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Cephalexin particles

Product description
Approved date: March 16, 2007
 
Date of revision: October 1, 2010
 
         November 30, 2015
 
Cephalexin particle instruction
 
 Please read the instructions carefully and use them under the guidance of a physician.
 
【Drug Name】
 
Common name: cephalexin particles
 
English name: Cefalexin Granules
 
Pinyin: Toubao’anbian Keli
 
[Ingredients] The main component of this product is: cephalexin. Its chemical name is: (6R,7R)-3-methyl-7-[(R)-2-amino-2-phenylacetamido]-8-oxo-5-thia-1-azabicyclo [4.2.0] Oct-2-ene-2-carboxylic acid monohydrate.
 
 
 
Molecular formula: C16H17N3O4S·H2O
 
Molecular weight: 365.41
 
【Properties】 This product is soluble particles.
 
[Indications] Applicable to acute tonsillitis, angina, otitis media, sinusitis, bronchitis, pneumonia and other respiratory infections, urinary tract infections and skin and soft tissue infections caused by sensitive bacteria. This product is an oral preparation and should not be used for severe infections.
 
[Specification] 125mg according to C16H17N3O4S
 
【Dosage】
 
Adult dose: Oral, usually 250 ~ 500mg (2 ~ 4 bags), 4 times a day, the highest dose of 4g a day. Patients with impaired renal function should be reduced according to the degree of renal dysfunction. Patients with simple cystitis, skin and soft tissue infections, and streptococcal angina have 500 mg (4 bags) every 12 hours.
 
Child dose: Oral, daily weight 25 ~ 50mg / kg, 4 times a day; skin soft tissue infection and streptococcal angina patients, 12.5 ~ 50mg / kg once a day, 2 times a day.
 
【Adverse reactions】
 
1. Nausea, vomiting, diarrhea and abdominal discomfort are more common.
 
2. Allergic reactions such as rash and drug fever can occasionally occur in anaphylactic shock.
 
3. Dizziness, diplopia, tinnitus, convulsions and other nervous system reactions.
 
4. Kidney damage may occur during the application of this product.
 
5. Occasionally, patients showed elevated serum aminotransferase and positive Coombs test. Hemolytic anemia is rare, and neutropenia and pseudomembranous colitis have also been reported.
 
[Contraindications] Those who are allergic to cephalosporins and those with penicillin anaphylactic shock or immediate response are prohibited.
 
【Precautions】
 
1. Before applying this product, you must inquire the patient's history of allergies to cephalosporins, penicillins and other drugs. Those with a history of anaphylactic shock with penicillin should not apply this product. Other patients must pay attention to cephalosporins when applying this product. The chance of cross-allergic reactions in penicillins is about 5% to 7%, and should be used with caution under close observation. In the event of an allergic reaction, the drug is discontinued immediately. In the event of anaphylactic shock, immediate rescue should be done on site, including measures to maintain airway patency, oxygen and adrenaline, and glucocorticoids.
 
2. Patients with a history of gastrointestinal disease, especially ulcerative colitis, Crohn's disease or antibiotic-associated colitis (cephalosporin rarely produces pseudomembranous colitis) and renal dysfunction should be used with caution.
 
3. Interference with diagnosis: Direct Coombs test positive reaction and urine sugar false positive reaction (copper sulfate method) may occur when applying this product; alkaline phosphatase, serum alanine aminotransferase and aspartate aminotransfer in a small number of patients The enzyme can be raised.
 
4. When oral doses exceed 4 g per day (anhydrous cephalexin), consideration should be given to switching to cephalosporin for injection.
 
5. Cephalexin is mainly excreted by the kidney, and patients with renal dysfunction should use this product to reduce the amount.
 
[Pregnant women and lactating women] This product can pass through the placenta, so pregnant women should be used with caution; this product can also be discharged through the milk, although there are no reports of cephalosporin problems in lactating women, but still have to be weighed After the pros and cons apply.
 
