Sundent Pharmaceutical Co., Ltd.  

Product Name: Amoxicillin Capsule 0.5g with GMP Certificate Model NO.: 0.125g, 0.25g, 0.5g Pharmaceutical Technology: Chemical Synthesis Type: Antibiotic Shape: Capsules Suitable for: Children, Adult Application: Internal Medicine Certification: GMP Standard: Bp, USP OEM: Available Shelf Life: 3 Years Trademark: Sundent Transport Package: 10capsules/Blister Specification: 0.125g, 0.25g, 0.5g Origin: China HS Code: 3004909099 Product Description DescriptionAmoxicillin capsule 0.125g, 0.25g, 0.5gIngredientsChemical name: (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·3H2OMolecular weight: 419.46CharacterThis product is a capsule, the contents of white or almost white powder.IndicationsAmoxicillin is suitable for the following infections caused by susceptible strains that do not produce β-lactamase strains:1. Upper respiratory tract infections such as otitis media, sinusitis, pharyngitis, and tonsillitis caused by hemolytic streptococcus, streptococcus pneumonia, staphylococcus or haemophilus influenzae.2. Genitourinary tract infections caused by E. coli, Proteus mirabilis, or Enterococcus faecalis.3. Skin and soft tissue infections caused by hemolytic streptococcus, staphylococcus or E. coli.4. Lower respiratory tract infections such as acute bronchitis and pneumonia caused by hemolytic streptococcus, streptococcus pneumoniae, staphylococcus or haemophilus influenzae.5. Acute and simple gonorrhea.6. This product can still be used to treat typhoid, typhoid carriers and leptospirosis; amoxicillin can also be combined with clarithromycin, lansoprazole triple eradication of gastric, duodenal Helicobacter pylori, lower gastrointestinal ulcers Recurrence rate.Specification0.125g, 0.25g, 0.5g (calculated as C16H19N3O5S)DosageOral. Adults once 0.5g, once every 6 to 8 hours, the daily dose does not exceed 4g.The daily dose of children according to body weight 20 ~ 40mg/Kg, once every 8 hours; 3 months or less the daily dose of the baby according to the weight of 30mg/Kg, once every 12 hours.Patients with severely impaired renal function need to adjust the dosage, with patients with an endogenous creatinine clearance rate of 10 to 30 ml/min every 0.25 to 0.5 g every 12 hours; patients with an endogenous creatinine clearance rate of less than 10 ml/min at 0.25 to 0.5 every 24 hours g.Adverse reactions1. 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.Occasionally central nervous system symptoms such as excitement, anxiety, insomnia, dizziness, and abnormal behavior.ContraindicationsPatients with positive penicillin allergy and penicillin skin test were banned.Precautions1. Penicillin oral drugs can cause anaphylactic shock and are more common in patients with penicillin or cephalosporin allergies. Before taking the drug, you must ask about the history of drug allergy and do a penicillin skin test. In the event of anaphylactic shock, local emergency treatment should be conducted to maintain airway patency, oxygen supply, and the use of epinephrine, glucocorticoids, and other treatment measures.2. This product is susceptible to rash in patients with infectious mononucleosis and should be avoided.3. Longer course of patients should check the liver, kidney function and blood routine.4. Amoxicillin can cause false positives in urine tests using Benedict or Fehling reagents.5. The following situations should be used with caution:(1) History of allergic diseases such as asthma and hay fever.(2) Dose may need to be adjusted when the elderly and renal function are severely damaged.StorageShading, sealed and stored.Product photoOur factoryThis product is produced in our GMP factory, all our facility has past China GMP, and also officially certificated by more than ten countries'MOH. Our ServiceWe can specially develop the products per customers' specification.We can offer OEM service with customers' private brands and labels.We can offer excellent after-sale service and professional technical support.Our Quality control systemIn manufacturing, quality is what sustains our life. Starting from the material selection, there are many factors thatcontribute to the quality control process. Our manufacturing facility isGMP certified. Quality Control (QC) and monitoring procedures are built into every aspect of our work.Our Quality Control System is outlined below:Initial inspection (such as raw material, excipients, package materials, etc.)In-process inspection (make sure that each testing items should be qualified )Final inspection before shipment of each order. Provide temperature control recorder when it is necessary for special market before loading.Our Registration Team and technical supportWe have experienced team to provide qualified and professional registration documents for most of countries. Up to present, we have registered more than hundred products and exported to more than 20 countries. Especially including those in Asia, Africa, South America, Middle east area and East Europe.We can provide regulatory documentsGMP Certificate / CE Certificate/NSF CertificateFree sales certificate Certificate of Pharmaceutical ProductsManufacture LicenseCTD Dossier.