Azithromycin Tablets USP 250mg Technical Specification:
| Product Name: | Azithromycin Tablets USP 250mg |
| Brand Name: | Generic |
| Strength: | 100mg, 250mg, 500mg |
| Dosage Form: | Film Coated Tablet |
| Route of Administration: | Via Oral Route |
| Packing: | 4s, 6s, 10s, 30s, 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: | Antibiotic, Antibacterial |
| Indication: | To treat a wide variety of bacterial infections |
| Storage: | Store at 20°C to 25°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 250mg
Each Film Coated Tablet Contains:
Azithromycin Dihydrate USP
eq. to Anhydrous Azithromycin.…………… 250mg
Excipients……………………………………..………Q.S.
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 and all drugs 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 at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
DOSAGE: See package insert for full prescribing information. Can be taken with or without food.