Rifaximin Tablet Technical Specification:
| Product Name: | Rifaximin Tablets BP 550mg |
| Brand Name: | Generic |
| Strength: | 200mg, 400mg, 550mg |
| Dosage Form: | Tablets |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 20s, 100s, 200s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, FSC, COPP and CTD Dossier |
| Therapeutic use: | Hepatic encephalopathy/Antibiotics/Diarrhea/ bowel syndrome |
| Indication: | Rifaximin is used to treat traveler’s diarrhea that is caused by a bacteria called Escherichia coli. It is also used to prevent hepatic encephalopathy, which is a condition that occurs when your liver does not work normally. This medicine is also used to treat irritable bowel syndrome with diarrhea. |
| Storage: | Store at room temperature. Protected from light and Moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Rifaximin BP 200mgTablet
Rifaximin BP 400mgTablet
Rifaximin BP 550mgTablet
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated tablet contains:
Rifaximin BP…….550mg
THERAPEUTIC INDICATIONS:
Rifaximin is used to treat traveler’s diarrhea that is caused by a bacteria called Escherichia coli. It is also used to prevent hepatic encephalopathy, which is a condition that occurs when your liver does not work normally. This medicine is also used to treat irritable bowel syndrome with diarrhea.
CAUTION:
Keep out of reach of children.
Please see package insert for complete information.
PHARMACIST: Dispense in tight multiple- unit container as defined in USP. Bulk package not for retail dispensing.
STORAGE & DOSAGE:
Storage: Store at 20℃ to 25℃ (68 ° F to 77°F)excursion permitted to 15° to 30℃ (59° to 86°F)(See USP Controlled Room Temperature)
Dosage: See accompanying package insert for complete dosage information.