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According to the results of the assessment of adverse drug reactions, in order to further ensure the safety of the public's medication, the State Drug Administration decided to uniformly revise
the contents of the instructions for cefazolin injection (including cefazolin sodium for injection and cefazolin sodium for injection/sodium chloride injection).
The relevant matters are hereby announced as follows:
the contents of the instructions for cefazolin injection (including cefazolin sodium for injection and cefazolin sodium for injection/sodium chloride injection).
The relevant matters are hereby announced as follows:
1.
The marketing authorization holders of the above-mentioned drugs shall report to the Drug Evaluation Center of the State Drug Administration or the provincial drug supervision and administration department for the record before December 30, 2022 in accordance with the relevant provisions of the Measures for the Administration of Drug Registration and other relevant provisions and in accordance with the requirements for the revision of the instructions of
cefazolin injections (see annex).
The marketing authorization holders of the above-mentioned drugs shall report to the Drug Evaluation Center of the State Drug Administration or the provincial drug supervision and administration department for the record before December 30, 2022 in accordance with the relevant provisions of the Measures for the Administration of Drug Registration and other relevant provisions and in accordance with the requirements for the revision of the instructions of
cefazolin injections (see annex).
Where the revised content involves the drug label, it shall be revised together, and the instructions and other contents of the label shall be consistent
with the original approved content.
Drugs produced on the date of filing shall not continue to use the original drug instructions
.
The holder of the drug marketing authorization shall replace the drug instructions and labels that have been shipped from the factory within 9 months after filing
.
with the original approved content.
Drugs produced on the date of filing shall not continue to use the original drug instructions
.
The holder of the drug marketing authorization shall replace the drug instructions and labels that have been shipped from the factory within 9 months after filing
.
Second, the holder of the drug marketing authorization shall carry out in-depth research on the mechanism of the occurrence of new adverse reactions, take effective measures to do a good job in publicizing and training on drug use and safety issues, and guide physicians and pharmacists to use drugs rationally
.
.
Third, clinicians and pharmacists should carefully read the revised content of the above drug instructions, and when selecting drugs, they should conduct full benefit/risk analysis
according to the newly revised instructions.
according to the newly revised instructions.
Fourth, patients should carefully read the drug instructions before taking drugs, and if they use prescription drugs, they should strictly follow the doctor's instructions
.
.
V.
The provincial drug supervision and administration department shall urge the drug marketing authorization holders of the above-mentioned drugs in the administrative region to do a good job of revising the corresponding instructions and replacing the labels and instructions as required, and strictly investigate and deal with violations of laws and
regulations in accordance with law.
The provincial drug supervision and administration department shall urge the drug marketing authorization holders of the above-mentioned drugs in the administrative region to do a good job of revising the corresponding instructions and replacing the labels and instructions as required, and strictly investigate and deal with violations of laws and
regulations in accordance with law.
This is hereby announced
.
.
Annex: Cefazolin injection instructions revision requirements
State Food and Drug Administration
September 29, 2022
annex
Revised requirements for instructions for cefazolin injections
1.
The following should be included under [Adverse Reactions].
The following should be included under [Adverse Reactions].
The following adverse reactions have been reported:
Skin and subcutaneous tissues: rash, itching, hyperhidrosis, flushing, angioedema, purpura allergic, urticaria, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized eruptive pustular dermatosis
.
.
Digestive system: oral candidiasis (oral thrush), dry mouth, bitter mouth, mouth ulcers, nausea, vomiting, stomach cramps, abdominal pain, bloating, diarrhea, constipation, hepatitis, jaundice, anorexia and pseudomembranous colitis
.
Pseudomembranous colitis may occur during or after
receiving antibiotic therapy.
Transient elevations
in serum aminotransferase (SGOT, SGPT) and alkaline phosphatase levels are seen.
Rarely nausea and vomiting
.
.
Pseudomembranous colitis may occur during or after
receiving antibiotic therapy.
Transient elevations
in serum aminotransferase (SGOT, SGPT) and alkaline phosphatase levels are seen.
Rarely nausea and vomiting
.
Systemic and topical reactions: drug heat, chest discomfort, fatigue, thrombophlebitis rarely given intravenous injection, rash, itching, swelling
at the injection site.
After intramuscular injection administration, pain is occasionally seen at the injection site, and some induration appears
.
at the injection site.
After intramuscular injection administration, pain is occasionally seen at the injection site, and some induration appears
.
Immune system: hypersensitivity, anaphylactic shock
.
