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Amoxicillin capsule

Product description
Approval date:
 
Amoxicillin capsule instruction manual
 
Please read the instructions carefully and use them under the guidance of a physician.
 
【Drug Name】
 
Generic Name: Amoxicillin Capsules
 
English name: Amoxicillin Capsules
 
Pinyin: Amoxilin Jiaonang
 
[Ingredients] The main ingredients of this product are: amoxicillin. Its chemical name is: (2S,5R,6R)-3,3-dimethyl-6-[(R)-(-)-2-amino-2-(4-hydroxyphenyl)acetylamino]-7 - Oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate.
 
Molecular formula: C16H19N3O5S·3H2O
 
Molecular weight: 419.46
 
【Properties】 This product is a capsule, the content of which is white or off-white powder or granules.
 
[Indications] Amoxicillin is suitable for the following infections caused by sensitive bacteria (not producing beta-lactamase strains):
 
1. Upper respiratory tract infections such as otitis media, sinusitis, pharyngitis, and tonsillitis caused by hemolytic streptococcus, Streptococcus pneumoniae, Staphylococcus or Haemophilus influenzae.
 
2. Genitourinary tract infections caused by Escherichia coli, Proteus mirabilis or Enterococcus faecalis.
 
3. Skin and soft tissue infections caused by hemolytic streptococcus, staphylococcus or Escherichia coli.
 
4. Lower respiratory tract infections such as acute bronchitis and pneumonia caused by hemolytic streptococcus, Streptococcus pneumoniae, Staphylococcus or Haemophilus influenzae.
 
5. Acute simple gonorrhea.
 
6. This product can also be used to treat typhoid, typhoid carriers and leptospirosis; amoxicillin can also be combined with clarithromycin and lansoprazole to eradicate stomach, duodenal Helicobacter pylori, reduce the recurrence rate of digestive ulcer .
 
[Specification] 0.25g (according to C16H19N3O5S)
 
【Usage and Dosage】 Oral. Adults once 0.5g (2 capsules), once every 6 to 8 hours, the daily dose does not exceed 4g. The daily dose of children is 20-40 mg/Kg, once every 8 hours; the daily dose of infants under 3 months is 30 mg/kg per body weight, once every 12 hours. Patients with severe renal impairment need to adjust the dose, in patients with endogenous creatinine clearance of 10 ~ 30ml / minute 0.25 ~ 0.5g (1 ~ 2) every 12 hours; patients with endogenous creatinine clearance of less than 10ml / minute 0.25 to 0.5 g (1 to 2 capsules) per 24 hours.
 
【Adverse reactions】
 
1. Gastrointestinal reactions such as nausea, vomiting, diarrhea, and pseudomembranous colitis.
 
2. Allergic reactions such as rash, drug fever and asthma.
 
3. Anemia, thrombocytopenia, eosinophilia, etc.
 
4. Serum aminotransferase can be slightly elevated.
 
5. A double infection caused by Candida or resistant bacteria.
 
6. Occasionally, central nervous system symptoms such as excitement, anxiety, insomnia, dizziness, and abnormal behavior.
 
[Contraindications] Penicillin allergy and penicillin skin test positive patients are banned.
 
【Precautions】
 
1. The penicillin sodium skin test must be done before use, and the positive reaction is disabled.
 
2. This product is prone to rash in patients with infectious mononucleosis and should be avoided.
 
3. Patients with longer course of treatment should be checked for liver and kidney function and blood routine.
 
4. Amoxicillin can cause false positives in the urine glucose test using Benedict or Fehling reagents.
 
5. The following conditions should be used with caution: (1) Those with a history of allergic diseases such as asthma and hay fever. (2) The dose may need to be adjusted in the elderly and in severely impaired renal function.
 
[Pregnant women and lactating women] Animal reproduction tests showed that 10 times the human dose of amoxicillin did not damage the fertility and fetus of rats and mice. However, there is still insufficient control in humans. In view of the fact that animal reproduction tests cannot fully predict human response, pregnant women should only use this product when it is necessary. Because a small amount of amoxicillin can be secreted from the milk, the lactating mother may cause allergies to the baby.
 
[Child medication] See [Usage and Dosage].
[Geriatric Use] It is not clear.
【medicine interactions】
 
1. Probenecid competitively reduces the secretion of renal tubules of this product. Both of them can cause the blood concentration of amoxicillin to increase and the half-life to prolong.
 
2. Chloramphenicol, macrolides, sulfonamides and tetracyclines interfere with the antibacterial effect of amoxicillin in vitro, but its clinical significance is unknown.
 
【Drug overdose】
 
 A prospective study involving 51 children showed that amoxicillin did not cause significant clinical symptoms when administered at doses up to 250 mg/kg. It has been reported that a small number of patients have renal insufficiency and oliguria due to excessive amoxicillin, but renal damage is reversible after stopping the drug.
 
[Pharmacology and Toxicology] Amoxicillin is a penicillin antibiotic, aerobic Gram-positive cocci, Escherichia coli, such as Streptococcus pneumoniae, Streptococcus hemolyticus, Streptococcus, Staphylococcus aureus, Enterococcus faecalis, etc. The β-lactamase-free strain and Helicobacter pylori of aerobic Gram-negative bacteria such as Proteus mirabilis, Salmonella, Haemophilus influenzae, Neisseria gonorrhoeae have good antibacterial activity. Amoxicillin exerts a bactericidal action by inhibiting the synthesis of bacterial cell walls, allowing bacteria to rapidly become spheroids to dissolve and rupture.
 
【Pharmacokinetics】
 
After oral administration, the absorption is rapid, about 75% to 90% can be absorbed from the gastrointestinal tract, and the effect of food on drug absorption is not significant. The peak plasma concentration (Cmax) after oral administration of 0.25 g and 0.5 g was 3.5-5.0 mg/L and 5.5-7.5 mg/L, respectively, and the peak time was 1-2 hours. This product is well distributed in most tissues and body fluids. The average drug concentration in patients with acute pneumonia or chronic bronchitis after oral administration of 0.5 g of this product for 2 to 3 hours and 6 hours was 0.52 mg / L and 0.53 mg / L, respectively, while the blood concentration was 11 mg / L and 3.5. Mg/L. In children with chronic otitis media, 1 to 2 hours after oral administration of this product, the concentration of the drug in the middle ear fluid is 6.2 mg / L. The concentration of cerebrospinal fluid in patients with tuberculous meningitis after oral administration of 1 g of this product is 0.1 to 1.5 mg/L, which is equivalent to 0.9% to 21.1% of the blood concentration in the same period. This product can pass through the placenta, the concentration in the cord blood is 1/4 to 1/3 of the maternal blood concentration, and also contains trace amounts in milk, sweat and tears. The protein binding rate of amoxicillin is 17% to 20%. The blood elimination half-life (t1/2β) of this product is 1 to 1.3 hours, about 24% to 33% of the dose is administered in the liver after administration, and 45% to 68% of the dose is administered in the urine from the urine in 6 hours. Excreted, some drugs are excreted through the biliary tract. The serum half-life of patients with severe renal insufficiency can be extended to 7 hours. Hemodialysis can remove this product, and peritoneal dialysis does not remove the product.
 
[Storage] Shading, sealed (10 ~ 30 ° C).
 
[Packaging] Aluminum-plastic packaging, 20 capsules per box; 24 capsules per box.
 
[Validity Period] 24 months
 
[Executive Standards] "Chinese Pharmacopoeia" 2005 Edition 2
 
[Approval No.] National Drug Standard H20056323
 
【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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