynecologic infections: Caused by Neisseria gonorrhoeae (penicillinase and non-penicillinase strains), Staphylococcus aureus (penicillinase and non-penicillinase strains), Bacteroides (excluding Bacteroides fragilis), Escherichia coli, and Klebsiella spp. For example: pelvic inflammatory disease, etc.
In clinical microbiology studies of skin and soft tissue infections, sensitive strains of aerobic and anaerobic microorganisms are often observed to grow together. This product is effective in treating these mixed infections with several isolated microorganisms.
This product can be used in combination with aminoglycosides for some confirmed or suspected cases of gram-positive or gram-negative sepsis, as well as other serious infections in which the causative organism has not been identified (see [Precautions]). The recommended dose of these two antibiotics can be determined according to the severity of the infection and the patient's own condition.
To reduce the development of resistant bacteria and to maintain the effectiveness of this and other antimicrobials, this product should only be used to treat or prevent infections caused by confirmed or highly suspected sensitive bacteria. Existing information on culture and sensitivity should be considered when selecting or adjusting antimicrobial therapy. If such data are not available, appropriate treatment can be empirically selected based on local epidemiology and sensitivity characteristics.
Prevention
Preoperative prophylactic use of Cefuroxime Sodium for Injection prevents the growth of sensitive pathogenic bacteria, thereby reducing the incidence of certain postoperative infections after surgical treatment with clean, contaminated or potentially contaminated (eg, vaginal hysterectomy). The effectiveness of intraoperative prophylactic use of antimicrobials depends on the time of administration. This product should generally be administered 0.5-1 hour before surgery so that the effective antibiotic concentration can be reached in the trauma tissue during surgery. If the operation is longer, it should be repeated intraoperatively.
Prophylactic medication is generally not required after surgery and should be stopped within 24 hours. In most surgeries, continued prophylactic use of antimicrobials does not reduce the incidence of subsequent infections, but rather increases the likelihood of adverse reactions and the development of bacterial resistance.
For patients undergoing open heart surgery, infection at the surgical site is a serious risk and is effective for perioperative use. It is recommended that such patients continue to use this product for at least 48 hours after the end of surgery. If infection is present, samples should be taken for culture to identify the causative organism and administer appropriate antimicrobial therapy.
【Specifications】 According to C ₁₆ H ₁₆ N ₄ O ₈ S
（1）0.5g；（2）0.75g；（3）1.5g
[Usage and dosage]
It can be injected deep intramuscularly, intravenously, or intravenously. Before intramuscular injection, there must be no blood withdrawn before injection.
Intramuscular injection: When administering, dissolve in 1.0mL sterile injection water per 0.25g, shake slowly to obtain a suspension, and then deep intramuscular injection.
Intravenous injection: 0.25g dissolved in at least 2.0mL sterile injection water, 0.75g dissolved in at least 6.0mL sterile injection water, 1.5g dissolved in at least 12.0mL sterile injection water, shaken well and then slowly injected intravenously, or added to intravenous infusion tube for drip.
General recommended dosage
Adults:
Most infections can be treated by intramuscular injection or intravenous injection of this product, 750mg each time, 3 times a day; For more severe infections, the dose should be increased to 1.5 g three times daily intravenously, or if needed, the interval between intramuscular or intravenous injections can be increased every 6 hours, for a total daily dose of 3 g to 6 g.
Infants and children:
The daily dose is 30~100mg/kg according to body weight, divided into 3 or 4 doses. For most infections, a daily dose of 60 mg/kg body weight is appropriate.
Newborn:
The dose is 30 to 100 mg/kg body weight/day in two or three doses. Newborns who are a few weeks old have a half-life of cefuroxime in their serum that can be three to five times higher than that of adults.
Older adults:
See dosage for adults.
Other recommended doses
Gonorrhea: A single dose of 1.5g should be given. This can be divided into 2×750 mg doses and injected intramuscularly to different areas, such as the sides of the buttocks.
Meningitis: This product is suitable for the treatment of bacterial meningitis caused by sensitive bacteria alone. The following dosages are recommended:
Infants and children:
200~240mg/kg per day according to body weight, divided into 3~4 times, intravenously, after 3 days of treatment, if clinical symptoms improve, the dose can be reduced to 100mg/kg per day according to body weight.