.
Mental and nervous system: dizziness, headache, generalized or local numbness, tremor, skin tingling, syncope, increased intracranial pressure, convulsions, spasms, drowsiness, irritability, insomnia, hallucinations, nightmares, vertigo, hot
flashes.
flashes.
Respiratory: dyspnea, pleural effusion, laryngeal edema, cough, rhinitis, bronchospasm, interstitial pneumonia, eosinophilic pneumonia
.
.
Cardiovascular system: palpitations, cyanosis, tachycardia, atrial fibrillation and other arrhythmias, decreased blood pressure, increased
blood pressure.
blood pressure.
Blood system: coagulation dysfunction, neutropenia, leukopenia, thrombocytopenia, thrombocytopenia, pancytopenia, basophilia, eosinophilia, agranulocytosis, eosinophilia, agranulocytosis, eosinophilia, leukocytosis, granulocytosis, mononucleosis, anemia, aplastic anemia, hemolytic anemia
.
.
Renal and urinary system: hematuria, urinary incontinence, elevated BUN value, elevated serum creatinine, interstitial nephritis, renal failure
.
Patients with reduced renal function may have encephalopathy reactions such as confusion and seizures when applying high doses (12g per day) of this product
.
.
Patients with reduced renal function may have encephalopathy reactions such as confusion and seizures when applying high doses (12g per day) of this product
.
Others: eyelid edema, dry eyes, blurred vision, arthralgia, muscle weakness, myalgia, tinnitus
.
Itching of the genitals and anus (including itching of the vulva, genital tumors and vaginitis
).
Dual infection with Candida albicans is rare
.
.
Itching of the genitals and anus (including itching of the vulva, genital tumors and vaginitis
).
Dual infection with Candida albicans is rare
.
2.
The following shall be included under [Taboo]
The following shall be included under [Taboo]
1.
Cefazolin allergy is contraindicated
.
Cefazolin allergy is contraindicated
.
2.
Other cephalosporin-based drug allergy is prohibited
.
Other cephalosporin-based drug allergy is prohibited
.
3.
It is contraindicated
in patients with a history of severe allergy to penicillin or other β-lactam drugs.
It is contraindicated
in patients with a history of severe allergy to penicillin or other β-lactam drugs.
3.
The following shall be included under [Precautions]
The following shall be included under [Precautions]
1.
Cross-allergic reactions: patients who are allergic to one cephalosporin or cephamycin (cephamycin) may also be allergic to other cephalosporins or cephalomycin; Patients allergic to penicillin, penicillin derivatives, or penicillamine may also be allergic
to cephalosporins or cephalomycin.
Cross-allergic reactions: patients who are allergic to one cephalosporin or cephamycin (cephamycin) may also be allergic to other cephalosporins or cephalomycin; Patients allergic to penicillin, penicillin derivatives, or penicillamine may also be allergic
to cephalosporins or cephalomycin.
Before using this product, the patient must be asked in detail whether he or she has a previous history
of allergy to cefazolin, other cephalosporins, penicillins, or other drugs.
People with a history of anaphylactic shock with penicillin drugs should not use this product
.
If an allergic reaction occurs during the course of treatment, the drug
should be discontinued immediately.
In the event of anaphylactic shock, it is necessary to keep the airway open, inhale oxygen, and give emergency measures
such as epinephrine, glucocorticoids, and antihistamines.
of allergy to cefazolin, other cephalosporins, penicillins, or other drugs.
People with a history of anaphylactic shock with penicillin drugs should not use this product
.
If an allergic reaction occurs during the course of treatment, the drug
should be discontinued immediately.
In the event of anaphylactic shock, it is necessary to keep the airway open, inhale oxygen, and give emergency measures
such as epinephrine, glucocorticoids, and antihistamines.
2.
Interference with diagnosis: 1% of patients applying cefazolin can have a positive direct or indirect antiglobulin Coombs test and a false positive reaction of urine glucose (copper sulfate method).
In a small number of patients, alkaline phosphatase and serum aminotransferase may be elevated
.
Interference with diagnosis: 1% of patients applying cefazolin can have a positive direct or indirect antiglobulin Coombs test and a false positive reaction of urine glucose (copper sulfate method).
In a small number of patients, alkaline phosphatase and serum aminotransferase may be elevated
.
3.
For patients with renal insufficiency:
For patients with renal insufficiency:
Patients with low urine output caused by impaired renal function or renal insufficiency should use this product with caution and must be reduced when applying
.
