Antibacterial Amoxycilin and Clavulanate Potassium Tablet 1g Western Medicine

• Application: Internal Medicine
• Usage Mode: For oral administration
• Suitable for: Elderly, Adult
• State: Solid
• Shape: Tablet
• Type: Biological Products
• Model NO.: AMC12061-04
• Pharmaceutical Technology: Chemical Synthesis
• Function: Antibiotic
• Registration: Available
• OEM/ODM: Available
• Documnets: GMP, Copp, Ctd
• Transport Package: 7*2′s/Box
• Specification: 875mg+125mg
• Trademark: MEDIPHARM/SHINEPHARM
• Origin: China
• HS Code: 3004909099
• Production Capacity: 500000 Boxes/Month

Product Description

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	Amoxicilin and Clavulanate Potassium               Tablets contain the equivalent of NLT 90.0%    98.5% and   NMT    120.0%    of   the    labeled    amount of amoxicilin(C16H19N3O5S) and clavulanic acid(C8H9NO5).	C16H19N3O5S: 99.5% C8H9NO5: 98.5%

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