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Cefuroxime Capsules Instructions
Please read the instruction manual carefully and use under the guidance of a physician
[Medication Name]
Generic name: Cefuroxime Capsules
Trade Name: Dalixin
English name:Cefuroxime Axetil Capsules
Hanyu Pinyin: Toubaofuxinzhi Jiaonang
[Ingredients]
The main ingredient of this product is cefuroxime.
Chemical name:(6R,7R)-7-[2-furanyl(methoxyimino)acetamido]-3-carbamoyloxymethyl-8-oxo-5- thiabicyclo-1-azabicyclo[4.2.0]Octa-2- span>ene-2-carboxylic acid,(1RS)-1-acetoxyethyl ester.
Chemical structure formula:
Molecular Formula:C20H22N4O10S
Molecular weight:510.48
[Properties]
The content of this product is white or off-white powder or granule.
[Indications]
This product is indicated for the treatment of the following infectious diseases caused by susceptible bacteria. (Cefuroxime susceptibility varies and applicable geographic, temporal, and local susceptibility data should be consulted, see [Pharmacology and Toxicology] section)
1.Acute tonsillitis, pharyngitis, and acute bacterial sinusitis: mild to moderate acute tonsillitis and pharyngitis by Streptococcus pyogenes-susceptible strains, and by Streptococcus pneumoniae susceptible strains or Haemophilus influenzae (only the non-producingβ- “font-family:equine”>lactamase strains) cause mild to moderate acute bacterial maxillary sinusitis.
2. Acute bacterial otitis media:by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase strains), Catamoras (including β-lactamase strains) or acute bacterial otitis media caused by Streptococcus pyogenes;
3. Acute exacerbation of chronic bronchitis:by Streptococcus pneumoniae, Haemophilus influenzae (β-lactamase-negative strains), Haemophilus parainfluenzae (β-lactamase-negative strains) causing acute attacks of bacterial chronic bronchitis;
4. Non-complicated skin and soft tissue infections:Non-complicated skin and soft tissue infections caused by sensitive Staphylococcus aureus (including β-lactamase strains) and Streptococcus pyogenes soft tissue infections, such as boils, pyoderma and impetigo;
5. Uncomplicated urinary tract infections:uncomplicated urinary tract infections caused by Escherichia coli or Klebsiella pneumoniae, such as pyelonephritis, cystitis, and urethritis;
6. For the treatment of early Lyme disease (adults and3Children over the age of 12 months): Early Lyme disease (wandering erythema) caused by a sensitive strain of Burkholderia sp.
7. Gonorrhea, uncomplicated acute gonococcal Urethritis and cervicitis: Gonorrhea, uncomplicated acute gonococcal urethritis and cervicitis caused by sensitive strains of Neisseria gonorrhoeae (penicillinase-producing and non-penicillinase-producing strains).
[Specifications]
0.125g(as per) family:Times New Roman”>C16H16N4O8Saccount)
[dosage]
The routine course of treatment for most infections is7days (range 5-10days).
AdultsAdultsAdults “font-family:Times New Roman”>
Oral daily2times, each time0.25gcefuroxime is effective in treating most infections. For example, acute tonsillitis, pharyngitis and acute bacterial sinusitis, acute bacterial otitis media, and uncomplicated skin and soft tissue infections.
In patients with mild to moderate acute exacerbations of chronic bronchitis: daily2times, each time0.25gor0.5g.
Patients with uncomplicated urinary tract infections are given daily2times, each time0.25gis usually adequate; the recommended dose for patients with pyelonephritis isdaily. span>2timeseach 0.25gtime.
For the treatment of uncomplicated gonorrhea, acute gonococcal urethritis and cervicitis in adults, the recommended dose is a single oral dose of1g.
Treatment of Lyme disease in adults and12 Lyme disease in children older than 12 years: the recommended dose is 2times daily, each time0.5g, take14 “font-family:isoline”>days (range 10-21days).
Children
Not yet3experience with cefuroxime in children younger than 3 months of age. 12 years of age, care needs to be taken to ensure the ability to swallow whole capsules. Therefore, other appropriate dosage forms of cefuroxime can be administered to younger pediatric patients.
