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ZHEJIANG JINHUA CONBA BIO-PHARM.CO.,LTD


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The product description

 [Ingredients]

Chemical Name: Formulations of Amoxicillin Capsulescontain amoxicillin,the chemical name is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:

Chemical Formula: C16H19N3O5S3H2O

Molecular Weight: 419.46.

Amoxicillin is an antibiotics in the penicillin group of drugs.

[Description]

This product is capsule.

 

[Indications]

Applicable to infection of sensitive bacteria(except ß-lactamase bacteria)

1.Infections of the upper respiratory of the ear, nose, and throat– due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniaeStaphylococcus spp., or H. influenzae.

2. Infections of the genitourinary tracts– due to E. coli, P. mirabilis, or E. faecalis.

3.Infections of the skin and skin structure– due to Streptococcus spp. (α- and β-hemolytic strains only),Staphylococcus spp., or E. coli.

4.Infections of the lower respiratory tract– due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae.

5.Gonorrhea, acute uncomplicated (ano-genital and urethral infections) –due to N. gonorrhoeae (males and females).

6.Treatment of the typhus ,bacilli carrier and febris hebdomadis-Amoxicillin capsulesin combination with

clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection andduodenal ulcer disease to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

[SpecificationEach capsule contains 0.25gamoxicillin as the C16H19N3O5S.

[Dosage and Administration] Amoxicillin capsules are administered orally.

1Adults: The dose is 0.5g each time(two pills for each time ) , Take it every 6-8 hours. the recommended upper dose of Amoxicillin is 4g/day (16 pills).

2. Pediatric patients over 3 Months: the recommended upper dose of Amoxicillin is 20-40 mg/kg/day divided q8h.

3Neonates and infants Aged less than or equivalent to 12 Weeks (≤3 Months)

the recommended upper dose of  Amoxicillin is 30 mg/kg/day divided q12h.

4.Dosing Recommendations for Adults with Impaired Renal Function

Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 0.25g-0.50g every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/min. glomerular filtration rate should receive 0.25-0.50g every 24 hours, depending on severity of the infection.

[Side effects ]

The common side effects are:

1.Nausea, vomiting, diarrhea and diphtheritic enteritis may appear.

2.Skin rash, drug fever and wheezing may appear.

3.Anemia ,thrombopenia and hypereosinophilia syndrome may appear.

4.SGOT and SGPT may increase slightly.

5.Double infection caused by Candida and drug-resistant bacteria

6.Rarely an effect on central nervous system symptoms of excitation,anxiety insomnia dizziness and abnormal behavior can happen.

[Contraindications]

7.A history of allergic reaction to any of the penicillins is a contraindication.

[Precautions]

1. Rarely an effect on anaphylactic shock of oral penicillin can happen, especially for the patient with a penicillin or cephalosporin allergic history. The patient should know clearly of his own drug-allergic history and is operated with penicillin skin test. If anaphylactic shock occurs, rescue the patient in-place immediately, keeping the airway unblocked,giving oxygen and applying adrenaline and glucocorticoids.

2. Infectious mononucleosis patient should not use this drug because of the skin rash risk if the drug is given.

3.For patient with long treatment course, the liver and kidney function and blood routine should be examed.

4.Amoxicillin will cause glycosuria test false positive because of the Benedit and fehling reagents.

5. The drug should be caution to use in these cases:

(1)Allergic diseases history of wheezing and hay fever.

(2)The dose needs to be adjusted for the elderly and whose kidneys are not working to full capacity.

[Pregnant and nursing women] Though animal studies have not show any toxicity and teratological effects towards fetus, only when antibiotic therapy is required during pregnancy, amoxicillin may be considered appropriate.

Amoxicillin is distributed into breast milk in low concentrations and should be used with caution in nursing women.

[Paediatrics]Still have no experience for children and reliable reference.

[Elderly]Still have no experiments for the eldly and reliable reference.

[Interaction]

1.Probenecid decreases the renal tubular secretion of amoxicillin, and concurrent use may result in increased and prolonged blood levels of amoxicillin.

2. Amphemycin, macrolides, sulfanilamide group and tetracyclines may interfere with the bactericidal effects of amoxicillin.but still uncertain about its clinical significance.

[Overdosage] A prospective study with 51 children indicated that the dosage of not more than 250mg/kg is unlikely to occur obvious symptoms, but acute ingestion of large doses may cause renal insufficiency and oliguria,renal damage can be reversed after stopping treatment.

 

[Pharmacology and Toxicology]

Amoxicillin is an antibiotics in the penicillin group active against both Gram-positive and Gram-negative organisms

Most strains of Haemophilus influenzae, Neisseria gonorrhoeae, Proteus mirabilis, Salmonellae, alpha- and beta-haemolytic Streptococci, Diplococcus pneumoniae, nonpenicillinase producingStaphylococci , Streptococcus faecalis, and Helicobacter pylori are sensitive to amoxicillin.

Amoxicillin is bactericidal against sensitive organisms during the stage of active multiplication. Amoxicillin exerts its mode of action by interfering with bacterial cell wall synthesis by acylating the enzyme transpeptidase, thus rendering it unable to cross-link muramic acid containing peptidoglycan strands. This inhibition of the biosynthesis of dipeptidoglycan, a substance necessary for cell wall strength and rigidity, results in a defective cell wall.

[Phamacokinetics]

After oral administration, this product is absorbed rapidly and about 75%-90% of Amoxycillin is absorbed in the gastrointestinal tract. Absorption is independent of meals. Oral dose of 0.25g and 0.5g of amoxycillin give average peak serum level in one to two hours or 3.5-5.0mg/L and 5.5-7.5mg/L respectively. This product diffuses rapidly into most body tissues and fluids. Patients with acute attack of pneumonia and chronic bronchitis of a 0.5g oral dose give average drug level in sputum of 0.52mg/L and 0.53mg/L in 2-3 hours and 6 hours respectively, with peak serum level are 11mg/L and 3.5mg/L.Child patients with chronic otitis media of a 1g dose give average drug level in eardrum fluid of 6.2mg/L. Patients with tuberculous of a 1g dose give average drug level in brain and spinal fluid of 0.1-1.5mg/L,equal to the peak serum level of 0.9%-21.1%.This drug can diffuse into placenta and the cord blood level is 1/4-1/3 of peak serum level in mother.Amoxycillin has been shown to diffuse into breast milk ,sweat and tears. The protein bound in serum is 17%-20%. The serum half-life of amoxycillin is 1-1.3 hours, but in the absence of renal function it is 7 hours. Metabolism of 24%-33% of dose is happened in liver.45%-68% of dose is excreted via the urine unchanged and few of dose is excreted via the biliary tract. Amoxycillin is removable from the circulation by haemodialysis and can not be removable by peritoneal dialysis.

[Storage] Protect from light and moisture. .

[Package]

Aluminum-plastic foil. 24 capsules/ box.

[Shelf life] 18 months

[Standard] ChP2005version-the second part.

[License No.] Guo Yao Zhun Zi H33021381

[Manufacturer]

Name: Zhejiang Jinhua CONBA Bio-pharm. Co., Ltd.

Address: 288 Jinqu road, Jinhua, Zhejiang province, China

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