Amoxicillin CapsulesPlease read the direction carefully and follow the doctor's advice.Contraindicated in the patients with the penicillin hypersensitiveness and positive penicillin skin test 【Drug name】Generic name: Amoxicillin CapsulesEnglish name: Amoxicillin Capsules【Component】The main component of this product is amoxicillin.Chemical name:(2S,5R,6R)-6-[[(2R)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7 -oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acidChemical structure:Molecular formula: C16H19N3O5S·3H2OMolecular weight: 419.46【Description】Powder or granules from white color to yellow are contained in capsules. 【Indications】Amoxicillin is intended for infections caused by sensitive organisms (β-lactamase non-producing bacteria). The infections are including:1. Upper Respiratory Tract Infection (tympanitis, nasosinusitis, pharyngitis, tonsillitis, among others) caused by hemolytic streptococcus, Streptococcus pneumonia, Staphylococcus or haemophilus influenza,2. Urogenital 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 Infection (acute bronchitis, pneumonia, among others) caused by hemolytic streptococcus, Streptococcus pneumonia, Staphylococcus or haemophilus influenza,5. Acute simple gonorrhea, and6. This product also can be sued for the treatment of typhoid, typhoidcarrier and leptospirosis; the three-drug therapy –amoxicillin, clarithromycin and lansoprazole can cure the helicobacter pylori of stomach and duodenum and decrease the recurrence rate of gastrointestinal ulcer.【Specification 】0.25g /capsule, calculated on C16H19N3O5S【Dosage and Administration】Adult Dosage: A single dosage for oral administration is 0.5g (two capsules) every 6 to 8 hours, and the total dosage of a day should not exceed 4g (16 capsules).Pediatric Dosage: The daily dosage for oral administration should be 20 to 40mg/Kg in three divided doses; for the less than three-month-old infants, the daily dosage is 30mg/Kg in two divided doses.For patients with severe renal impairment, the dosage should be adjusted. Patients with the endogenous creatinine clearance rate between 10 and 30ml/min should take 0.25 to 0.5g (1 to 2 capsules) every 12 hours; patients with the endogenous creatinine clearance rate lower than 10ml/min should take 0.25 to 0.5g (1 to 2 capsules) every 24 hours.【Adverse reactions】1. Gastrointestinal reactions including nausea, vomit, diarrhea and pseudomembranous enteritis,2. Allergic reactions including rash and asthma,3. The appearance of anemia, thrombocytopenia and the increase of eosinophile granulocytes,4. The slight increase of serum aminopherase,5. The superinfection caused by candida or drug-fast bacteria, and6. The occasional appearance of central nervous system signs including exhilaration, worry, insomnia, dizziness and dystrophy.【Contraindications】This product is forbidden to treat patients allergic to penicillin and with positive skin test of penicillin.【Precautions】1. This product is an oral drug of penicillins, which may cause, occasionally, allergic shock, especially, for the patients with allergic history of penicillins andcephalosporins. Before prescribing, the doctor should inquire the detailed history of allergy to drugs of patients and let them take a skin test of penicillin. If there is an allergic shock, the emergency treatment should be taken on the spot immediately, keeping the airway opened, oxygen given, adrenalin and glucocorticoid applied, and among others.2. It is easy for the patients with fectious mononucleosis to develop skin rash, so they should avoid to using the drug.3. Using this product in a long cause of treatment, patients should have an examination on liver function, renal function and blood routine.4. Amoxicillin may cause a false positive in the urinary glucose test using Benedict or Fehling reagent.5. Patients，under following circumstances, should use the drug with caution.(1) Patients with a history of allergic diseases, such as asthma and hay fever.(2) The dosage may need to be adjusted for senior patients and patients with severe renal impairment【Use during Pregnancy and lactation】In the reproduction test on animals, the dosage of Amoxicillin, 10 times more than that used by human, has not damaged the fertility and fetuses of rats and mice. But the control study is still insufficient in human test. Given that the reproduction test on animals could not predict the human reactions to the drug completely, pregnant women should not administrate it unless they have to. For a small amount of amoxicillin is secreted in latex, infants may develop allergic reaction after milked. 【Pediatric Use】There is no experiment conducted in this group and no reliable references. 【Use in the Elderly】There is no experiment conducted in this group and no reliable references. 【Drug Interactions】1. Benemid, competitively, reduces the tubular secretion of this product and the usage of the two, simultaneously, will increase the blood concentration of amoxicillin and prolong the half life period.2. The antibiotic action of amoxicillin will be interfered by chloramghenicols, macrolides, Sulfonamides and tetracyclines in vitro, whose clinic significance is still unknown.【Overdosage】Pointed out in the prospective study with 51 children, the administrated dosage of amoxicillin, lower than 250mg/Kg, will not cause obvious clinical symptoms. It is reported that a few patients developed renal insufficiency and oliguria because of the overdosage of amoxicillin. But the renal insufficiency was reversible when the drug was withdrawn.【Pharmacology and toxicology】Amoxicillin is an antibiotic of penicillins, possessing a well antibacterial function against streptococcus including Streptococcus penumoniae and Streptococcus hemolyticus, aerobic gram positive coccus including staphylococcus penicillinase non-producing and e nterococcus faecalis, and β-lactamase non-producing strains and helicobacter pylori of aerobic gram negative coccus including escherichia coli, proteus mirabilis, Salmonella, haemophilus influenza, and gonococci. Amoxicillin exerts its bactericidal effect by inhibiting the formation of cell walls of bacteria, getting the bacteria changed into spheroid, dissolved and ruptured. 【Pharmacokinetics】Administrated orally, this product can be absorbed quickly –75 to 90 percent of it absorbed by gastrointestinal tract. Food has insignificant impact on the absorption of the drug. Taking 0.25 to 0.5g of the drug orally, the patients get their maximum blood concentration between 3.5 and 5.0mg/L, and 5.5 and 7.5mg/L respectively within 1 to 2 hours. The drug is well distributed in most tissues and body fluid. For the patients, with acute paroxysm of pneumonia or chronically asthmatic bronchitis, taking 0.5g dosage orally in 2 to 3, and 6 hours ago, will have an average drug concentration in sputum 0.52mg/L and 0.53mg/L respectively. The blood concentrations in the same period are 11mg/L and 3.5mg/L. whereas, if the pediatric patients take this product orally, 1 to 2 hours later, their drug concentration in the middle ear fluid will be 6.2mg/L. In addition, administrating 1g the drug, patients with tuberculous meningitis have a 0.1 to 1.5mg/L drug concentration in cerebrospinal fluid (equivalent to 0.9 to 21.1 percent of the blood concentration in the same period )2 hours later. This drug can permeate the placenta and its concentration in cord blood amounts to one fourth to one third of that in the mother’s body. There is also a tiny amount in latex, sweat and tear. Furthermore, the protein binding tatio of amoxicillin is 17 to 20 percent, and the elimination half-life (T1/2) of the drug in blood is between 1 and 1.3 hours. 24 to 33 percent of the dosage administrated is metabolized in liver, and 45 to 68 percent of it excreted through urine in original form6 hours later. There is part of the drug excreted through the biliary tract. The elimination half-life (T1/2) of the drug in blood will be prolonged to7 hours for the patients with severe renal insufficiency. This product can be eliminated by the hemodialysis, but not the peritoneal dialysis.【Storage】Store with seal, away from light at a temperature between 10 to 30℃【Package】Boxes of 50capsules (10capsule ×5) in press-through pack【Period of Validity】36 months.【Operative standard】China Pharmacopoeia 2010 Ⅱ【Approval number】【Manufacturer】。
