| Product Name: | Rifampicin + Isoniazid Tablet USP |
| Brand Name: | Generic |
| Strength: | 450mg+300mg |
| Dosage Form: | Tablets (Film coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anti-tuberculosis |
| Indication: | Rifampin and isoniazid combination is used to treat tuberculosis (TB) infection. It may be taken alone or with one or more other medicines for TB. Rifampin belongs to the class of medicines called antibiotics and works to kill or prevent the growth of bacteria. |
| Storage: | Store at 20° to 25°C (68° to 77°F). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Rifampicin & Isoniazid Tablet USP (450mg+300mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Rifampicin & Isoniazid Tablet USP (450mg+300mg)
Each Film-coated tablet contains:
Rifampicin USP…………………….….450mg
Isoniazid USP……………………………300mg
Color: Ferric Oxide Black USP-NF
THERAPEUTIC INDICATIONS:
Rifampin and isoniazid combination are used to treat tuberculosis (TB) infection. It may be taken alone or with one or more other medicines for TB. Rifampin belongs to the class of medicines called antibiotics and works to kill or prevent the growth of bacteria.
CAUTION & WARNING:
CAUTION:
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Read the enclosed leaflet before use.
Keep the 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).
Dosage: As directed by the Physician