Cefuroxime Axetil Tablets USP 125mg Technical Specification:
| Product Name: | Cefuroxime Axetil Tablets USP 125mg |
| Brand Name: | Generic |
| Strength: | (500mg), (250mg), (125mg) |
| Dosage Form: | Tablets |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | β-lactam Antibiotic, Anti-bacterial & Cephalosporins. |
| Indication: | Cefuroxime is used to treat a wide variety of bacterial infections. This medication is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Cefuroxime Axetil Tablets USP 500mg
- Cefuroxime Axetil Tablets USP 250mg
- Cefuroxime Axetil Tablets USP 125mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Cefuroxime Axetil Tablets USP 500mg
Each film-coated tablet contains:
Cefuroxime Axetil USP
Equivalent to Cefuroxime…………..500mg
Excipients………………………………….q.s.
Color: Red oxide of iron
- Cefuroxime Axetil Tablets USP 250mg
Each film-coated tablet contains:
Cefuroxime Axetil USP
Equivalent to Cefuroxime ………..250mg
Excipients………………………………….q.s.
Color: Tartrazine
- Cefuroxime Axetil Tablets USP 125mg
Each film-coated tablet contains:
Cefuroxime Axetil USP
Equivalent to Cefuroxime ………..125mg
Excipients………………………………….q.s.
Color: Sunset yellow FCF
THERAPEUTIC INDICATIONS:
Cefuroxime is used to treat a wide variety of bacterial infections. This medication is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
DOSAGE: As directed by the Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Cefuroxime Axetil Tablets USP 500mg
b) Cefuroxime Axetil Tablets USP 250mg
c) Cefuroxime Axetil Tablets USP 125mg
b) Cefuroxime Axetil Tablets USP 250mg
c) Cefuroxime Axetil Tablets USP 125mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Cefuroxime Axetil Tablets USP 500mg
Each film coated tablet contains:
Cefuroxime Axetil USP
Equivalent to Cefuroxime…………..500mg
Excipients………………………………….q.s.
Color: Red oxide of iron
b) Cefuroxime Axetil Tablets USP 250mg
Each film coated tablet contains:
Cefuroxime Axetil USP
Equivalent to Cefuroxime ………..250mg
Excipients………………………………….q.s.
Color: Tartrazine
c) Cefuroxime Axetil Tablets USP 125mg
Each film coated tablet contains:
Cefuroxime Axetil USP
Equivalent to Cefuroxime ………..125mg
Excipients………………………………….q.s.
Color: Sunset yellow FCF
Each film coated tablet contains:
Cefuroxime Axetil USP
Equivalent to Cefuroxime…………..500mg
Excipients………………………………….q.s.
Color: Red oxide of iron
b) Cefuroxime Axetil Tablets USP 250mg
Each film coated tablet contains:
Cefuroxime Axetil USP
Equivalent to Cefuroxime ………..250mg
Excipients………………………………….q.s.
Color: Tartrazine
c) Cefuroxime Axetil Tablets USP 125mg
Each film coated tablet contains:
Cefuroxime Axetil USP
Equivalent to Cefuroxime ………..125mg
Excipients………………………………….q.s.
Color: Sunset yellow FCF
THERAPEUTIC INDICATIONS:
Cefuroxime is used to treat a wide variety of bacterial infections. This medication is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
DOSAGE: As directed by the Physician.
DOSAGE: As directed by the Physician.










