Tofacitinib Tablets 5mg Technical Specification:
| Product Name: | Tofacitinib Tablets 5mg |
| Brand Name: | Generic |
| Strength: | 5mg |
| Dosage Form: | Tablet |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 60s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antirheumatic, Immunosuppressant |
| Indication: | To treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis |
| Storage: | Store below 30°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Tofacitinib Tablets 5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Tofacitinib Tablets 5mg
Each Film Coated Tablet Contains:
Tofacitinib Citrate IP
eq. to Tofacitinib…………5mg
Excipients……………………Q.S.
Colour: Titanium Dioxide IP
THERAPEUTIC INDICATIONS:
It is used to treat moderate to severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis; helps decrease pain, tenderness & swelling in the joints by reducing inflammation and also helps to slow down the progression of bone and joint damage.
CAUTION & SCHEDULE:
CAUTION:
Keep medicine out of reach of children.
Tablet should be swallowed whole; not to be crushed or chewed.
WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF Rheumatologist or Specialist in internal medicine or Dermatologist.
STORAGE & DOSAGE:
STORAGE: Store in cool and dry place at a temperature below 30°C. Protect from light and moisture.
DOSAGE: As directed by the Physician.