As with other β-lactam antibiotics, seizures
may occur if inappropriately high doses are given to patients with impaired renal function (creatinine clearance less than 55 mL/min).
.
As with other β-lactam antibiotics, seizures
may occur if inappropriately high doses are given to patients with impaired renal function (creatinine clearance less than 55 mL/min).
4.
Patients with liver function impairment, renal function impairment or malnutrition, patients with a long course of treatment and patients who have been stable after anticoagulation therapy in the past may have the risk of
cefazolin-related prothrombin activity decline.
Patients with liver function impairment, renal function impairment or malnutrition, patients with a long course of treatment and patients who have been stable after anticoagulation therapy in the past may have the risk of
cefazolin-related prothrombin activity decline.
5.
Long-term application can lead to overgrowth of drug-resistant bacteria of this product, and once a double infection occurs during treatment, appropriate measures
should be taken in time.
Long-term application can lead to overgrowth of drug-resistant bacteria of this product, and once a double infection occurs during treatment, appropriate measures
should be taken in time.
6.
Like all cephalosporins, this product is used with caution in patients with gastrointestinal diseases, especially patients with
a history of colitis.
Like all cephalosporins, this product is used with caution in patients with gastrointestinal diseases, especially patients with
a history of colitis.
7.
Almost all antimicrobial drugs, including cefazolin, have been reported in the application of Clostridium difficile associated diarrhea (CDAD), the severity of which ranges from mild diarrhea to fatal colitis
.
Antimicrobial therapy alters the normal flora at the colon of the patient, leading to Clostridium difficile overgrowth
.
Almost all antimicrobial drugs, including cefazolin, have been reported in the application of Clostridium difficile associated diarrhea (CDAD), the severity of which ranges from mild diarrhea to fatal colitis
.
Antimicrobial therapy alters the normal flora at the colon of the patient, leading to Clostridium difficile overgrowth
.
Toxins A and B produced by Clostridium difficile are responsible for the occurrence of
CDAD.
Strains that produce high levels of toxins in Clostridium difficile can cause increased morbidity and mortality in CDAD, and because these infections are antimicrobial-refractory infections, colectomy
may be required in such patients.
Patients who develop diarrhea after antibiotic use must consider the possibility of
developing CDAD.
It has been reported in the literature that CDAD occurs 2 months after the end of antimicrobial therapy, so careful patient history
is required when performing CDAD identification.
CDAD.
Strains that produce high levels of toxins in Clostridium difficile can cause increased morbidity and mortality in CDAD, and because these infections are antimicrobial-refractory infections, colectomy
may be required in such patients.
Patients who develop diarrhea after antibiotic use must consider the possibility of
developing CDAD.
It has been reported in the literature that CDAD occurs 2 months after the end of antimicrobial therapy, so careful patient history
is required when performing CDAD identification.
Once a patient is suspected or confirmed to have CDAD, it may be necessary to stop the antibiotics the patient is receiving (except for antibiotics that have a direct inhibitory effect on Clostridium difficile).
Patients should also be administered appropriately to fluids and electrolytes, protein supplementation, antibiotics for Clostridium difficile infection, and surgical evaluation based on clinical indications
.
Patients should also be administered appropriately to fluids and electrolytes, protein supplementation, antibiotics for Clostridium difficile infection, and surgical evaluation based on clinical indications
.
8.
This product is compatible with the following drugs are contraindicated, can not be the same bottle drip: amikacin sulfate, kanamycin sulfate, chlortetracycline hydrochloride, oxytetracycline hydrochloride, erythromycin gluconate, polymyxin sulfate B, colistin sodium mesylate, calcium
gluconate.
This product is compatible with the following drugs are contraindicated, can not be the same bottle drip: amikacin sulfate, kanamycin sulfate, chlortetracycline hydrochloride, oxytetracycline hydrochloride, erythromycin gluconate, polymyxin sulfate B, colistin sodium mesylate, calcium
gluconate.
4.
The following shall be included under [Medication for pregnant and lactating women].
The following shall be included under [Medication for pregnant and lactating women].
Studies of reproductive toxicity in rats, mices and rabbits have not been seen in studies of impaired fertility due to cefazolin or damage
to fetals.
However, adequate and well-controlled studies
have not been conducted in pregnant women.
Since animal reproduction testing does not always predict human reactions, this product should only be used
when explicitly needed.
to fetals.
However, adequate and well-controlled studies
have not been conducted in pregnant women.
