Generic name: Amoxicillin Granules

Originally used name: Amoxicillin granules

Trade name: Zailin

Chinese Phonetic Alphabet:Amoxicillin Keli

This product contains Amoxicillin as its main ingredient. Chemically it is is (2S5R6R)-3£¬3-dimethyl-6-[(R)-(-)-2-amino-2-(4-hydroxyphenyl)acetamido]-7-oxo-4-thia-1-azadicyclo-[320] heptane-2-carbocylic acid trihydrate. It has the following chemical strcture:

The amoxicillin molecular formula is C₁₆H₁₉N₃O₅S•3H₂O and the molecular weight is 419.45.

This is a yellowish granules and powder with fragrant smell and sweet taste.

Amoxicillin is indicated for treatment of the infections ( including lower respiratory tract infection typhoid and urinary tract infections) when caused by susceptible strains ( Only betalactamase ¨C negative ) of microorganisms :

1. Otitis media sinusitis pharyngitis tonsolitis due to S pyogene Streptococcus pneumoniae S.A and H influenzae.

2. Infection of genitourinary tract due to Escherichia coli P. mirabilis and Enterococcus faecalis.

3. Infection of skin and soft tissue due to Streptococcus spp. or E.coli.

4. Infections of lower respiratory tract due to Streptococcus spp. Streptococcus pneumoniae or H influenzae.

5. Acute uncomplicated Gonorrrhea.

6. Typhoid and Leptospinosis. Amoxocillin in combination with lansoprazole and clarathromycin is indicated for treatment of patients with H pylori infection and duodenal ulcer disease.

0.125g (calculated as C₁₆H₁₉N₃O₅S).

Oral administration: Open the sache add granule to cold water shake well before drink.

For children: The recommended daily dose is 20 to 40 mg/kg body weight for every 8 hours; The recommended dose for neonates and premature: 50mg each time For infants under 3 months of age: daily dose is 30mg/kg body weight every 12 hours.

For adult: 0.5g (4 bags) each time every 6 to 8 hours. The daily dose shall not exceed 4g (32 bags).

1. Gastrointestinal tract reactions such as nausea vomiting diarrhoea and pseudomembranous colitis.

2. Anaphylactic reactions such as skin eruption drug fever and asthma.

3. Anaemia thrombocytopenia eosinophilia and others.

4. Slightly rise in AST (SGOT) and/or ALT (SGPT).

5. Super- infection due to Monilia or drug-fast bacteria.

6. Rare case of central nervous system symptoms such as agitation anxiety insomnia dizziness and behavioral changes may also be found occasionally.

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

1. Patients with acute epidemic infection adenitis should avoid this product because of possibility of erythra..

2. Patients prescribed long-term treatment with this product should have hepatic function renal function and routine blood examinations.

3. Amoxicillin may result in a false positive result when testing for the presence of glucose in the urine using Benedict or Fehling¡¯s solution.

4. This product should be cautiously used in the following cases:

(1). Patients with a hypersensitive history including asthma and allergic cold.

(2). Dose adjustment may be required for aged patients and the patients with seriously impaired renal function.

(3). 0.25 to 0.5g (2 to 4 bags) each 12 hours may be given for the patients whose endogenous creatinine clearance rate is between 10 and 30ml/min; or 0.25 to 0.5g (2 to 4 bags) each 24 hours for the patients whose endogenous creatinine clearance rate is below 10ml/min.

It is shown in an animal reproduction test that 10 times of the dose for human does not show impairment of fertility their embryos and gets of rat and mouse. However no sufficient study on human is available now. Because of the fact that that the impact to human cannot be predicted from the result of the animal experience pregnant woman should only use this product only when it is necessary.

Small amount of Amoxicillin may be excreted into mother¡¯s milk. Amoxocillin used by nursing mother may lead to sensitization of infants.

Amoxicillin can used by children

Dose adjustment may be required in aged people with impaired renal function.

1. Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased serum levels of amoxicillin and prolonged half-life.

2. Chloramphenicol macrolides sulfonamides and tetracyclines may interfere with the anti-bacteril activities of Amoxicillin. However the clinical significance of this interaction is not well established.

A prospective clinical study of 51 pediatric patients suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms. Overdosage which resulting oliguric renal insufficiency has been reported in s small number of patients. These renal impairment are reversible after discontinuation of medication.

Amoxicillin is a kind of penicillin antibiotics. It exhibits good antimicrobial activities against Streptococcus Spp( inckuding S pneumoniae S hemolytic strains) S.A spp (betalactamase ¨C negative strains) Enterococcus faecalis Escherichia coli H influenzae. P. mirabilis and neisseria gonorrhoeae.

Amoxillin acts through the inhibition of biosynthesis of cell wall mucopeptide so as to turn the bacteria into glomeration and cause breakage and lysis of bacteria .

Following oral administration amoxicillin is absorbed rapidly and about 75 to 90% may be absorbed via the gastrointestinal tract. The peak concentration level of the drug in blood C_max are 5.1m