| Product Name: | Levofloxacin and Ambroxol (Sustained Release) Tablets |
| Brand Name: | Generic |
| Strength: | (250mg+75mg), (500mg+75mg) |
| Dosage Form: | Tablets (Un-coated bi-layered) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Anti-biotic, Anti-bacterial, Anti-parasitic, Anti-infective |
| Indication: | In adults for the treatment of various infections caused by susceptible bacteria, including infections of the upper respiratory tract, lower respiratory tract, skin, skin structures, urinary tract, and prostate. |
| Storage: | Store below 25°C. Protect from Light and moisture. |
Levofloxacin and Ambroxol (Sustained Release) Tablets (500mg+75mg) Technical Specification:
GENERIC NAME OF THE MEDICINAL PRODUCT:
1) Levofloxacin and Ambroxol (Sustained Release) Tablets (250mg+75mg)
2) Levofloxacin and Ambroxol (Sustained Release) Tablets (500mg+75mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Levofloxacin and Ambroxol (Sustained Release) Tablets (250mg+75mg)
2. Levofloxacin and Ambroxol (Sustained Release) Tablets (500mg+75mg)
1. Levofloxacin and Ambroxol (Sustained Release) Tablets (250mg+75mg)
Each Un-coated bi-layered tablet contains:
Levofloxacin Hemihydrate IP
Equivalent to Levofloxacin…..250mg
Ambroxol Hydrochloride IP….75mg
(In sustained release form)
Excipients………………………….…q.s
Colour: Titanium Dioxide IP
2. Levofloxacin and Ambroxol (Sustained Release) Tablets (500mg+75mg)
Each Un-coated bi-layered tablet contains:
Levofloxacin Hemihydrate IP
Equivalent to Levofloxacin…..500mg
Ambroxol Hydrochloride IP….75mg
(In sustained release form)
Excipients………………………….…q.s
Colour: Ponceau 2R
THERAPEUTIC INDICATIONS:
LEVOFLOXACIN+ORNIDAZOLE belongs to the class of ‘antibiotics’, primarily used to treat diarrhea and dysentery. It helps treat various bacterial and parasitic infections, such as pneumonia, bronchitis, intestinal, vaginal, urinary tract infections and genital infections. CAUTION & SCHEDULE:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
SCHEDULE: SCHEDULE H1: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.
It is dangerous to take this preparation except in accordance with medical advice.
STORAGE & DOSAGE:
Storage: Store below 25°C.
Protect from Light and moisture.
Dosage: As directed by the Physician.