[Name of drug]
Common name: amoxicillin capsule
Trade name: amoxicillin capsule (Harbin medicine)
English name: Amoxicillin Capsules
Phonetic full code: AMoXiLinJiaoNang (HaYao)
[Main ingredients] The main ingredient of this product is amoxicillin. Its chemical name is (2S, 5R, 6R) - 3,3-dimethyl-6 - [(R) - (-) - 2-amino-2 - (4-hydroxyphenyl) acetamido] - 7-oxo-4-thia-1-azabicyclo [3.2. O] heptan-2-carboxylic acid trihydrate.
[Ingredients]
Molecular formula: C16H19N3O5S · 3H2O
Molecular weight: 419.46
[Properties] This product is a capsule with white or almost white powder content, and tastes slightly bitter.
[Indications/Indications] It is applicable to infection caused by sensitive bacteria, such as hemolytic streptococcus, streptococcus pneumoniae, Escherichia coli, Proteus mirabilis or enterococcus faecalis.
[Specification and model] 0.25g , 0.5g
[Usage and dosage] Take orally:
1. 0.5g once for adults, once every 6-8 hours, and the daily dose shall not exceed 4g.
2. The daily dose for children is 20 ~ 40mg/Kg, once every 8 hours; The daily dose for infants under 3 months old is 30mg/Kg, once every 12 hours.
3. For patients with severe renal function damage, the dosage should be adjusted, among which the endogenous creatinine clearance rate is 0.25-0.5g every 12 hours for patients with 10-30ml/min; The patients with endogenous creatinine clearance rate less than 10ml/min were 0.25-0.5g every 24 hours.
[Adverse reactions]
1. Gastrointestinal reactions such as nausea, vomiting, diarrhea and pseudomembranous enteritis.
2. Allergic reactions such as skin rash, drug fever and asthma.
3. Anemia, thrombocytopenia, eosinophilia, etc.
4. Serum aminotransferase may be slightly increased.
5. Double infection caused by candida or drug-resistant bacteria.
6. Central nervous system symptoms such as excitement, anxiety, insomnia, dizziness and abnormal behavior are occasionally seen.
[Contraindication] Penicillin allergy and penicillin skin test positive patients are prohibited.
[Precautions]
1. Penicillin oral drugs can occasionally cause anaphylactic shock, especially in patients with a history of penicillin or cephalosporin allergy. Before using the drug, you must inquire about the drug allergy history in detail and conduct penicillin skin test. In case of anaphylactic shock, rescue shall be carried out on the spot, and treatment measures such as keeping airway unblocked, oxygen inhalation, and application of adrenaline and glucocorticoid shall be taken.
2. Patients with infectious mononucleosis are prone to skin rash when using this product, so it should be avoided.
3. Patients with a long course of treatment should check liver and kidney functions and blood routine tests.
4. Amoxicillin may cause false positive urine glucose test with Benedit or Fehling reagent.
5. Use with caution in the following cases:
1. Have a history of allergic diseases such as asthma and hay fever.
2. It may be necessary to adjust the dosage in the elderly and when the renal function is seriously damaged.
[Children's medicine] 1. Please consult a doctor or pharmacist for children's dosage. 2. Children must be used under adult supervision.
[Medication for elderly patients] The dosage or interval of medication should be adjusted according to the renal function under the guidance of the physician.
[Medication for pregnant and lactating women] Animal reproductive test showed that amoxicillin 10 times the human dose did not damage the fertility and fetus of rats and mice. However, there is still a lack of adequate control studies in humans. In view of the fact that animal reproductive tests cannot completely predict human responses, pregnant women should only use this product when it is really necessary. Since a small amount of amoxicillin can be secreted in the milk, the baby may be allergic after taking it by the nursing mother.
[Drug interaction] 1. Probenecid competitively reduces the renal tubule secretion of this product, and the simultaneous use of both can cause the increase of amoxicillin blood concentration and prolong the half-life. 2. Chloramphenicol, macrolides, sulfonamides and tetracyclines interfere with the antibacterial effect of amoxicillin in vitro, but their clinical significance is unknown.
[Drug overdose] A prospective study involving 51 children showed that amoxicillin did not cause significant clinical symptoms when the dosage was not more than 250mg/Kg. It is reported that a few patients have renal insufficiency and oliguria due to amoxicillin overdose, but the renal function damage is reversible after drug withdrawal.
[Pharmacology and Toxicology] Amoxicillin is a penicillin antibiotic, which does not produce penicillin against Streptococcus pneumoniae, hemolytic streptococcus, Staphylococcus aviruleus, Enterococcus faecalis and other aerobic gram-positive cocci, Escherichia coli, Proteus mirabilis, Salmonella, Haemophilus influenzae, Neisseria gonorrhoeae and other aerobic gram-negative bacteria β Lactamase strains and Helicobacter pylori have good antibacterial activity. Amoxicillin plays a bactericidal role by inhibiting the synthesis of bacterial cell wall, enabling bacteria to quickly become globules and dissolve and break.
[Pharmacokinetics] 1. The drug is absorbed rapidly after oral administration, about 75%~90% can be absorbed from the stomach and intestines, and food has no significant effect on drug absorption. After oral administration of 0.25g and 0.5g, the peak plasma concentration (Cmax) was 3.5-5.0mg/L and 5.5-7.5mg/L, respectively, and the peak time was 1-2 hours. 2. The product is well distributed in most tissues and body fluids. The average drug concentration in sputum of patients with acute attack of pneumonia or chronic bronchitis 2~3 hours and 6 hours after oral administration of 0.5g of this product was 0.52mg/L and 0.53mg/L respectively, while the blood drug concentration in the same period was 11mg/L and 3.5mg/L. In children with chronic otitis media, the drug concentration in middle ear fluid is 6.2mg/L 1-2 hours after oral administration of 1g of this product. The concentration of cerebrospinal fluid in patients with tuberculous meningitis 2 hours after oral administration of 1g of this product is 0.1 ~ 1.5mg/L, which is equivalent to 0.9% ~ 21.1% of the blood concentration in the same period. 3. This product can pass through the placenta, and its concentration in the umbilical cord blood is 1/4~1/3 of that in the mother's blood. It also contains trace amounts in milk, sweat and tears. The protein binding rate of amoxicillin was 17%~20%. The blood elimination half decline period (t1/2?) of this product is 1~1.3 hours. After taking the drug, about 24%~33% of the dosage is metabolized in the liver. Within 6 hours, 45%~68% of the dosage is excreted from the urine as the prototype drug, and 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 the product, while peritoneal dialysis has no effect.
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