Newborn:
Intravenous: The starting dose is 100 mg/kg per day for body weight.
According to clinical needs, the dose can be reduced to 50mg/kg per day according to body weight.
Adults:
3g of this product is administered intravenously every 8 hours. There is insufficient data to recommend dosage for intrathecal injections.
Preventive treatment
The general dose is 1.5g intravenously, which is used for abdominal, pelvic and orthopedic surgery with the introduction of anesthetic, and the additional dose is 750mg intramuscularly injected twice at 8 hours and 16 hours after surgery. In heart, lung, esophageal and vascular surgery, with the introduction of anesthetic, 1.5g of this product is generally injected intravenously, and then 750mg of this product is continued intramuscularly within the next 24 to 48 hours, three times a day. In total joint replacement surgery, 1.5 g of cefuroxime powder can be dry mixed with a bag of methyl isobutyrate cement powder before adding liquid monomer.
Dosage in case of renal impairment :
Cefuroxime is excreted through the kidneys, so it is the same as the disposal method of similar antibiotics, and for patients with impaired renal function, it is recommended to reduce the dosage of this product accordingly to compensate for the slower excretion. However, dose reduction should only be done if creatinine clearance drops to 20 ml/min or less. For adults with significant renal impairment (creatinine clearance 10-20ml/min), the recommended dose is 750mg twice daily. For patients with severe renal impairment (creatinine clearance rate is less than 10ml/min), the appropriate dosage is 750mg once a day. See the table below, children with renal insufficiency should also refer to the table below for adjustment.

For patients undergoing dialysis, 750mg of this product is given at the end of each dialysis. For continuous peritoneal dialysis, the appropriate dose is 750 mg twice daily. For patients with renal failure undergoing continuous arteriovenous hemodialysis or high-flow hemodialysis in the intensive care unit, the appropriate dose is 750 mg twice daily. For patients with low-flow hemodialysis, see "Dosage in case of renal impairment" for dosing.
Compatibility taboos
It is compatible with most commonly used intravenous solvents and electrolytic solutions.
The pH value of Sodium Bicarbonate Injection (2.74% W/V) will significantly affect the color of the solution, so it is not recommended to use this injection as a dilution of this product. However, if needed, if the patient is being treated with intravenous sodium bicarbonate, this solution can be introduced directly into the delivery system tube.
This product should not be mixed with aminoglycoside antibiotics in the syringe.
[Adverse reaction]
Adverse drug reactions are very rare (<1/10000), and most of them are mild and transient.
Since most adverse reactions are not applicable to calculating the frequency of occurrence, the following classifications of adverse reactions are estimated. In addition, the frequency of adverse reactions related to this product may vary depending on the indication.
Data to determine the frequency of adverse effects ranging from very common to rare are from large-scale clinical studies. For the frequency of other adverse events (i.e., adverse reactions with a frequency < 1/10000, etc.), post-marketing surveillance data are mainly used and usually refer to the reporting rate rather than the actual frequency of occurrence.
The frequency of adverse reactions is defined as:
Very common ≥ 1/10
Common ≥ 1/100 and < 1/10
Uncommon ≥ 1/1000 and < 1/100
Rare ≥1/10000 and <1/1000
Very rare <1/10000
Infections and invasive diseases
Rare: Candida overgrowth
Diseases of the blood and lymphatic system
Common: neutropenia, eosinophilia
Uncommon: leukopenia, decreased hemoglobin concentration, positive Coomb's test
Rare: thrombocytopenia
Very rare: hemolytic anemia. Cephalosporins are easily absorbed to the surface of the red blood cell membrane and interact with antibodies against these drugs, resulting in a positive Coomb's test (which can interfere with cross-matching) and, very rarely, hemolytic anemia.
Post-marketing surveillance found that this product still has case reports of pancytopenia, decreased hematocrit, prolonged prothrombin time, and bleeding.
Immune system disorders
Allergic reactions include:
Uncommon: rash, hives, itching
Rare: drug fever
Very rare: interstitial nephritis, anaphylaxis, cutaneous vasculitis.
Post-marketing surveillance found that this product also has case reports of angioedema, serum disease-like syndrome (urticaria accompanied by arthritis, arthralgia, myalgia and fever, etc.), severe anaphylaxis, anaphylactic reactions, anaphylactic shock.
