Cefixime Tablets USP 400mg Technical Specification:
| Product Name: | Cefixime Tablets USP 400mg |
| Brand Name: | Generic |
| Strength: | 400mg, 200mg |
| Dosage Form: | Tablet (Film coated) |
| Route of Administration: | Via Oral route |
| Packing: | 10s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, COPP, FSD and CTD Dossier |
| Therapeutic use: | Anti-bacterial, Beta lactam antibiotic |
| Indication: | Bacterial infections of the ear, respiratory tract, throat, urinary tract biliary tract and genital tract. |
| Storage: | Store below 30°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Cefixime Tablets USP 400mg
Cefixime Tablets BP 200 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Cefixime Tablets USP 400mg
Each Film Coated Tablet Contains:
Cefixime Trihydrate USP
eq. to Anhydrous Cefixime ……400 mg
Excipients …………………………..….Q.S.
Colour: Titanium Dioxide USP
THERAPEUTIC INDICATIONS:
To treat a wide variety of Bacterial infections of the ear, nose or sinuses (such as sinusitis), urinary system (such as bladder and kidney infections), throat infections (such as tonsillitis, pharyngitis) and lungs (such as bronchitis, pneumonia).
Also effective for Typhoid (enteric) fever and Gonorrhoea.
CAUTION & WARNING:
Keep out of reach of children.
Swallow the medicine whole; do not chew/ crush.
STORAGE & DOSAGE:
Storage: Store below 30 ˚C. Protect from light and moisture.
Dosage: As directed by the Physician.