Approved on.
Date of revision.
Cephalexin Capsules Instructions
Please read the instructions carefully and use under the guidance of your physician
[Drug Name]
Generic Name: Cefradine Capsules
English name: Cefradine Capsules
Hanyu Pinyin: Toubaolading Jiaonang
[become
Participation
The main ingredient of this product is cefradine.
Chemical name: (6R,7R)-7-[(R)-2-amino-2-(1,4-cyclohexadien-1-yl)acetylamino]-3- methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
Chemical structure formula.
Molecular Formula:C16H19N3O4S
Molecular weight:349.40
[sex
Situation
The content of this product is white to light yellow powder or granule.
[suitable for
Applicable
Sickness]
For acute pharyngitis caused by sensitive organisms, tonsillitis It is suitable for acute pharyngitis, tonsillitis, otitis media, bronchitis and pneumonia and other respiratory tract infections, genitourinary tract infections and skin soft tissue infections caused by sensitive bacteria. This product is an oral preparation and should not be used for severe infections.
[regulation
Gauge
0.25g(byC16H19N3O4Scount)
[dosage]
To be taken orally.
Common dosage for adults: once0.25~0.5gper6 hourly, which can be increased to 1gonce for more serious infections. family:Arial”>, but the total amount in a day should not exceed4g. Pediatric dose: once6.25-12.5mg/kg by body weight, per6hours.
During treatment, regardless of the patient’s age and weight, the The maximum dose of cefradine is 1g/times per :Times New Roman”>6hours.
As with other antibacterial therapies, cefradine treatment should be continued at least until at least 48-72hours after the patient’s symptoms of infection have resolved or evidence of bacterial clearance has been obtained. In the treatmentAgroupβ-infections due to Streptococcus haemolyticus, treatment is recommended for at least10days to facilitate prevention of rheumatic fever or glomerulonephritis. In the treatment of chronic urinary tract infections, frequent bacteriologic and clinical evaluation of the patient during treatment and for several months after treatment is necessary. Treatment of persistent infections may need to be carried out over several weeks. Patients should not take less than the recommended dose as described above. Pediatric patients should not take more than the recommended adult dose of this product.
Dose for patients with renal insufficiency:
Patients not on dialysis: the following dosing The principle is to administer the following dose at 500mg/times, every6hourly dosing11dosing regimen is based on a dosing regimen that is adjusted for differences in creatinine clearance. Further adjustments to the dosing regimen may be required during actual use due to dosage form selection and individual patient variation.
Creatinine clearanceDoseDosing interval>20ml/min500mg6 hours5-20ml/min250mg6 hours＜5ml/min250mg12 hoursPatients on long-term, intermittent hemodialysis:
Take at the start of dialysis =”font-family:Times New Roman”>250mg
The first12hours after administration250mg
After the start of dialysis36-48hourly250mg
[Adverse Reactions]
The incidence of adverse reactions to this product is approximately6%. Common adverse reactions include tongue inflammation, nausea, vomiting, diarrhea or loose stools, upper abdominal discomfort, abdominal pain, and gastrointestinal reactions such as colitis. Pseudomembranous enterocolitis, eosinophilia, directCoomb’stest positive reaction, peripheral blood picture leukocytosis and neutropenia seen in individual patients. Transient elevation of blood urea nitrogen, transient elevation of serum aminotransferase, serum alkaline phosphatase, bilirubin, and lactate dehydrogenase may occur in a few patients. Long-term application may lead to dysbiosis, vitamin deficiency or secondary infections, and occasionally vaginal candidiasis. In China, post-marketing adverse reactions have been reported. The use of this product may lead to hematuria, and there have been rare cases of psychiatric abnormalities, hearing loss, delayed allergic reactions, anaphylaxis, dysuria, pharmacological hemolysis, cardiac arrhythmia and other rare adverse reactions with this product. Allergic reactions are occasionally seen. The incidence of drug rash is approximately1% to 3%. Patients who have previously experienced an allergic reaction, as well as those with a history of allergy, asthma, hay fever, or rubella, are more likely to experience an allergic reaction after taking this product. Symptoms of allergic reactions include mild rubella or rash, pruritus, and arthralgia. As with other cephalosporins, a very small number of patients have experienced allergic reactions, erythema multiforme, Stevens-Johnsonsyndrome, toxic epidermal necrolysis.