Since animal reproduction testing does not always predict human reactions, this product should only be used
when explicitly needed.
With cefazolin used before caesarean section, the drug concentration in the umbilical cord blood is about 1/4 to 1/3
of the maternal drug concentration.
This product does not seem to have adverse effects on the
fetus.
of the maternal drug concentration.
This product does not seem to have adverse effects on the
fetus.
Lactating women have a low content in the milk of this product, but lactating women should still suspend breastfeeding
when taking the drug.
when taking the drug.
V.
The following should be included under [Medication for the Elderly].
The following should be included under [Medication for the Elderly].
In a clinical trial of 920 patients treated with cefazolin, 313 participants (34%) were 65 years and older and 138 subjects (15%) were 75 years and older
.
The safety and efficacy of this product in these elderly subjects were generally not different
from those of young subjects.
Other clinical reports have not seen significant differences between elderly patients and young patients, but the possibility
that a small number of elderly patients are more sensitive to this product cannot be ruled out.
.
The safety and efficacy of this product in these elderly subjects were generally not different
from those of young subjects.
Other clinical reports have not seen significant differences between elderly patients and young patients, but the possibility
that a small number of elderly patients are more sensitive to this product cannot be ruled out.
This product is excreted by the kidneys, so patients with renal insufficiency may be at greater
risk of toxicity.
Elderly patients are usually due to decreased renal function, so this product is significantly longer than T1/2 in the elderly than young people, and the dosage should be appropriately reduced or prolonged according to changes in renal function
.
risk of toxicity.
Elderly patients are usually due to decreased renal function, so this product is significantly longer than T1/2 in the elderly than young people, and the dosage should be appropriately reduced or prolonged according to changes in renal function
.
6.
The following should be included under [Drug Interactions].
The following should be included under [Drug Interactions].
1.
This product is applied in combination with gentamicin or amikacin, which can enhance the antibacterial effect
in vitro.
This product is applied in combination with gentamicin or amikacin, which can enhance the antibacterial effect
in vitro.
2.
Cefazolin is combined with warfarin, due to the decrease in the synthesis of vitamin K-dependent coagulation factors, the risk of bleeding increases
.
Cefazolin is combined with warfarin, due to the decrease in the synthesis of vitamin K-dependent coagulation factors, the risk of bleeding increases
.
3.
Cefazolin is combined with live typhoid vaccine, the immune effect of the latter is reduced
.
Cefazolin is combined with live typhoid vaccine, the immune effect of the latter is reduced
.
4.
This product is combined with anti-infective drugs (such as aminoglycosides, polymyxin E, polymyxin B), iodine-containing contrast agents, organoplatin compounds, high-dose methotrexate, certain antiviral drugs (such as acyclovir, sodium phosphinoformate), cyclosporine, tacrolimus and diuretics (such as furosemide) may increase renal toxicity, it is recommended to monitor kidney function
.
This product is combined with anti-infective drugs (such as aminoglycosides, polymyxin E, polymyxin B), iodine-containing contrast agents, organoplatin compounds, high-dose methotrexate, certain antiviral drugs (such as acyclovir, sodium phosphinoformate), cyclosporine, tacrolimus and diuretics (such as furosemide) may increase renal toxicity, it is recommended to monitor kidney function
.
5.
When cefazolin is combined with probenecid, probenecid may reduce the tubular secretion of cephalosporins, and probenecid can lead to an increase in the blood concentration of this product and a prolonged
blood half-life.
When cefazolin is combined with probenecid, probenecid may reduce the tubular secretion of cephalosporins, and probenecid can lead to an increase in the blood concentration of this product and a prolonged
blood half-life.
6.
Cefazolin contains methiotetrazole side chain, drinking alcohol or drinking ethanol-containing beverages or intravenous injection of ethanol-containing drugs during medication can cause alcohol-absorptive sulfur-like reactions (also known as: disulfiram-like reactions).
Cefazolin contains methiotetrazole side chain, drinking alcohol or drinking ethanol-containing beverages or intravenous injection of ethanol-containing drugs during medication can cause alcohol-absorptive sulfur-like reactions (also known as: disulfiram-like reactions).
(Note: If the security content of the original approval specification is more comprehensive or stricter than the requirements of this amendment, the original approved content
shall be retained.
) If other contents of the description are inconsistent with the above revision requirements, they shall be revised
together.
）
shall be retained.
) If other contents of the description are inconsistent with the above revision requirements, they shall be revised
together.
）
