| Product Name: | Isoniazid Tablet USP |
| Brand Name: | Generic |
| Strength: | 50mg, 100mg, 150mg, 300mg |
| Dosage Form: | Tablets (Un-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: | Isoniazid tablets are recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. |
| Storage: | Store at 20° to 25°C (68° to 77°F). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Isoniazid Tablet USP 50mg
- Isoniazid Tablet USP 100mg
- Isoniazid Tablet USP 150mg
- Isoniazid Tablet USP 300mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Isoniazid Tablet USP 50mg
Each Un-coated tablet contains:
Isoniazid USP …………………….….50mg
Excipients………………………………q.s. - Isoniazid Tablet USP 100mg
Each Un-coated tablet contains:
Isoniazid USP …………………….….100mg
Excipients………………………………q.s. - Isoniazid Tablet USP 150mg
Each Un-coated tablet contains:
Isoniazid USP …………………….….150mg
Excipients………………………………q.s. - Isoniazid Tablet USP 300mg
Each Un-coated tablet contains:
Isoniazid USP …………………….….300mg
Excipients………………………………q.s.
THERAPEUTIC INDICATIONS:
Isoniazid tablets are recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance.
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.