Usually administered at a daily20.125g or daily. family:Times New Roman”>2times, each time10mg/kg body weight at a maximum daily dose of0.25g
For acute tonsillitis and pharyngitis and acute bacterial sinusitis, daily2times per day0.125g, with a maximum daily dose of0.25g.
For uncomplicated skin and soft tissue infections, the recommended dose for administration is daily2 “font-family:equivocal”>times at 0.25g or daily2times, each time15mg/kg body weight at a maximum daily dose of 0.5g.
For acute bacterial otitis media,2children over the age of 2 years are usually given a dose of 2times daily, each time0.25gor daily22times per day15mg/kg body weight, with a maximum daily dose of0.5g.
For children with uncomplicated urinary tract infections give daily2times, each time15 mg/kg, up to a maximum daily2times, each time0.25g; the recommended dose for patients with pyelonephritis is 2times daily, each time15 mg/kg at most per dose0.25g at a maximum of10-14, with a recommended course of family:equine”>days.
Treatment3 months to 12year-old children with Lyme disease: the recommended dose is daily2times per day0.25g(or15mg/kg body weight), taking14days (range10-21days).
Elderly and renal injury patients
In patients with renal impairment or on renal dialysis or in the elderly, when the maximum daily dose does not exceed1g , no special precautions are required.
[Adverse Reactions]
Most of the adverse drug reactions caused by cefuroxime are mild and transient in nature.
Since most adverse events do not have data applicable to the calculation of frequency (e.g., there is no corresponding placebo-controlled clinical study to observe the occurrence of a certain adverse event) Therefore, the following classification of the frequency of adverse reactions is estimated. In addition, the incidence of adverse events resulting from the administration of cefuroxime may vary by indication.
Data used to determine the incidence of various types of adverse events ranging from very common to rare were obtained from large clinical studies. For the incidence of other adverse events (e.g., incidence<1/10000 of adverse events, etc.), post-marketing surveillance data were primarily used and usually use reported rates rather than actual incidence rates. If data from placebo-controlled clinical studies are lacking for an adverse event and in some cases data from clinical studies were used to calculate the incidence, in such cases the calculation is usually based on data on the occurrence of adverse events associated with drug use (as assessed by the investigator).
The incidence of an adverse event is defined as:
Very common ( ³1/10)
Common (³1/100and<1 /10)
Unusual (³1/1000and< 1/100)
Rare (³1/10,000and< ;1/1000)
Very rare (& lt;1/10000)
Infectious and invasive diseases
Common: Candida overgrowth
Hematologic and lymphatic system disorders
Common: Eosinophilia
Unusual: Coombtest positive, thrombocytopenia and leukopenia (sometimes more severe)
Very rare: hemolytic anemia
Cephalosporins are readily absorbed into the surface of the red blood cell membrane and interact with antibodies against such drugs, resulting inCoomb test positive (which can interfere with cross-matching) and in very rare cases cause hemolytic anemia.
Allergic reactions include
Unusual: rash
Rare: hives, pruritus
Very rare: drug fever, serum sickness, and tachyphylaxis
Neurological disorders
Common: headache, dizziness
Digestive disorders
Common: Gastrointestinal disorders including diarrhea, nausea and abdominal pain
Unusual: vomiting
Rare: pseudomembranous colitis (see [Precautions])
Hepatobiliary dysfunction
Common: eosinophilia and transient liver enzymes(ALT[i.e.SGPT], AST [i.e.SGOT]andLDH)Horizontal Height Increase
Very rare: jaundice (mainly cholestatic jaundice), hepatitis
Dermal and subcutaneous tissue disorders
Very rare: erythema multiforme,Stevens-Johnson syndrome and toxic epidermolysis bullosa (exanthematous necrolytic release)
See Immune System Disorders
Rare interstitial nephritis
[Contraindicated]
Contraindicated in patients with hypersensitivity to cephalosporin antibiotics.
[Precautions]
To penicillin or to other Special attention should be given to patients with hypersensitivity to beta – lactam antibiotics.
As with other antibacterial drugs, the use of cefuroxime can cause overgrowth of Candida and prolonged use can cause overgrowth of other non-susceptible bacteria (e.g., Enterococcus and Clostridium difficile), requiring interruption of therapy.
