Levofloxacin Tablets USP 500mg Technical Specification:
| Product Name: | Levofloxacin Tablets USP 500mg |
| Brand Name: | Generic |
| Strength: | 250mg, 500mg, 750mg |
| Dosage Form: | Film Coated Tablet |
| 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: | Antibiotic, Antibacterial |
| Indication: | To treat bacterial infections in many different parts of the body |
| Storage: | Store at 20° to 25°C |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Levofloxacin Tablets USP 250mg
Levofloxacin Tablets USP 500mg
Levofloxacin Tablets USP 750mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Levofloxacin Tablets USP 500mg
Each Film Coated Tablet Contains:
Levofloxacin Hemihydrate USP
eq. To Levofloxacin………………….500mg
Excipients…………………………………Q.S.
Colour: Titanium Dioxide IP
THERAPEUTIC INDICATIONS:
It is used for the treatment of nosocomial pneumonia, community-acquired pneumonia, acute bacterial rhinosinusitis, acute bacterial exacerbation of chronic bronchitis, acute bacterial prostatitis, acute pyelonephritis, urinary tract infection, skin or skin structure infections, prophylaxis and treatment of plaque due to Yersinia pestis and to reduce the incidence of disease progression of inhalational anthrax.
CAUTION & WARNING:
CAUTION:
Keep medicine out of reach of children.
This drug may cause low blood sugar and mental health related side effects.
WARNING:
IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT IN ACCORDANCE WITH THE MEDICAL ADVICE.
NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.
STORAGE & DOSAGE:
STORAGE: Store at 20° to 25° (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).
DOSAGE: As directed by the Physician.