Tapentadol Extended Release Tablets Technical Specification:
| Product Name: | Tapentadol Extended Release Tablets |
| Brand Name: | Generic |
| Strength: | 50mg, 75mg,100mg,150mg, 200mg |
| Dosage Form: | Tablets (film-coated tablet) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 20s, 100s, 300s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Treatment of chronic pain/Opioid analgesic |
| 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 below 30℃, protect from Moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Tapentadol Extended Release 50mg Tablets
Tapentadol Extended Release 75mg Tablets
Tapentadol Extended Release 100mg Tablets
Tapentadol Extended Release 150mg Tablets
Tapentadol Extended Release 200mg Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated extended release tablet contains:
Tapentadol Hydrochloride IP
Eq. to Tapentadol …….75mg
Excipients……q.s.
Colour: Titanium Dioxide IP & Ferric Oxide USP-NF
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 & SCHEDULE:
Keep out of reach of children.
SCHEDULE :H PRESCRIPTION DRUG:WARNING: Not sold by retail without prescription of the Registered Medical Practitioner Only.
STORAGE & DOSAGE:
Storage: Store below 30℃, protect from Moisture.
Dosage: As directed by the Physician.