See other skin and subcutaneous tissue diseases and kidney and urinary system diseases.
Diseases of the gastrointestinal system
Uncommon: Gastrointestinal disturbances, including diarrhea and nausea
Very rare: pseudomembranous colitis.
Post-marketing monitoring found that this product still has case reports of abdominal distension, abdominal pain, and heartburn.
Diseases of the hepatobiliary system
Common: Transient increased liver enzyme levels
Very rare: transient bilirubin levels are elevated
Although transient increases in serum liver enzyme levels or bilirubin levels occur especially in patients with liver disease, there is no evidence of liver damage.
Skin and subcutaneous tissue diseases
Very rare: erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome
See Immune System Disorders.
Kidney and urinary system diseases
Very rare: elevated serum sarcatinine, elevated blood urea nitrogen, and decreased creatinine clearance.
See Immune System Disorders.
Post-marketing surveillance found that there were still case reports of hematuria, interstitial nephritis, and acute kidney injury (including acute renal failure).
Various neurological diseases
Post-marketing monitoring found that this product still has case reports of dizziness, headache, convulsions, syncope, drowsiness, local numbness, and individual reports of seizures.
Systemic disease and various reactions at the site of administration
Common: Injection site reactions may include pain and thrombophlebitis
Pain at the site of intramuscular injection, especially at larger doses, but there is no need to stop treatment.
Post-marketing monitoring found that this product still has case reports of fever, chills, fatigue, edema, and local swelling.
Other
Post-marketing monitoring found that this product also has case reports of skin flushing, tinnitus, hearing loss, conjunctivitis, palpitations, chest tightness, tachycardia, dyspnea, abnormal blood pressure, irritability, abnormal appetite, disulfiram-like reactions, and laryngeal edema.
【Contraindications】 This product is prohibited for those who are allergic to cephalosporins.
[Precautions]
Although cross-reactivity has been reported, cephalosporin antibiotics are generally safe for use in patients who are allergic to penicillin. However, special attention should be paid to patients with a history of penicillin or β-lactamase allergy.
Although the results of biochemical experiments related to renal function will change, they are not clinically significant. However, for patients with impaired renal function, their renal function should be monitored as a preventive measure.
Particular care should be taken when high-dose cephalosporin antibiotics are given in patients treated with a combination of strong diuretics such as furanoaniline or aminoglycoside antibiotics, as renal impairment has been reported with concomitant therapy. Renal function should be monitored in these patients, older patients, and patients with pre-existing renal impairment (see Dosage).
As with other therapies, cefuroxime has been reported to have mild to moderate hearing loss in a small number of children when used to treat meningitis. Positive for Haemophilus influenzae in cerebrospinal fluid cultures for 18-36 hours was also noted after treatment with cefuroxime sodium injection, as well as other antibiotics, but the clinical significance of this was unknown.
As with other antibiotics, the use of this product can cause overgrowth of Candida and long-term use can cause overgrowth of other non-sensitive bacteria such as Enterococcus and Clostridium difficile, in which case treatment needs to be interrupted.
Pseudomembranous colitis has been reported with antibiotics, ranging in severity from mild to life-threatening. Therefore, it is serious that the above diagnosis should be taken into account in patients who develop diarrhea during or after the use of antibiotics. If the patient has prolonged or severe diarrhea or abdominal cramps, treatment should be stopped immediately and the patient should be further examined.
Compatibility and stability
This product should not be administered in the same container as aminoglycoside antibiotics; Precipitation occurs when mixed with vancomycin.
Intramuscular injection: Prepare a suspension with sterile injection water, which should be used immediately, such as at room temperature for no more than 2 hours, if stored in the refrigerator at 5 °C, it should not exceed 24 hours.
Intravenous bolus: Prepared with sterile injection water to make a solution, it should be used immediately, if left at room temperature for no more than 2 hours, if stored in the refrigerator at 5 °C, it should not exceed 24 hours.
Intravenous infusion: Prepared with sterile water for injection to make a solution, it should be used immediately, if it is placed at room temperature for no more than 3 hours, if stored in the refrigerator at 5 °C, it should not exceed 24 hours.
Impact on driving and operating machinery
The effects of its use on driving and operating machinery have not been studied. However, combined with the known adverse reactions of cefuroxime sodium, the use of this product is unlikely to affect driving and operating machinery.
