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Amoxicillin granule

Product description
Approved date: March 16, 2007
 
Date of revision: September 30, 2010
 
         November 30, 2015
 
Amoxicillin granule
 
Please read the instructions carefully and use them under the guidance of a physician.
 
【Drug Name】
 
Common name: Amoxicillin granules
 
English name: Amoxicillin Granules
 
Pinyin: Amoxilin Keli
 
[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 granules and powder;
 
[indications]
 
For the following infections caused by sensitive bacteria (not producing β-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. Urogenital tract infections caused by Escherichia coli, Proteus mirabilis or Enterococcus faecalis.
 
3. Skin and soft tissue infections caused by Streptococcus hemolyticus, Staphylococcus or Escherichia coli.
 
4. Lower respiratory tract infections such as acute bronchitis and pneumonia caused by Streptococcus hemolyticus, 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 digestive ulcer Recurrence rate.
 
[Specification] 0.125g according to C16H19N3O5S
 
【Dosage】
 
    oral. Rip the pouch, pour the powder into the appropriate amount of cold water, shake it, and take it.
 
Pediatric: The daily dose is 20-40 mg/kg, once every 8 hours. Newborns and premature infants are orally administered 50 mg each time, and infants under 3 months are given a daily dose of 30 mg/kg.
 
Amoxicillin granules for children
 
age
 
Each time
 
Daily usage
 
Within one year of age
 
0.5 bags
 
3 times a day
 
Or as directed by a doctor
 
1 to 3 years old
 
1 bag
 
3 to 5 years old
 
1.5 bags
 
5 to 10 years old
 
2 bags
 
10 years old
 
2 to 3 bags
 
 
Adult: 0.5g (4 bags) at a time, once every 6-8 hours, the daily dose does not exceed 4g (32 bags).
 
【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 increased.
 
5. Double infection caused by Candida or resistant bacteria.
 
6. Occasionally, central nervous system symptoms such as excitement, anxiety, insomnia, dizziness and abnormal behavior.
 
[taboo]
 
Those who are allergic to penicillin or positive for penicillin skin test are banned.
 
【Precautions】
 
1. Infectious mononucleosis patients with this product is prone to rash, should be avoided.
 
2. Patients with longer course of treatment should check liver and kidney function and blood routine.
 
3. Amoxicillin can cause false positives in the urine glucose test using Benedict or Fehling reagents.
 
4. It should be used with caution in the following cases:
 
(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 severely impaired renal function.
(3) Patients with an endogenous creatinine clearance rate of 10 to 30 ml/min are 0.25 to 0.5 g per 12 hours; patients with an endogenous creatinine clearance of less than 10 ml/min are 0.25 to 0.5 g per 24 hours.
 
[Pregnant women and lactating women]
 
Animal reproduction tests showed that 10 times the human dose of amoxicillin did not impair the fertility and fetal life 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 medication] is not clear.
 
【medicine interactions】
 
1. Probenecid competitively reduces the secretion of the renal tubules of the product, and the simultaneous application of both can cause an increase in the blood concentration of amoxicillin and an increase in half-life.
 
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, such as Streptococcus pneumoniae, Streptococcus hemolyticus, Staphylococcus aureus, Enterococcus faecalis, Escherichia coli, Proteus mirabilis, and Salmonella The non-lactamase-producing strains and Helicobacter pylori of aerobic Gram-negative bacteria such as bacteria, Haemophilus influenzae, and 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, and about 75% to 90% can be absorbed from the gastrointestinal tract. The peak plasma concentrations (Cmax) after oral administration of 0.25 g, 0.5 g, and 1 g were 5.1 mg/L, 10.8 mg/L, and 20.6 mg/L, respectively, and the peak time was 1 to 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 (t1/2b) of this product is 1 to 1.3 hours, about 24% to 33% of the dose after administration is metabolized in the liver, and 45% to 68% of the administered amount within 6 hours is the original drug from the urine. Excreted in the middle, 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] Protect from light and seal (10 ~ 30 ° C).
 
[Packing] aluminum-plastic composite bag, 12 bags per box; 15 bags per box; 24 bags per box.
 
[Validity Period] tentatively 24 months
 
[Executive Standards] "Chinese Pharmacopoeia" 2015 Edition 2
 
[Approval No.] National Drug Standard H44024478
 
【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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