Tofacitinib Extended Release Tablet Technical Specification:
| Product Name: | Tofacitinib Extended Release Tablet |
| Brand Name: | Generic |
| Strength: | 5mg, 10mg, 11mg, 22mg |
| Dosage Form: | Film Coated Tablet |
| Route of Administration: | Via Oral Route |
| Packing: | 30s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, COPP, FSD and CTD Dossier |
| Therapeutic use: | Antirheumatic, Immunosuppressant |
| Indication: | To treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis |
| Storage: | Store at 25°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Tofacitinib Tablets 5mg
Tofacitinib Tablets 10mg
Tofacitinib Extended Release Tablet 11mg
Tofacitinib Extended Release Tablet 22mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Tofacitinib Extended Release Tablet 11mg
Each Film Coated Tablet Contains:
Tofacitinib Citrate
eq. to Tofacitinib…………11mg
Excipients……………………Q.S.
Colour: Ferric Oxide Red USP-NF
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 & WARNING:
Read package leaflet before use.
Keep medicine out of reach of children.
To be sold by retail on the prescription of Rheumatologist or specialist in Internal Medicine or Dermatologist or Gastroenterologist or Hepatologist or Orthopedician.
STORAGE & DOSAGE:
STORAGE: Store at a temperature not exceeding 25°C.
DOSAGE: As directed by the Physician.