Neurological disorders: β-Endocannabinoid effect encephalopathy (e.g., confusion, disorders of consciousness, seizures, movement disorders).
Liver: Isolated Glutathione aminotransferase (SGPT/ALT), glutathione aminotransferase (SGOT/AST), total bilirubin, and serum alkaline phosphatase were elevated without hepatocellular injury.
Renal: Some applications of patients treated with cephalosporins showed transient elevated blood urea nitrogen (BUN) and =”font-family:Times New Roman”>50 years of age or older had an increased incidence. In adults in whom serum creatinine levels were measured, it was found that serum creatinine levels were not elevated in the presence of elevated blood urea nitrogen levels.
Other adverse reactions to this product include dizziness, chest tightness, and vulvovaginal candidiasis .
[PROHIBITED
Absence
Known hypersensitivity to any cephalosporin antibiotic or This product is contraindicated in persons with known hypersensitivity to any cephalosporin antibiotic or any component of this product, and a history of penicillin anaphylaxis or immediate reaction.
[Precautions]
1. span>Patients should be asked about their history of allergy to cephalosporins, penicillins and other drugs before applying this product. span>5%~7%, and should be used with caution under close observation. Discontinue the drug as soon as an allergic reaction occurs. If anaphylaxis occurs, immediate in situ resuscitation is required, including measures to maintain a patent airway, oxygenation, and application of epinephrine and glucocorticoids.
2. style=”font-family:Arial”>Patients treated with cephalosporins (including cefradine) as well as other broad-spectrum antibiotics have had pseudomembranous enterocolitis; therefore it is important to consider the occurrence of pseudomembranous enterocolitis in patients who develop diarrhea while receiving antimicrobial therapy. In patients with milder symptoms of enterocolitis, symptom relief is possible with discontinuation of the drug; in patients with moderate or severe disease measures should be taken depending on the patient’s symptoms.
3. style=”font-family:Arial”>Application of all antimicrobials (including this product) almost always has Clostridium difficile-associated diarrhea (CDAD) has been reported and can range in severity from mild diarrhea to fatal colitis. It is important to consider CDAD in patients with diarrhea that occurs after antimicrobial application. BecauseCDADcan occur after antimicrobial applicationin 2months after antimicrobial application, so the history must be carefully traced. Once the patient is suspected or confirmed to haveCDAD, it may be necessary to discontinue the antimicrobial agent the patient is receiving (except for those with direct C. difficile inhibitory effect on C. difficile).
4. style=”font-family:Arial”>The use of medication containing β-lactams can cause encephalopathy ( e.g., confusion, impaired consciousness, seizures, movement disorders); especially in patients with renal insufficiency and beta-lactam overdose.
5. style=”font-family:Arial”>This product is primarily excreted by the kidneys and the dose must be reduced or the dosing interval extended in cases of decreased renal function. When using this product in patients with known or suspected renal impairment, because cefradine accumulates in serum or tissues, close clinical observation and appropriate laboratory tests should be performed, and dosing should be adjusted appropriately for the degree of renal insufficiency (see Dosage and Administration). The use of this product may lead to hematuria as reported in post-marketing adverse reactions in China. Children are a susceptible group for the development of this product, so it should be used with caution and monitored in patients with reduced renal function and children.
6. style=”font-family:Arial”>Patients on this product may have a false positive reaction when urine glucose is measured by the copper sulfate method, and if an enzymatic assay is used (e.g., Clinistix®) sup>andTes-Tape®) for urine glucose testing, there are no false positive results. Similar to other cephalosporins, directCoomb’s test positive reactions have rarely been reported.
7. style=”font-family:Arial”>As with other antibiotics, long-term use of this product can lead to overgrowth of non-susceptible microorganisms.
8. style=”font-family:Arial”>If the inner package is opened or damaged, do not use it.
[For Pregnant and Lactating Women]
This product can cross the placental barrier into the fetal It can also enter the milk. Use with caution in pregnant and lactating women.