Pseudomembranous colitis has been reported with antimicrobial therapy, ranging in severity from mild to life-threatening. Therefore, the correct diagnosis should be considered for diarrhea that occurs while a patient is receiving antimicrobial therapy or at the end of therapy. If there is persistent or severe diarrhea, or if the patient develops abdominal cramps, treatment should be stopped immediately and the patient should be further examined.
Glucose oxidase assay or hexokinase assay is recommended for monitoring blood glucose levels in patients taking cefuroxime. Cefuroxime has no effect on creatinine results measured using the alkaline picric acid method.
Treatment of Lyme disease with cefuroxime was found to have a Hirschsprung’s reaction(Jarisch-Herxheimer reaction)+. This is due to the bactericidal activity of cefuroxime against pathogenic bacteria causing Lyme disease (e.g., Burkholderia spirochetes). Patients should be informed that the above reactions are common with the administration of antimicrobial drugs for Lyme disease and are usually a self-limiting process.
+Only for Lyme disease.
When performing sequential therapy treatment, the time to change from the injectable to the oral form depends on the severity of the infection, the clinical condition of the patient, and the susceptibility of the pathogenic bacteria. A change to oral dosing should only be made when the patient’s clinical condition has significantly improved. If the patient’s clinical condition does not improve after 72 hours of injectable therapy, the patient’s treatment regimen should be redefined. Please refer to the relevant instructions for the use of cefuroxime sodium prior to initiating sequential therapy treatment.
Effects on driving and operating machines
As this product may cause dizziness, caution should be used when patients are driving or operating machinery.
[For Pregnant and Lactating Women]
There is no clinical evidence of embryopathogenic or teratogenic effects of cefuroxime. However, as with all drugs, use this product with caution in patients in early pregnancy. Cefuroxime is secreted into breast milk, so caution should be exercised when cefuroxime is administered to nursing women.
[Pediatric use]See [Dosage].
[For Elderly]See [Dosage]
[Drug Interactions]
Medicines that reduce gastric acid may result in reduced bioavailability of cefuroxime compared to fasting, easily offsetting the increased absorption after eating.
Like other antibacterial drugs, this product may affect intestinal flora, leading to decreased estrogen reabsorption and reduced efficacy of combined oral contraceptive use.
For patients being treated with this product, glucose oxidase or hexokinase assays are recommended for measuring blood glucose levels due to the possibility of false-negative ferricyanide test results. This product does not affect creatinine results as determined by the alkaline picrate method.
Co-administration with probenecid increases the area under the curve of the mean serum concentration drug-timeby 50%. Dialysis reduces cefuroxime blood levels.
In treatment with cephalosporins, there have beenCoomb test positive. This phenomenon can interfere with cross-matching.
[Drug overdose]
Signs and symptoms
Overdose of cephalosporins can cause stimulation of the brain, which can lead to convulsions.
Treatment
Hemodialysis or peritoneal dialysis can reduce cefuroxime blood levels.
[Pharmacology and Toxicology]
Cefuroxime is an oral precursor to the bactericidal cephalosporin antibiotic cefuroxime, which is effective against mostβ-lactamase tolerance and can act broadly on both gram-positive and gram-negative bacteria.
Microbiology
Cefuroxime ester derives its bactericidal activity in vivo from its parent compound, cefuroxime. Cefuroxime is a well-characterized, effective antibacterial agent with a broad spectrum and bactericidal activity against a wide range of common pathogens, including β-lactamase producing The bactericidal activity was observed in all bacteria.
Cefuroxime has bactericidal activity against bacterialβ-lactamases with good stability, and is therefore effective against many ampicillin- and amoxicillin-resistant strains. The bactericidal activity of cefuroxime comes from the inhibition of cell wall synthesis by binding to key target proteins.
The prevalence of acquired resistance is geographically and temporally dependent and correlates very well with the choice of strain. Especially when treating severe infections, local information on drug resistance needs to be obtained.
