| Application: | Internal Medicine |
|---|---|
| Usage Mode: | For oral administration |
| Suitable for: | Elderly, Children, Adult |
| State: | Solid |
| Shape: | Tablet |
| Type: | Generic Medicines |
| Samples: |
|---|
| Customization: |
|---|
Suppliers with verified business licenses
Audited Supplier 
Indicatios:
Amoxicillin and Clavulanate Potassium Tablets is indicated for the treatment of the following infections in adults and children:
• Acute bacterial sinusitis (adequately diagnosed)
• Acute otitis media
• Acute exacerbations of chronic bronchitis (adequately diagnosed)
• Community acquired pneumonia
• Cystitis
• Pyelonephritis
• Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis.
• Bone and joint infections, in particular osteomyelitis.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Dosage and administration:
For adult dose:
One Amoxicillin and Clavulanate Potassium Tablet per 12h.
Pediatric Patients
Pediatric patients weighing 40 kg or more should be dosed according to the adult commendations.
The Amoxicillin and Clavulanate Potassium Tablets should not be used until the pediatric patient weighs at least 40 kg or more.
If it is considered that a higher daily dose of amoxicillin is required, it is recommended that another preparation of Amoxicillin and Clavulanate Potassium Tablets is selected in order to avoid administration of unnecessarily high daily doses of clavulanic acid.
The duration of therapy should be determined by the response of the patient. Some infections (e.g. osteomyelitis) require longer periods of treatment. Treatment should not be extended beyond 14 days without review .
Storage:
Store in the original package in order to protect from light.
Do not store above 25°C.
| Testing terms | Standards | Results |
| Identification | The retention times of the major peaks of the Sample solution correspond to those of the Standard solution. |
Complies |
| Water | ≤11.0% | 9.2% |
| Weight variation | Meet the requirement | Complies |
| Dissolution Rate | NLT 85% of the labeled amount of C16H19N3O5S and NLT 80% of the labeled amount of C8H9NO5. |
C16H19N3O5S: 96% 100% 100% 99% 100% 100% C8H9NO5: 92% 98% 97% 97% 98% 98% |
| Microbiological quality |
Total aerobe count≤10³cfu/g The total combined molds and yeasts count≤10²cfu/g Absence of Escherichia coli |
<10cfu/g <10cfu/g Negative |
| Assay | Amoxicillin and Clavulanate Potassium Tablets contain the equivalent of NLT 90.0% 98.5% and NMT 120.0% of the labeled amount of amoxicillin(C16H19N3O5S) and clavulanic acid(C8H9NO5). |
C16H19N3O5S: 99.5% C8H9NO5: 98.5% |
Suppliers with verified business licenses
Audited Supplier 
){kind=link}
){kind=link}