【Ingredient】This product is a compound preparation. Each tablet contains Amoxicillin
(C16H19N3O5S) 0.875g and Clavulanic Acid (C8H9NO5) 0.125g.
【Characteristics】The product is a film-coated tablet,
and the white to pale yellow after coating is removed.
【Suitability】The product is used for the treatment of serious infections or respiratory
infections caused by sensitive strains from β-lactamase as specified in the following conditions.
1. Lower respiratory tract infection: caused by Hemophilus or Moraxella produced from β-lactamases.
2. Otitis media: caused by Hemophilus or Moraxella produced from β-lactamases.
3. Nasosinusitis: caused by Hemophilus or Moraxella produced from β-lactamases.
4. Skin and soft tissue infection: caused by Staphylococcus, Escherichia coli or Klebsiella produced from β-lactamases.
5.Urinary tract infection: caused by Escherichia coli, Klebsiella or Enterobacteriaceae.of infections mentioned above, the infection caused by bacteria
sensitive to Ampicillin can also be treated with this product because it contains Amoxicillin.Therefore, the complex infection caused by microorganisms
sensitive to Ampicillin and microorganisms produced from β-lactamase is sensitive to this product and there is no need to use other antibiotics.Because
Amoxicillin is more effective against Streptococcus Genicularis in vitro than Ampicillin and Penicillin, Therefore, most of Streptococcus
Pneumoniae which are neutral sensitive to Ampicillin or Penicillin are completely sensitive to Amoxicillin and this product, thus Bacteriological tests shall be
carried out with surgery in order to detect pathogenic bacteria and their sensitivity to this product.When infection may involve the above-mentioned
microorganisms that produce β-lactamases. Treatment should be started before bacteriological and sensitivity tests are obtained in order to detect
pathogenic bacteria and their sensitivity to this product. Once the results are known, the treatment plan should be adjusted in a timely manner.
【Specification】1.0g (C16Hi19N3O5S 0.875g與C8H9NO5 0.125g)
【Usage and Dosage】] This product is limited to adults and children weighing more than 40Kg (or over 12 years old). Take orally.
Dosage: 1.0g (1 tablet) at a time, one time every 12 hours.For patients with impaired renal function: patients with impaired renal function generally are not
require a dose reduction; Patients with severe renal function impairment with creatinine clearance rate less than 30m/mim should not take this product.
For patients with liver function damage: should this product with caution, and they should regularly examine liver function.
Product Center> Amoxicillin and Clavulanate Potassium Tablets
Multinational Authoritative
Recommended Drug
In 1999 , experts from the Centers for Disease Controland Prevention in the United States reached a consensus that the curative effect of Streptococcus Pneumoniae plays the most important role. in the empirical treatment of acute otitis media. Amoxicillin / Clavulanic Acid is listed as a recommended drug because it has good efficacy against Streptococcus Pneumoniae and can kill Hemophilus Influenzae and Katamora producing
β-lactamase at the same time.
Model prescription Information of World Health Organization in 2001 Amoxicillin / Clavulanic Acid is recommended for inhaled pneumonia, lung abscess, acute attack of chronic bronchitis, otitis media and acute sinusitis.
In 2001, the French Society for Infected Diseases recommended the use of Amoxicillin and / Clavulanic Acid for the treatment of elderly patients with Community-Acquired Pneumonia (CAP) who need hospitalization and elderly patients with Community-Acquired Pneumonia who also suffer from other diseases
Recommended drugs for CAP experience in Respiratory Group of Pediatrics Branch of Chinese Medical Association in 2013
Multinational Recommended Drug Solution
Scientific Ratio
The duration of antibiotic concentration in plasma exceeding MIC (T > MIC) is an important parameter to evaluate the curative effect.
In the study of the inhibitory effect of different dosage regimens on Hemophilus Influenzae,
Amoxicillin t > MIC could achieve the best curative effect 164 at 40%, Cmax/MIC,
reflected the peak value of Amoxicillin in simulated plasma at 7: 1 showed antibacterial concentration is higher,
that is to say, the ratio is the best.
Taking a Lead in Consistency Evaluation
The evaluation process of generic drug consistency in Amoxicillin and Clavulanate Potassium
Tablets saves the cost of time and cost technical evaluation,
and the risk of non-reference preparation.
The number of competing brands in market of the same variety is reduced, and meanwhile the drugs through consistency evaluation will gradually stand firm in the market and win an absolute dominant position.
The drugs that fails to pass the consistency evaluation will be eliminated out. The advantage of drug bidding group: the generic drugs that pass the quality consistency evaluation will have obvious advantages in the bidding rules.
Amoxicillin and Clavulanate Potassium Tablets standard reference preparation: originally developed product by GSK, Amoxicillin and Clavulanate Potassium Tablets (specification 1g and 7:1)
Amoxicillin and Clavulanate Potassium Tablets standard reference preparation: originally developed product by GSK, Amoxicillin and Clavulanate Potassium Tablets (specification 1g and 7:1)
Ensure Lean & Leap Amoxicillin and Clavulanate Potassium Tablets (7:1)
to pass the consistence evaluation rapidly, taking a lead than other drugs including tablets, granule, dispersible tablets and capsules which have no standard reference preparation.
Lean & Leap Amoxicillin
and Clavulanate Potassium Tablets (Specification 1g, 7:1 )
Other tablet preparations (other than specification 1g and 7:1) and forms of drug (granule, dispersible tablets, capsules) have no standard reference preparation.
Effective Treatment
The efficacy of amoxicillin clavulanate potassium in the treatment of acute upper respiratory tract infection in infants is better than that of amoxicillin.
128 cases of acute upper respiratory tract infection were divided into Amoxicillin Clavulanate Potassium treatment group
and Amoxicillin treatment group. The curative effect and ADR were compared and the results showed that the curative effect of Amoxicillin
and Clavulanic Potassium group was significantly better than that of Amoxicillin group (* p < 0.05),
but there was no significant difference in side effects between the two groups (* * p > 0.05).
The therapeutic effect of Amoxicillin and Clavulanate Potassium in the treatment of gastric ulcer
and chronic gastritis was significantly better than that of Amoxicillin.
Meta-analysis concerning efficacy and incidence of side effects of Amoxicillin and Clavulanate Potassium
and Amoxicillin in the treatment of gastric HP infection are carried out, involved are totally 10 research articles and 1447 patients.
The results showed that the odds ratio of HP eradication odds ratio was 2.29 (the more the odds ratio was greater than 1,
the more significant the difference was), the difference was statistically significant (p < 0.00001).
Therefore, it can be considered that the effect of HP eradication in Amoxicillin group is significantly better than that in Amoxicillin group.
The odds ratio of side effects was 109. There was no significant difference in the incidence of adverse reactions between the two groups (p >0.05).
Enzymatic Raw Material
Enzymatic Amoxicillin
Green
use only biological enzyme agents to reduce toxic emissions
Safety
no toxic chemical solvent is added, the residual impurity is less, and the incidence of allergy is low
Stable
the secondary crystal is bigger and more stable, which is more convenient for preservation
.
Highly efficient
The content of the products of the same specification is 2% higher than that of the chemical products, and the curative effect is more accurate
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