[Children’s medication]
Domestic post-marketing adverse reactions reported with this product Children are susceptible to the development of hematuria and should be administered with caution and monitored in pediatric patients.
[Geriatric Use]
Elderly patients with decompensated renal function The dose should be reduced or the dosing interval should be extended as appropriate.
[Drug Interactions]
1.Cephalosporins delay the excretion of phenytoin sodium in the renal tubules.
2. The combination of Protaxon with cephalosporin antibiotics may increase nephrotoxicity.
3.Co-administration with strong Diuretics may increase nephrotoxicity when combined with strong diuretics.
4.Co-administration with Methicillin has synergistic effect on Gram-negative bacilli such as Escherichia coli and Salmonella spp. in combination.
5. Propofol may delay the excretion of this product.
[Drug overdose]
This trial was not performed and no reliable references are available.
[Pharmacology and Toxicology]
This product is a first-generation cephalosporin that is effective against non-penicillinase and penicillinase-producing Staphylococcus aureus, coagulase-negative Staphylococcus It has good antibacterial effect on some strains of Gram-positive cocci, such as non-penicillinase and penicillinase-producing Staphylococcus aureus, coagulase-negative Staphylococcus, Agroup hemolytic streptococci, Streptococcus pneumoniae and Streptococcus gramineus. Anaerobic gram-positive bacteria are mostly sensitive to this product, and Bacteroides fragilis is resistant to this product. Methicillin-resistant Staphylococcus spp. and Enterococcus spp. are resistant to this product. The effect of this product on gram-positive and gram-negative bacteria is similar to that of cefadroxil. It has some effect on Neisseria gonorrhoeae and is also active against enzyme-producing Neisseria gonorrhoeae; it is less active against Haemophilus influenzae.
[Pharmacokinetics]
The product is rapidly absorbed after oral administration and is taken orally on an empty stomach0.5g,11~18mg/Lthe peak blood concentration (Cmax) arrives at 1hour after administration, with a blood elimination half-life (t1/2β) is1 hour. Food in the gastrointestinal tract may retard the absorption of cefradine, but total absorption is not affected. The product is well distributed in tissue body fluids. Concentrations in liver tissue are equal to serum concentrations. Effective concentrations can be obtained in myocardium, uterus, lung, prostate and bone tissue. Concentrations in brain tissue are only 5% to 10% of concurrent blood concentrations, and even lower concentrations in cerebrospinal fluid. It crosses the blood-placental barrier into the fetal circulation, and a small amount is excreted via breast milk. The serum protein binding rate is6% to 10%. After oral administration0.5g Roman”>6hours of cumulative excretion of the administered dose90%or more. Small amounts of this product are excreted from the bile, the latter at concentrations up to 4fold of the serum concentration. It is rarely metabolized in the body and can be cleared by hemodialysis and peritoneal dialysis. Propofol reduces the renal excretion of this product.
[storage
Storage
Seal and store in a cool, dark (away from light and not exceeding 20℃).
[package
Package
Polyvinyl chloride solid pharmaceutical rigid tablets and aluminum foil for pharmaceutical packaging, plus polyesteraluminum/polyethylene pharmaceutical composite film and solid pharmaceutical paper bag with silica gel desiccant. 10granules//plate:1board/bag/box,2board/bag/box,3board/bag/box;12grain/board:1board//bag/box,box,2boards/bag/box,3boards/bag/box.
[with
Effective
Duration 12months
[Executive Standard]
[Approval number][Approval number “font-family:Times New Roman”>
State PharmacopoeiaH13020787
[Drug Marketing Authorization Holder]
Name
Name: Shiyao Group Ouyi Pharmaceutical Co.
Registered Address: Yangzi Road, Shijiazhuang Economic and Technological Development Zone88No.
Postal Code:052165
Tel:0311-87886158,0311-67163660
Fax Number:0311-87171665
[Manufacturer]
Corporate Name: Shiyang Group Ouyi Pharmaceutical Co. family:Times New Roman”>
Manufacturing Address: Yangzi Road, Shijiazhuang Economic and Technological Development Zone88No.
Postal Code:052165
Tel:0311-87886158,0311-67163660
Fax Number:0311-87171665