[Medication for pregnant and lactating women]
There is no experimental evidence that cefuroxime may cause embryonic pathogenicity or fetal malformations. But like all medications, it should be used with caution in the first trimester.
Cefuroxime can be secreted through milk and should be used with caution in lactating women.
[Children's medication]
See [Usage and Dosage].
[Medication for the elderly]
See [Usage and Dosage].
[Drug Interactions]
1. It has been reported that the combination of aminoglycoside antibiotics and cephalosporins can cause nephrotoxicity.
2. Clinical use of cephalosporin Patients will have false positives when checking urine glucose with the Spot or Fischeri or Clintest Tablets test, but there will be no false positives when tested with enzymes. If a false negative result can be obtained by the ferrocyanic acid method during blood glucose checking, cefuroxime sodium will not interfere with the determination of urine and blood creatinine values by the alkaline picric acid method.
3. Cefuroxime is compatible with the following drugs and contraindications: amikacin sulfate, gentamicin, kanamycin, tobramycin, neomycin, chlortetracycline hydrochloride, oxytetracycline hydrochloride, oxytetracycline hydrochloride, colistin sodium mesylate sulfate, polymyxin sulfate B, erythromycin gluconate, erythromycin lacconate, lincomycin, sulfazo, aminophylline, soluble barbiturates, calcium chloride, calcium gluconate, diphenhydramine hydrochloride and other antihistamines, lidocaine, norepinephrine, m-hydroxylamine, methylphenidate, succincholine, etc. Occasionally, it may be contraindicated with the following drugs: penicillin, methicillin, hydrocortisone sodium succinate, phenytoin, prochlorperazine, B vitamins and vitamin C, hydrolyzed proteins.
4. Strong diuretics such as furosemide, itaninic acid, and bumetanide, antitumor drugs such as kanibiccil and strepzocin, as well as aminoglycoside antibiotics combined with cefuroxime may increase nephrotoxicity.
5. Rodic acid can enhance the antibacterial activity of cefuroxime against certain gram-negative bacilli that are resistant to lactamase production.
6. Like other antibiotics, this product may affect the intestinal flora, resulting in reduced estrogen reabsorption and reduced efficacy of concomitant oral contraceptives.
[Drug overdose]
Taking too many doses of cephalosporins can cause brain irritation and convulsions. Hemodialysis or peritoneal dialysis reduces serum concentrations of cefuroxime.
[Pharmacology and Toxicology]
Pharmacological effects
Cefuroxime is a bactericidal cephalosporin antibiotic that resists most β-lactamases and is effective against a wide range of Gram-positive and Gram-negative bacteria.
The incidence of acquired resistance depends on geographic location, time, and selected genus, and can be at high levels. It is necessary to obtain local information on drug resistance, especially when treating severe infections.
Microbial susceptibility to cefuroxime in vitro
If the clinical effectiveness of cefuroxime is demonstrated in clinical trials, it is marked with an asterisk (*).
Common sensitive strains
Aerobic gram-positive bacteria :
Staphylococcus aureus (methicillin sensitive)*
Coagulase-negative staphylococci (methicillin-sensitive).