In vitro microbial susceptibility to cefuroxime sodium
Where clinical efficacy of cefuroxime sodium has been demonstrated in clinical trials, remarks are asterisked(*). Common sensitive strainsaerobic gram-positive bacteria:
Staphylococcus aureus (methicillin-sensitive)*
Coagulase-negative Staphylococcus (methicillin-sensitive)
Streptococcus pyogenes*
β-Streptococcus haemolyticusOxigenic Gram-negative bacteria:
Haemophilus influenzae*, including ampicillin-resistant strains
Haemophilus parainfluenzae*
Katamora*
Neisseria gonorrhoeae* , the including penicillinase-producing and non-penicillinase-producing strainsAnaerobic Gram-positive bacteria:
Streptococcus alginolyticus spp..
Propionibacterium spp.Spirals:
Spirochetes borreliae* Strains with acquired resistance problems Oxigenic Gram-positive bacteria :
Streptococcus pneumoniae*Oxigenic Gram-negative bacteria:
Citrobacter spp. excluding Citrobacter floridis.
Enterobacter spp. excluding Enterobacter aerogenes and Enterobacter cloacae
Escherichia coli*
Klebsiella spp. including Klebsiella pneumoniae*
Amoeba chimaera
Amoeba spp. excluding Aspergillus paniculans and Proteus vulgaris
Providinium spp.Anaerobic Gram-positive bacteria:
Clostridium spp. excluding Clostridium difficileAnaerobic Gram-negative bacteria:
Bacillus spp. excluding Bacteroides fragilis
Clostridium spp.Inherently drug-resistant bacteriaOxigenic Gram-positive bacteria:
Enterococcus spp. including Enterococcus faecalis and Enterococcus faecalis
Listeria monocytogenesOxigenic Gram-negative bacteria:
immobile bacilli.
Burkholderia cepacia
Campylobacter spp.
Flaudibacter citrate
Enterobacter aerogenes
Enterobacter cloacae
Morgan Morganella
Pancreas aeruginosa
Pseudomonas putida
Pseudomonas spp. including Pseudomonas aeruginosa
Salmonella mucilaginosa
Maltophilia narrow-feeding strainsAnaerobic Gram-positive bacteria:
Clostridium difficileAnaerobic Gram-negative bacteria:
Bacteroides fragilisother:
Chlamydia spp..
Mycoplasma spp.
Legionella spp.
[Pharmacokinetics]
Absorption
After oral administration, cefuroxime is absorbed in the gastrointestinal tract and rapidly hydrolyzed in the intestinal mucosa and blood, releasing cefuroxime into the circulatory system. Optimal absorption is obtained by taking this product after a meal. After oral administration2to3to33. Roman”>3hours to peak cefuroxime blood levels (4.1 mg/L).
Distribution
Protein binding capacity varies widely depending on the method of measurement, and is approximately33% to 50%.
Metabolism
Cefuroxime is not metabolized.
Elimination
Serum half-life of1to1.5hours .
Cefuroxime sodium is excreted by glomerular filtration and in the form of renal tubular secretion. Combination with probenecid increases the area under the curve at mean serum concentrations of drug-. family:Times New Roman”>50%.
Renal impairment:
Pharmacokinetic studies of cefuroxime sodium have been performed in patients with varying degrees of renal impairment. In this group of patients, cefuroxime sodium clearance half-life increased with decreasing renal function, and therefore this is the basis for the recommended dose modifications (see [Dosage]). In patients receiving hemodialysis, the presence of at least 60% of the totalcefuroxime at the start of dialysisin4hours of cefuroxime is cleared during dialysis. Therefore, an additional single dose of cefuroxime should be supplemented after completion of hemodialysis.
[Storage]
Shade, seal, and store in a cool place (not more than 20). family:equinox”>℃) for storage.
[Package]
Polyamide/Aluminium/Polyvinyl Chloride Cold Press Molded Solid Pharmaceutical Compound Rigid Tablets and Aluminum Foil for Pharmaceutical Packaging, per small box/. family:Times New Roman”>12grain,18grain,24grain.
[Expiration date]
36months
[Executive Standard]
[Approval number]
State Drug CertificateH20000401
[Manufacturer]
Company Name: Sinopharm Zhijun (Shenzhen) Pharmaceutical Co.
Manufacturing Address: Lanqing Road, Guanlan Hi-Tech Park, Longhua New District, Shenzhen16 “font-family:equals line”>No.
Postal Code:518110
Phone Number:400-880-2335
Fax number: (0755)82263799 (0755)82429265
Service Email: vip @szzhijun.com
URL:www.szzhijun.com