| Type: | Generic Medicines |
|---|---|
| Material: | Plastic |
| Ethylene Oxide Sterilization: | Ethylene Oxide Sterilization |
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Composition:
Amoxiciln and Clavulanate Potassium 1g Film Coated Tablet: Each film coated tablet contacines Amoxiilin Trihydrate USP equivalent to Amoicilin 875mg and Clavulanate Potassium USP equivalent to Clavalanic acid 125mg.
Indications:
Amoxicilin and Clavulanate Potassium is indicated for treatment of the following bacterial inlections due to susceptible organisms:
-Upper respiratory tract infection (including ENT) , e.g. tonsillitis, sinusitis, otitis media;
-Lower respiratory tract infections, e.g. actue and chronic bronchitis, lobar and bronchopneumonia.
-Gentio-urinary tract infection, e.g. cystitis, urethritis, pyelonephritis, pelvic infection, chancroid, gonorrhoea.
-Skin and soft tissue infection, e.g. boils, abscesses, cellulitis, animal bites, wound infections.
-Bone and joint infections, e.g. osteomyelitis
Dosage and Administration:
Amoxiclin and Clavulanate Potassiummay be administrated without regards to meals. However, to munimize potential pastrointestinal intolerance, administer at the start of a meal.
Adults and Children over 12 years:
Mild-Moderate infections: One Amoxilln and Clavulanate Potassium 375mg tablet every 8 hours.
Severe infections: One Amoxiclin and Clavulanate Potassium 625mg tablet every 8 hours or one 1g tablet every 12 hours.
Severe dental infections( but not generally first-line): one KONN One Amoiclin and Clavulanate Potassium 375mg tablet every 8hour lor 5 days.
Drug interaction:
Prolongation of bleeding time and prothrombin time have been reported in some patients receving amoxicilin clavulanic acid. Amoxicilin and Clavulanate Potassium should be used with care in patients on anti-coagulant therapy,in common with other broad-spectrum antibiotics, Amoxiciln and Clavulanate Potassium may reduce the efficacy of oral contraceptives and patients should be wamed accordingly.
Storage:
Store at room temperature below 30c, in a dry place, protected from light.
| 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% |
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