Azithromycin Tablets USP 500mg Technical Specification:
| Product Name: | Azithromycin Tablets USP 500mg |
| Brand Name: | Generic |
| Strength: | 100mg, 250mg, 500mg |
| Dosage Form: | Film Coated Tablet |
| Route of Administration: | Via Oral Route |
| Packing: | 3s, 30s |
| 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: | Antibiotic, Antibacterial |
| Indication: | To treat a wide variety of bacterial infections |
| Storage: | Store below 30°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT
Azithromycin Dispersible Tablet 100mg
Azithromycin Tablets USP 250mg
Azithromycin Tablets USP 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
A. Azithromycin Tablets USP 500m
Each Film Coated Tablet Contains:
Azithromycin Dihydrate USP
eq. to Anhydrous Azithromycin.…………… 500mg
Excipients……………………………………..………Q.S.
Colour: Approved colours used.
THERAPEUTIC INDICATIONS:
Azithromycin is used to treat certain bacterial infections, such as bronchitis; pneumonia; sexually transmitted diseases (STD) and infections of the ears, lungs, sinuses, skin, throat, and reproductive organs.
CAUTION & warning:
Read enclosed leaflet before use
Keep this medicine out of reach of children.
Swallow the tablet with a drink of water.Do not chew or crush the tablet.
To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
STORAGE: Store below 30°C in a dry place. Protect from direct sunlight.
DOSAGE: As directed by the Physician or see package insert for full prescribing information.