Linezolid Tablets USP 600mg Technical Specification:
| Product Name: | Linezolid Tablets USP 600mg |
| Brand Name: | Generic |
| Strength: | 600mg |
| Dosage Form: | Film Coated Tablet |
| Route of Administration: | Via Oral Route |
| Packing: | 4s, 10s, 16s, 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, Anti-infective |
| Indication: | To treat certain serious bacterial infections |
| Storage: | Store at 20° to 25°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Linezolid Tablets USP 600mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Linezolid Tablets USP 600mg
Each Film Coated Tablets Contains:
Linezolid USP…………………..600 mg
Excipients………………….……Q.S.
Colour: Titanium Dioxide USP
THERAPEUTIC INDICATIONS:
It is used for the treatment of bacterial infections of lungs (Pneumonia), skin, soft tissues and infections that are resistant to other antibiotics.
CAUTION & WARNING:
CAUTION:
Keep medicine out of reach of children.
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); excursions permitted to 15° to 30°C (59° to 86°F). Protect from light.
DOSAGE: As directed by the Physician.
