Cefixime Dispersible Tablets 400mg Technical Specification:
| Product Name: | Cefixime Dispersible Tablets 400mg |
| Brand Name: | Generic |
| Strength: | 400mg |
| Dosage Form: | Tablet (Uncoated Dispersible) |
| 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 25°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Cefixime Dispersible Tablets 400mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Cefixime Dispersible Tablets 400mg
Each Uncoated Dispersible Tablet Contains:
Cefixime Trihydrate USP
eq. to Anhydrous Cefixime ……400 mg
Excipients …………………………..….Q.S.
Colour: Sunset Yellow FCF
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.
To be sold by retail on a prescription of Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store in a cool and dry place below 25˚C. Protect from light and moisture.
Dosage: As directed by the Physician.
Direction: Disperse the tablet in a tablespoonful of water before administration.