Streptococcus pyogenes*
β-Hemolytic Streptococcus
Aerobic gram-negative bacteria :
Haemophilus influenzae, including ampicillin-resistant strains*
Haemophilus parainfluenzae*
Moraxella catarranger*
Neisseria gonorrhoeae*, including both penicillinase-producing and non-penicillinase strains
Neisseria meningitidida
Shigella genus
Anaerobic Gram-positive bacteria :
Digestive Streptococcus
Propionibacterium
Spirochetes :
Borrelia burgdorferi*
Bacteria with acquired drug resistance problems
Aerobic gram-positive bacteria :
Streptococcus pneumoniae*
Streptococcus grass greener
Aerobic gram-negative bacteria :
Pertussis bordetella
Citrate spp. does not include Citrate fraudi
Enterobacteriaceae spp., excluding aerogenic Enterobacteriaceae and Enterobacteriaceae cloacae
Escherichia coli*
Klebsiella spp., including Klebsiella pneumoniae*
Proteus miraculous
Proteus spp. excludes Proteus panerii and Proteus vulgaris
Providence fungi
Salmonella spp
Anaerobic Gram-positive bacteria :
Fusobacterium spp. excludes Clostridium difficile
Anaerobic gram-negative bacteria :
Bacteroides spp. does not include Bacteroides fragilis
Clostridium spp
Inherently resistant bacteria
Aerobic gram-positive bacteria :
Enterococcus genera, including Enterococcus faecalis and Enterococcus faecalis
Listeria monocytogenes
Aerobic gram-negative bacteria :
Acinetobacter spp
Onion Burkholder fungus
Campylobacter genus
Citrate bacillus fraudi
Enterobacteria aerogeniens
Enterobacteriaceae claugua
Morgan Morgan
Proteus panerii
Proteus vulgaris
Pseudomonas spp. spp
Serratia marcescens
Maltophilic narrow-eating monas
Anaerobic Gram-positive bacteria :
Clostridium difficile
Anaerobic gram-negative bacteria :
Bacteroides fragile
Other :
Chlamydia
Mycoplasma genus
Legionella spp
Toxicology Research
Genotoxicity: Although no lifelong studies in animals have been conducted to evaluate the potential carcinogenicity of cefuroxime, no mutagenic effects have been found in micronucleus and bacterial tests.
Reproductive toxicity: Rats were given cefuroxime at a dose of 1000mg/kg/day, and there was no significant effect on animal fertility. Mice and rats were given cefuroxime at a dose of 3200mg/kg/day, and no damage to fetal development was observed. However, the animal-human correlation is not supported by clinical studies.
[Pharmacokinetics]
According to the Physicians' Desk Reference, the average peak blood concentration of cefuroxime at a dose of 0.75g of this product was 27μg/ml and the peak time was 45 minutes (ranging from 15~60 minutes). After intravenous injection of 0.75g and 1.5g, the plasma concentration reached about 50μg/ml and 100μg/ml at 15 minutes, respectively, and the effective plasma concentration could be maintained for 5.3 hours and 8 hours or more or higher, respectively. After administering a dose of 1.5g to normal subjects intravenously every 8 hours, there was no accumulation of cefuroxime in the blood. The half-life of intravenous or intramuscular administration is approximately 80 minutes.
About 89% of the drugs are excreted by the kidneys within 8 hours after administration, resulting in high urine drug concentrations.
After a single dose of 0.75g intramuscular cefuroxime was injected 8 hours, the urine drug concentration could reach an average of 1300 μg/ml. After a single dose of 0.75g and 1.5g intravenous cefuroxime for 8 hours, the urine drug concentration reached an average of 1150 μg/ml and 2500 μg/ml.
If probenecid is taken orally at the same time, it can prolong the tubular excretion time of cefuroxime, reduce renal clearance by about 40%, increase blood concentration by about 30%, and extend plasma half-life by about 30%. Cefuroxime reaches therapeutic concentrations in pleural fluid, joint fluid, bile, sputum, bone, and aqueous humor.
Studies have shown that cefuroxime can reach therapeutic concentrations in the cerebrospinal fluid of adult and pediatric meningitis patients. Cefuroxime can be measured in the cerebrospinal fluid of patients with meningitis who have taken multiple medications.
The serum protein binding rate of cefuroxime is about 50%.
[Storage]
Store away from light and no more than 25°C.
[Packaging]
Medium borosilicate glass controlled injection bottle + sterile powder for injection coated ethylene Teflon copolymer film chloride butyl rubber stopper + aluminum plastic combination cap packaging for antibiotic bottle. (1) 1 bottle per box (2) 10 bottles per box.
[Validity period]
24 months
[Implementation standards]
The National Medical Products Administration has YBH01072026 standards
[Approval number]
Sinopharm standard word H20065669 (0.5g).
Sinopharm quasi-word H20065670 (0.75g).
Sinopharm quasi-word H20065672 (1.5g).
[Drug marketing authorization holder]
Name: Guangdong Jincheng Jinsu Pharmaceutical Co., Ltd
Registered address: No. 10, Shennong Road, Torch Development Zone, Zhongshan City, Guangdong Province
[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
Service hotline: 400-9988-970
Telephone number: (0760) 22830525 (switchboard).
Fax number: (0760) 22578279
Website: http://www.gdjcjs.com