Tapentadol Extended Release Tablets Technical Specification:
| Product Name: | Tapentadol Extended Release Tablets |
| Brand Name: | Generic |
| Strength: | 50mg, 100mg, 150mg, 200mg, 250mg |
| Dosage Form: | Tablets |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 20s, 100s, 300s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP,DMF, COPP,FSC and CTD Dossier |
| Therapeutic use: | Treatment of chronic pain/Opioid receptor blocker |
| Indication: | Tapentadol Extended Release Tablets is used to relieve moderate to severe pain in adults. Tapentadol binds with certain opioid receptors to block pain signals from reaching the brain. |
| Storage: | Store at 20℃ (68 F-77 F). Excursions permitted to 15℃-30℃ (59 F-86 F) (See USP Controlled Room Temperature). Protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Tapentadol Extended Release USP 50mg Tablets
Tapentadol Extended Release USP100mg Tablets
Tapentadol Extended Release USP 150mg Tablets
Tapentadol Extended Release USP 200mg Tablets
Tapentadol Extended Release USP 250mg Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each tablet contains Tapentadol USP …….200mg
THERAPEUTIC INDICATIONS:
Tapentadol Extended Release Tablets is used to relieve moderate to severe pain in adults. Tapentadol binds with certain opioid receptors to block pain signals from reaching the brain.
CAUTION:
Keep out of reach of children.
Swallow tablet whole, do not Chew, Crush or dissolve.
STORAGE & DOSAGE:
Storage: Store at 20℃ (68 F-77 F). Excursions permitted to 15℃-30℃ (59 F-86 F) (See USP Controlled Room Temperature). Protect from moisture.
Dosage: See package insert for full prescribing information.