Amoxycillin Granules

Amoxicillin Granules
 

Generic name: Amoxicillin Granules
Brand name: Zailin
Composition: (2S,5,R,6,R)-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
Chemical structure:

 

Molecular formula: C16H19N3O5S•3H2O
Molecular weight:419.45
Strength:0.125g
Description :Zailin is granular and powder; aromatic, sweet.
Indications:
Infections caused by susceptible, non-penicillinase-producing organisms including:
Upper respiratory tract infections Skin and soft tissue infections
Lower respiratory tract infections Gonorrhea
Otitis media Non-specific urethritis
Upper urinary tract infections Typhoid fever
Lower urinary tract infections Gastro-intestinal tract infections

Dosage and Administration:

Taken orally. Tear the packet, put the powder into a cup with proper amount of cold water, Shake well and
then take it.For children: The recommended daily dose is 20~40mg/kg based on patient weight, 1 time every
8 hours. For neonates and premature infants , the dose is 50 mg each time; and for  infants less than 3
months ,the daily dose is 30 mg/kg based on patient weight, 1 time every 12 hours.For adult: 0.5g (4 packets)
each time, every 6 to 8 hours, the daily dose should be no more than 4g (32 packets ). 

Precautions:
Gastro-intestinal disturbances including diarrhoea, nausea and vomiting occur frequently. 
Allergic reactions may occur, presenting as a pruritic skin rash, an erythematous skin reaction or urticaria.
In this event withdrawal of ACUCIL is necessary.
Should a serious anaphylactic reaction occur, ACUCIL should be discontinued and the patient treated with
adrenaline, corticosteroids and antihistamines.Treatment with ACUCIL may give rise to a maculopapular rash
during therapy or within a few days after completion thereof. The incidence of maculopapular rash is
especially high in patients suffering from infectious mononucleosis. Pseudomembranous colitis has been
reported. Super-infections with non-susceptible organisms may occur. Caution must be exercised in treating
patients with dehydration or oliguria because of the possibility of crystalluria.The use of this antibiotic may
lead to the appearance of resistant strains of organisms and sensitivity testing should, therefore, be carried
out wherever possible, to ensure the appropriateness of the therapy.
Pharmacology and toxicology:
Amoxycillin is a penicillinase-susceptible penicillin. Amoxycillin exhibits in vitro bactericidal activity against a
wide range of Gram- negative and Gram-positive organisms including.
(In vitro sensitivity does not necessarily imply in vivo efficacy):
Gram-positive bacteria: Gram-negative bacteria:
Staphylococcus aureus* Neisseria gonorrhoea
(penicillin sensitive) Neisseria meningitidis**
Streptococcus pyogenes Haemophilus influenzae
Streptococcus viridans* Bordetella pertussis
Streptococcus faecalis* Escherichia coli
Streptococcus pneumoniae* Salmonella typhi
Corynebacterium species* Salmonella species
Clostridium species* Shigella species
Bacillus anthracis* Brucella species
  Proteus mirabilis
* Sensitivity tests must be performed.
** Except type b-strains causing meningitis in children 

Amoxycillin is well absorbed orally. After oral administration there is no significant difference between the
peak serum levels in fasting and non-fasting subjects.
The presence of food does not interfere with the absorption of amoxycillin. Amoxycillin may, therefore, be
taken with meals. There is a linear/dose response in peak serum levels after oral administration. 
There is insufficient evidence at present to show that ACUCIL penetrates into the cerebro-spinal fluid in
therapeutic quantities and it should, therefore, not be used in the treatment of cerebro-spinal infections. 
Approximately 60% of an oral dose of amoxycillin is excreted unchanged in the active form into the urine
within 6 hours.
Pharmacokinetics
Absorption:
Amoxycillin is stable in the presence of acidic gastric secretions. Peak blood levels are achieved 1-2hr after
administration. There is a linear dose response in peak serum levels.   Food does not interfere with the
absorption of amoxycillin.
Distribution:
Approximately 18% of the total plasma amoxycillin content is protein bound. Amoxycillin diffuses readily into
most body tissues with the exception of the brain and spinal fluid. Inflammation generally increases the
permeability of the meninges to penicillins and this may apply to amoxycillin.
Excretion:
The elimination half-life is approximately 1hour. Amoxycillin is primarily excreted via the kidneys.
Small amounts of the drug are also excreted in the faeces and bile.
Amoxycillin crosses the placenta and is distributed into breast milk.
SIDE EFFECTS AND SPECIAL PRECAUTIONS
Skin rashes are the most common side effects and vary from maculopapular to urticarial.
Urticarial reactions are typical of penicillin hypersensitivity reactions.
If serious anaphylactic reaction occurs, Amoxicillin Hexal 500 should be discontinued and the patient treated
with adrenalin, corticosteriods and antihistamines.Most patients with infectious mononucleosis develop a
maculopapular rash, and patients with other lymphoid disorders seem to be more at risk. Avoid using in these
instances.
Gastro-intestinal side effects including diahrroea, nausea and vomiting may occur quite frequently.
Pseudomembranous colitis has also been reported.
Super-infection is relatively common.
Doses should be reduced in severe renal failure.
Use in pregnancy : animal reproduction studies have failed to demonstrate a risk to the foetus. However,
there are no adequate and well controlled studies in pregnant women.
Storage:Protect from light, and keep air-tightly.
Packs: 125mg /sachet,  12 sachets/Box
Shelf-life:36 months