[Child medication] See [Usage and Dosage].
 
[Geriatric Use] There is no reliable reference material.
 
【medicine interactions】
 
1. When combined with cholestyramine (cholestyramine), the average blood concentration of cephalexin can be lowered.
 
2. Probenecid can delay the renal excretion of this product. It has also been reported that probenecid can increase the excretion of this product in bile.
 
[Drug overdose] There is no reliable reference material.
 
[Pharmacology and Toxicology] 1. Pharmacology Cephalexin is a first-generation cephalosporin with an antibacterial spectrum similar to that of cefotaxime, but its antibacterial activity is worse than the latter. In addition to Enterococcus, methicillin-resistant Staphylococcus, most strains of Streptococcus pneumoniae, hemolytic streptococcus, or penicillin-producing Staphylococcus are sensitive to this product. This product has a good antibacterial effect on Neisseria, but Haemophilus influenzae is less sensitive to this product; this product has certain antibacterial effects on some Escherichia coli, Proteus mirabilis, Salmonella and Shigella. The remaining Enterobacteriaceae bacteria, Acinetobacter, Pseudomonas aeruginosa, and Bacteroides fragilis are resistant to this product. Fusobacterium and Vesococcus are generally sensitive to this product, and anaerobic Gram-positive cocci are moderately sensitive to this product.
 
2. Toxicology The oral lethal dose of cephalexin in mice was 2600 mg/kg.
 
[Pharmacokinetics] This product is well absorbed. The peak plasma concentration (Cmax) is 1 hour after oral administration of 500 mg of this product on an empty stomach, with an average of 18 mg/L. Taking the medicine after the meal prolonged absorption and decreased the peak concentration of blood, but the amount of absorption was not reduced. The absorption of this product can be increased in children with celiac disease and small intestine diverticulum, and can be delayed and reduced in patients with Crohn's disease and cystic fibrosis. Although the gastrointestinal absorption of the elderly is not reduced, the blood concentration is maintained longer than that of young people. The blood elimination half-life (t1/2β) of this product is 0.6-1.0 hours. Adding probenecid can increase the blood concentration, t1/2β can be extended to 1.8 hours; t1/2β can be prolonged to 5-30 hours in renal failure; The neonatal t1/2β was 6.3 hours. After absorption, the product is widely distributed in the body fluid of each tissue. The average concentration in the sputum is 0.32 mg/L after oral administration of 500 mg every 6 hours, and the concentration in the purulent sputum is higher. The pus drug concentration is basically equal to the blood drug concentration, and the drug concentration in the joint cavity exudate is 50% of the blood drug concentration. This product can enter the fetal blood circulation through the placenta, maternal amniotic fluid; breast milk oral 500mg after the milk concentration of 5mg / L. About 5% of the oral dose is discharged from the bile, and the concentration of the drug in the bile is 1-4 times the blood concentration. The serum protein binding rate is 10% to 15%. The product is not metabolized in the body, and the cumulative dose of urine is discharged from 80% to 90% in 24 hours. After 500 mg orally, the peak concentration of urine drug can reach 2200 mg/L. Cephalexin can be removed by hemodialysis and peritoneal dialysis.
 
[Storage] shading, sealed, and stored in a cool dark place (not to exceed 20 ° C).
 
[Packing] aluminum-plastic composite bag, 12 bags per box; 32 bags per box.
 
[Validity Period] 24 months
 
[Executive Standards] "Chinese Pharmacopoeia" 2015 Edition 2
 
[Approval No.] National Drug Standard H44021596
 
【manufacturer】
 
  Company Name: Guangdong Pi Di Pharmaceutical Co., Ltd.
 
  Production address: No. 66, Pidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
 
  Postal code: 529331
 
  Phone number: (0750) 2789348
 
400-8899-328 (National Service Phone)
 
  Fax number: (0750) 2789348
 
  Website: http://www.pdpharm.com
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